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(XEVMPD) Bulk Update Manager

1. eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 19 59 5 Submitting a request to create the product set Having set a series of filters as described in section 4 the user may now proceed to submitting a request to create the product set using the requesting area of the page This area is shown in the figure below Figure 13 The product set request area Activ e Filters Eire on the Name of the Filter to disable enable EV Code List Title Count 2 Request Refresh List The requesting area is divided into two areas the Active Filters area and the main active area 5 1 1 Examine the preview and prepare a count In order to prepare a count of the number of products to be included in the requested product set click the count button in the active area this action causes a count of the number of products to be included in the requested product set to be displayed in the count field to the right of the count button If the count of products is not as expected then the user may perform several actions e g e Examine the Preview List to check the products being included in the requested product set e Re enter or clear data in one or more of the filter fields the filters in use will be coloured blue and will appear in the active filters list e Explore the effect of temporarily removing filters on the counts and preview by using the Active Filters area as desc
2. Remove Change Create Change 10 To substitute MedDRA version 15 referenced some of these AMPs create another Action pdassep AAA HUMAN PRODUCTION V 7 12 1 Actions Remove Action Add new Action For every Product selected execute the Changes Authorised Product lz Create Filter MN ial ah B From ORG3190 GIPHARMA IT TORINO 15 z To ORG1233 Remove Change Create Change Remove Action Add new Action For every Product selected execute the Changes Create Change Create Filter 11 Choose a Filter pdassep AAA Actions HUMAN PRODUCTION V 7 12 1 Remove Action Add new Action For every Product selected execute the Changes Authorised Product lz Create Filter kzl Cange From ORG3190 GIPHARMA IT TORINO 15 To ORG1233 Remove Change Create Change Remove Action Add new Action For every Product selected where this is true Create Change Choose a Section Remove Filter then execute the Changes Create Filter 11 Choose the applicable section and element For every Product selected where this is true Authorised Product Drug Indication Choose an Element 7 Choose an Element MedDRA Level 4MedDRA Code MedDRA Version eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager Page 52 59 EMA 623491 2014 13 Choose a Predicate and value For every Product selected where this is true Authorised Product Drug Indication
3. All Products Compound NO Pharmaceutical Search form at Authorised Pharmaceutical Form level All Products Compound NO Search Any referenced ATC code All Products Compound NO Any referenced Search MedDRA code in the Indications section List of pharmaceutical forms EV Code current pharmaceutical form name List of pharmaceutical forms EV Code current pharmaceutical form name List of ATCs ATC Code current ATC name List of MedDRA Codes MedDRA code most recent MedDRA code description On clicking refresh the list is restricted to the first 50 pharmaceutical form values that are used in any product which is owned by any organisation with the same HQ as the logged in user and which fulfils the search criteria in the control text box On clicking refresh the list is restricted to the first 50 pharmaceutical form values that are used in any product which is owned by any organisation with the same HQ as the logged in user and which fulfils the search criteria in the control text box On clicking refresh the list is restricted to the first 50 ATC values that are used in any product which is owned by any organisation with the same HQ as the logged in user and which fulfils the search criteria in the control text box On clicking refresh the list is restricted to the first 50 MedDRA values that are used in any product which is owned by any organisation with the same HQ as the logged in
4. EUROPEAN MEDICINES AGENCY IENCE MEDICINES HEALTH 05 November 2014 EMA 623491 2014 Information and Communications Technology eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager User manual Version 1 0 30 Churchill Place e Canary Wharf e London E14 5EU e United Kingdom Telephone 44 0 20 3660 6000 Facsimile 44 0 20 3660 5555 Ea Send a question via our website www ema europa eu contact An agency of the European Union European Medicines Agency 2014 Reproduction is authorised provided the source is acknowledged Table of contents Da TL MECOGUCEION oers N E E 4 2 Accessing the bulk update manager tol sssssnssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 5 2 1 User ACCESS requirementsS s ssersrerrsrrrrerrrrrrrsrrrrsrrrrsrrrrsrrrrrrrrrrrrsrrrrererrerrrrrrrrrrne 5 2 2 SYStem Requirements rsrissrrisrinierna rir nA AO EAAS ER ERRER 5 2 3 Locating th bulk update manager LOO srsrsscurriserisrtseiisenisrni nione En Ei 5 3 Overview of the bulk update manager tOOl sssnssnssn22222222222222222222220 7 4 Setting the filters for creating a products Set ccccccccccccccccceeeeeeeeeeeeeeeeeees 9 Dds Genel al DEIMCID Ee T T A E A E A E E E mde E 9 4 2 Types of query building control sssssssrsrrererrererrererrsrrrrerrrrerrrrerrerrrrererrerrrrerrren gt 10 Aade DAC CONGO peira aAA A AAA AE EAN E AEN 10 A A ete ee ee ee AE ee A A E A ST 10 A2 COMMOUNG Scarch MEIGS acneso
5. Multiple selection list ae Order Code L Text 2 Enter the Title of your request and perform Count to display the number of entities for which you will perform the bulk update Title MAH and MedDRA 25 Refresh List 3 Click on Request Request Title Size Status MAH and MedDRA on 04 11 2014 15 39 Bulk Decoded 25 Queued momentarily Cancel 4 Click on Refresh List Your request is now loaded in the download area MAH and MedDRA on 04 11 2014 15 39 Bulk Decoded 25 287 KB Completed Open Archive 5 Click on Open The Bulk Update operations page is now open Eudravigilance xEVMPD Bulk Update O EUROPEAN MEDICINES AGENCY pdassep AAA MAH and MedDRA 2014 11 04 15 39 16 01 m pdassep AAA Actions HUMAN PRODUCTION W 7 12 1 For every Product selected execute the Changes Create Filter 6 Click on Create Change and select the section in which you wish to perform the change eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 50 59 Authorised Product Authorised Product Authorised Product Attachment Authorised Product Attachments Authorised Product Authorisation Authorised Product Authorisation Medicinal Product Type Authorised Product Authorisation Medicinal Product Types Authorised Product Authorised Pharmaceutical Forms Authorised Product Drug ATC Authorised Product Drug ATCs Authorised Product Drug
6. The steps required by a user to create a change are as follows Note A change can be created with or without specifying a condition In cases where no condition has been stated the change will be performed on all products in the product set eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 31 59 1 Click the Create Change button to allow for the selection of a section to be used to formulate the change 2 Select a section from the drop down list Depending on the selection the system displays and prepopulates the data elements dropdown 3 Select a data element from the drop down list Depending on the selection the system displays and prepopulates the change type dropdown 4 Select an appropriate change type from the default values Depending on the selection the system displays and prepopulates the value dropdown 5 If applicable enter the value for which the action must be satisfied 6 Enter the correct new value which should be used to update the selected data element 7 The user has now completed entering a single change 8 Should the user wish to specify additional changes they can click on the Create Change button which will allow for the entry of an additional action on the same set of conditions for a product 8 7 Adding Removing Action sets An Action set contains the sum of the conditions and changes to be applied to each product within the produ
7. MedDRA Version Is Phare a Wale 7 ies a Predicate 5 Remove Filter Is Not Is Missing Is Not Missing For every Product selected where this is true Authorised Product Drug Indication MedDRA Version Is 5 Choose a Value Choose a Value 115 19 17 1 1 14 Create a new change by following steps 6 9 Actions Remove Action Add new Action For every Product selected execute the Changes Authorised Product pdassep AAA HUMAN PRODUCTION V 7 12 1 MAH z Change Create Filter eaa From ORG3190 GIPHARMA IT TORINO 15 x To ORG1233 Remove Change Create Change Remove Action Add new Action For every Product selected where this is true Authorised Product Drug Indication Authorised Product Drug Indication x MedDRA Version lal Change zl MedDRA Version lz Is z From 15 19 lz 15 19 To 17 1 R Filter Remove Change then execute the Changes Sa Create Filter 15 Click on Bulk Update at the bottom of the page Title Bulk Update A message with the Bulk Update result will be displayed eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager Page 53 59 EMA 623491 2014 A Result Bulk Update completed successfully 16 Go to EVWEB section Web Trader subsection Bulk Update and retrieve your folder Create and Send ICSRs Create and Send Acks wEB Trader ICSRs Create and Send Product Reports Medicin
8. in any role NO NO NO NO NO List Transition Format Pre Transition Format Current date Current date List Yes No List of substances EV Code current preferred name Transition Format Products with associated QPPV and Legal Basis information Pre Transition Format Products without associated QPPV and or Legal Basis information For authorised products the start date is overridden to the 5 March 2012 If the date supplied is before this date it is omitted from the filters If no date is supplied the end date defaults to the date the request is processed A product is defined as re linked by the EMA if it has been updated by the EMA as a result of data cleaning activities since it was last submitted by the product owner On clicking refresh the list is restricted to the first 50 Substances that are used in any product which is owned by any organisation with the same HQ as the logged in user and which fulfils the search criteria in the control text box eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 15 59 Filter Label Control Type Product Attribute Searched Specific to Authorised Product Data Displayed Pharmaceutical Form Administrable Pharmaceutical Form Authorised ATC Code Indication MedDRA code All Products Compound NO Pharmaceutical Search form at Pharmaceutical Product level
