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"Online Variation Submission" User Manual ( PDF

1. Suche nach Nr oder ENR 7 1 2 AMIS variation report The AMIS variation report contains the following information The unique entry number of the medicinal product The application date freely assigned by the user The serial number default value 01 where several variations are made on one day this value always increases by 1 in each case The structure number of variation particulars from the AMIS database The structure number text The processing status The contact person at the CA An authorisation letter where relevant gt gt With the structure numbers displayed it should be noted that validation and evaluation can lead to deviations from the originally submitted variations Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 60 von 64 Seiten ROBERT KOCH INSTITUT tw he Bundesamt f r She Bundesinstitut eee gt Paul Ehrlich Institut Di D Verbraucherschutt und Te f r Arzneimittel y Pa d Lebensmiitelsicherhert und Medizinprodukte Ih medizinwiisen Ft LE XK PharmNet Bund on ce N V Online Variation Submission User manual 04 07 FHARMNET HOME PHARMNET Postfach POSTFACH ANDERUNGSANZEIGEN VOREINSTELLUNGEN LOGOUT Antragstefiei 13 04 2007 17 11 55 Zulassungsinhaber 1 2 0 build 20070412 Unternehmernummer Suche nach ENR Startdatum Es wurden folg
2. Suche nach Nr ENR SUCHEN Suche nach Sendedatum Es wurden folgende gesendete Anzeigen gefunden weitere ll 2007 09 23 2 09 384510 73 03 2007 iz07 20 20 03 2007 2007 03 20 ie TE ie mm eS A ag MET il E WERE a ki ar EE r i ae DOO DD Ge a DOODDGSZ The last column again contains an i field By hovering the mouse pointer over this field information from the AMIS database is displayed in the explanatory window including status information the contact person at the CA and where available the authorisation letter 7 1 1 1 Search for registration number or ENR The search for registration number ENR can be front masked or end masked using a Example End masking With end masking a is placed at the end of the entered sequence of digits gesendete nderungsanzeigen AMIS Anderungsanzeigen Gesendete Anzeigen Antragsteller zulassungsinhaber Pharmazeutischer Unt Unternehmernummer 0000000 125 ne mmer enr arzneimitemame oesenistam 20 04 2007 Test 4rzneimittel f r 2007 04 24 20 04 2007 Test Arzneimittel f r 2007 04 20 ray 70 04 2007 Test Arzneimittel f r 2007 04 20 2 Test Arzneimittel f r 2007 04 19 Test 4rzneimittel f r 2007 04 19 pce FURUCK WEITER The search result displays all datasets that begin with the number 000001 Notice The next version of the user manual will contain screenshots
3. p ALLE BISHERIGEN DATEN BERNEHMEN wp Mitvertreiber ge ndert in Nr 2007429 Name BFARM BUNDESINSTITUT FUER ARZNEIMITTEL UND MEDIZINPRODURTE Hersteller nicht in Katalog gefunden Bemerkung L SCHEN ZUR CKSETZEN BERNEHMEN When selecting variation particulars supported by catalogue data the available data from AMIS database will be inserted into the form For pharmaceutical companies their assigned number PNR will be displayed alongside Where there are multiple fields i e more than one dataset is available for the selected structure number the respective datasets will be displayed additionally as exemplified by the co distributor Mitvertreiber Unternehmernummer Mitvertreiber bisher PNR 4 BEIB Nr 8002429 a t Name BFARM BUNDESINSTITUT FUER ARZNEIMITTEL UND MEDIANPRODUKTE Bemerkung Za Anzahl vorhandener Datens tze Information gem der AMIS DB ALLE BISHERIGEN DATEN UBERNEHMEN The next dataset is accessed by clicking on the double arrow beside the number of datasets The last dataset is accessed by clicking on the button next to that double arrow with vertical line By clicking the button an empty field is generated in which a new dataset can be entered Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 23 von 64 Seiten ROBERT KOCH INSTITUT ns H Bundesamt fir the Bundesinstitut i
4. As with the national procedure a confirmation dialogue will then be displayed Once this is confirmed the data are submitted definitely Note In the first phase there is a strict interpretation of the Variation Regulation with reference to the resulting conditions and documentation in such a way that in accordance with the selected main and consequential changes these are automatically attached to the variation If in individual cases not all conditions and documentations can be fulfilled then the remarks field can be used to provide information regarding which conditions and documentations are not fulfilled In this case the variation form which is submitted to the BfArM can be amended to accommodate the changes in the remarks field If the remarks field does not contain any information the variation is to be submitted unchanged Documentation Further documenta yes no Windows Internet Explorer 3 The notification will mow be submitted Soe EEEE EE Would you like to continue Die G allgeme en Anzeigeverfa ki Abbrechen e Commission Regulation 5 Remark lf the data has been successfully transmitted the user will receive a confirmation message and can print out the document Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 52 von 64 Seiten ROBERT KOCH INSTITUT Bundesamt h r the Bundesinstitut 2 Paul Ehrlich Instit
5. Paul Ehrlich Institut F I Verbraucherschutz und EY N f r Arzneimittel KL ip reer tu Sara nad npn i k meditinw Lian Lebensmiitelsicherhert und Medizinprodukte 4 N PharmNet Bu nd m h Online Variation Submission User manual 04 07 Mitvertreiber neuen Datensatz hinzuf gen Mitvertreiber bisher Datensatz 1 von 4 TA Nr 8002429 Ti 1 F IN _ s BFARM BUNDESIN n chsten Datensatz anzeigen Bemerkung letzten Datensatz anzeigen TIP Where there are numerous datasets users are recommended to call up the structure number in the Entering Data step and then to generate a status report Consideration should be taken of the fact that the data for the individual structure numbers will only be inserted following the initial call of the corresponding tab in the status report In the status report all datasets are displayed together enabling a swift and easy determination to be made as to whether the Current data corresponds with the user s own records Following the check the user can return to the structure number in order to proceed with processing If the Current data are correct the required change can be carried out in the lower part of the form depending on the individual case either by Overwriting the dataset with a new one in the example a co distributor is cancelled and a new one takes its place Inserting a new dataset in the example an additional co distributor is added
6. ROBERT KOCH INSTITUT Bundesamt h r the Bundesinstitut 4 Paul Bhrlich Institut DIMI 63 Vorbraucherschulz und T f r Arzneimittel IK N Sa acienared K Senn enh kenne medizinwiise Lebensmittelsicherhert und Medizinprodukte PharmNet Bund ur oo V Online Variation Submission User manual 04 07 5 aes Upload Titel Wahlen Sie die hochzuladende Datei von Ihrem Rechner aus rtf pdf C Dokumente und Einstellungen homkigene Vateien Camtasia Studio Deskts Durchswwchien ZUR CKSETZEN DATEI SENDEN Once a file is selected in order to allow verification it will be displayed together with the file path If the correct file has been selected it will be attached to the variation on the PharmNet Bund server by choosing Submit file If a file has been chosen by mistake the selection can be Cancelled Following completion of the upload the file will be displayed with the new system allocated name 1 and the original name 2 with or without the file path depending on the presettings chosen Clean a 4 20070419211555 cv rtf T Original C Dokumente und Einstellungen horn Eigene Dateien Camtasia 1 Studio Desktop Test rtf 9 By clicking on the hyperlink 3 the file can be opened on the PharmNet Bund server by selecting the bin 4 the file can be deleted again from the server Clean Version i Dokumente und Wiretap genthorn cigene Dateien Camtasia 3 Studio Desktop Test rtf A Note
7. 1 SUBMIT NOTIFICATION ee Datum der Anzeige Nefarenca FREFERENDES LOGOUT Reference to activity fo From 12 24 2007 21 8 FA Fike number 1 2 8 build 20070255 Bezug herstellen remark Contaci Person kontaktperson Name ser Hann beim Phone 0222 2307332 E Mail hom hn da Sey oF hie Dayer Sheel 1 Son Hama Puer harn As with national variations the details of the contact person are populated with the data of the presettings or data from a master copy template The details for the first signatory in the Sign of the Cover Sheet area are obligatory At Mode of Process select the second option for European variations and then select an ENR that is valid for BfArM Antragsteller Sign of the Cover Sheet Sign Name Muster Mann Sign Place Bonn I Sign Function xyz Sign Name Sign Place Sign Function Please determine the mode of process and select the drug for which the changes shall be notified Mode of Process Please determine n of Changes pursuant to 529 AMG Notification of Changes pursuant to Variation Regulation ENR Please specify the ENR of the drug for which the changes shall be notified ENR SELECTION L Show open notifications of change for the specified ENR These details are entered into the variation form by clicking on Next Notice The next version of the user manual will contain screenshots and explanations in English It will be publi
8. are included where applicable Summary of Product Characteristics pload file s Choose the document type of the upload file Clean Version Germ Clean Version Engl Highlighted Version Germ Highlighted Version Engl Change Index Germ Change Index Engl Choose a file for upload from your computer rtf pdf O Labelling L Package leaflet insert O Mock ups O Specimens 6 2 6 Status of variation As with national variations with European variations users have the option of generating a status report at any time The report here is in two parts The variation form in Word 2003 format and the cover letter in pdf format which contains all other important information in particular details of the uploaded documents Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 48 von 64 Seiten eye ROBERT KOCH INSTITUT ns ES Bundesamt f r She Bundesinstitut x gt Paul Ehrlich Institut D Verbraucherschutz und E fir Arzneimittel p f q aniani Kin Fen und ee Lebensenitelsicherheit und Medizinprodukte h 1 Ta medizinwinson d Pi PharmNet Bund Online Variation Submission User manual 04 07 1 Basics 3 Changes 4 Var Data tatus Submit 30 04 2007 10 00 27 Notification Status of Variation WICHTIG Bitte kontrollieren Sie vor dem Senden noch einmal genau Ihre Angaben Nach erfolgreicher bertragung
9. INT PharmNet Bund on ee N JEL Online Variation Submission User manual 04 07 6 2 7 Submit variation Before the variation can be submitted the user has to complete specific declarations with respect to the variation Submit DOOCDDODS Variation Notification Submit Notification Declaration of the Applicant for Type IA or Type IB I hereby submit a notification for the above Marketing Authorisation to be varied in accordance with the proposals given above I declare that Please tick the appropriate declarations There are no other changes than those identified in this application except for those addressed in other variations submitted in parallel such parallel variations should be specified under Other Application s The change s will not adversely affect the quality efficacy or safety of the product All conditions as set for the notification s concerned are fulfilled The required documents as specified for the notification s concerned have been submitted Where applicable national EMEA fees have been paid This notification has been submitted simultaneously in RMS and all CMSs for products within the Mutual Recognition Procedure or both to EMEA and Rapporteur only for products within the Centralised Procedure Change will be implemented from Next production run next printing d Date The information regarding the signatory is taken by the tool from the master information Signatory Fe
10. If a structure number is deselected during the generation of a variation where an upload has already been processed the file will then be deleted automatically from the PharmNet Bund server Upload structure numbers are often consequential changes There is an option to mark SKNR not relevant for the current variation here as well In the Remarks field a plausible reasoning should be inserted This information will be appended to the variation by clicking on Accept i gh RT Matrice eee s ZUR CKSETZEN DATEI SENDEN ZUR CKSETZEN BERNEHMEN Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 22 von 64 Seiten ROBERT KOCH INSTITUT Bundesamt Mir the Bundesinstitut Faul Ehrlich Institut DIMI 63 Vorbraucherschulz und TS f r Arzneimittel cA N e e Eu Kan seed kenne medizinwinien Lebensentelsicherheit und Medizinprodukte d A 4 PharmNet Bund Online Variation Submission User manual 04 07 6 1 5 3 Forms with catalogue support Pharmaceutical companies This form type is assigned to all structure numbers for which information is stored in catalogues made available by the CAs For example this may be information about pharmaceutical companies pharmaceutical forms and the type of application Mitvertreiber Mitvertreiber bisher EEB Nr 2007429 Name 1 BFARM BUNDESINSTITUT FUER ARZNEIMITTEL UND MEDIZINPRODUKTE Bemerkung