9. 4 2 2 Simple list In cases where the values appear as simple lists of values in the EV system i e authorisation status then the available data is presented as a simple list Figure 7 Use of a simple drop down filter control Authorisation Status Refresh Clear Valid Suspended Authorisation Statuses of Products Not Valid Withdrawn by Marketing Authorisation Holder Lookup automatically executed Multiple selection list Notes for use of simple lists e The list is automatically filtered to contain only those values in use within the products of the logged in user s organisation HQ e The list of presented values takes no account of the values selected in any other filter control e These lists can be refreshed using the button to the right of the control but by default contain all values used in the products of the logged in user and all other users belonging to the same HQ e Selections in the list are cleared using the button to the right of the control eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 10 59 e Selections can be made as follows To select a single item click on the item Use shift click to select a continual range of items Use control click to select a range of items with gaps in e If all values in a control are selected then it is more efficient to clear the control and make the search field inactive as us
10. 9 OUICK ETO ren e QUIO Greece ran a aS 44 SMES i AEN 6 PE E A E A A A A er A E E eee E A 44 Zu OS ord tp E E E E T E E E E T 44 Ferai 8 i a ACCO aaraa E E A E E E E AERA 44 Fi Zoe CUS a E E E E E E A E O EE 44 9 2 3 Requesting an Product set ssssrssrererrsrrrrerrrrerrrrsrrrrrrrrrrrrrrrrrerrrrerrrrerrrrerrren gt 45 9 2 4 Monitoring an request to create a product Set s ssrsersrrererrrrrrrsrrrrerrrrerrrrerrren gt 45 22 9 BUIK Update OperatiONSeessrroririanronndr nr rieien ie NOI OE NRAN arrie Dr adaa 45 TO ANN OX sisiran aai 46 10 1 Step by Step Guide Change of QPPV nssnasunnsnurnnrrererrererrererrsrrrrnrrrrerrrrerrrrene 46 10 2 Step by Step Guide Change of MAH and MedDRA VersSiONn cceceeeeeeeseeeeeeees 50 10 3 Step by Step Guide Addition of an Authorised Pharmaceutical Form and change of the Administrable Pharmaceutical ForM esssrssrererrsrerrsrrrrerrrrrrrerrrrsrrrrerrrrerrrrrrrrrene 56 eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 3 59 1 Introduction The Agency has introduced a tool by which Eudravigilance system registered users with permissions to view and submit xEVMPD data may preform bulk data operations for their products held in the xEVMPD This can be performed for a small or large number of products with minimal repetitive effort The tool facilitates editing of key data fields and supports the re subm
11. Compound l that are used in the authorised product generic name field i Authorised Product l Ta Generic name Search for any authorised product which is owned by any Generic Name A organisation with the same HQ as the logged in user and which fulfils the search criteria in the control text box Company Name Authorised Free Text YES List of Names On clicking refresh the list is restricted to the first 50 values product Compound that are used in the authorised product company name field Authorised Product ake Company name Search for any authorised product which is owned by any Company Name ue organisation with the same HQ as the logged in user and which fulfils the search criteria in the control text box EV Code All Products EV Free Text NO List of Products On clicking refresh the list is restricted to the first 50 values Code Compound that represent any product which is owned by any EV Code Product Se uae l Search ean organisation with the same HQ as the logged in user and which fulfils the search criteria in the control text box Preview List All Products EV Searchable NO List of Products On clicking refresh the list is restricted to the first 50 values Code Simple List that represent any product which is owned by any EV Code Product Name organisation with the same HQ as the logged in user and which fulfils the search criteria in the control text box AND all of the other criteria set in the preceding filter fields
12. Indication Authorised Product Drug Indications Authorised Product Pharmaceutical Product Authorised Product Pharmaceutical Product Active Ingredient Authorised Product Pharmaceutical Product Active Ingredients Authorised Product Pharmaceutical Product Adjuvant Authorised Product Pharmaceutical Product Adjuvants Authorised Product Pharmaceutical Product Drug Routes Authorised Product Pharmaceutical Product Excipient Authorised Product Pharmaceutical Product Excipients Authorised Product Pharmaceutical Product Medical Device Authorised Product Pharmaceutical Product Medical Devices Authorised Product Pharmaceutical Product Route of Administration Authorised Product Pharmaceutical Products Authorised Product Presentation Authorised Product Previous EV Code Authorised Product Previous EV Codes 7 Choose an Element which you wish to change Authorised Product Choose an Element Choose an Element Operation Type Comments Info Date Master File Location PhV enquiry email PhV enquiry Phone OPPV 8 Choose an Action you wish to perform on the selected element Authorised Product MAH Bfe B 9 Specify which value From should be changed To eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 51 59 Authorised Product MAH Change From ORG3190 GIPHARMA IT TORINO 15 To ORGI233
13. Product set a title a Giving a title we make it easier to identify particular product sets if you or your organisation make many requests 3 Should I include the date or format in my export title a This is not advised because the system will add this information to the title 9 2 4 Monitoring an request to create a product set 1 Why does the monitoring area say that my export of few products is likely to take a long time a Export requests are added to the queue in the order in which they arrive although you cannot see them there a many requests in the queue in front of yours 2 don t need my export anymore and it is still in the queue what should do a Please cancel the request to free up processing time for other users 3 The system says that my export is in the queue and the count of progress is not changing or its time to completion is not changing why not a In order to update the time to completion you need to click the Refresh Lists button 9 2 5 Bulk Update Operations 1 How can I save my entered conditions and actions 2 have accidentally removed the action and condition criteria entered can this be retrieved a Unfortunately there is no option but to repeat the request and delete the failed export If the problem persists please contact the Article 57 help desk 3 don t need my product set anymore and it is still in download area what should do a Please archive the request to free up screen s
14. in the list Figure 11 Use of the free text filters Any Name CLA Copy New Delete CLAFORAN 0 5 G a Refresh Clear a okt ge gamer CLAFORAN 1 G POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE IV Press Enter or A a test the filter CLAFORAN 1 0 G Click on a Preview Value to set the Free Text Filter CLAFORAN 2 0 G TROCKENSTECHAMPULLEN Order Text CLAFORAN I V Any Name CLE Copy New Delete CLEXANE a Refresh Clear aye etn CLEXANE 10 000 ANTI XA I E ML RAZTOPINA ZA INJICIRANJE V VECODMERNI VIALI Press Enter or Refresh to test the filte CLEXANE 10 000 ANTI XA LE 1 ML RAZTOPINA ZA INJICIRANJE V NAPOLNJENI INJEKCUSKI BRIZC Click on a Preview Value to set the Se Text Filter CLEXANE 100 MG Order V Text CLEXANE 100 MG OPLOSSING VOOR INJECTIE Any Name CLEXANE 2 000 UI ANTI XA 0 2 ML PFS Copy New Delete CLEXANE 2 000 UI ANTI XA 0 2 ML PFS Refresh Clear pe illo a aap CLEXANE 2000 NE 0 2 ML 20 MG OLDATOS INJEKCIO ELORETOLTOTT FECSKENDOBEN Press Fnter or Refresh i test the filter CI FXANF 320000 ANTLXA 11 3 N MI Cliek an tha Mama af thn Ciltar tn e The control may be emptied using the clear button to the right e Each repeat except the last remaining may be deleted e Each repeat may be cleared refreshed or duplicated as before by using the appropriate button within the control e The searched value is the value in each text box To trans
15. is carried out on the result of the first action and so on until each set of actions have been completed and the resultant file becomes available for validation Thus for the example above the bulk update generator will e Set the Operation type to Invalidate MA and the Authorisation Status to Not Valid Not submitted for renewal by MAH for all products in the set Then e Set invalidated date to 20 June where the MAH is ORG2762 Then e Set invalidated date to 21 June where the MAH is ORG3190 eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 39 59 Then e Set invalidated date to 22 June where the invalidated date is still missing after the two set steps above 8 10 2 Example 2 User wishes to perform an interim phase update In this example let us assume that the user wishes to perform an interim phase update on a product set and this set represents all off his products which have the ingredient x in any role The user knows that some of these products are in tablet form and some in suspension form but all of the products in the set have the same legal basis The following screen shots provide an example of how the update can be achieved using the solution Given a bulk update product set of all products owned by the user or other users with the same HQ as the user filtered on the basis of ingredient x in any role Figure 3 Example 2a Set the operation type and
16. to create a single search to list the values required the control can be duplicated to perform an or search within this particular field In order to do this use the new creates an empty control or the copy duplicates the values in the current control button to the right See Figure 9 Figure 10 Search tips for compound controls searching using multiple copies of the same field Ingredient SUB118 21071 45mig SUB11842MIG COD LIVER OIL TYPE B SUB21071 ETANOLO Ingredient Copy New Delete Refresh Clear e The control may be cleared using the clear button to the right e Each repeat except the last remaining may be deleted e Each repeat may be cleared refreshed or duplicated as before by using the appropriate button within the control e Selections can be made within each control in a field as follows To select a single item click on the item Use shift click to select a continual range of items Use control click to select a range of items with gaps in e If all values in a control are selected then it is more efficient to clear the control and make the search field inactive as using no filter for a field gives better system performance than setting all of the values within the field e If either more than fifty or zero values are returned by the refresh action then the background colour of the list is yellow e Some fields are exclusive to authorised products
17. update manager tool located a https eudravigilance ema europa eu evmpdex bulkmanager asp Can bookmark that location a Yes Why am I refused access a This may be because you don t have sufficient user privileges or your organisation does not have the correct profile the message you receive should give you more information Refer to Section 2 Accessing the bulk update manager tool Which user name password should use a The one that was issued to you when you registered for a EudraVigilance account If you have changed your password use the latest value have forgotten my user name password what should do a Apply for a reminder from the registration team by email to EudraVigilanceRegistration ema europa eu quoting salient details e g name organisation etc Why didn t the system ask me for a password a You are already logged on in an EV WEB session Why won t the system work on my computer a Itis likely that your system does not meet the stated system requirements refer to Section 2 2 System Requirements for further details 9 2 2 Filters L 2 3 What happens if don t set any filters a All of your products and those of your HQ and all other affiliates will be exported Subject to certain date restrictions for authorised products Why do have to hit refresh before a filter is populated a This is to enhance the performance of the system some of the filters have to check in big lists fo