11. The MAH will therefore also receive a status report in the same way for conventional variations 8 Support In addition to this manual users are also provided with other forms of assistance or these will be added shortly Suggestions for the improvement of the application will be noted and included into the application development process Updates on the PharmNet Bund homepage will inform users about new or changed functionalities Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 61 von 64 Seiten so ROBERT KOCH INSTITUT DID BP Netvrevcherschute uns BE fr arnein EX Se Lebensenitelsicherheit und Medizinprodukte i Ti TEN Le medizinwinien d 4pharmNet Bund Online Variation Submission User manual 04 07 8 1 Online support At various places within the application itself under Explanations on the right of the screen there are notes on how to use the application correctly Kooperation im Geschaftsbereich des FR Bundesministerium dy fiir Gesundheit CH N PharmNet Bund PHARMNET HOME Bearbeiten Sie eine PHARMNET gt gt gt nderungsanzeigen gt gt gt Arbeitskorb ERLAUTERUNG Anderungsanzeige indem Sie entweder eine noch Arbeitskorb nicht gesendete Anzeige NDERUNGSANZEIGEN 4 Anderungsanzeigen in nderungsanzeigen in Arbeit Arbeit ausw hlen oder ARBEITSKORB 9 g eine neue Anzeige VOREI
12. persons authorised by it i e the CAs do not have any access to data and documents that have not yet been sent 4 The Submit procedure makes the data available to the CAs by means of the import application 5 The CAs collect the data and integrate it within their own independent data systems Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 4 von 64 Seiten ROBERT KOCH INSTITUT Bundesamt fur Bundesinstitut S Paul Ehrlich Institut DI D W Verbraucherschwli und he f r Arzneimittel PX Trana Bar Garn una leprae L in Lebensmittelsicherheit und Medizinprodukte TE Le 4 ih harmNet Bund Online Variation Submission User manual 04 07 3 Registration The Registration tool is an independent application and is not part of the Online Variation Submission product Information on registration is made available on the BfArM homepage for example 4 Screen Layout 4 1 Start screen The navigation is arranged with various logical aspects and a repetitive structure so that it can be used intuitively The pages have both a header and footer with the logos of PharmNet Bund and the institutions contributing to PharmNet Bund Under the header on the right there is a link to the contact form which enables users to ask questions to the Helpdesk about applications at PharmNet Bund The left margin is where the navigation bar is located
13. there are differences due to the different legal basis and the mandatory European form To comply with published requirements and guidance documents two types of documents are generated 1 The fully completed variation form 2 The cover letter to the CAs with the necessary additional information In contrast to the national variations and the cover letter both of which are generated as a pdf document the European variation form is produced in Microsoft Word format compatible with the 2003 version and later This enables the user who employs Word for the online application with the BfArM generated form to use it for other participating countries too If no further processing is planned the document can be opened and printed out with the Word 2003 Viewer available free of charge The Variations menu is displayed in English only At present when the European Variation procedure is selected the navigation switches automatically from German to English The application will soon be enhanced to permit user language select from the very outset PHARMNET HOME PHARMNET Notification of change gt gt Basic Data EXPLANATION et ask Area 1 Basics BEER 3 4 Submit NOTIFICATIONS OF CHANGE TASK AREA 00000516 29 03 2007 07 50 11 Notification BASIC DATA BASIC DATA VARIATION Basic Data VARIATION CHANGES Title of notification 29 03 2007 07 51 1 VARIATION DATA Dte notification of change 01 04 2007 STATUS OF VARIATION
14. Deleting an existing dataset in the example a co distributor is cancelled In principle the respective pharmaceutical company can be selected in two ways 1 If known the PNR can be entered directly 2 Alternatively under Name the first letters in this case of the pharmaceutical company can be entered The catalogue displays all entries with this combination of letters The required company can be selected by mouse click Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 24 von 64 Seiten ROBERT KOCH INSTITUT a he Bundesamt fir the Bundesinstitut Paul Ehrlich Institut i oh Kerbraucherschwi und TS fiir Arzneimittel 3 MIX Basata Ux Sans nh haian medizinwiise Lebensnmtelsicherheit und Medizinprodukte A I 4 Ion Za i PharmNet Bund np u gt UN Online Variation Submission User manual 04 07 ALLE BSHERIGEN DATEN BERNEHMEN Eingabe der fertin Bu Eingabe der ersten En Buchstaben des pU Nr 002429 il Name 2 BFARM BUNDESINSTITUT FUER ARZNEIMITTEL UND MEDIZINPRODUKTE _ Hersteller nicht in Katalog gefunden Bemerkung LOSCHEN ZURUCKSETZEN BERNEHMEN If entries in the catalogue are very similar following selection the mouse can be hovered over the i field to display the complete address in a pop up Deletion of a dataset is carried out by selecting the required dataset and clicking the Delete button
15. Info rmati onen linke Navigation gesendete Anzeigen auflisten 4 2 Further basics of navigation The navigation bar changes as the processing progresses at the same time the central area is organised into a tab structure During processing the navigation can be controlled using either the tabs or the navigation bar on the left It is not required that users work through the tabs from left to right or the navigation bar from top to bottom Users can at any time move back to change the entries made previously A status report can also be generated at any time displaying the current status of the variation Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 5 von 64 Seiten Bundesamt fir the Bundesinstitut l 2 pauk Erri N ne w F I Varhraucherachutt und AY f r Arzneimittel TX A medizinwinne Lebensnmtelsicherheit und Medizinprodukte ty Le Y PharmNet Bund Tin Ni Online Variation Submission User manual 04 07 FHARMNET HOME FHARMNET nderungsanzeigen Auswahl des Anderungstatbestandes POSTFACH ANDER UNGSANZEIGEN ARBEITSKORB 00000651 13 04 2007 15 26 3 STAMMDATEN DER ANZEIGE AUSWAHL DES ANDERUNGSTATBESTANDES EINGABE DER DATEN STATUS DER ANZEIGE SENDEN DER ANZEIGE As arule entries are confirmed at the bottom of the page fields such as Next Accept Submit data Various basic functions are provi
16. RA en l Lebensmittelsicherheit und Medizinprodukte x gt Le medizinwissen d N 4pharmNet Bu nd Online Variation Submission User manual 04 07 The package sizes can be entered as free text and a grading from N1 N3 can be added Further information can be added to the Peculiarities line and the Remarks field The Remarks field is particularly to be used for information on the primary packaging if the medicinal product is authorised with different types of primary packaging e g blister packs and glass bottles 6 1 5 7 Shelf life form In the shelf life form the entry stored in AMIS is represented by means of a logical structure The value of the shelf life is specified as a 3 digit number and then connected to a unit by means of the appropriate button nderung der Dauer der Haltbarkeit des Arzneimittels und Ergebnisse von Haltbarkeitsversuchen Par 22 1 14 Dauer der Haltbarkeit bisher Wert der Dauer O03 Einheit der Dauer Tagfe G Wochein Monate Jahre O Stundein O Minutetn ae 2 nichts zutreffend Neue Einheit Bemerkung ALLE BISHERIGEN DATEN BERNEHMEN p Dauer der Haltbarkeit ge ndert in Wert der Dauer O03 eye Je let IDEEN Te Mn Ben a e ee D ey ey i IY a Pe TUT mu a 52 a ay T a a TN I ey a Ty i in en If the shelf life cannot be represented using the units on offer this form type enables other units to be entered Minutetn J nichts zutreffend w
17. Sendedatum 2007 04 19 5 Arzneimittelname gesendetam oases eases s h te ni Tel IE C sso e ter Is Tell IE EEE resa En Fe re JB E aber FURUCK The matching data are displayed Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon D w E Bundesamt fir She Bundesinstitut D Vorbraucherschuir und 4 f r Arzneimittel Lebensnitelsicherheit und Medizinprodukte medizinwinien WEITER ROBERT KOCH INSTITUT ea x IK Seite 58 von 64 Seiten Ehrlich i amp erie cS 4 N N PharmNet Bund m 7 Ta Online Variation Submission User manual 04 07 gesendete Anderungsanzeigen EIEE ni eae EEEn Gesendete Anzeigen Antragsteller zulassungsinhaber Pharmazeutischer Unternehmer Mustermann Unternehmernummer 0000000 Suche nach Sendedatum SUCHEN 1 Ser Test Arzneimittel f r EN 2 aall Test rzneimittel f r 2007 04 19 U ars ZUR CK WEITER Suche nach Nr oder E ha Date searches may also be end masked gesendete Anderungsanzeigen WERTEN Gesendete Anzeigen Antragsteller Endmaskierung Zulassungsinhaber BfArM Burfere Terre erer Medizinprodukte Unternehmernummer 8002429 i Suche nach Nr oder ENR i SUCHEN Suche nach Sendedatum 2007 04 27 Bean BI U E Ba ee Nr CS Arzneimitismame oesendstem Testarzneimittel D 10 26 04 2007 3 2
18. Underneath the navigation bar on the left there is a date stamp which displays the time of the last activity performed by the user Below the date stamp there is the version number and the date of the last update of the displayed page in this case the Task Area page In the centre is the actual task area frame On the right hand side there is the Explanations panel This panel provides users with additional information Kooperation im Geschaftsbereich des OAD Renee PharmNet Bu zum N VL PENOREENGNG Kontaktformular PHARMNET gt gt gt nderungsanzeige n gt gt gt Arbeitskorb Bearbeiten Sie eine POSTFACH nderungsanzeige indem Arbeitskorb Sie entweder eine noch nicht ANDERUNGSANZEIGEN gesendete Anzeige Anderungsanzeigen in ARBEITSKORBt w Anderungsanzeigen in Arbeit Arbeit ausw hlen oder eine neue Anzeige entweder als VOREINSTELLUNGEN keine Anzeigen in Arbeit leeres Formular oder unter OGOUT Verwendung einer L U gespeicherten Vorlage erstellen 19 04 2007 51 11 Neue Anzeige 1 2 0 build 28070412 Au erdem k nnen Sie bereits gespeicherte Vorlagen bearbeiten oder l schen leeres Formular Anzeige mit folgendem Titel kopieren ANZEIGEN AUFLISTEN Ihre Eingabe wird automatisch endmaskiert Sie k nnen weitere Maskierungen durch das Symbol vornehmen Verwaltung von Vorlagen neue Vorlage erstellen keine Vorlagen gespeichert weitere Gesendete Anzeigen
19. als eingereicht SENDEN DER ANZEIGE STATUS DRUCKEN VOREINSTELLUNGEN LOGOUT Anzeige a von nderungen nach 829 und oder 105 1 2 5 Bull EFi U Arzneimittelgesetz Nummer der 00000005 Anzeige Tital dar An nirnn o 1 The user can print out the form at any time in order for example to conduct internal company discussions or obtain other contributions etc If the status report is generated before submission some details will be missing which are contained in the clean copy following submission This is intended to prevent the mistaken submission of drafts as originals Drafts do not have a sent date a signature line a barcode the info box whether other documentation has been submitted with the paper version or the organisational unit in the address of the CA gt gt Drafts moreover have the watermark DRAFT Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 32 von 64 Seiten gt i REF ROBERT KOCH INSTITUT he Bundesamt f r he Bundesinstitut gt Faul Ehrlich Institut Verbraucherschut und f r Arzneimittel Me ely er zur ut imene Lebersnittelsicherheit und Medizinprodukte S one medizinwinsen 4 pharmNet Bund T Mi Online Variation Submission User manual 04 07 Platz f r BfArM Eingangssternpel An das Bundesinstitut f r Arzneimittel und Medizinprodukte Kurt Georg Kiesinger A
20. and explanations in English It will be published soon Seite 56 von 64 Seiten DIMNI Bi Ben OK Sy mean Lebensmittelsicherheit und Medizinprodukte E meditinwissen Fu Le 4 N PharmNet Bund _ Online Variation Submission User manual 04 07 m 7 W ko n yy Antragsteller ulassungsinhaber Pharmazeutischer Unternehmer Mustermann SUCHEN Suche nach Sfadedatum we LS ena arzneimiteinsme oesengetam 00000109 elm 02 a Test Arzneimittel f r 2007 04 74 i Example Both front and end masking With front end masking the sequence of digits is bracketed with two SUCHEN gesendete nderungsanzeigen Wee eE e EEEE Gesendete Anzeigen Antragsteller Ziffer 4 Front Endmaskierung Zulassungsinhaber Bf rM Bundesinsteut f Unternehmernummer 8002429 i Suche nach Nr oder ENR SUCHEN Suche nach Sendedatum SLICHENPY a ee ke Be Testarzneimittel D 10 26 04 2007 2007 04 26 ae 00000298 7 7 42 18 1998986 mg ml Pulver und E L sungsmittel Testarzneimittel A 10 B 26 04 2007 2007 04 26 le Iooonnzos 25 04 20 le f mi Pulver und IR ee la Im The search result displays all medicinal products which have this number sequence in the registration number orthe ENR Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 57 von 64 Seiten ROBERT KOCH INSTITUT ns ES Bundesa
21. application is launched 2 Basic Principles 2 1 Legal basis Variations for national approvals are to be submitted to the national licensing authorities For approval on a purely national level the applicant must notify the CA without delay pursuant to 29 Abs 1 AMG by providing the appropriate documentation where there are changes to the product information and documentation as defined by 22 to 24a and 25b Following the issue of the Marketing Authorisation the Marketing Authorisation Holder MAH must comply with this obligation In regard to changes of national authorisations which are issued by means of the mutual recognition procedure MRP or the decentralised procedure DCP the provisions of the Commission Regulation EC 1084 2003 apply Use of the Online Variation Submission application is currently voluntary because the submission of an electronic application is not required by either the AMG or the AMG e Submission Ordinance AMG EV Since the current registration procedure does not yet satisfy the requirements of the German Signature Law the following documentation must also be submitted to the CAs in paper along with the electronic submission when using the online application Variation form generated automatically by the application Expert reports regulation from the AMG eSubmission ordinance Product information where the variation content is not adequately described in the variation form Use