18. user and which fulfils the search criteria in the control text box eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 16 59 Filter Label Product Attribute Searched Control Type Specific to Authorised Product Data Displayed MAH Sponsor Authorised Compound NO List of MAHS Sponsors On clicking refresh the list is restricted to the first 50 values roduct MAH Search that are used in any product which is owned by an p EV Code Name mae l ni i 7 l organisation with the same HQ as the logged in user and Development Country City l l EA which fulfils the search criteria in the control text box Product Sponsor QPPV Authorised Simple List YES List of QPPVs Presents a list of the QPPVs that are registered for roduct QPPV organisations with the same HQ as the logged in user and p z QPPV Code Name Z Pee a used in any authorised product which is owned by any organisation with the same HQ as the logged in user Master File Authorised Simple List YES List of Master File Presents a list of the MFLs that are used in any authorised Location product Master Locations product which is owned by any organisation with the same File Location HQ as the logged in user EV Code Country City Postcode Street Owner All Products Simple List NO List of Registered Presents a list of sender IDs for organisations message Organisation EudraVigilance Organisations sende
19. 2 AND 21 June if the MAH is ORG3190 Note that in this case there could be other products in the set which would have the invalidate operation prepared and these would in this example lead to these product invalidations being rejected since the required invalidation date is not present in products where the MAH is neither ORG2762 or ORG3190 This feature of the business rules should not be used as a failsafe method of ensuring data quality for bulk updates rather care should be taken in obtaining the original dataset or a further set of instructions should be issued as shown in the following example In this further case we are assuming that in addition to the two defining sets of data the MAHs there are further products in the batch which are to be withdrawn Example 1c Ensuring all products have a value in a required field eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 38 59 Figure 37 Example 1c Ensuring all products have a value in a required field Eudravigilance xEVMPD Bulk Update pdassep VB change MAH and QP 2014 10 22 17 29 39 01 O EUROPEAN MEDICINES AGENCY Acti pdassep AAA a HUMAN PRODUCTION V 7 9 0 Remove Action Add new Action r For every Product selected execute the Changes Authorised Product Authorisation EH Authorisation Status Change From 1 Valid 24 To Not Valid Not Submitted for Renewal by Marketing A
20. 9 DATest_Bulk Update03 Update PRD1598970 DATest_Bulk Update04 Update PRD1598971 DATest_Bulk Update05 Update PRD1598972 DATest_Bulk Update06 Update PRD1598973 DATest_Bulk Update07 Update PRD1598974 DATest_Bulk Update08 Update PRD1598975 DATest_Bulk Update09 Update PRD1598976 DATest_Bulk Update10 Update PRD507683 MIBITEC 1 mg zestaw do sporzdzania preparatu radiofarr Update PRD1598966 DATest_Bulk Update Update PRD1598985 DATest_Bulk Update 1111 Update PRD1598986 DATest_Bulk Update01 1111 Update PRD1598987 DATest_Bulk Update02 1111 Update PRD1598988 DATest_Bulk Update03 1111 Update PRD1598989 DATest_Bulk Update04 1111 Update PRD1598990 DATest_Bulk Update05 1111 Update PRD1598991 DATest_Bulk Update06 1111 Update PRD1598992 DATest_Bulk Update07 1111 Update PRD1598993 DATest_Bulk Update08 1111 Update PRD1598994 DATest_Bulk Update09 1111 Update PRD1598995 DATest_Bulk Update10 1111 Update PRD1598996 DATest_Bulk Update 1 Update PRD1598997 DATest_Bulk Update01 1 Update PRD1598998 DATest_Bulk Update02 1 Update PRD1598999 DATest_Bulk Update03 1 Update PRD1599000 DATest_Bulk Update04 1 Update PRD1599001 DATest_Bulk Update05 1 Update PRD1599002 DATest_Bulk Update06 1 Update PRD1599003 DATest_Bulk Update07 1 Update PRD507687 MIBITEC 1 mg zestaw do sporzdzania preparatu radiofarr Update PRD507681 MIBITEC 1 mg T
21. Administrable Pharmaceutical Form In this example we will perform the following actions e Fora pre defined set of AMPs which currently do not contain any value in the Authorised Pharmaceutical Form section We will add the value POWDER FOR SOLUTION FOR INJ ECTION We will change the value currently referenced in the Administrable Pharmaceutical Form from POWDER FOR SOLUTION FOR INJECTION to SOLUTION FOR INJECTION Authorised Pharmaceutical Forms Pharmaceutical Products 1 amp POWDER FOR SOLUTION FOR INJECTION 1 Create Filter EV Code PRD507683 PRD507687 PRD507688 PRD507684 PRD507686 PRD507682 PRD747510 PRD747511 PRD1 Refresh Clear Free Text Filter on EV Code Allows pipe separated list Press Enter or Refresh to test the filter Click on an EV Code to add it pipe separated to Order F Code Text the Free Text Filter 2 Enter the Title of your request and perform Count to display the number of entities for which you will perform the bulk update Title Pharm Form change Count Refresh List Title Pharm Form change 14 Refresh List 3 Click on Request Pharm Form change on 04 11 2014 12 58 Bulk Decoded 14 Queued momentarily Cancel 4 Click on Refresh List Your request is now loaded in the download area Pharm Form change on 04 11 2014 12 58 Bulk Decoded 14 179 KB Completed Archive 5 Click on Open The Bulk Update operations page is no
22. D1598997 DATest_Bulk Update01 1 Update Authorised PRD1598998 DATest_Bulk Update02 1 Update Authorised PRD1598999 DATest_Bulk Update03 1 Update Authorised PRD1599000 DATest_Bulk Update04 1 Update Authorised PRD1599001 DATest_Bulk Update05 1 Update Authorised PRD1599002 DATest_Bulk Update06 1 Update Authorised PRD1599003 DATest_Bulk Update07 1 Update Authorised PRD507687 MIBITEC 1 mg zestaw do sporzdzania pr Update Authorised PRD507681 MIBITEC 1 mg Trousse pour pr paration ra Update Authorised PRD507688 MIBITEC 1 mg Kit f r ein radioaktives Arzn Update Authorised PRD507684 MIBITEC 1 mg Kit f r ein radioaktives Arzn Update Authorised PRD507686 MIBITEC 1 ma Kit f r ein radioaktives Arzn 1 r eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 34 59 Figure 36 EV WEB bulk update Load Display Settings X pdassep AAA HUMAN PRODUCTION V 7 12 1 Create and Send ICSRs Create and Send Acks WEB Trader ICSRs ai Create and Send Product Reports edicinal Products MedDRA ol Reset Application Reset Section Clear Local Import Create Ack Reload XEVPRM Message a AAA pdassep_AAA Change of MAH_360_vb_2014 10 28_16 31 45 01 New gt Products Update PRD1598967 DATest_Bulk Update01 Update PRD1598966 DATest_Bulk Update02 Update PRD159896
23. IPINE BESILATE 5 MG TABLETS PRD484791 AMLODIPINE BESILATE 5 MG TABLETS PRD4848655 AMLODIPINE BESILATE 5 MG TABLETS PRD484676 AMLODIPINE BESILATE 5 MG TABLETS PRD484787 AMLODIPINE BESILATE 5 MG TABLETS PRD580607 CALCIUM C neo SLOVAKOFARMA PRD562098 BRONCHOSAN PRD591660 Calcium Sumiv SLOVAKOFARMA PRD518746 REPAGLINIDE ZENTIVA 2 MG COMPRIME If more than one thousand or zero values are in the preview then the background of the list is Shown in yellow Required products can be selected from the preview list using the standard selection methods To select a single item click on the item Use shift click to select a continual range of items Use control click to select a range of items with gaps in eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 14 59 4 2 6 List of filter fields available Table 1 below shows a list of all of the filter fields available along with key information about each field Table 1 Filter fields reference Filter Label Specific to Authorised Product Data Displayed Transition Start Date End Date Relinked by EMA Ingredient Product Control Attribute Type Searched All Products Simple List EMA specific data All Products Calendar Loading date All Products Calendar Loading date All Products Simple List EMA specific data All Products Compound Any substance Search
24. Page 5 59 Eudra w igiiance gt EVWEB Please select the initial of the Organisation ID gt xEVMPD Export AIBIC DIE FIG H IIT I KILIM IN O P Q RIS TI U VIW Y Z 0 9 EV Data Warehouse i eine Organisation Name Organisation ID Whichever way the tool is accessed the user will be presented with a standard password entry screen in which the EudraVigilance user name and password must be entered exactly as supplied set Note that if one already has an EVWEB session active on the same computer the authentication from this session is carried forward to the export tool thus this step is omitted If the user or organisation does not fulfil the access criteria described in the user access requirements section then one of a number of messages will be displayed and access to the tool will be denied Figure 2 Typical entry denial message O Ea aa accede Eudravigilance xEVMPD Bulk Update The Bulk Update is only available to Users of Organisations in the XEVMPD Human Community that have permission to Send xEVMPD Data Assuming authentication is successful the user may proceed as described in the following sections eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 6 59 3 Overview of the bulk update manager tool The process for using the tool at its simplest level can be summarised as follows Figure 3 Bulk update manager process 1 Create the 2 Define 3 Gen
25. Remove Action Eudravigilance xEVMPD Bulk Update pdassep VB change MAH and QP 2014 10 22 17 29 39 01 pdassep AAA HUMAN PRODUCTION V 7 9 0 A Add new Action For every Product selected execute the Changes Create Filter Remove Action z Authorised Product Authorisation Assign Value Full application Article 8 3 of Directive No 2001 83 EC Remove Change Create Change Add new Action Legal Basis For every Product selected where this is true Authorised Product Authorised Pharmaceutical Forms Authorised Pharmaceutical Form Is Missing Remove Filter then execute the Changes Create Filter Remove Action Authorised Product Authorised Pharmaceutical Forms Authorised Pharmaceutical Form Add Pharmaceutical Form EV Code PF123456 Remove Change Create Change Add new Action For every Product selected execute the Changes Create Filter Create Change Figure 5 Example 2b Set second authorised pharmaceutical form O EUROPEAN MEDICINES AGENCY Ne MEDICINES HEALTH Actions Remove Action Eudravigilance xEVMPD Bulk Update pdassep VB change MAH and QP 2014 10 22 17 29 39 01 pdassep AAA HUMAN PRODUCTION V 7 9 0 A Add new Action For every Product selected execute the Changes Create Filter Remove Action Add new Action For every Product selected where this is true Authorised Product Authoris