22. are very pleased to present the Online Variation Submission application the first phase of the Pharmnet Bund de Electronic Application Filing Module The Online Variation Submission application provides both the pharmaceutical industry and the CAs with a highly modern safe and reliable method for the electronic submission of national variations pursuant to 29 German Drugs Law AMG and European variations according to Regulation 1084 2003 EC to www pharmnet bund de Please take the time to familiarise yourself with the various functions described in this manual The Online Variation Submission application enables pharmaceutical companies both to create national variations in accordance with 29 German Drugs Law AMG and European variations pursuant to Commission Regulation EC 1084 2003 using the data stored with the Competent Authorities CAs and also to submit these generated variations directly to the CAs As with any software the Online Variation Submission application is undergoing continual development The version that is presented here supports the functions described in this manual This development phase moreover has seen the adoption in the planning process of other functions for future extension of the application These other upgrades of the Online Variation Submission application and the extension to cover other types of applications such as Marketing Authorisation Applications are planned for the time immediately after the
23. by entering the current one Kooperation im Geschaftsbereich des FR Bundesministerium f r Gesundheit 4 T Phi PharmNet Bund PHARMNET HOME PHARMNET gt gt gt Voreinstellungen ERLAUTERUNG VOREINSTELLUNGEN Passwort LOGOUT 14 02 2007 16 17 16 unter Ihrem Usercode zus tzlich zu sch tzen 1 0 2 build 20070214 Definieren ndern Sie hier ein Passwort maximal 16 Stellen um den Zugang Bei allen folgenden Dialogen ist der Zugang nur m glich wenn Usercode und Passwort eingegeben werden Altes Passwort Neues Passwort Neues Passwort best tigen DATEN SPEICHERN ABBRECHEN The Task List The task list gives the user access to all the important functions to begin processing Variations in process New variation Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 8 von 64 Seiten ROBERT KOCH INSTITUT Bundesamt fir Bundesinstitut Paul Ehrlich Institut DIMI W Vorbraucherschutz und MR f r Arzneimittel EK N Lebensenitelsicherheit und Medizinprodukte 3 k medizinwinno A a 4 A pharmNet Bund m u Online Variation Submission User manual 04 07 Template administration Submitted variations PHARMNET Anderungsanzeigen Arbeitskorb Arbeitskorb Anderungsanzeigen in Arbeit keine Anzeigen in Arbeit Neue Anzeige G leeres Formular Verwaltung von Vorlagen neue Vorlage erstellen k
24. der 4nderungsanzeige gilt die nderungsanzeige als eingereicht erzeugt Entwurf des seins PRINT STATUS PDF Yariation Formulars Pee Variation Nummer der Anzeige Titel der Anzeige Datum Anderungsanzeige Sendedatum der Anzeige Zulassungsinhaber Unternehmernummer Online Usernurnrmer PEAS BfArM Online Username Bezug Bezug auf Yorgang worn Aktenzeichen Bemerkung Ansprechpartner The two documents are generated by clicking on the respective fields Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 49 von 64 Seiten ROBERT KOCH INSTITUT Bundesamt fir Bundesinstitut Faul Ehrlich Institut tat Verbraucherschut und MR f r Arzneimittel EK Lebensenitelsicherheit und Medizinprodukte 3 Ty gt one medizinwinien ONG pi N lt PharmNet Bund An das Bundesinstitut f r Platz f r BfArM Eingangssternpel Arzneimittel und Medizinprodukte an FG11 Kurt Georg Kiesinger Allee 3 D 53175 Bonn Nummer der Anzeige Titel der Anzeige Datum Anderungsanzeige sendedatum der Anzeige Zulassungsinhaber Unternehmernummer Online Usernummer Online Username Bez uc Bezug auf Vorgang yom Aktenzeichen Bemerkung Ansprechpartner Name Telefon E Mail Angaben zum Arzneimittel Arzneimittelbezeichnung Darreichungsform Variation 00000397 30 04 2007 10 00 27 30 04 2007 Fharmazeu
25. following information The automatically assigned registration number in the form of a unique identifier The title freely assigned by the user The unique entry number of the medicinal product ENR The name of the medicinal product as defined in AMIS database The date of submission The variation form and for European variations the additional cover letter gt gt For filtering the listings two options are available 1 Search for a registration number or ENR By entering the first digits of the registration number or ENR the variations can be filtered for the relevant entry 2 Search for submission date The required variations can be searched by entering a specific submission date Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 55 von 64 Seiten ROBERT KOCH INSTITUT Bundesamt hur Bundesinstitut E Paul E riich Institut rT W Vorbraucherschuir und MR f r Arzneimittel Me q Durnas ha Gare imi enprns Lebensmittelsicherheit und Medizinprodukte S one medisinwinsen d A PharmNet Bund Online Variation Submission User manual 04 07 PHaR MANET Post ach ERLAUTERUNG a EHR Oll amp sie N gi ner ta 1 kingei i el D22E ANDERUNGSANZEIGEN Gesendete Anzeigen Antragsteller Baschaid MM 13 04 2007 14 29 01 Zulassungsinhaber 1 2 0 build Z0070412 Untemehmemummer VOREINSTELLUNGEN
26. has similar functionalities as the type Form with catalogue support for pharmaceutical companies but is adapted to meet the requirements for displaying parallel import countries Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 27 von 64 Seiten ROBERT KOCH INSTITUT ns H Bundesamt fir the Bundesinstitut Paul Ehrlich Institut D dh Kerhraucherschwi und dd f r Arzneimittel es IK q Burma Ku Fea vi rpm Lebensentelsicherheit und Medizinprodukte h meditinwissen A PharmNet Bund an a _ sia Online Variation Submission User manual 04 07 30 04 2007 09 77 74 Anzeige Parallelimportlander zus tzlich Parallelimporte bisher Staat Packungsgr e zul Datum EMR AM Bezeichnung im Ausland Staat nicht in Katalog gefunden Bemerkung No ALLE BISHERIGEN DATEN BERNEHMEN fe By entering a letter in the Country line the country catalogue is opened from where the user can select the required country ALLE BISHERIGEN DATEN BERNEHMEN fe Parallelimporte ge ndert in ci ae Staat qg i GA GABUN ah GAMBIA GE GEQRGIEN GH GHANA Gl GIBRALTAR GD GRENADA GRIECHENLAND GROENLAND Ss LIE RONLAND GP GUADELOUPE Packungsgr e zul Datum MR AMl Bezeichnung im Ausland Staat nicht in Katalog gefunden Bemerkung Note Even though the catalogue provides a
27. i Reference SUBMIT NOTIFICATION PREFERENCES Reference to acl Benutze f hrung LOGOUT from in Englisch File number 01 04 2007 14 26 05 1 1 0 build 20070307 Remark 6 2 1 Task Area frame The Task Area contains the same functions as the national variations that have been described above 6 2 2 Master data As with national variations a European variation can also be assigned a user defined title and a submission date This is done by overwriting the default title title date stamp date current date with which the variation is generated There is also the option of referring to a former submission or activity Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 37 von 64 Seiten ROBERT KOCH INSTITUT u he Bundesamt fur the Bundesinstitut i D PE Verbraucherschwii und TS fiir Arzneimittel cK D Lebensentelsicherheit und Medizinprodukte medizinwinne Faul Ehrlich Instituf amp kavia al mei P apno T Le A 4 A 4pharmNet Bund A Online Variation Submission User manual 04 07 PHARMAET HOHE PHARMAET ee Nohheaten of change gt Bari Ota Ed WST BOK HOTIFICATIONS OF CHANGE 1 Tasis WR GOODS 19 08 S007 21 20 09 BASIS DATA BASIC DATA YASLATIOR Basic Data Titel der Anzeige ie ee Tide of nobecabon ie 2023 03 JVARLATIEN DATS ii Gate nobficaton of STATUS OF WARLATION change
28. large number of countries the general rules as to which countries are authorised for parallel imports also apply to Online Variation Submission as well Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 28 von 64 Seiten ROBERT KOCH INSTITUT Bundesamt fir Bundesinstitut Faul Ehrlich Institut tat Verbraucherschut und MR f r Arzneimittel EK Lebensenitelsicherheit und Medizinprodukte 3 Ty gt one medizinwinsen d A PharmNet Bu nd Online Variation Submission User manual 04 07 Ny ALLE BISHERIGEN DATEN BERNEHMEN fr Parallelimporte ge ndert in al Staat EL GRIECHENLAND Packungsgr e zul Datum EMR AM Bezeichnung im Ausland Staat nicht in Katalog gefunden Bemerkung L SCHEN ZUR CKSETZEN BERNEHMEN This form type also allows a free text entry where the required State is not stored in the catalogue WisStaat nicht in Katalog gefunden ogtext Bemerkung 6 1 5 6 Package size form The package size form largely corresponds with the functionalities of the Form with catalogue support type Package sizes do not comprise a catalogue so that entries are performed using free text In addition a grading of N1 to N3 can be entered using the appropriate radio button This entry will not be assessed within the terms of the variation and is added only as additional information Notice The next version of th
29. the AM number is four digit with the number of the strength and the serial number of the variation to be entered in three digit format Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 39 von 64 Seiten gt i REF ROBERT KOCH INSTITUT he Bundesamt f r he Bundesinstitut gt Faul Ehrlich Institut Verbraucherschut und f r Arzneimittel Me ely er zur ut imene Lebersnittelsicherheit und Medizinprodukte S one medizinwinsen PharmNet Bund Tin A Online Variation Submission User manual 04 07 POST BOX S Submit NOTIFICATIONS OF CHANGE 00000006 19 04 2007 21 28 08 TASK AREA Notification BASIC DATA bernahme nach Auswahl Type of Application BASIC DATA VARIATION Basic Data Variation ERAN General Information Part I HUMAN METERINARY VARIATION DATA STATUS OF VARIATION SUBMIT NOTIFICATION L NATIONAL AUTHORISATION IN MRP variation number PREFERENCES O COMMUNITY AUTHORISATIO LOGOUT Be l EMEA variation number EMEA 19 04 2007 21 30 27 C NATIONAL AUTHORJSATION ONLY 1 2 5 build 20070420 A Reference Member manuelle DAT O BE O BG O CY O Cz O DE O DK Eingabe oder Oea OFfR O Ol Os OF Ow Ow OMT ONL O NO OPL OPT O SI O SK O UK ber Kopier Vorlage vorbelegt Concerned Member State s Ll Al II BE LI BS CL CY Li cz 0 Be LC DE LFES I ee ee ee ee Se ae CL LU CJ L
30. 007 04 26 St 10000298 node 1998986 mg mi Pulver und sn m L sungsmittel Testarzneimittel 4 10 26 04 2007 2007 04 26 oo000 96 10 56 37 1999069 mg mil Pulver und 11 00 17 978 L sungsmittel Testarzneimittel E 10 26 04 2007 i 2007 04 26 DOOM LT e ees 1998963 mg mi Pulver und en col L sungsmittel SSS BB he ch al gt SSS aT All variations which match the search profile are listed By entering 2007 04 for example all variations from April 2007 will be listed Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 59 von 64 Seiten i zosia ROBERT KOCH INSTITUT w he Bundesamt f r She Bundesinstitut Paul Ehrlich Institut Vorbraucherschuir und 4 f r Arzneimittel EK q Durenan ia Gars i kepre Lebensentelsicherheit und Medizinprodukte f ks T Le medisinwinsen d N A PharmNet Bu nd Online Variation Submission User manual 04 07 gesendete Anderungsanzeigen AMIS nderungsanzeigen Gesendete Anzeigen Antragsteller ulassungsinhaber EfArM Bundesinstitut fuer Arzneimittel und Medizinprodukte Unternehmernummer 8002429 Suche nach Sendedatum Testarzneimittel C 10 00000041 OML 9 1935992 mg ml Pulver und L sungsmittel Testarzneimittel D 10 12 028 2007 04 20 00000024 e noe 1998986 mg fl Pulver und 13 45 45 199 L sungsmittel Testarzneimittel B 10 ee ae
31. A a Lebensnitelsicherheit und Medizinprodukte medizinwiasen Paul Ehrlich Institut ra Le 4 N PharmNet Bu nd Online Variation Submission User manual 04 07 Entries made in this way are not automatically added to the respective catalogue during the processing these will be assessed by the CAs and added to the catalogue as appropriate 6 1 5 4 Form with catalogue support Pharmaceutical form The pharmaceutical form has similar functionalities as that for pharmaceutical companies As only one pharmaceutical form is permissible in each case there are no functions for adding further datasets or for switching between several datasets 30 04 2007 09 46 54 Anzeige Bezeichnung der Darreichungsform Darreichungsform bisher Darreichungsform 048 Filmtablette d Darreichungsform nicht in Katalog gefunden Bemerkung W ALLE BISHERIGEN DATEN BERNEHMEN fe Darreichungsform ge ndert in Darreichungsform 048 Filmtablette Darreichungsform nicht in Katalog gefunden Bemerkung L SCHEN ZUR CKSETZEN BERNEHMEN By using the mouse to click on the pharmaceutical form field the catalogue is opened This displays all entries that contain the term entered as a word By clicking on one of the terms displayed anew pharmaceutical form can be selected Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 26 von 64 Se
32. ANDERUNGSTATBESTANDES Bezeichnung des Arzgeimi EINGABE DER DATEN Text bisher Test Arzneimittel f Bemerkung STATUS DER ANZEIGE Variation particulars that have not yet been processed are identified by an empty box a variation particulars that have been processed are marked with a green tick in a green box b The change is carried out in the usual way by clicking on Next Accept Submit data etc buttons at the bottom of the page Test Arzneimittel f r Muster 6 1 5 Partial forms In the Online Variation Submission application all the variation particulars are assigned to defined partial forms which are equipped with various functions Available partial forms 1 Free text form Upload form Forms with catalogue support Package size form Shelf life form oh ge ey 6 1 5 1 Free text form Unstructured data may be entered in the free text fields Provided that data are available in AMIS for the selected variation particular e g for the name of the medicinal product the data will be automatically entered into the forms in the Current text and Text changed to fields If no corresponding data are stored in the AMIS database in relation to the variation particular the form remains empty Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 18 von 64 Seiten sO ROBERT KOCH INSTITUT ne he Bundesamt fir She Bundesinstitut D One Werbraucher