26. aici Reset Section Clear ol Remote Impo Num Name NumvCount__ Type Date Run to Excel Fies pdassep AAA Change of QPPV 2014 11 04 13 52 29 01 2014 11 04 15 13 29 Buik Update i TY 0003 pdassep AAA 2014 11 04 _13 48 38 01 FOLDER 2014 11 04 13 48 36 E eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 48 59 NOTE If your folder is not listed refresh the section 12 Double click on the folder name The New and Original subfolders will be displayed Type 0001 FOLDER 0002 New FOLDER 2014 11 04 15 13 29 0003 Org FOLDER 2014 11 04 13 52 27 13 Double click on the New subfolder The relevant XML file will be displayed XML 2014 11 04 15 13 29 00002288 0002 pdassep AAA Change of QPPV_2014 11 04_13 52 29 01 0001 xml 1 1 14 Press Remote I mport to view the content of the XEVPRM file Create and Send ICSRs Create and Send Acks ICSRs Create and Send Product Reports Medicinal Products MedDRA o Reset Application Reset Section Clear Local Import CEAk Reload El Imported Messages 1 hie Name Value _ Authorised Products 23 er XEVPRM b m ei Message Number 0001 La Outbox RS Run to Excel Fil Original Sender AAA j ER Message Date 04 11 2014 13 52 31 Bulk Update Authorised Products 23 Archive 15 To reload the XEVPRM to your Create and Send Product Rep
27. ain only those values in use within the products of the organisation HQ of the logged in user but refresh must be clicked on in order to show the values e The list of presented values takes no account of the values selected in any other filter control e There is a limit of 50 values presented in each list whether the search box contains a value or not If this number is exceeded then the background colour of the list becomes yellow as shown in the example above e Once loaded the list may be ordered by either EV Code or text value using the order boxes to the right e The presented list can itself be filtered using the search box at the top of the control area see Figure 8 The search can be based on either EV Codes or names text Multiple values can be separated by use of the pipe character Any value can use the wildcard character in any position in the string eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 11 59 Figure 9 Search tips for compound controls using special characters in searching Use of wildcard and pipe character Ingredient SUB 127 A TOCOPHEROL SUB12705MIG ACACIA SUB12730MIG ACETYLSALICYLIC ACID After entering search string click fefresh to perform the search e For situations where it is not possible to create a single list within a field e g where more than fifty values are required or when it is not possible
28. al Products MedDRA al Reset Rese Section Clear o Remote Import T e Num Name o NumCount Type Date gt Run to Excel Files FOLDER pdassep AAA MAH and MedDRA 2014 11 04 15 39 16 01 2014 11 04 16 02 31 Bulk Update 0003 pdassep AAA Change ofQPPV_2014 11 04_13 52 29 01 FOLDER 2014 11 04 15 13 29 a Archive 0004 pdassep AAA 2014 11 04_13 48 38 01 FOLDER 2014 11 04 13 48 36 NOTE If your folder is not listed refresh the section 17 Double click on the folder name The New and Original subfolders will be displayed Name Num Count ype 000i FOLDER 0002 New FOLDER 2014 11 04 16 02 31 0003 Org FOLDER 2014 11 04 15 39 18 18 Double click on the New subfolder The relevant XML file will be displayed Create and Send ICSRs Create and Send Acks WEB Trader ICSRs Create and Send Product Reports Medicinal Products MedDRA 2 Reset ae Reset Section Clear Remote import o pNum Name NuvCount Type Date 0001 FOLDER 0002 pdassep AAA MAH and MedDRA 2014 11 04 15 39 16 01 0001 xml 1 1 X 2014 11 04 16 02 31 00002439 E Archive 19 Press Remote I mport to view the content of the XEVPRM file Create and Send ICSRs Create and Send Acks Create and Send Product Reports Medicinal Products MedDRA o Reset Application Reset Section Clear Local import Create Ack Reload E Imported Messages 1 n uae Haa Description Name Value Authoris
29. and as such these should not be used if development products are expected in the import as there is no circumstance where the use of these filter can yield development products Where this is the case it is indicated in Table 1 eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 12 59 4 2 4 Free text compound controls There are a number of filter controls where the only value searched is the value in a text box but a results list below the control previews the values that would be found by the typed filter condition In the example in Figure 10 the user has prepared a filter which returns every product with any name beginning with CLA a second filter with the text CLE any name beginning with CLE and a third which was prepared using the same CLE search and then clicking on one particular result in the list after clicking refresh In this case the combined filters set for any product name would be any name starting with CLA OR any name starting with CLE OR CLEXANE 2000 UI ANTI XA 0 2ML PFS NOTE Only the value in each clear text box is used for the filter To search for a specific term use the text box to enter a term using wild cards or if necessary and click the refresh button The preview list may be ordered by text by use of the text box to the right If the specific term is seen in the preview list then that value can be transferred to the text box by clicking on it
30. ange Adds a new sub Action Create Change Section dropdown This contains the various sections in relation to the xEVMPD hierarchy data structure Note some of the sections are repeated with a plural e g Attachment and Attachments This is to differentiate between where the change is to be applicable to values within the section or to check for the existence of entries in the section For further details on this refer to Example 3 Modifying a current value for a repeatable section eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 29 59 Figure 25 Section dropdown Choose a Section Choose a Section Authorised Product Authorised Product Attachment Authorised Product Attachments Authorised Product Authorisation Authorised Product Authorisation Medicinal Product Type Authorised Product Authorisation Medicinal Product Types Authorised Product Authorised Pharmaceutical Forms Authorised Product Drug ATC Authorised Product Drug ATCs Authorised Product Drug Indication Authorised Product Drug Indications Authorised Product Pharmaceutical Product Authorised Product Pharmaceutical Product Active Ingredient Authorised Product Pharmaceutical Product Active Ingredients Authorised Product Pharmaceutical Product Adjuvant Authorised Product Pharmaceutical Product Adjuvants Authorised Product Pharmaceutical Product Drug Routes Auth
31. armaceutical Product Excipients Authorised Product Pharmaceutical Product Medical Device Authorised Product Pharmaceutical Product Medical Devices Authorised Product Pharmaceutical Product Route of Administration Authorised Product Pharmaceutical Products Authorised Product Presentation Authorised Product Previous EV Code Authorised Product Previous EV Codes 7 Choose an Element which you wish to change Authorised Product Choose an Element m Choose an Element Operation Type Comments Info Date MAH Master File Location PhV enquiry email Ph V enquiry Phone 8 Choose an Action you wish to perform on the selected element eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 47 59 Authorised Product OPPV Choose an Action cal Change Remove Change Create Change 9 Specify which value should be changed Authorised Product OPPV BE Change From 10149 22 f To 15525 Remove Change Create Change 10 Click on Bulk Update at the bottom of the page Title Bulk Update A message with the Bulk Update result will be displayed A Result Bulk Update completed successfully 11 Go to EVWEB section Web Trader subsection Bulk Update and retrieve your folder Create and Send ICSRs S Create and Send Acks a CSRs Create and Send Product Reports Medicinal Products mea DRA 2 Reset
32. combination of filters has between one and two hundred products affected then it will be necessary to load two sets of products into EVWEB for submission the first containing 100 products and the second the remainder In this case when preparing to load the files in EVWEB for final editing and submission the user is eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 35 59 presented with two files with the following naming convention e g MyProductExport_1 6 2014 1 xml AND MyProductExport_1_ 6 2014 2 xml 5 The user can then a Double click a single file which allows the user to view the xml message generated from the bulk update b Select the Remote Import button for a single file which will import the file generated from the bulk update into EVWEB i The user then clicks the Reload button which will load the file into the Create and Send Products section Note For files containing large numbers of products gt 40 this loading stage may take up to 5 minutes 6 Once the products are loaded the user may edit any data as normal in EVWEB validate the products and submit the message 8 10 Practical Examples 8 10 1 Example 1 User wishes to invalidate medicinal products In this example the user has decided to prepare a set of products for which he needs to invalidate the MA because he did not submit the MA for renewal as per below Figure 1 Examp
33. ct set These actions must be carried out sequentially i e one after the other moving down the screen A user can specify as many action sets as required To add an Action set the user can select the Add new Action button by doing so the user is presented with the entire new Action set with blank values as detailed below Figure 30 Adding Removing Action sets gt pdassep AAA Actions HUMAN PRODUCTION V 7 12 1 Add new Action Action set 1 lt For every Product selected execute the Changes _Create Change Create Filter Add new Action For every Product selected execute the Changes Create Change Create Filter Action set 2 Add new Action Create Change Action set 3 For every Product selected execute the Changes Create Filter To remove an Action set the user can select the Remove Action button By doing so the section is removed Note If any criteria has been entered in either the condition or change section this will be cleared and lost without prompting the user for confirmation of removal eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 32 59 8 8 Confirming generation of Bulk Update Once all applicable actions have been entered the user generates an updated product set by clicking the Bulk Update button The system responds by performing the requested updates and upon successful completion presents the user with th
34. ditions set in the Conditions section e Action set Both the conditions and changes areas may be repeated within the interface to allow the user to define a set of actions which must be carried out in series i e one after the other moving down the screen A user may set as many conditions as required and as many changes as required within each action set e Bulk Update Button Once the user is satisfied that all action sets have been defined this button will perform the bulk update operation and generate the edited data for the product set based on the specified action sets eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 26 59 8 3 Conditions screen section The general layout of the condition section of the screen is presented as follows Figure 19 Conditions Screen page For every Product selected where this is true Section Authorised Product Element lt EVCode Is z gt Predicate Value lt PRD1598966 1 Remove current condition lt _ Remove Filter then execute the Changes Create new condition lt Create Filter e Section dropdown This contains the various sections in relation to the xEVMPD hierarchy data structure NOTE Some of the sections are repeated with a plural e g Attachment and Attachments This is to differentiate between where the condition is to be applicable to values within the section or to check
35. e a Section Authorised Product Authorised Product Attachment Authorised Product Attachments Authorised Product Authorisation Authorised Product Authorisation Medicinal Product Type Authorised Product Authorisation Medicinal Product Types Authorised Product Authorised Pharmaceutical Forms Authorised Product Drug ATC Authorised Product Drug ATCs Authorised Product Drug Indication Authorised Product Drug Indications eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 42 59 As a result the user can only use the action type Add or Remove as these are the only applicable actions The user can then choose to add a new indication and remove any unwanted indications as displayed below Figure 7 Example 4a Add and remove in simple repeatable sections Add new Action Authorised Product Drug Indications Drug Indication l Add MedDRA Code 10041480 Remove Change Authorised Product Drug Indications Drug Indication Remove MedDRA Code 10041458 SPECT 1 l Remove Change 8 10 5 Example 5 Replacing the value in non repeatable fields This example deals with replacing or adding a value in a single non repeatable field i e QPPV product short name company name etc In this example the scenario presented is a change of QPPV pharmacovigilance contact email and telephone Figure 8 Example 4 Simple replacem
36. e following confirmation message Figure 31 Bulk Update confirmation Message from webpage A Result Bulk Update completed successfully 8 9 Confirming amp validating the submission of Bulk Update via EVWEB Once the user has generated the updated product set from the Bulk Update a series of files will then become available in a new folder in the WEB Trader area of EVWEB as displayed below 8 9 1 General Layout of screens Figure 32 EVWEB bulk update parent folder view Display Settings v Create and Send ICSRs Create and Send Ac wee Trader D SRs Create and Send Product Reports Medicinal Products MedDRA 2 o Reset Application Reset Section Clear Imported Messages AAA pdassep_AAA Change of MAH_360_vb_2014 10 28_16 31 45 01 New psa Num Name 0 N UM Count Type Date Size pdassep_AAA_Change of MAH_360_vb_2014 1 FOLDER 2014 10 28 16 40 12 pdassep_AAA MAH2_2014 10 28_14 00 38 01 FOLDER 2014 10 28 14 00 45 pdassep_AAA MAH2_2014 10 28_13 43 36 01 FOLDER 2014 10 28 13 43 37 pdassep AAA MAH2_2014 10 28_13 43 17 01 FOLDER 2014 10 28 13 43 17 pdassep AAA MAH2_ 2014 10 28 13 43 02 01 FOLDER 2014 10 28 13 43 02 pdassep AAA MAH2_ 2014 10 28 _13 34 33 01 FOLDER 2014 10 28 13 34 35 pdassep AAA MAH1_2014 10 28 13 32 29 01 FOLDER 2014 10 28 13 32 50 pdassep AAA 2014 10 28 _13 31 13 01 FOLDER 2014 10 28 13 31 39 pdassep AAA 2Altvenproducts_2014 10 28_ 12 FOLDER 2014 10 28 12 49 34 pdassep AAA My4prod
37. e system previews the number of products that will be included in the product set if this number is zero the request will be rejected if the number is not zero then the request joins the export queue and may be seen in the Request Monitoring Area described in section 6 eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 21 59 6 Monitor the progress of pending requests Once a request has been received by the system and until it is ready for download it can be seen in the request monitoring area This area shows all requests which are pending for all users with the same HQ as the logged in user The area is shown below Figure 15 The request monitoring area Queued momentarily Request Title Status Requested on 21 10 2014 14 52 Bulk Decoded Queued momentarily The monitoring and download area must be manually refreshed using the refresh lists button in the request submission area The table of pending requests contains four columns thus e Request Title The name of the request note this example shows the default name the formats chosen and demonstrates why it is a good idea to name your requests for easier reference later e Size This is a count of the number of products to be included in the product set Ifthe status is In Progress the figure in brackets shows the progress through this number of products e Status This is either In Progr
38. ed Pharmaceutical Forms z Authorised Pharmaceutical Form Is Missing Remove Filter then execute the Changes Create Filter Remove Action z Authorised Product Authorisation Legal Basis Assign Value Full application Article 8 3 of Directive No 2001 83 EC Remove Change Create Change Authorised Product Authorised Pharmaceutical Forms Authorised Pharmaceutical Form Add Pharmaceutical Form EV Code PF123456 Remove Change Create Change LARI Add new Action For every Product selected where this is true Authorised Product Authorised Pharmaceutical Forms z Authorised Pharmaceutical Form Is Missing Remove Filter then execute the Changes Create Filter Bulk Update Title Authorised Product Authorised Pharmaceutical Forms Authorised Pharmaceutical Form Add Pharmaceutical Form EV Code PF654321 Remove Change Create Change A similar set of additions would also be required for the medicinal product types fields depending on the values required within the product set eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 41 59 8 10 3 Example 3 Modifying a current value for a repeatable section This example describes the process whereby a user wishes to modify a current repeatable value such as replacing the current drug indication with ano
39. ed Products 25 gt Message Type AEVPRM H Inbox Message Number 0001 fee Outbox E CR Excel Fil Original Sender AAA m EE Message Date 04 11 2014 15 39 22 Bulk U pdate Authorised Products 25 Archive eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 54 59 20 To reload the XEVPRM to your Create and Send Product Reports section click on the Reload button Your XEVPRM will be displayed in your Create and Send Product Reports section Create and Send ICSRs Create and Send Acks WEB Trader ICSRs Create and Send Product Reports Medicinal Products o Reset Application Reset Section Clear Replicate validate Send XML z RTF Remove E E R E XEVPRM Message A FI Products Update PRD480105 C H U pdate PRD480106 C i l lndate PRANAANIAT f Name Value So EV Code ogee R iis Operation Type Update 2 In all AMP entities which previously referenced ORG3190 the MAH has been updated to ORG1233 In those AMP entities which previously referenced MedDRA version 15 MedDRA version 17 1 is now referenced You can now further amend the individual product entities validate and send the XEVPRM eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 55 59 10 3 Step by Step Guide Addition of an Authorised Pharmaceutical Form and change of the
40. edicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 58 59 Type 0001 0002 New FOLDER 2014 11 04 13 19 11 0003 Org FOLDER 2014 11 04 12 56 40 13 Double click on the New subfolder The relevant XML file will be displayed Mum Name Oaa NumCount Type Date Size 0001 FOLDER 0002 pdassep AAA Pharm Form change_ 2014 11 04 _12 56 40 01 0001xml 1 1 AML 2014 11 04 13 19 11 00001583 14 Press Remote I mport to view the content of the XEVPRM file Create and Send ICSRs Create and Send Acks WEB Trader ICSRs Create and Send Product Reports Medicinal Products MedDRA o Reset Application Reset Section Clear Remote import o SS Num Name NuiCourt 0001 FOLDER 0002 pdassep AAA Pharm Form change 2014 11 04 12 58 40 01 0001 xml 1 1 XML 2014 11 04 13 19 11 00001583 a Archive 15 To reload the XEVPRM to your Create and Send Product Reports section click on the Reload button Your XEVPRM will be displayed in your Create and Send Product Reports section where you can further amend the individual product entities validate and send the XEVPRM Create and Send ICSRs Create and Send Acks ICSRs Create and Send Product Reports Medicinal Products MedDRA ol Reset Application Reset Section Clear Replicate validate Send XML z RTF Remove E L R E XEVPRM Message ee Description NameValue O O OoOo O au oda
41. ent on single non repeatable fields Add new Action Authorised Product Ph enquiry Phone Change From 33450993070 1 To 33 45099 30 80 Remove Change Authorised Product OPPV Change From 10149 1 To 10250 Remove Change Authorised Product PhV enquiry email Change From pharmacovigilance adacap com 1 To fred mahname com Remove Change eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 43 59 9 Quick reference guide 9 1 Quick Guide The steps required to prepare an export are as follows N aai eae 9 2 Log on to https eudravigilance ema europa eu evmpdex bulkmanager asp Using the fields in the filter section prepare a product set which targets the products required for the bulk update Most controls behave very similarly to those in EV WEB See section 4 Submit the request to create the product set and give the request a title See section 5 Monitor the queue until the request is completed See section Elect to perfom the bulk update on the product set as per section 7 Define the bulk update operations for the conditions See section 8 3 Define the bulk update operations for the actions See section 8 5 Confirm submission of bulk update See section 8 7 Confirm amp validate submission of bulk update via EV WEB See section 8 8 FAQs 9 2 1 User Access 4 Where is the bulk
42. erate 4 Confirm amp product set for appropriate edited data for validate 5 System updates xEVMPD products that editing rules for product set via submission via EV repository require updating product set Bulk Update Tool Web 1 The user queries the xEVMPD data for their products to create a product set this defines the range of products for which the bulk updates are to be performed on 2 The user then defines the conditions and actions for key data fields that are required to be updated from the defined product set 3 The user generates an updated product set containing the pre configured data via the Bulk Update Manager Tool 4 The user validates and submits the data via EVWEB 5 The EV system updates the xEVMPD repository to reflect the changes from the bulk update operation The query screen is presented below and contains four main functional areas Figure 4 The bulk update manager query screen O ooo a Eudravigilance xEVMPD Bulk Update Manager Filt Se ere ae tne ag ers er Name is highlig er is valued The Active Filters section will display the Valued Filters and allow to disable them HUMAN PRODUCTION V 7 8 1 Transition Start Date End Date Relinked by EMA Authorised Development Ingredient Qu ery Pharmaceutical Form e a ATC Code Build Ing Indication MedDRA Code MAH Sponsor QPPV Master File Location Owner Organisation Authorisation Country Code Authorisation Procedure Active Filters Poa ee
43. ess or Queued The text after the status provides an estimate of when the export may be complete This estimate takes into account the number of products the total number of products to be exported in the queue and the average performance of the system for the format of export that each request ahead in the queue requires Note momentarily means within the next minute e Cancel Button If a mistake in the filters set or other request parameter is identified please use this button to cancel the request Please remember that each request is dealt with in turn and unnecessary or erroneous requests delay every user s requests When a request is completed either successfully or because of a failure then the record is moved to the download area the next time that the Refresh Lists button is clicked the use of the download area is described in the following section On occasions exports may be queued for some time this is because each request is dealt with in turn Figure 14 below shows the monitoring area from point of view of two unrelated users one MAH 2 has a request for 3000 products in progress whilst the other MAH 1 is next in the queue eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 22 59 Figure 16 The request monitoring area from two different user s point of view What MAH 1 sees What MAH 2 sees Note Click the Refresh List button in