33. Anzeige 007 0402 13 17 1290 Zulsssungzinhaber Fharmaszeuischer Untemehmer Mustermann Ihterehrnernurnmer 0000000 Colne Usermunimer FERIEN re ra Le Et Aatz t r Btarkt Eingangssteripe An ker Bundesinstitut f r Arzneimittel und Medizinprodukte an A311 Kuteorg Kesinger Allee 3 D 53175 Bonn rslon enthalt zusatzliche lagen im Vergleich zu den eingereichten Unterlagen von nderungen nach 28 undfoder 105 Arzneimittelgesetz Mumme der Anzeige Le Tita der Anzeige Han z Datum Andsungsanzeige 02 04 2007 Sendedaium der Anzeige 2007 O 02 13 44 02642 dulassungsinhaber Fhamszeuischer Unternehmer Mustermann Intenehrnermursener 0000000 Cnling Leemurnmmer PEAS Online Leemare Muster Mann Eszug Bezug auf Vorgang yon Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 36 von 64 Seiten Ep ROBERT KOCH INSTITUT tw he BL the Bundesinstitut j Paul Ehrlich Institut Di D vie Vorbraucherschuir und Liv f r Arzneimittel OK Durasa ir Sara urd brprnis Lebensmiitelsicherhert und Medizinprodukte medizinwissen j N LE INT PharmNet Bund on ee N JEt Online Variation Submission User manual 04 07 6 2 European variations according to Regulation 1084 2003 EC The generation of European variations with the Online Variation Submission application follows the same principles as purely national variations By necessity
34. Clicking on Accept will add the data to the variation If corrections need to be made to the Current data this is carried out in a similar way as above except current data cannot be deleted directly by using a button If one or more too many datasets are displayed in Current data the entry must be removed e g with select and cut transferred to the remarks field and a brief reasoning must be entered as per usual Note Where current data are changed before entering the actual change the current data must be transferred to the lower part of the form i e the data must be synchronised in advance This is done by activating the Transfer all current data button wy ALLE BISHERIGEN DATEN BERNEHMEN wy If the required entry is not available in the catalogue the user has the option of selecting the Entry manufacturer in this case not found in catalogue check box and adding a free text entry Depending on the structure number selected further documentation may be required e g Certificate of Registration Certificate of Suitability etc Mir E EPI F E TI bF r EEE TEE T EEE ee TEE a ee ee in _ Hersteller nicht in Katalog gefunden Berfekkung L SCHEN Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 25 von 64 Seiten ROBERT KOCH INSTITUT w E Bundesamt fiir She Bundesinstitut D Worbraucherschutz und Te f r Arzneimittel t c
35. KOOPERATION IM GESCHAFTSBEREICH DES A Bundesministerium 4 N 7 PharmNet Bund ui ONLINE VARIATION SUBMISSION USER MANUAL CONTENTS 1 Introduction 2 2 Basic Principles 2 2 1 Legal basis 2 2 2 Technical principles 3 sean t Version 0 7 44 5 Updated 04 05 2007 4 2 Further basics of navigation 5 5 Presettings 6 PORN 5 1 Variations in progress 9 SEA gaan 5 2 New variations 10 Submission 5 3 Template administration 10 Dr Michael Horn 5 4 Sent variations 11 BfArM 6 Generation of Variations 11 lassnas 6 1 National variations according to 29 German Drugs Law 11 SO 6 1 1 Master data of the variation 1 gt i 11 a A 6 1 2 Selecting variation particulars 2 15 a 6 1 3 Deleting variation particulars 17 93175 Bonn 6 1 4 Data input 3 17 Tel 49 1888 307 4332 6 1 5 Partial forms 18 horn bfarm de 6 1 6 Status of the variation 32 6 1 7 Submitting the variation 33 6 2 European variations according to Regulation 1084 2003 EC 37 6 2 1 Task Area frame 37 6 2 2 Master data 37 6 2 3 Variation master data 39 6 2 4 Variation changes 42 6 2 5 Variation data 45 6 2 6 Status of variation 48 6 2 7 Submit variation 51 7 Virtual Mailbox 54 7 1 Structure 54 7 1 1 Submitted variations report 54 7 1 2 AMIS variation report 60 7 2 Status information 61 8 Support 61 8 1 Online support 62 8 2 FAQs 62 8 3 Users forum 62 8 4 Helpdesk 62 4 A PharmNet Bund Online Variation Submission User manual 04 07 1 Introduction We
36. N Speichung von Pfadangaben Adress nderung C Adressdaten ndern Personliche Angaben andern Passwort Passwort definieren ndern E Passwort ndern Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 7 von 64 Seiten ROBERT KOCH INSTITUT Bundesamt fir Bundesinstitut Paul Ehrlich Institut DT oR Verbraucherschutz und oR f r Arzneimittel OK eat Soren ts Son et cree Lebensmittelsicherhert und Medizinprodukte g A medizinwinien PharmNet Bund Tin A Online Variation Submission User manual 04 07 Registration information can be updated in the Address change field Mandatory fields are indicated by an asterisk The mail address recorded here will be used for communications via the mailbox mails automatically dropped when there is a change in status GCcviggeeecetinne on Ian ll f Merian iun Ur onune PharmNet Bund SS a 77777 u 4 2t g 4 iiher rate ipres upar i s pati t d Aupa ai vw Epa Nachname Wannen Firma tta tie Pannat Lae Zusatz Stra e Haus Nr Kamp eng A gt nderung der PLZ Ort em dem Kontaktinformationen Postfach PLZ Postfach Nr band I Telefon ma mare Fax u ur E Mail Adresse Sapia W ee sR ee Pflichtfelder sind mit einem Deisy mams i o en eee ee Me 4 In the Password field a new password can be set
37. N PharmNet Bund HER er Vs sia Online Variation Submission User manual 04 07 lf similar variations are frequently needed all the relevant elements can be copied into a template and this can be retrieved when required All master data for variations need only be entered once Created templates can also be changed or deleted at any time Once templates have been created theycan be selected under New variations as well 5 4 Sent variations By using the Sent variations options all variations sent to the CA will be listed Gesendete Anzeigen O gesendete Anzeigen auflisten 6 Generation of Variations 6 1 National variations according to 29 German Drugs Law 6 1 1 Master data of the variation 1 Selecting New variations and clicking on Next will open the Master data window The line highlighted in colour under the tabs contains the following information Unique identification number of the variation in this case 00000004 Procedure in this case zero because this procedure will first be assigned at a later stage Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 11 von 64 Seiten ROBERT KOCH INSTITUT Bundesamt f r the Bundesinstitut gt Faul Ehrlich Institun DIMI ad Verbraucherschulz und TS fiir Arzneimittel i CX q en Seen ed ees medizinwinne Lebensmittelsicherheit und Medizinprodukte en vl 4 d A PharmN
38. NSTELLUNGEN keine Anzeigen in Arbeit LOGOUT _ POSTFACH entweder als leeres 4 Formular oder unter Verwendung einer Neue Anzeige eri D pa ieee D OF als is Feat peer yon el C neue Vorlane erstellen gespeicherten Vorlage erstellen Au erdem k nnen Sie bereits gespeicherte vorlagen bearbeiten oder l schen 82 FAQs Updated answers to frequently asked questions are displayed both on the BfArM homepage and in the future on the PharmNet Bund homepage FAQs supplement the information contained in this manual and will be incorporated into future versions of this manual 8 3 Users forum Plans are in place to set up a users forum in the coming months at PharmNet Bund de to provide users with an extra information resource and forum for the exchange of ideas etc 8 4 Helpdesk For any problems that may arise with the application the Helpdesk can be contacted by means of the contact field which is available on every page of the application Clicking on Contact creates an email for asking the question Attachments can also be added Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 62 von 64 Seiten ROBERT KOCH INSTITUT ns H Bundesamt fir the Bundesinstitut i Paul Ehrlich Institut Di D ore Verhraucherschulz und G f r Arzneimittel 0 CX Fis Sarg ed kenne Lebensmiitelsicherher
39. V CJ MT J NL J NO J PL J PT L SI CL SK LJ UK O NONE Tvne of Annlication For Type Il variations the selection must be specified in greater detail Type of Application er L Type IB O Type I O Safety C Indication Condition indication listed in the Human Register of designated Orphan Medicinal Products O Yes O No O following Urgent Safety Restriction Spezifizierung Quality einer Typ ll LJ Other Variation Annual variation for human influenza vaccines General Information Part I Invented Name Test Arzneimittel fur Muster Eingabe der Strength s 2 a Arzneimittel bezeichnung Pharmaceutical form s aA Active substance s mit amis Daten Substance 1 IE n vorbelegt Acetylsalicylsaeure Ph Eur Substance 2 Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 40 von 64 Seiten ROBERT KOCH INSTITUT a Bundesamt fir She Bundesinstitut i i Paul Ehrlich Institut DI Di Verbraucherschiig und f r Arzneimittel OK N el ln Lebensenntelsicherheit und Medizinprodukte N medizinwinien Tu A 4 N PharmNet Bu nd 7 Online Variation Submission User manual 04 07 6 2 3 2 General Information Part Il In the General Information Part Il area specific details on the company and the medicinal product are entered The name of the medicinal product and of the active pharmaceutical ingred
40. aluation of the Package Leaflet the Summary of Product Characteristics Fachinformation and the Labelling Provided that the document type relating to the selected structure number is defined by default particularly the Package Leaflet the Summary of Product Characteristics Fachinformation and the Labelling document file names will be created by the system according the AMG eSubmission Ordinance during the Submit procedure IF the document type is not pre defined e g expert reports the area Further upload is to be used and where available the document naming convention from the explanatory notes on the AMG eSubmission Ordinance or from Table of the element of files names see implementation of the AMG eSubmission Ordinance at www bfarm de is to be used at the beginning of the file name e g gos 001 Free text qts Free text qws Free text In case of Package Leaflet Summary of Product Characteristics Fachinformation and Labelling the original and the newly created file names will be stated in the form As described in the Presettings section the sender has the option to include into or omit the original file path from the file name Attachment of files is carried out by clicking on the Browse button selecting the respective file from the user s own local file system Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 21 von 64 Seiten
41. and parallel variations is to be entered Submit OOOOO00S Vanation Notification Variation Dat aration Data Kurzdarstellung laufender bzw paralleler Verfahren Other Application s Please provide brief info vanation s submitted st parallel or renewal appli ey or line extension s Test Daten 1 Scope Please specify scope of the change s in a concise way Test Daten 2 Kurzdarstellung des Rahmens der Anderungen The scope of the planned change is briefly stated and where necessary distinguished from other variations Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 45 von 64 Seiten ROBERT KOCH INSTITUT Bundesamt f r Bundesinstitut Paul Ehrlich Institut DIMI W Verbraucherschuts und w f r Arzneimittel EK Lebensmiitelsicherhert und Medizinprodukte 1s A medizinwirion LE 4 4 pharmNet Bund Ve Online Variation Submission User manual 04 07 TIP For open variations the report in Step 1 can be used as the current information source for selecting the medicinal product and the procedure nr m u mm m o m n s n s mem lL ENR 1393023 ENR SELECTION i show onen notifications of change for the specified ENR A brief justification is then given for the planned changes including the consequential changes and the proposed changes are entered verbally A document ca
42. auswahlen hs The upload is displayed in the form with the title freely assigned by the user in this case Title 1 the name assigned by the system and the original name either with or without the file path depending on the presettings selected The uploaded document can be viewed by clicking on the system name or deleted by clicking on the bin Change to Module 4 Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 44 von 64 Seiten ROBERT KOCH INSTITUT ns H Bundesamt f r the Bundesinstitut gt Paul Bhrlich Institut D ir Verbraucherschwis und T f r Arzneimittel 5 MX eee fe Sn es Lebensmittelsicherheit und Medizinprodukte i u x meditinwissen y d Pi PharmNet Bund Online Variation Submission User manual 04 07 Choose the document type of the upload file 11 Upload Title Titel 1 _I2 Upload Title 13 Upload ne C14 Upload 15 Upload s Title Systemname der Datei Choose 4 A upload from your computer rei pdf Durchsuchen 4 Titel 1 20070430100748 m upla rtf T Orginal CA Dokumente und Einstellungen horn Eigene Originalname Dateien C amtasia Studio Desktop ea Test rth der Datei hier i SUBMIT FILE inkl Pfad SUBMIT FI 6 2 5 Variation data In the fourth step the information specific to the procedure will be entered According to the Notice to Applicants a brief summary of the open
43. can be deselected in a similar manner as they were selected Clicking the previously selected check box in the Variations particulars tab again will deselect this variation particular This change of the variation particulars is then accepted by clicking on Next Individual variation particulars may be deleted at any time of the user s choice prior to submission i e the user always has the option of returning to the Variations particulars tab Structure numbers of consequential changes cannot be deleted as long as the main variation particular remains selected If the user considers these structure numbers not to be relevant for his or her specific variation the option exists to notify the CA by marking SKNR not relevant for the current variation 6 1 4 Data input 3 To enter the contents of the variation the left hand navigation bar is expanded to include the selected structure numbers and placed in tab form in the task area frame Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 17 von 64 Seiten ROBERT KOCH INSTITUT Bundesamt f r the Bundesinstitut 2 Faul Ehrlich Institun DIMI i Verbraucherschuiz und FR f r Arzneimittel i CX ely ert medizinwiise Lebensnmtelsicherheit und Medizinprodukte XK PharmNet Bund on ce N V Online Variation Submission User manual 04 07 POSTFACH ANDERUNGSANZEIGEN ARBEITSKORB STAMMDATEN DER ANZEIGE AUSWAHL DES