44. fer a preview value to the text box click on the value required e If either more than fifty or zero values are returned by the refresh action then the background colour of the list is yellow e Some fields are exclusive to authorised products and as such these should not be used if development products are expected in the import as there is no circumstance where the use of these filter can yield development products Where this is the case it is indicated in Table 1 4 2 5 The preview field This is a special filter field which unlike all the other filter fields can be updated to show a preview of the first 1000 products that fulfil all of the criteria set in the other fields and its own filter text This list eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 13 59 is used in a similar way to a compound field but without the opportunity to replicate the field The field functions as a preview or final filter before requesting the export Figure 12 Use of the preview list field Preview List PRD428436 CALSYN 200 Load Clear PRD531633 SPOFAX Filter on EV Code The list is loaded using all the other Filters PRD531634 Spofax Up to a 1000 EV Codes will be loaded PRD484627 AMLODIPINE BESILATE 5 MG TABLETS Order Code C Text Multiple selection list PRD484521 AMLODIPINE BESILATE 5 MG TABLETS PRD484577 AMLODIPINE BESILATE 5 MG TABLETS PRD484615 AMLOD
45. for the existence of entries in the section For further details refer to Example 3 Modifying a current value for a repeatable section Figure 20 Section dropdown For every Product selected where this is true Choose a Section Choose a Section Authorised Product ised Product Attachment thorised Product Attachments orised Product Authorisation thorised Product Authorisation Medicinal Product Type orised Product Authorisation Medicinal Product Types Authorised Product Authorised Pharmaceutical Forms Authorised Product Drug ATC Authorised Product Drug ATCs ised Product Drug Indication ised Product Drug Indications thorised Product Pharmaceutical Product orised Product Pharmaceutical Product Active Ingredient Authorised Product Pharmaceutical Product Active Ingredients Authorised Product Pharmaceutical Product Adjuvant Authorised Product Pharmaceutical Product Adjuvants Authorised Product Pharmaceutical Product Drug Routes Authorised Product Pharmaceutical Product Excipient Authorised Product Pharmaceutical Product Excipients Authorised Product Pharmaceutical Product Medical Device Authorised Product Pharmaceutical Product Medical Devices Authorised Product Pharmaceutical Product Route of Administration Authorised Product Pharmaceutical Products Authorised Product Presentation Authorised Product Previous EV Code Authorised Product Previous EV Codes eX
46. gredient Pharmaceutical Form Active expanded Authorised Development Authorised Development controls Active Relinked by EMA contracted controls Authorised Development Active Filters eae on the Name of the Filter to disable enable Relinked by EMA Type Request Area Active Filters a on the Name of the Filter to disable enable Relinked by EMA Fype eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 9 59 Table 1 shows the filter fields available and key facts about these fields 4 2 Types of query building control As will be seen there are a number of different fields that can be set as filters The type of presented filter differs between fields but is one of the following types 4 2 1 Date controls Calendar controls are used where appropriate the control is accessed by clicking in the box when the field is expanded Figure 6 Use of a calendar control Start Date Date of the Last Update Close End Date October 2014 Relinked by EMA Tue Wed Thu 1 2 Authorised Development 7 8 9 Ingredient 23 Pharmaceutical Form ATC Code To select a date click on the number in the calendar To change the year use the double arrows and to change the month use the single arrows If a date is selected and appears in the box above the calendar then this may be cleared by clicking the clear button to the right of the expanded section
47. ilter This clears and removes the condition for the specific condition set e Create Filter This adds a new condition eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 28 59 8 4 Steps to create a condition The steps required by a user to create a condition are as follows 1 3 5 Click the Create Filter button to allow for the selection of a section to be used to formulate the condition Select a section from the drop down list Depending on the selection the system displays and prepopulates the data elements dropdown Select a data element from the drop down list Depending on the selection the system displays and prepopulates the predicate dropdown Select an appropriate predicate from the default values Depending on the selection the system displays and prepopulates the value dropdown If applicable enter the value for which the condition must be satisfied The user has now completed entering a single condition Should the user wish to specify additional conditions the user may click the Create Filter button and follow the same steps as described here Changes screen section The general layout of the change section is presented as follows Figure 24 Changes screen section Section Authorised Product 7 Element appv Change Action Type Old Value lt From EEE To New value Enter a value Remove current sub Action _Remove Ch
48. ilter as indicated in the strikethrough text ingredient in the Active Filters area Note that the ingredient filter field label text remains blue Figure 14 Activate or deactivate set filters Relinked by EMA Clear Products affected by the Data Cleaning activities of EMA Ingredient Copy New i SUB13730MIG ETHANOL Refresh Clear Subst A a E A E N SUB121173 WATER FOR INJECTION PH EUR Multiple selection list SUB12585MIG SODIUM HYDROXIDE SUB03087MIG MANNITOL SUBO00001MIG UTIBAPRILAT Order Code E Text Pharmaceutical Form ATC Code Indication MedDRA Code MAH Sponsor QPPV Master File Location p E l l Click on the Name of the Filter to Active Filters easke aire Relinked by EMA agredient Title Count Count Request Refresh List To reactivate the ingredient filter the t gredtent text should be left clicked once Having decided on the active filters to apply for the export the user should proceed to setting the output format as described in 5 1 3 5 1 3 Making a request to create the product set Having set all required active filters and setting the output format the user may optionally set a title for the product set request to make it easier to identify later and proceed to submitting the request by clicking the request button in the requesting area If the title is not set then it will default to the user name and date Upon clicking the request button th
49. ing no filter for a field gives better system performance than setting all of the values within the field e In some cases the control may appear empty even after using the refresh button when this occurs the background of the list will appear yellow The situation arises when the Organisation HQ of the logged in user does not have any products which contain one of the values that could be in the list i e if an organisation only has development products in the xEVMPD and the authorisation status filter is being used e Some fields are exclusive to authorised products and as such these should not be used if development products are expected in the import as there is no circumstance where the use of these filter can yield development products Where this is the case it is indicated in Table 1 4 2 3 Compound search fields In cases where the values represent entities in the xEVMPD i e pharmaceutical form and for all product name fields then the compound search controls are used to set filters Figure 8 Use of a compound search control Ingredient Copy New Substances referenced in Product Ingredients ahaaa biped eden Seepage aap z Refresh Clear SUB00875MIG BROMHEXINE HYDROCHLORIDE Mitt eceancne R SUB13276MIG CEFOTAXIME SODIUM SUB03581MIG OXYBUTYNIN HYDROCHLORIDE Order Code Text SUB20777 VINORELBINE TARTRATE Notes for use of compound search controls e The list is automatically filtered to cont
50. isplay Settings X Create and Send ICSRs Create and Send Acks WEB Trader ICSRs Create and Send Product Reports Medicinal Products o Reset Application Reset Section Clear Remote Import o AAA pdassep_AAA_Change of MAH_360_vb_2014 10 28_16 31 45 01 0002 New FOLDER 2014 10 26 16 40 15 Bulk Update 0003 Org FOLDER 2014 10 28 16 31 51 f Archive Figure 34 EVWEB bulk update file view Display Settings Create and Send ICSRs eate and Send Acks WEB Trader ICSRS Create and Send Product Reports Medicinal Products MedDRA Run to Excel Files pdassep AAA Change of MAH 360 vb 2014 1 2014 10 28 16 40 15 00012079 Bulk Update pdassep AAA Change ofMAH 360 vb 2014 1 2014 10 28 16 40 14 00007295 Archive pdassep AAA Change of MAH_ 360 vb 2014 1 2014 10 28 16 40 14 00012142 pdassep AAA Change of MAH 360 vb 2014 1 2014 10 28 16 40 13 00012144 Figure 35 EV WEB bulk update Import Display Settings 5 pdassep AAA HUMAN PRODUCTION V 7 12 1 Create andSendICSRs Create and Send Acks WEB Trader ICSRs Create and Send Product Reports Medicinal Products o Reset Application Reset Section Clear Local Import Create Ack Reload X Ei Imported Messages 1 gt AAA pdassep_AAA_Change of MAH_360_vb_2014 10 28_16 31 45 01 New D r r amp Authorised Products 100 Message Type XEVPRM Update Authorised PRD1598967 DATest_Bulk Update01 Message Number 0001 4 Upda
51. ission of this data to the xEVMPD repository This document describes the use of this tool by system users other than the European Medicines Agency EMA This document is divided into eight main sections which reflect the flow of use of the tool as follows e Section 2 describes how to access the bulk update manager tool e Section 3 provides an overview of the use of the tool e Section 4 describes in detail the process of setting query filters in preparation for creating a product set e Section 5 describes how to submit a request e Section 6 describes how to monitor the progress of a pending request e Section 7 describes how to deal with downloading a completed request e Section 8 describes in detail the use of the Bulk Update operations e Section 9 is a quick reference guide and answers frequently asked questions eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 4 59 2 Accessing the bulk update manager tool 2 1 User access requirements The bulk update manager tool is open to any user fulfilling all of the following criteria e Isa member of an Organisation registered by the EudraVigilance Registration Team in the production environment Ifthe user s organisation has been able to submit product messages successfully this is already the case e The registered organisation is a member of the EV Human xEVMPD community Ifthe user s orga