44. ded 1 Radio buttons By using a radio button a single choice is selected The last selected button will normally be marked Neue Anzeige gres Formular 2 Check boxes Check boxes differ from radio buttons in that several choices can be selected or in some cases no entry needs to be made at all 217 Angaben und Pr fung 0204 Angaben und Unterlagen zur ana 3 Information field i field The i field can be activated to obtain additional information by hovering the mouse pointer over the field without clicking the left or right stems buttons Bi 4 Transfer all current data In various forms the data currently stored in AMIS will be transferred to the y ALLE BISHERIGEN DATEN BERNEHMEN W current and future text fields of the forms If the current data do not correspond with the data held by the company the data can be changed When changing these current but apparently incorrect data the user should insert an explanation as to why he or she thinks the discrepancy has arisen e g see variation dated xxx into the remarks field Before the intended changes are performed the changed current data should be transferred again Note Correcting the current data does not automatically update the AMIS database The changed information will be submitted along with the variation and during processing at the CA a check will be performed to see if an error has indeed occurred Where necessary the staff of t
45. e user manual will contain screenshots and explanations in English It will be published soon Seite 29 von 64 Seiten ROBERT KOCH INSTITUT ed he Bundesamt h r the Bundesinstitut 2 Faul Ehrlich Institun I Verbraucherschwiz und EY N f r Arzneimittel y CX ey reer tr Sara nt npn Lebensnittelsicherheit und Medizinprodukte s 1 Fu a medi Ei wiiion PharmNet Bund Cx A Online Variation Submission User manual 04 07 30 04 2007 09 2 7124 Packungsgr e Zustimmungspflichtig Packungsgr e bisher Packungsgr e OP10 Einstufung CO Ni O N2 O N3 nichts zutreffend Besonderheiten Bemerkung ALLE BISHERIGEN DATEN BERNEHMEN fe Packungsgr e ge ndert n Packungsgr e OP10 Einstufung O Na O N2 O Na nichts zutreffend Besonderheiten Bemerkung L SCHEN ZUR CKSETZEN BERNEHMEN Clicking on the button allows other package sizes to be displayed No ALLE BISHERIGEN DATEN BERNEHMEN fr Packungsgr e ge ndert n lt lt BE Packungsgr e OP 20 Einstufung O N1 O N2 Na nichts zutreffend Besonderh n Bemerkung L SCHEN ZUR CKSETZEN BERNEHMEN Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 30 von 64 Seiten ROBERT KOCH INSTITUT Bundesamt fir Bundesinstitut PFaul Ehrlich Institun rn he Werbraucherschutz und oR fur Arzneimittel SMDK
46. ed the data are sent definitely Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 34 von 64 Seiten ROBERT KOCH INSTITUT Bundesamt fir Bundesinstitut Faul Ehrlich Institut rn Verbraucherschutz und MR f r Arzneimittel OK ely ee at rt rpm Lebensmittelsicherheit und Medizinprodukte gt Le medisinwinsen XK PharmNet Bund on ee N vo Online Variation Submission User manual 04 07 Senden der Anzeige Dokumentation Mit der Papiervers reicht i Windows Internet Explorer x nein Ihre Anzeige wird nun bertragen Wallen Sie fortfahren Oo Allgemeine Nutz tktronischen ons gemab Die Gallgemei Anzeigeverfah Commission Re Bemerkung BERNEHMEN ENDEN If the data have been successfully sent the user will receive a message confirming the action with the option of printing the message PHARMNET gt gt gt nderungsanzeigen gt gt gt Senden der Anzeige 00000005 Senden der Anzeige Ihre Anzeige wurde erfolgreich bertragen Sie k nnen nun eine druckbare Version Ihrer Daten pdf Format anfordern DATEN DRUCKEN Depending on whether additional documentation is to be submitted with the paper version the variation is presented differently 1 If no further documentation is to be submitted the form will have a green framed info box with a notice indicating that t
47. eine Vorlagen gespeichert Gesendete Anzeigen O gesendete Anzeigen auflisten WEITER 5 1 Variations in progress With the Variations in progress field users are given a list of all the variations which have been started but not yet submitted to the CA Saving of the variations is carried out automatically Processing can be interrupted at any time Data loss will not occur This allows variations to be recommenced at a later time The task list always displays the last 5 variations If more that 5 are open another field is displayed which shows all the variations currently in progress In order to continue with the processing of a variation the required variation is selected followed by a clicking on Next located at the bottom of the task list If a variation already commenced is no longer needed it can be completely deleted by selecting the Delete variation command Anderungsanzeigen in 4rbeit 00000057 14 02 2007 11 43 44 00000055 14 02 2007 11 18 49 ANDERUMGSANZEIGE L SCHEN Note If several users are working under one ID one PNR it is recommended that the variations be labelled with a clear title e g beginning with the initials of the respective user It may also make sense to incorporate other information into the title because these variations can be used at a later time as master copies for subsequent variations Notice The next version of the user manual will contain screenshots and explanations in Engl
48. el Neue Einheit ogtext Bemerkung Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 31 von 64 Seiten ROBERT KOCH INSTITUT a he Bundesamt fir She Bundesinstitut 2 Paul Ehrlich Institut D PE Werbraucherschwii und TS fiir Arzneimittel i MX rege Ee San ad es Lebensmittelsicherheit und Medizinprodukte i u x medizinwinien m FA PharmNet Bund a ch N vo si Online Variation Submission User manual 04 07 6 1 6 Status of the variation Preparing a national variation or a European variation the user can at any time display a status report This is generated in real time online in each case and will contain the entries made up until the particular point in time Variation particulars will be included in the report following the initial click in the Entering data step For national variations the report corresponds to the later form and offers a good overview of the current status PHARMNET HOME PHARMNET gt gt gt nderungsanzeigen gt gt gt Status der Anzeige POSTFACH 2 Arbeitskorb 2 Anderungen NDERUNGSANZEIGEN ARBEIT SKORB 00000005 Anzeige STAMMDATEN DER ANZEIGE AUSWAHL DES Status der Anzeige NDERUNCS i N 2 aac Mn ze WICHTIG Bitte kontrollieren Sie vor dem Senden noch einmal genau Ihre EINGABE DER DATEN Angaben Nach erfolgreicher bertragung der nderungsanzeige gilt die ee Anderungsanzeige
49. en ENR offene ungsanzeigen f r gew hlte ENR anzeigen The purpose of the Variations status report is primarily to support quality assurance On the one hand it is made certain that variations are not submitted repeatedly on the other hand a warning is given that due to open variations the AMIS data does not correspond with the documentation of the MAH This should be considered prior to correcting the current data see above Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 14 von 64 Seiten ROBERT KOCH INSTITUT Bundesamt fir Bundesinstitut PFaul Ehrlich Institun rT he Werbraucherschutz und oR fur Arzneimittel SMDK RA en Lebensmittelsicherheit und Medizinprodukte x gt Le medizinwinsen PharmNet Bund in XA Online Variation Submission User manual 04 07 2 nderungen Sachstand Anderungsanzeigen Antragsteller Zulassungsinhaber Pharmazeutischer Unternehmer Mustermann Unternehmernummer 0000000 zu der von Ihnen gew hlten ENR wurden folgende nderungsanzeigen gefunden die bei der Bundesoberbeh rde noch nicht abgeschlossen sind ee NS sknntem stand Dj iene Jfanceben der ci gem sine L235 ZUR CK WEITER 6 1 2 Selecting variation particulars 2 Following the switch from the master data to the variation particulars the user assigned title and variation type is shown in the line highlighted
50. en der Anzeige POSTFACH 5 _ Arbeitskorb 1 Stamm 2 Anderungen 3 Daten Senden NDERUNGSANZEIGEN CEL ARBEITSKORB 00000005 Test 1 STAMMDATEN DER aldai ANZEIGE AUSWAHL DES Senden der Anzeige NDERUNGSTATBESTANDES Dokumentation EINGABE DER DATEN STATUS DER ANZEIGE Mit der Papierversion werden weitere Dokumentationen eingereicht O ja lt SENDEN DER ANZEIGE nein VOREINSTELLUNGEN LOGOUT Allgemeine Nutzungsbedingungen Tye allgemeinen Nutzungsbedingungen des BfArM zum 19 04 2007 21 19 42 1 2 5 build 20070420 ktronischen Anzeigeverfahren f r Anzeigen nach 829 AMG owie Variations gem Commission Regulation EC 1084 2003 werden akzeptiert Bemerkung BERNEHMEN The user must also indicate acceptance of the General Terms and Conditions of Use By clicking on the link the user can read the current Conditions of Use and print these out if required Only once these have been accepted the Submit button is activated and the variation can then be sent Allgemeine Nutzungsbedingungen Y Die F allgemeinen Nutzungsbedingungen des BfArM zum elektronischen Anzeigeverfahren f r Anzeigen nach 529 AMG sowie Variations gem Commission Regulation EC 1084 2003 werden akzeptiert Bemerkung BERNEHMEN After clicking on Submit a confirmation dialogue is displayed asking if the user does indeed intend to submit the variation If this is confirm
51. ende AMIS nderungsanzeigen gefunden Antrags ENR Brief Nr SENR SENA Text Stand datum eo Nichtwirksame Bestandteile nach __ 20030718 Io o054 es as Beanstandung The search function corresponds to that of the Submitted variations report except that the date is entered with the following format yyyymmdd i e without a hyphen 7 2 Status information The following status messages are available Submitted The electronic variation was successfully transmitted to the CA Received The paper version has been received by the CA In progress The validation has been completed The variation has been transferred for assessment This status change is accompanied by assignment of a contact person End of procedure positive The variation procedure was positively completed End of procedure negative The variation procedure was negatively completed Objection An objection was raised with respect to the variation Withdrawal of the variation The variation was withdrawn by the applicant gt gt Positive decisions for electronically submitted variations will be sent via the virtual mailbox only in cases of no authorisation letter by registered mail or instruction on right to appeal as required by law Note The AMIS variations report also includes conventionally posted variations These paper based variations will be included into the report only after a status change relevant for the mailbox
52. enshots and explanations in English It will be published soon Seite 20 von 64 Seiten mn ROBERT KOCH INSTITUT tw he Bundesamt f r She Bundesinstitut 3 Faul Ehrlich Institut Vorbraucherschuir und Ir f r Arzneimittel EK q Draai La Sira wpa knpn l Lebensenitelsicherheit und Medizinprodukte i 1 TEN Le medizinwinsen d 4pharmNet Bund Online Variation Submission User manual 04 07 Angaben der GI gem Par 11 AMG Datei Upload Wahlen Sie den Dokumenttyp der hochzuladenden Datei aus Clean Version 1 Basistpyen f r bekanntes Highlighted Version U ploadobjekt Anderungsindex Bilddatei 1 weiterer Upload Titel 2 weiterer Upload gt 2 freier Upload 3 weiterer Upload Titel O 4 weiterer Upload Titel O 5 weiterer Upload Titel Titel sofern vorhanden mit Wahlen Sie die hochzuladende Datei von Ihrem Re AMG EV k rzel beginnen ZUR CKSETZEN DATEI SENDEN f r die vorliegende 3 Abwahl einer SKNR sofern f r die Anzeige nicht erforderlich Bemerkung ZUR CKSETZEN BERNEHMEN In contrast to the previous email procedure here the option of uploading several documents for one structure number exists e g SKNR 0039 change of the invented name consequential change SKNR 1002 change of the package leaflet It is therefore highly recommended to upload a clean version for the later release to the public and a highlighted version for the ev
53. es paid if applicable Amount Please specify fee category under National Community rules Orphan Drug fee exemption granted attach feg Notification of the competent authority a Main Signatory Status Job title xyz Frint name Muster Mann Date A 19 04 2007 Second Signatory Status Job title Print name Date Finally as with the national variations it must be noted whether other documentation will accompany the paper version The General Terms and Conditions of Use must be accepted Further explanations for the BfArM may also be entered The variation can then be submitted Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 51 von 64 Seiten ROBERT KOCH INSTITUT ns ES Bundesamt fir She Bundesinstitut i Paul Ehrlich Institut DI N verbraucherschug und f r Arzneimittel EK q re Lebensentelsicherheit und Medizinprodukte TE My meditinwisen A pharmNet Bu nd 3 Online Variation Submission User manual 04 07 Documentation Further documentation will be filed with paper version Notwendige yes Zusatzangaben f r das no BfArM Terms and conditions Die allgemeinen Nutzungsbedingungen des BfArM zum elektronischen Anzeigeverfahren f r Anzeigen nach 529 AMG sowie Variations gem Commission Regulation EC 1084 2003 werden akzeptiert M glichkeit f r weitere Erlauterungen fHinweise
54. esse Anrede Elektronische ees Anderungsanzeige E Mail ausw hlen Thema is Elektronische nderungsanzeige EN Oh website Meldungsnummer Betr e angeben Nachricht Anliegen exakt schildern und ggf Telefonnummer angeben Etat tne Eingaben l schen Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 64 von 64 Seiten ROBERT KOCH INSTITUT w he Bundesamt f r She Bundesinstitut Paul Ehrlich Institut DI D FR Vorbeaucherschutz und aS f r Arzneimittel Y PaA Lebensmiitelsicherhert und Medizinprodukte 3 1 aiiai FI Le