52. ist is restricted to only those values that are used in any authorised product which is owned by any organisation with the same HQ as the logged in user On clicking refresh the list is restricted to the first 50 values that are used in any product name field for any product which is owned by any organisation with the same HQ as the logged in user and which fulfils the search criteria in the control text box On clicking refresh the list is restricted to the first 50 values that are used in the product name field for any product which is owned by any organisation with the same HQ as the logged in user and which fulfils the search criteria in the control text box eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 18 59 Filter Label Product Attribute Searched Control Type Specific to Authorised Product Data Displayed Short Name Authorised Free Text YES List of Names On clicking refresh the list is restricted to the first 50 values product Short Compound l that are used in the authorised product short name field for Authorised Product l o SERA name Search any authorised product which is owned by any organisation Short Name l I l l with the same HQ as the logged in user and which fulfils the search criteria in the control text box Generic Name Authorised Free Text YES List of Names On clicking refresh the list is restricted to the first 50 values product
53. le la preparing a bulk invalidate medicinal product message eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 36 59 xEVMPD Bulk Update Windows Internet Explore Eudravigilance xEVMPD Bulk Update pdassep VB change MAH and QP 2014 10 22 17 29 39 01 O EUROPEAN MEDICINES AGENCY SCIENCE MEDICINES HEALTH pd Actions HUMAN PRODUCTION V 7 9 0 Remove Action Add new Action For every Product selected execute the Changes Authorised Product Authorisation C Filter Authorisation Status Change From 1 Valid 24 To Not Valid Not Submitted for Renewal by Marketing Authorisation Holder Remove Change Create Change Title Bulk Update If we further suppose that there are two different invalidation dates which apply to the product set and there is a single piece of data which defines the differences The user can now go on to define different update rules for different subsets of the data as shown below eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 37 59 Figure 2 Example 1b Setting a value dependent on the value in another field xEVMPD Bulk Update Windows Internet Explore O EUROPEAN MEDICINES AGENCY Eudravigilance xEVMPD Bulk Update pdassep VB change MAH and QP 2014 10 22 17 29 39 01 Actions HUMAN Ts i oe A Remove Action Add new Action For every Prod
54. legal basis Eudravigilance xEVMPD Bulk Update pdassep VB change MAH and QP 2014 10 22 17 29 39 01 O EUROPEAN MEDICINES AGENCY pdassep AAA Actions HUMAN PRODUCTION V 7 9 0 Remove Action Add new Action For every Product selected execute the Changes Authorised Product Authorisation _Create Filter Legal Basis Assign Value Full application Article 8 3 of Directive No 2001 83 EC Remove Change Create Change Note that we have set the operation type to Assign and the legal basis for all of the products Note also that the action section contains a further Create change button this will always be added within each section as each action is added so that further actions can be taken at the same stage and if not selected as in this case will be ignored We now have a Set of instructions to add the legal basis to each of the products to the product set but clearly if the message were generated and submitted now it would fail validation because the authorised pharmaceutical form s and medicinal product type s are absent Assuming the scenario described in the introduction to this example the authorised pharmaceutical forms can be added as Shown below eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 40 59 Figure 4 Example 2b Set first authorised pharmaceutical form O EUROPEAN MEDICINES AGENCY Actions
55. lters in this section of the application If no filters are set then by default the following products will become available upon processing of the request e The current version of all authorised products last submitted or updated on or after 5 March 2012 under Article 57 business rules that is the responsibility of the logged on user s organisation headquarter organisation PLUS e The current version regardless of submission date of every authorised product that is the responsibility of the logged on user s organisation headquarter organisation When filters are applied each product that is returned must fulfil the criteria set in all of the fields with filters set however some fields offer the opportunity to prepare one or more lists of values in which case within this field only a product only needs to fulfil one of the selected criteria plus all the criteria set in the other filter fields in order to be included in the export Expansion and contraction of individual filter controls is toggled by clicking on the relevant field label If values have been set within a field then the label will be blue and the label or a shortened version of it will appear in the active filters area of the requesting area This sequence of events is shown for various filter fields below Figure 5 Different views of a filter field Transition Start Date Inactive End Date contracted Relinked by EMA controls Authorised Development In
56. ms 7 Authorised Pharmaceutical Form Add a Pharmaceutical Form EV Code PHFOO201MIG Remove Change Authorised Product Pharmaceutical Product Pharmaceutical Form EV Code Change From PHFOO201MIG Standard POWDER FOR SOLUTION FOR INJECTION 14 B To PHFOO231MIG Remove Change Create Change 10 Click on Bulk Update at the bottom of the page Title Bulk Update A message with the Bulk neon result will be shane A Result Bulk Update completed successfully 11 Go to EVWEB section Web Trader subsection Bulk Update and retrieve your folder Create and Send ICSRs Create and Send Acks EA ICSRs Create and Send Product Reports Medicinal Products MedDRA o Reset Application Reset Section Clear Remote Impc amp XEVPRM AAA 04 11 2014 10 14 34 Imported Messages 1 fra Num Name o oooO ooo oo NMCont _ Type _ Date 0001 FOLDER Outbox ta tes cal Filan pdassep AAA Pharm Form change 2014 11 04 12 58 40 01 FOLDER 2014 11 04 13 19 11 0003 pdassep AAA MAH change_2014 11 04_10 14 32 01 FOLDER 2014 11 04 11 10 06 0004 pdassep AAA 2014 10 30_15 06 49 01 FOLDER 2014 10 30 15 06 51 e Archve 0005 pdassep AAA Change ofMAH_360 vb 2014 10 28 16 31 45 01 FOLDER 2014 10 28 16 40 12 NOTE If your folder is not listed refresh the section 12 Double click on the folder name The New and Original subfolders will be displayed eXtended EudraVigilance M
57. nisation has been able to submit product messages successfully this is already the case e The user must be a recognised user associated with the registered organisation and must be in possession of a EudraVigilance user name and password e The user must have permission to send and view xEVMPD data in the EudraVigilance system e The user must belong to an MAH or sponsor organisation 2 2 System Requirements The bulk update manager tool is designed to work on machines operating under Windows 7 using Internet Explorer 8 IE8 or above Earlier versions of Windows Internet Explorer and other operating systems browsers will not receive support for the export tool should issues arise Note that if the export tool is used in IE8 it is necessary to disable compatibility mode for the browser as described here http windows microsoft com en gb internet explorer use compatibility view ie ie 8 2 3 Locating the bulk update manager tool The bulk update manager tool can be accessed directly via an IE browser at the following URL which may be bookmarked https eudravigilance ema europa eu evmpdex bulkmanager asp Alternatively the application may be accessed via the main EudraVigilance secure home page where a link will be found in the EV Services section at the top left hand corner of the webpage Figure 1 The EV Services frame eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014
58. ompleted Archive 5 Click on Open The Bulk Update operations page is now open Eudravigilance xEVMPD Bulk Update O EUROPEAN MEDICINES AGENCY pdassep AAA Change of QPPV 2014 11 04 13 52 29 01 pdassep AAA Actions HUMAN PRODUCTION V 7 12 1 Add new Action For every Product selected execute the Changes _Create Change Create Filter 6 Click on Create Change and select the section in which you wish to perform the change eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 46 59 Authorised Product Choose a Section Authorised Product Authorised Product Attachment Authorised Product Attachments Authorised Product Authorisation Authorised Product Authorisation Medicinal Product Type Authorised Product Authorisation Medicinal Product Types Authorised Product Authorised Pharmaceutical Forms Authorised Product Drug ATC Authorised Product Drug ATCs Authorised Product Drug Indication Authorised Product Drug Indications Authorised Product Pharmaceutical Product Authorised Product Pharmaceutical Product Active Ingredient Authorised Product Pharmaceutical Product Active Ingredients Authorised Product Pharmaceutical Product Adjuvant Authorised Product Pharmaceutical Product Adjuvants Authorised Product Pharmaceutical Product Drug Routes Authorised Product Pharmaceutical Product Excipient Authorised Product Ph
59. orised Product Pharmaceutical Product Excipient Authorised Product Pharmaceutical Product Excipients Authorised Product Pharmaceutical Product Medical Device Authorised Product Pharmaceutical Product Medical Devices Authorised Product Pharmaceutical Product Route of Administration Authorised Product Pharmaceutical Products Authorised Product Presentation Authorised Product Previous EV Code Authorised Product Previous EV Codes e Element dropdown This contains the various data elements available within the elected section in relation to the xEVMPD hierarchy data structure Figure 26 Element dropdown Authorised Product Presentation Choose an Element Choose an Element Full Presentation Name Package Description Product Company Name Product Form Name Product INN Common Name Product Short Name Product Strength Name e Change Type dropdown This details the type of change to be applied on the Action set Figure 27 Change Type dropdown Choose an Action 7 Choose an Action Prepend Append Change Assign Remove eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 30 59 The following is a complete list of the available values which may be selected only a subset of these will be available depending on the element selection o Change This type of action will search for a specific value in the specified data element and replace this