55. et Bund Online Variation Submission User manual 04 07 PHARMMNET HOME FHARMNET Anderungsanzeigen Stammdaten der Anzeige POSTFACH ANDERUNGSANZEIGEN ARBEITSKORB pears STAMMDATEN DER ANZEIGE ee Stammdaten der Anzeige LOGOUT 19 04 2007 21 04 47 19 04 2007 21 04 47 Datum Anderungsanzeige 19 04 2007 1 2 5 build 20070420 Bezug ggf Bezug Bezug auf Vorgang herstellen vom Aktenzeichen Bemerkung Ansprechpartner Ansprechpartner Name Marier Hamn gem ie Telefon 0228 2074332 Registrierung E Mail hom bfam de Beneath the heading Master data of the variation the variation can be assigned to a freely selectable title Below this a date of the variation can be freely assigned However the date should not be later than the planned submission date 00000004 NULL Stammdaten der Anzeige Test 1 Datum nderungsanzeige 19 04 2007 In this screen a reference can be noted to another concrete procedure In addition a contact person must be named for this variation procedure By default the fields will be populated with the data stored under the presettings or those from a selected template or master copy The name s location and function of the subsequent signatory ies are then entered The entries for the first person are mandatory fields those for the second person are optional By selecting the procedure there is a separation between either a national variation or a variatio
56. f Contact During variation procedure Company name Contact name Muster Mann Address Address addition eco Nummer gem europ ei Regeln anpassen Country Telephone number 0228 2074332 Fax number E mail Kornabfarn de After completion variation Company name Contact name Address Address addition zipcode City Country Telephone number Fax number E mail Applicant s reference TIP Due to the large amount of data to be entered manually in the General Information Part Il it is strongly recommended that company specific templates are prepared in advance If a variation has already been generated for a medicinal product by this software tool this can then be used as a master copy for subsequent variations 6 2 4 Variation changes Irrespective of whether the variation is a Type IA IB or a Type II variation in the next step the user is presented with the catalogue of minor changes or with the form for major changes 6 2 4 1 Type IA and IB variations The catalogue for minor changes contains all 46 positions for main changes and consequential changes If the Type IA is selected then the IA options are made available both for the main change and for the consequential changes For Type IB changes the IA options are inactivated for the main changes For the consequential changes both types are available for selection Notice The next version of the user manual will contain screenshots and explana
57. h LE i S pharmNet Bund u 7 ko n Online Variation Submission User manual 04 07 upload file s Choose the document type of the upload file Clean Version Germ Clean Version Engl Highlighted Version Germ Highlighted Version Engl Change Index Germ Change Index Engl Choose a file for upload from your computer rtf pdf Durchsuchen SUBMIT FILE In the Annexes area the decision is made as to which part of the product information will accompany the variation To do so the required check box is clicked Annexes The following amended product information text proposals Annexes are included where applicable J Summary of Product Characteristics LSLabelling L Package leaflet insert O Mock ups O Specimens BACK NEXT By clicking on SPC for example a further check box is displayed with which the upload window can be opened Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 47 von 64 Seiten JBER Mi T ne he Bundesamt fir She Bundesinstitut ne eee bie D werbaucherschuti und E g f r Arzneimittel p d Lebensmiitelsicherhert und Medizinprodukte medizinwiasen S Erler TS Le 4 AN 4pharmNet Bund 7 hy en Online Variation Submission User manual 04 07 Annexes The following amended product information text proposals Annexes
58. hat data has been successfully submitted 2 If additional documentation is to be submitted the info box will be framed in red Depending on the particular case an organisational unit will be included in the address of the CA The original variation has the watermark FINAL Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 35 von 64 Seiten ROBERT KOCH INSTITUT ns ES Bundesamt fir She Bundesinstitut se Faul Ehrlich Institui Di D Vorbraucherschutz und f r Arzneimittel EK q Tareas ir Sarn und npr Lebensenitelsicherheit und Medizinprodukte k meadizinwiirion A PharmNet Bund Cu _ Online Variation Submission User manual 04 07 lt is important to state expressly that no subsequent changes must be made to the variation except the handwritten signature The user has agreed to accept this and the other conditions of using this procedure by his or her confirmation of the General Terms and Conditions of Use te En wird Hatz f r Pfrkt Eingangs stempel An her Bundesinstitut fir Arzneimittel und Medizinprodukte an 214 Kurttaaorg KiesingerAllaa 3 D 53175 Bonn Paplerversion ohne weitere Unterlagen im Vergleich zu den elektranisch eingereichten Unterlagen Anzekje von Anderungen nach 28 und oder 105 Arznaim ittalgasatz Hurn der Anzeige EEE Ener Tita der Anzeige Hon 1 Daim Andsungsanzeige 02 04 2007 Serdedatur der
59. he CA will then correct the data in the AMIS database 5 Presettings By clicking on Presettings below the task list on the navigation bar on the left the user can set various preferred settings for the application Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 6 von 64 Seiten w he Bundesamt f r he Bundesinstitut Paul Ehrlich Institut Di D Vorbraucherschutz und TS 1 f r Arzneimittel OK Burma Kin Set ed cies Lebensnittelsicherheit und Medizinprodukte j 3 meditinwissen TE Le d N 4 PharmNet Bund Online Variation Submission User manual 04 07 NK to u PharmNet Bund S PHARMNET HOME ANDERUNGSANZEIGEN ARBEITSKORB VOREINSTELLUNGEN PHARMNET gt gt gt nderungsanzeigen gt gt gt Arbeitskorb Arbeitskorb Anderungsanzeigen in Arbeit C 00000057 14 02 2007 11 43 44 eer C 00000056 14 02 2007 11 18 49 1 0 2 build 20070214 ANDERUNGSANZEIGE LOSCHEN Neue Anzeige leeres Formular Anzeige mit folgendem Titel kopieren das Symbol vornehmen am i PH ANZEIGEN AUFLISTEN Ihre Eingabe wird automatisch endmaskiert Sie k nnen weitere Maskierungen durch Kooperation im Geschaftsbereich des FR Bundesministerium f r Gesundheit ERL UTERUNG Bearbeiten Sie eine nderungs nzeige indem Sie entweder eine noch nicht gesendete Anzeige Anderungsanzeigen in Arbeit ausw hlen oder eine
60. ients are taken from AMIS and added to an empty form The Strength and Pharmaceutical form s fields are mandatory and must be completed manually Due to the structuring of the product name into three parts i e Invented Name Strength and Pharmaceutical form the name of the medicinal product cannot currently be displayed directly from AMIS This information must be distributed among three fields for the complete description to be displayed under the Invented Name The active pharmaceutical ingredients are taken from AMIS as is the German marketing authorisation number Ma numberts 19990230000 w aus AMIS bernommen Name and address of MA holder Company name Address Address addition zipcode City Country The other data are to be entered appropriately Where necessary the telephone number must be amended in accordance with the European Guidelines this should thus be carried out in the presettings The data entry is confirmed by clicking on NEXT Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 41 von 64 Seiten ROBERT KOCH INSTITUT Bundesamt fir the Bundesinstitut 2 Faul Ehrlich Institun DIMI 63 Kerbraucherschwi und TS fiir Arzneimittel E cA p q eee Ee Fag h ces medizinwiise Lebensnmtelsicherheit und Medizinprodukte A IM A d A pharmNet Bund Online Variation Submission User manual 04 07 Name and address o
61. ikationen betreffend Informationstexte nach 22 Abs 7 AMG Packungsgr e Beh ltnis Parallelimport Pharmakovigilanz Pharmazeutische Unternehmer Mitvertreiber Hersteller Adresse Risikoangaben in Informationstexten Zusammensetzung Darreichungsform Anwendung betreffend HH HH HH Hr Hr Hr Hr ALLES AUFKLAPPEN ALLES ZUKLAFPEN AUSWAHL ANZEIGEN WEITER Regardless of whether the variation particulars selected manually or according to category depending on the main variation consequential changes will be displayed These proposed consequential changes will primarily ensure that the variation is complete This pre selection of the variation particulars does not relieve the MAH of the responsibility of stating a full description of the planned changes with documentation The proposed consequential changes are for support purposes only Auswahl des Anderungstatbestandes per Kategorie Anlass der nderung erg nzende Angaben o Bezeichnung des Arzneimittels 1002 Angaben der GI gem Par Li AMG 1064 Angaben auf Beh ltnis gem Far i0 AMG gaben auf auberer Umh llung gem Par 10 AMG Angaben nach Paragr Lis Fachinformation Dokumentati g betreffend T Haltbarkeit beth voraussichtliche Herstellung Analytik Kontrollmethoden spei Folge nderungen Informationstexte nach 22 Abs 7 AMG EEE To improve the overview the selection of variation particulars on the basis of categories offer
62. in colour Stamm a Anderungen 3 Daten Status Senden 00000005 Auswahl des Anderungstatbestandes Angaben der Stamm Informationen wurden bernommen Direkte Auswahl des Anderungstatbe SKNR Mehrere SKNR sind mit Semikolon zu Areusmbl Arm fades thant da mae bw oe The variation particulars can be selected in two ways 1 Manual entry of the structure number SKNR The currently valid SKNR lists are published on the BfArM homepage 2 Selection of variation particulars according to category Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 15 von 64 Seiten ROBERT KOCH INSTITUT ne he Bundesamt fir he Bundesinstitut DI nl Vorbraucherschwis und ee EK Lebensenittelsicherheit un izinprodukte k i medizinwinien Yme Le amp rie LNA PharmNet Bund ae BD N V Online Variation Submission User manual 04 07 Arbeitskorb 00000003 Anzeige Auswahl des Anderungstatbestandes Direkte Auswahl des Anderungstatbestandes per SKNR SKNR Auswahl der Mehrere SKNR sind mit Semikolon zu trenng Anderungstatbestande Auswahl des Anderungstatbestandes per Kategorie Anlass der nderung erg nzende Angaben Besondere Informationstexte erg nzende Angaben Bezeichnung Dokumentation betreffend Haltbarkeit betreffend Herstellung Analytik Kontrollmethoden Spezif
63. in screenshots and explanations in English It will be published soon Seite 63 von 64 Seiten ROBERT KOCH INSTITUT u piet ine al he BL the Bundesinstitut ps Di DI Vorbraucherschutz und 7 f r Arzneimittel SH DK Lebensentelsicherheit und Medizinprodukte Vu A medicine Lian PharmNet Bund Tin Ni Online Variation Submission User manual 04 07 a What sequence of actions was performed b Screenshots of the displays the error messages etc 4 Where there are technical problems information on what browser incl version is to be used for example Users can also click on the Contact button outside the Online Variation Submission application to open a contact form that likewise enables questions to be asked regarding the application Kooperation im Gesch ltsbenesch des f ANZA Ae Bundesministerium U or f f r Gesundheit HOME CLINICAL TRIALS PharmNet Bund ELEKTRONISCHE ANDERUNGSANZEIGEN Elektronische Anderungsanzeige ist ein Teilprojekt der elektronischen Antragsstellung das in seiner Endausbaustufe der Art ragsstellu ng an die Bu indesoberbah r rden unter Ber r cksichtigun 3 der rechtlic hen Rahmenbed ingungen for r alle KONTAKTFORMULAR Bel Fragen zum PharmNet Bund 4ngebot f llen Sie einfach folgendes Formular aus Bitte beachten Sie dass die gekennzeichneten Pflichtfelder fe ausgef llt werden m ssen Sie erhalten eine Kopie Ihrer Nachricht an die angegebene E Mailadr
64. ish It will be published soon Seite 9 von 64 Seiten ROBERT KOCH INSTITUT at he Bundesamt fir the Bundesinstitut 4 Paul Bhrlich Institut he Vorbraucherschulz und TS fiir Arzneimittel 7 XK Burn tin Sars ak unbe medizinwinien Lebensenitelsicherheit und Medizinprodukte Ta 44 4 PharmNet Bund Online Variation Submission User manual 04 07 5 2 New variations When the application is first opened the user only has the option of selecting an empty form to create a new variation Neue Anzeige leeres Formular lf there are variations in progress or if variations have already been submitted a new option appears in the New variations field which enables this variation to be used as a master copy To restrict the selection the title if the complete title is known or a part of the title can be entered The entry will be automatically end masked By using a other maskings can be performed Kooperation im Geschaftsbereich des FR Bundesministerium RS f r Gesundheit CE f Pharmhet Bund PHARMNET HOME PHARMNET gt gt gt nderungsanzeigen gt gt gt Arbeitskorb ERLAUTERUNG Sees Bearbeiten Sie eine NDERUNGSANZEIGEN Arbeitskorb nderungsanzeige indem m Sie entweder eine noch ARBEITSKORB nicht gesendete Anzeige Anderungsanzeigen in VOREINSTELLUNGEN F f Arbeit ausw hlen oder Anderungsanzeigen in Arbeit eine neue Anzeige LOGOUT entweder als leeres C 00000057 14 02 2007 11 43 44 Form
65. iten ROBERT KOCH INSTITUT w he Bundesamt fir She Bundesinstitut gt Faul Ehrlich Institut Di D Worbraucherschutz und re f r Arzneimittel CX ssaa ia Garn eat Urne Lebensmiitelsicherhert und Medizinprodukte medetenw Lian nn LE A pharmNet Bund m Mi W T Online Variation Submission User manual 04 07 Bezeichnung der Darreichungsform Darreichungsform bisher Darreichungsform 048 Filmtablettel O48 FILMTABLETTE S66 FILMTABLETTEN UND CREME 357 FILMTABLETTEN UNG INFUSIONSLOESUNG 354 FILMTABLETTEN UND INFUSIONSLOSUNG 370 FILMTABLETTEN UND MAGENSAFTRESIST m TABLETTEN 335 FILMTABLETTEN UND PULVER 336 FILMTABLETTEN UND VAGINAL OVULA d Darreichungsform nicht in Katalog gefunden Bemerkung This will be transferred into the upper line Darreichungsform bisher Darreichungsform 351 FILMTABLETTEN UND INFUSIONSLOSUNG If the user wants to enter his or her own term this is made possible by clicking on the pharmaceutical form not found in catalogue field Anzeige Bezeichnung der Darreichungsform Darreichungsform bisher Darreichungsform 351 FILMTABLETTEN UND INFUSIONSLOSUNG int Darreichungsform nicht in Katalog gefunden ogtext Bemerkung ALLE BISHERIGEN DATEN BERNEHMEN Wy 6 1 5 5 Form with catalogue support Parallel import countries The form for displaying parallel import countries applies only to parallel imports
66. le 1 d Change to Module 2 hange to Module 3 hange to Module 4 Change to Module 5 overview d Summary d Updated addendum After clicking on the upload function is displayed Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 43 von 64 Seiten r PEF ROBERT KOCH INSTITUT tw he Bundesamt f r She Bundesinstitut gt Paul Ehrlich Institut Verbraucherschug und 4 f r Arzneimittel EK q Tacs Br Saru urd enprime Lebensmittelsicherheit und Medizinprodukte Ta medizinwinien A pharmNet Bu nd Online Variation Submission User manual 04 07 Type II Changes for human medicinal products only Change to Module 1 Change to Module 2 Change to Module 3 load filets LI change to Module 4 d Change to Module 5 overview d Summary d Updated Addendum If an upload is to be carried out the appropriate radio button is activated a title assigned to the upload anda file selected pdf or rtf The selected file is then uploaded Type II Changes for human medicinal products only d Change toii changeta Upload ausw hlen Change to Module he document type of a OT Upload Title upload filets Titel vergeben w anar Title 3 Upload Title 4 Upload Title 5 Upload Title Choose a file for upload from your computer rtf pdf SUBME FILE Datei
67. llee 3 D 53175 Bonn Anzeige von nderungen nach 829 und oder 8105 Arzneimittelgesetz Nummer der Anzeige 00000396 Titel der Anzeige 30 04 2007 09 46 54 Datum Anderungsanzeige 30 04 2007 sendedatum der Anzeige Zulassungsinhaber Pharmazeutischer Unternehmer Mustermann Unternehmernummer O00 0000 Online Usernummer PEAQO023 Online Username Muster Mann Bezug Bezug auf Vorgang vom Aktenzeichen Bemerkung Ansprechpartner Name Muster Mann Telefon 0228 2074332 E Mail harn bfarm de Angaben zum Arzneimittel Arzneimittelbezeichnung mi fal L i Li 6 1 7 Submitting the variation If all the required changes have been made the variation can be sent Activating the last tab Submit or Submit the variation requires following actions Prior to submission the user must specify if documentation other than that submitted electronically will be sent with the paper version Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 33 von 64 Seiten ROBERT KOCH INSTITUT ne he Bundesamt f r She Bundesinstitut gt Faul Ehrlich Institut Di D PE Verbraucherschwtz und T f r Arzneimittel 3 CX Baari Lin fears ural nprs Lebensmiitelsicherhert und Medizinprodukte h medizinwisser iii i N ec PharmNet Bund mpe ae 4 r Online Variation Submission User manual 04 07 PHARMNET HOME PHARMNET gt gt gt Anderungsanzeigen gt gt gt Send
68. mt f r She Bundesinstitut Paul EBhrlich Institut DI Di Worbraucherschutz und f r Arzneimittel ere eee OK Lebensmittelsicherhett und Medizinprodukte i w zu medigs nwinieon TE Le T u 7 nn PharmNet Bund te gesendete Anderungsanzeigen AMIS Anderungsanzeigen Gesendete Anzeigen Antragsteller Zulassungsinhaber Unternehmernummer BfArM Bundesinstitut fuer Arzneimittel und Medizinprodukte 5002429 SUCHEN 2007 04 25 a 2 4 __ E Hee Le 13 50 25 8861 2007 04 25 O8 Ob 4a a7 2007 04 23 LES RE E 1998992 dhe neimittel D 10 ee ml Pulver und fig ml Pulver und Losungsmittel T F H Testarzneimittel B 1 OO000011 Test 20 04 2007 1999046 mg ml Pulver und 08 43 55 L sungsmittel HI Test an B 10 ee ee 2007 04 20 13 35 45 1192 E 2007 04 20 a Waly ately eye E 000022 45 Test 5 HI Variation 2007 04 20 Oe 57135 440 B e 1 1 2 Search for date H I J Online Variation Submission User manual 04 07 To perform a date search the date in entered in yyyy mm dd format in the search box and the search function IS gesendete Anderungsanzeigen activated AMIS Anderungsanzeigen Gesendete Anzeigen gesuchtes Datum in dieser Form eintragen Pharmazeutischer 0000000 Antragsteller zulassungsinhaber Unternehmernummer Suche nach Nr oder ENR Suche nach
69. n be optionally attached for example if describing the change using the form does not prove practical In that case the attachment will be referenced in the Present Proposed fields Consideration should be taken of the fact that currently only the BfArM receives this document for other countries the variation form would require supplementation Background for Change amp Justification for Consequential Changes Please give brief background explanation for the proposed changes to your MA as well as a justification in case of consequential changes if applicable Test Daten 5 DO Begr ndung der geplanten nderungen Present and Proposed Wording or Specification Present Proposed Gegen berstellung bisherige Angaben k nftige Angaben O upload filets 4nnexes The following amendecpgaduct information text where applicable O Summary of Product hard ial Labelling ial Package leaflat insert LI Mock ups a Specimens By clicking on the check box the upload area is opened with upload options for 6 different document types Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 46 von 64 Seiten ROBERT KOCH INSTITUT Bundesamt fir the Bundesinstitut Paul Ehrlich Institut D bab Ed Vorbraucherschutz und TS fiir Arzneimittel cA ee aam ir Sani ah legumes Lebensnmtelsicherheit und Medizinprodukte h A a medizinwiate T
70. n within MR or DC procedures The medicinal product is selected for which the variation is to be made This can be done either by manually entering the ENR or by selecting the correct one from an ENR list activate the option ENR Selection Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 12 von 64 Seiten DMD ee ee Oaa Lebensnittelsicherheit und Medizinprodukte K medizinwinsen _ Le A XR i PharmNet Bund an a N V iii Online Variation Submission User manual 04 07 Unterzeichnung des Anschreibens Unterschrift Name Unterschrift Ort Unterschrift Funkt Daten f r Unterschrift Name Unterschriftenzeile Unterschrift Ort Unterschrift Funkt Bitte bestimmen Sie die Art des Verfahrens und w hlen Sie das AM aus f r das nderungen angezeigt werden sollen Auswahl des Werfahrens Bitte w hlen Sie das richtige Verfahren aus Auswahl des C Anzeige einer nderung gem 29 AMG lt lt Verfahens O Anzeige einer nderung gem Variation Regulation ENR Bitte geben Sie die ENR f r das Arzneimittel an f r das nderungen angezeigt werden sollen ENR ENR AUSWAHL Eingabe oder Auswahl der ENR ENR anzeigen The ENR list shows all medicinal products registered for the pharmaceutical company that is logged on and which according to the AMIS database are authorised a
71. nd or are marketable If the user intends to submit a national variation by clicking on Variation pursuant to 29 German Drugs Law AMG the page changes again and the tab structure for national variations will appear after the next page change Auswahl des Verfahrens Bitte w hlen Sie das richtige Verfahren aus Anzeige einer nderung gem 529 AMG C Anzeige einer nderung gem Variation Regulation Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 13 von 64 Seiten ROBERT KOCH INSTITUT tw he Bundesamt fir he Bundesinstitut 4 Paul Ehrlich Institut Di D I Verbraucherschwis und 1 f r Arzneimittel 4 A f a Fam uni ehe Lebensentelsicherheit und Medizinprodukte a ai medizinwiisen Le PharmNet Bund Tin Ni Online Variation Submission User manual 04 07 FHARMNET Anderungsanzeigen Stammdaten der Anzeige 2 Anderu ngen 00000004 ENR Liste i m mn 1 ABBRECHEN BERNEHMEN The available data of the medicinal product required is transferred to the form by activating the option field and clicking on Accept For both national variations and variations within MR or DC procedures there is the option to create a report of the ongoing variations including details of the variation particulars for the ENR in question ENR Bitte geben Sie die ENR f r das Arzneimittel an f r das nderungen angezeigt werden soll
72. neue nzeige entweder als leeres Formular oder unter Verwendung einer gespeicherten Vorlage erstellen Au erdern k nnen Sie bereits gespeicherte vorlagen bearbeiten oder l schen a The options available include The timeout automatic logout if there is no activity can be freely selected Choosing whether to specify the file path of the uploaded document in the form Changing personal information and the password PHARMNET HOME PHARMNET gt gt gt Voreinstellungen POSTFACH E instel er NDERUNGSANZEIGEN Voreinstellungen VOREINSTELLUNGEN LOGOUT 19 04 2007 16 57 32 1 2 0 build 20070412 Timeout Zeit in Voreinstellungen Voreinstellungen andern ndern Sie die Angaben in den jeweiligen Feldern und bet tigen Sie anschlie end die Schaltfl che speichern oder nur aktuell ndern im letzten Fall gelten die nderungen nur f r die aktuelle Sitzung Minuten Allgemeine L nge einer Liste ndert die Anzahl der ausgegebenen Zeilen pro Seite Anzahl Zeilen der Anzeigenliste nach ANZEIGEN AUFLISTEN Arbeitskorb 15 Anzahl Zeilen der ENR Liste nach ENR AUSWAHL Stammdaten 15 Anzahl Zeilen des Sachstands nderungsanzeigen zu ausgew hlter ENR imeout Zeit in Minuten nach der bei Inaktivit t die Session automatisch beendet wird Speichern lokaler Pfadangaben von Upload Dateien ne orheben des Suchbegriffs in ausgegebenen Texten A DATEN SPEICHERN NUR AKTUELL NDERN ABBRECHE
73. ns in English It will be published soon Seite 53 von 64 Seiten P PEF ROBERT KOCH INSTITUT w he Bundesamt fir She Bundesinstitut Sz gt Paul Ehrlich Institut D Verbraucherschulz und f r Arzneimittel OK ely ee at rt rpm Lebensmmittelsicherheit und Medizinprodukte h gt Le medizinwinsen INT PharmNet Bund on ee N Online Variation Submission User manual 04 07 7 Virtual Mailbox Another component of the first phase of the Online Variation Submission application is a Virtual Mailbox which provides the user with an overview of his or her variations the processing status and where applicable the outcome of the procedure Here the submitted variations will be made permanently available together with the authorisation letter from the CA which will be available shortly The Virtual Mailbox made available by the Online Variation Submission application is a precursor of the future virtual mailbox which is currently being developed by PharmNet Bund as its own product The Virtual Mailbox can be opened via the navigation bar on the left k re all ETW ee a oe NT a lee ae ew ies eee as ce PHARMNET gt gt gt Anderungsanzeigen gt gt gt Arbeitskorb FHARMNET HOME Arbeitskorb POSTFACH ANDERUNGSs EIGEN ARBEITSKORB Anderungsanzeigen in Arbeit EE N keine Anzeigen in Arbeit LOGOUT Neue Anzeige Ee DG 200 a i Ge 1 1 0 build 20070307 O ssras aria aan u nn nn U ee ee Oe 7 1 Structure The c
74. riation forms All entries and attached documentation are stored directly on the target computer at PharmNet Bund It is not possible to generate variation forms when offline The application is available from Monday to Friday between 8 am and 6 pm An information notice will be displayed outside of these hours Vielen Dank f r Ihr Interesse an den Elektronischen nderungsanzeigen Bitte besuchen Sie uns innerhalb der unten angegebenen Servicezeiten wieder Mo Fr von 8 00 Uhr bis 18 00 Uhr It is strongly recommended that users of the application have a high speed internet connection broad band The following system requirements and recommendation also apply In order to render a paper version of variations pursuant to EC 1084 2003 users are required to use the Word 2003 Viewer This is available as a Download free of charge Where the generated versions are to be modified pursuant to EC 1084 2003 e g for conventional submission in other Member States users will require a Microsoft Word compatible word processing program version 2003 and later The application has been developed and tested using the web browser Internet Explorer Version 6 and Adobe Acrobat Reader Version 6 It is therefore recommended not to use earlier versions The full functionality of the application cannot be guaranteed when using alternative web browsers e g Firefox The following figure illustrates the underlying technical structure Notice The nex
75. rs of the Online Variation Submission application must accept the currently valid German Terms and Conditions of Use GTC Use The GTC of Use can be accessed on the Submit page Use of the PharmNet Bund portal is subject to the Declaration and Notice on Liability Links and Linking Copyright Data protection found under the Legal Notice Impressum Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 2 von 64 Seiten ROBERT KOCH INSTITUT Bundesamt fur Bundesinstitut gt gt Faul Ehrlich Institut rn W Verbraucherschwii und W f r Arzneimittel PX in oan aale icherheit j i medii w o Lebonsmittels und Medizinprodukte N I 5 44 A P armNet Bund Online Variation Submission User manual 04 07 Kooperation im Gesch fte h des f gt a N MR Bundesministerium N f r Gesundheit U PharmNet Bund Br MPRESSUN E Ch h _ ui SSS HOME CLINICAL TRIALS ELEKTRONISCHE ANDERUNGSANZEIGEN ELEKTRONISCHE ANDERUNGSANZEIGEN Elektronische Anderungsanzeige ist ein Teilprojekt der elektronischen Antragsstellung des in samer Endausbaustufe dar Antragsstellung an die Bundesoberbeh rden unter Ber cksichtigung der rechtlichen Rahrnenbedingungen f r alla 2 2 Technical principles The Online Variation Submission application is a web based application enabling the generation of online va
76. s three options 1 Expand everything All variation particulars are offered 2 Close completely No variation particulars are offered Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 16 von 64 Seiten oe ROBERT KOCH INSTITUT w he Bundesamt f r Se Bundesinstitut Paul Ehrlich Institut Di D vie Vorbraucherschutr und d f r Arzneimittel i OK aara ir Saar ad igre Lebensmiitelsicherhert und Medizinprodukte medizinwiisen Lec d A pharmNet Bund Online Variation Submission User manual 04 07 3 Display selection Those categories remain open in which at least one SKNR was selected Auswahl des Anderungstatbestandes per Kategorie Anlass der nderung erg nzende Angaben Besondere Informationstexte erg nzende Angaben Bezeichnung Dokumentation betreffend Haltbarkeit betreffend Herstellung Analytik Kontrollmethe en betreffend Informationstexte nach 22 Abs 7 aM Optionen Packungsgr e Beh ltnis Parallelimport Pharmakovigilanz Pharmazeutische Unterneh Risikoangaben in Informdtio t ete ttt te tt t Zusammensetzung ALLES AUFKLAPPEN ALLES UKLAPPEN AUSWAHL ANZEIGEN Following the selection of the required variation particulars the user moves to the next step input of the actual variation content by clicking on Next 6 1 3 Deleting variation particulars Variation particulars
77. schwii und 4 f r Arzneimittel cK D Lebensmiitelsicherhert und Medizinprodukte 7 meditinwissen a Eeu Erich neth T Le A lX PharmNet Bund Er ot N vo Online Variation Submission User manual 04 07 Bezeichnung des Arzneimittels Text bisher Test Arzneimittel fir Muster Bemerkungsfeld bei Anderung des mem a bisherigen Textes z B vgl Anderungsanzeige vom xx yy ZZZz Text ge ndert in Test Arzneimittel f r Muster Mann A k nftiger Text BER Bemerkungsfeld f r zus tzlich Angaben nu u z B vgl identische Anderung f r ENR 1234567 vom xx yy ZZZz ZUR CKSETZEN BERNEHMEN In many free text forms the Text changed to field includes a document upload function This can be used two ways 1 Attaching additional supporting documentation 2 For empty forms uploading the contents of the change e g in the format of a tabulated comparison or in case of large amounts of text such as variations of the side effects Text ge ndert in Ol Datei en hochladen Bemerkung 6 1 5 2 Upload form Note The obligations of the AMG eSubmission Ordinance are fulfilled for variations submitted via this online procedure by uploading the required documents concomitantly i e an additional submission via the email procedure is not required The published conditions regarding the document type and format to be submitted rtf pdf as well as naming convention apply irrespective of the method of s
78. shed soon Seite 38 von 64 Seiten r REFS ROBERT KOCH INSTITUT tw E Bundesamt f r She Bundesinstitut gt Paul Ehrlich Institut Verbraucherschuts und 4 f r Arzneimittel st gt K q Tuas Br Saru urd inprimrs Lebensmittelsicherhett und Medizinprodukte s 1s medizinwinien Le PharmNet Bund ra 7 N AS Online Variation Submission User manual 04 07 As an alternative to direct entry of the ENR the list of available medicinal products will be displayed by using the ENR Selection option enabling a selection then to be made PHARMNET HOME FHARMNET gt Notification of change gt Basic Data POST BOX NOTIFICATIONS OF CHANGE TASK AREA 00000006 Notification ENR auswahlen BASIC DATA BASIC DATA VARIATION VARIATION CHANGES Drug name Test Arzneimittel f r Muster VARIATION DATA STATUS OF VARIATION SUBMIT NOTIFICATION PREFERENCES LOGOUT CANCEL 19 04 2007 21 26 30 179 C hald annonam 6 2 3 Variation master data The next step is entry of the master data of the variation 6 2 3 1 General Information Part In the General Information Part area the variation type the variation number and the concerned Member States will be defined The fields of the MRP DCP variation number with a grey background automatically contain the selection Human the RMS and the variation type The fields with a white background are completed manually According to the Best Practice Guide
79. t und Medizinprodukte 2 i medisins Lor i Le PharmNet Bund CH A Online Variation Submission User manual 04 07 Mail an helpdesk e submission bfarm de 5 x Datei Bearbeiten Anzeigen Aktionen Werkzeuge Konten Fenster Hilfe Senden 3 Abbrechen a Adresse SS Rechtschreibprifung E Mail Sendeoptionen Von Michael Horn ae An heipdesk e submission bfarm de BE Betreff 244 Allgemein Mitteilung Senden x Abbrechen e amni Adresse hd Beif ger konto Nowell Groupwise If the email is generated from a status where the registration number is known this will be automatically added to the Subject field Mail an helpdesk e submission bfarm de e oj x Datei Bearbeiten Anzeigen Aktionen Werkzeuge konten Fenster Hilfe a Mail sendeoptionen Adresse lal ae 27 Rechtschreibpr fung Wor Michael Horn cc Gn heipdesk e submission bfarm de BK Betreff lia 00000481 E Mitteilung A Senden 5 Abbrechen Senden Konto Novell GroupWise In order for the Helpdesk team to deliver an effective response as soon as possible the following information should be included 1 Name of the questioner including relevant contact data e g telephone number 2 Registration number of the particular variation 3 Precise description of the problem e g Notice The next version of the user manual will conta
80. t version of the user manual will contain screenshots and explanations in English It will be published soon Seite 3 von 64 Seiten ROBERT KOCH INSTITUT Paul Eh irlich Instit uf ne H Bundesamt fir the Bundesinstitut Di D CE Vorbraucherschutz und I f r Arzneimittel CX A medisins 10 ip m Le A Lebensmiitelsicherhert und Medizinprodukte f NUN PharmNet Bund an ec Vs iii Online Variation Submission User manual 04 07 Portal Online AA Formularsystem _ 7 gt Validierung L 2 3 Online oig RER Pr sentation V2 m application ae N Formularsystem cS u 2 4 ams DB Online AA Benutzerf hrung uw S a Persistenz Backend 4 Provision of Online AA Online AA ar data for Rules Formular UUM EEE a Textobjekte Competent Templates Inhalte Authorities Import Anwendung Bereitstellung 5 Transfer of data to Y y Y Competent Authorities data BS AMIS ae BVL PEI ans Tagesproduktion eher 1 Users go to www pharmnet bund de and enter username and password before proceeding to access the Online Variation Submission application 2 The application provides the online forms and contents Documents uploaded by the user will be stored on the PharmNet server 3 As long as the variation has not been submitted the data are available only to the MAH and other
81. tions in English It will be published soon Seite 42 von 64 Seiten ROBERT KOCH INSTITUT Bundesamt fir the Bundesinstitut 4 Faul Ehrlich Institun DIMI 63 Verbraucherschutz und T f r Arzneimittel i CX po Maiani Ee Fap ed pi medizinwiise A Lebonsmiitelsicherhent und Medizinprodukte A IM A N N PharmNet Bund _ Online Variation Submission User manual 04 07 f Type IA and IB Changes Main Conse quential Change 5 change IA IB IA IB 1 Change in the name and or address of the marketing MN authorisation holder 2 Change in the name of the medicinal product E oO 3 Change in name of the active substance d d 4 Change in the name and or address of a manufacturer of the active substance where no Ph Eur Certificate of d Suitability is available the finished product 6 Change in ATC Code a Medicinal products for human use d d b Medicinal products for veterinary use d d 7 Replacement or addition of a manufacturing site for part II or all of the manufacturing process of the finished u m eee 3 Change in the name and or address of a manufacturer of Apart from the restrictions just described above the choice of changes is at the discretion of the user 6 2 4 2 Type Il variations For Type Il variations the module in which changes are to be made is selected 3 Changes 30 04 2007 10 00 27 Notification Type II Changes for human medicinal products only Change to Modu
82. tischer Unternehmer Mustermann Oooooo0 FEA00023 Muster Mann Muster Mann 0228 2074332 harn bfarm de Test Arzneimittel f r Muster Filmtablette APPLICATION FOR VARIATION TO A MARKETING AUTHORISATION Online Variation Submission User manual 04 07 HUMAN eg VETERINARY NATIONAL AUTHORISATION IN MRP COMMUNITY AUTHORISATION C NATIONAL AUTHORISATION ONLY MRP variation number DEHIN EMEA variation number Reference Member State DAT OBE Qee Der Dez ADE DK DEE MEL QES DF FR Hu DIE Os OF Ou Oot Ow Oe Om ON Ono GPL OPT Oro Ose Ls Osk Ouk Concerned Member State s MAT XIBE LBG Olew cz CIDE Ciok JEE JEL les CIF CIFR CHU CIE Js OT Du GILT Du Div CIMT Bane LINO DIPL OPT LIRO JSE LISI Lisk LJUK LJNONE Type of Application L Type IA L Type IB Type Il L_ Safety Indication Condition indication listed in the Human Register of designated Orphan Medicinal Products Yes following Urgent Safety Restriction Ex Quality Other _ Annual variation for human influenza vaccines No Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 50 von 64 Seiten nn ROBERT KOCH INSTITUT ne he Bundesamt fir the Bundesinstitut gt Faul Ehrlich Institut Di D sch Verbraucherschutz und T f r Anneimittel a cA p fener fu Garn urd iru Lebensnmtelsicherheit und Medizinprodukte h A medizinwinne L
83. ubmission for exceptions in regard to product information see below Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 19 von 64 Seiten oe ROBERT KOCH INSTITUT w he BL In the or gt Paul Ehrlich institut Di D ar Verbraucherschwiz und Ke f r Arzneimittel AXK Tawar La fare rad ingame Lebensmiitelsicherhert und Medizinprodukte medizinwiisen Le XK i PharmNet Bund l on era N V Online Variation Submission User manual 04 07 Angaben der GI gem Par 11 AMG Datei Upload Wahlen Sie den Dokumenttyp der hochzuladenden Datei aus Clean Version Highlighted Version nderungsindex Bilddatei 1 weiterer Upload Titel 2 weiterer Upload Titel 3 weiterer Upload Titel 4 weiterer Upload Titel 5 weiterer Upload Titel Wahlen Sie die hochzuladende Datei von Ihrem Rechner aus rtt pdf ZURUCKSETZEN DATE SENDEN C SKNR f r die vorliegende Anzeige nicht relevant Bemerkung ZUR CKSETZEN BERNEHMEN The upload form is provided for all structure numbers which require a document upload Several options are displayed 1 Upload of predefined document types 2 Upload of documents with user specified allocation of title 3 Option to mark SKNR not relevant for the current variation 4 Entering remarks Notice The next version of the user manual will contain scre
84. ui DIMI 63 Verbraucherschwii und TS f r Arzneimittel IK N Zu viel Eu Ka a chemi medizinwiise Lebensnmtelsicherheit und Medizinprodukte PharmNet Bund _ Online Variation Submission User manual 04 07 FHARMNET gt gt gt Notification of change Submit Notification 30 04 2007 10 00 27 Notification Submit Notification Your notification was submitted successfully Now you can demand a printable version of your data pdf format MS Word 003 format PDF BfArM cover sheet W MS Word 2003 Variation Notification Auswahl PRINTLELATA As with the national procedure the letter to the BfArM now contains all the required features of the original including the watermark FINAL LNOTIIKOTOLOIITC Platz f r BfArM Eingangsstempel An das Bundesinstitut f r Arzneimittel und Medizinprodukte an FG11 Kurt Georg Kiesinger Allee 3 D 53175 Bonn Papierversion ohne weitere Unterlagen im Vergleich zu den elektronisch eingereichten Unterlagen Variation Nummer der Anzeige 00000397 Titel der Anzeige 30 04 2007 10 00 27 Datum Anderungsanzeige 30 04 2007 Sendedatum der Anzeige 2007 04 30 10 13 29 399 Zulassungsinhaber Pharmazeutischer Unternehmer Mustermann Unternehmernummer 0000000 Online Usernummer PEA00023 Online Username Muster Mann Bezug Bezug auf Vorgang vom Aktenzeichen Bemerkung Notice The next version of the user manual will contain screenshots and explanatio
85. ular oder unter Verwendung einer gespeicherten Vorlage erstellen er C 00000056 14 02 2007 11 18 49 U ANDERUNGSANZEIGE L SCHEN Au erdem k nnen Sie bereits gespeicherte Neue Anzeige Vorlagen bearbeiten oder Voreinstellung leeres Formular l schen Anzeige mit folgendem Titel kopieren ANZEIGEN AUFLISTEN Ihre Eingabe wird automatisch endmaskiert Sie k nnen weitere Maskierungen durch das Symbol vornehmen Verwaltung von Vorlagen C neue Vorlage erstellen keine Vorlagen gespeichert Gesendete Anzeigen C gesendete Anzeigen auflisten Nach Auswahl auf weiter klicken 5 3 Template administration Apart from the creation of new variations the application also offers the option of creating templates Verwaltung von Vorlagen neue Vorlage erstellen keine Vorlagen gespeichert The creation of templates offers a variety of benefits e g Where there are several users each single user can define his or her own standard template with his or her contact data so that every variation form is correctly initialised in advance Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 10 von 64 Seiten ROBERT KOCH INSTITUT ed he Bundesamt h r the Bundesinstitut Paul Et hrlich Institut on Verbraucherschutz und dr f r Arzneimittel YW cK oe Lebensmiitelsicherhert und Medizinprodukte Vu A GN medizinwirion SU
86. urrent mailbox consists of two reports which are generated when the mailbox is opened The user can select between the two reports by using the tab The Submitted variations report contains the data stored by PharmNet Bund The AMIS variations report provides information on variations stored in the AMIS database operated by the CAs 7 1 1 Submitted variations report Notice The next version of the user manual will contain screenshots and explanations in English It will be published soon Seite 54 von 64 Seiten ROBERT KOCH INSTITUT w he Bundesamt bur the Bundesinstitut Paul Ehrlich Institut Di D ore Verhraucherschulz und TS fiir Arzneimittel cK aT ir Sabra rat kepranana Lebensmiitelsicherhert und Medizinprodukte i medizinwinne Le PharmNet Bund CEL XA Online Variation Submission User manual 04 07 FHARMNET HOME PHARMNET Postfach POSTFACH gesendete nderungsanzenpen ANDERUNGSANZEIGEN i VOREINSTELLUNGEN ee AA F Lice Antragsteller 13 04 2007 14 79 01 Fe Zulasseungsenhaber 1 2 0 build Z0070412 Unternehmemummer Suche nach Hr ENR SUCHEN Suche nach Sendedatum Es wurden folgende gesendete Anzeigen gefunden 4 Arrocimittelname gesendet am m poe _ e Aal 23 03 2007 2007 03 23 are 12 09 38 10 g E 20 03 2007 2007 03 20 al DDOODDZZ feos hero a A TI The Submitted variations report contains the

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