60. orts section click on the Reload button Your XEVPRM will be displayed in your Create and Send Product Reports section Create and Send ICSRs Create and Send Acks WEB Trader ICSRs Create and Send Product Reports Medicinal Products o Reset Application Reset Section Clear Replicate validate Send XML ZIP RTF Remove E E RI E XEVPRM Message P Description NameValue O O OoOo O HU pdate PRD480107 Description Name Value i i T i j f _ E Update PRD480108 eee fal Indate PRNAANANG ae ee The QPPV in each AMP has been changed and contains the new value i e QPPV Code 15525 You can now further amend the individual product entities validate and send the XEVPRM eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 49 59 10 2 Step by Step Guide Change of MAH and MedDRA version In this example we will perform the following actions e For any product referencing an MAH organisation with EVCode ORG3190 We will change the MAH to reference ORG1233 and Ifan older MedDRA version is referenced i e 15 in any of these entities we will also change the referenced MedDRA version for the latest available MedDRA version 17 1 1 Create a Filter MAH Sponsor ORG3190 Copy New ORG3190 GIPHARMA IT TORINO Refresh Clear MAHs or Sponsors referenced in Products Lookup Filter on Name and E e
61. pace 4 have extracted an export and there are many xml files why a The limit of the number of products within any one xml file is 100 since you requested more products than this you have many files each containing a maximum of 100 files in your zip file eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 45 59 10 Annex 10 1 Step by Step Guide Change of QPPV In this example we will perform the following action e Fora pre defined set of AMPs we will change the currently referenced QPPV Code 10149 to another QPPV Code 15525 1 Create a Filter EV Code PRD507683 PRD507687 PRD507688 PRD507684 PRD507686 PRD507682 PRD747510 PRD747511 PRD7 Refresh Clear Free Text Filter on EV Code Allows pipe separated list Press Enter or Refresh to test the filter Click on an EV Code to add it pipe separated to Order Code Text the Free Text Filter 2 Enter the Title of your request and perform Count to display the number of entities for which you will perform the bulk update Active Filters ai on the Name of the Filter to disable enable FV Code Title Change of QPPV 23 Refresh List 3 Click on Request Change of QPPV on 04 11 2014 13 52 Bulk Decoded 23 Queued momentarily Cancel 4 Click on Refresh List Your request is now loaded in the download area Change of QPPV on 04 11 2014 13 52 Bulk Decoded 23 269 KB C
62. r IDs that have submitted products and which have message the same HQ as the logged in user SenderlD Name S oe sender ID Authorisation Authorised Simple List YES List of Countries On clicking refresh the list is restricted to the first 50 Country Code product countries that are used in any authorised product which is Authorisation country Country Code Name owned by any organisation with the same HQ as the logged in user eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 17 59 Filter Label Product Control Specific to Authorised Product Attribute Type Searched Data Displayed Authorisation Procedure Authorisation Status Any Product Name Full Name Authorised Simple List YES product Authorisation procedure Authorised Simple List YES product Authorisation Status All products Free Text NO Any name Compound Search Authorised Free Text NO product Full Compound presentation Search name Development product Name List of Authorisation Procedures Procedure name List of Authorisation Statuses Status name List of Names List of Names Authorised Product Name Development Product Name On clicking refresh the list is restricted to only those values that are used in any authorised product which is owned by any organisation with the same HQ as the logged in user On clicking refresh the l
63. r values used in many thousands of products Loading all of this data when it might not be needed to prepare the export would slow the application down Why are some labels blue a These indicate filters where a selection has been made eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 44 59 4 used a filter and its label is not blue why not a Although you visited a filter you have not selected any of the presented values therefore the filter is not used 5 My filter is blue but it doesn t make any difference to the results count or preview why not a It is possible that the filter is inactivated check that the filter label is not in Strikethrough text in the Active Filters area b It is possible that other filters prevent a particular filter from making the expected difference try making some filters inactive in the Active Filters area to see the effect on the export count 6 have set the filters that think need but the product count is zero or not what expected what could cause this a You may have set filters which mean that no product can fulfil all of the filter fields try making some inactive in the Active Filters area to see the effect on the export count 9 2 3 Requesting an Product set 1 Why won t the system accept my request a The combination of filters that you have made excludes all of your products 2 Why should I bother to give my
64. ribed in the following section Having obtained the required number of products the user should proceed to making a product set request as described in 5 1 3 5 1 2 Temporarily remove filters The active filters area is supplied to allow users to experiment with the filters that are applied without recourse to clearing filter field values it achieves this by listing all active filter fields and allowing the user to toggle whether or not each field is used in the preview list count and final submission To deactivate or activate any active filter simply click on the corresponding label in the active filter list as required If the active filter list text relating to a field is shown in normal text then it is active being applied to the count Preview List and final export conversely if it shown in strikethrough text then all filters in this particular field are not applied to these three functions Note that all of the selected values in a deactivated filter are ignored even if the filter has many repeats in the case of a complex search filter Note also that for the purpose of saving space some names are abbreviated eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 20 59 In the example below the user has set filters for Authorised Development abbreviated to type and ingredient as indicated by the filter field labels in blue text and chosen to disable the ingredient f
65. rousse pour pr paration radiopharmaceutic Update PRD507688 MIBITEC 1 mg Kit f r ein radioaktives Arzneimittel Update PRD507684 MIBITEC 1 mg Kit f r ein radioaktives Arzneimittel Update PRD507686 MIBITEC 1 mg Kit f r ein radioaktives Arzneimittel Update PRD507682 MIBITEC 1 ma Kit f r ein radioaktives Arzneimittel il EE EE a a 4 Fe EE A A F 8 9 2 Steps to confirm and submit message via EVWEB The steps required by a user to confirm and validate the submission of the bulk update are as follows 1 The user navigates to the WEB Trader section of EVWEB 2 The user selects the Bulk Update menu from the tree hierarchy as per Figure 31 3 The system displays the parent folders which the users can navigate and contains the following subfolders as per Figure 32 a New subfolder The newly generated product set as a result of the bulk update operations b Org subfolder The original product set prior to performing the current bulk update operations 4 The user navigates to the New subfolder and is presented with the files representing a subset of products from the product set limiting the files to 100 products per submission as per Figure 33 Note If a product set resulting from a
66. rrrrrrrrrrrerrrn 29 Dea eles SC Cel e Oaa AAN 29 6 0 Steps LO Cheate a Chang Cvsicuprcvandancesuseumnaaniaecenimouesansel ONTON DTREO 31 8 7 Adding Removing Action SetS s sssssrsrerrerrrrrrrerrerrrrrrrrrerrrrsrrrrerrrrerrrrrrrrrrrrerrrr 32 8 8 Confirming generation of Bulk Update essssererrersrrsrrrrerrrrrrrrrrrrsrrrrerrrrerrrrereren gt 33 8 9 Confirming amp validating the submission of Bulk Update via EVWEB ccce cece ees 33 8 9 1 General Layout of screens s seserssrerrererrerrrrrrrerrrrrrrrrerrrrerrrrsrrrrerrrrrrrrrrrrerern 33 8 9 2 Steps to confirm and submit message via EVWEB cccccccceeee esse cece eeeeeeeeenenes 35 8 10 Practical EXAMPIES cece ccc cece cece cece eee eee eee eee e eee e eee e eee eee eee ESSE SSeS e eee E EEE REESE ES ESSEEEES 36 8 10 1 Example 1 User wishes to invalidate medicinal Products ccccceeeceeeeeeeeeees 36 8 10 2 Example 2 User wishes to perform an interim phase Update ccc cece eeeeeeees 40 8 10 3 Example 3 Modifying a current value for a repeatable SeCtION cccee cece cere eee 42 8 10 4 Example 4 Adding and removing simple repeatable sections ccccee eee e eens 42 8 10 5 Example 5 Replacing the value in non repeatable fieldS c cece cece eeee seen ee eeees 43 eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 2 59
67. t ont a Requesting Title Count Count Request Refresh List Request Title Size Request Monitoring Downloading of Product set eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 7 59 The purpose of each of these areas is described in more detail in the following sections e The query building area is used to set a series of criteria which will limit the products to be edited to create the product set e The requesting area is used to identify the request and obtain a count of the number of products to be edited as part of the product set as well as submitting the updated request e The request monitoring area is used to advise the user of the progress towards completion of the request product set and can be used by the user to cancel outstanding requests e The downloading of product set area is used to download the files generated when the request for the product set is fulfilled eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 8 59 4 Setting the filters for creating a products set 4 1 General principles In preparing a product set the user should limit the request to only those products which require updating please note that requests that involve large numbers 1000 of products will cause delays for all other users of the system Limiting a request is achieved by setting a series of fi
68. t zip file e Status This is either Completed Error or Cancelled Ifthe value is Error then the row will be coloured red If errors persist with a particular user s download please refer to the FAQs section prior to contacting the Article 57 helpdesk Ifthe value is Cancelled then the row is highlighted yellow and the download and archive buttons are not available e Open Button This button opens a new window to allow the user to enter the bulk update operations whereby the user defines the set of changes and associated conditions to be performed on the specified product set as further elaborated in section 8 e Archive Button For users that perform many bulk updates the archive button is provided to remove updates that are no longer of any interest i e they failed or have been successfully processed locally by the user Once archived bulk updates cannot be retrieved except by request from the EMA eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 24 59 8 Bulk Update operations This section describes the steps required by the user to enter the bulk update operations This gives the user the ability to enter a set of defined conditions and associated changes to be performed for every product within the specified product set 8 1 General Principles The product set will be blank each time the set is loaded as per Figure 18 The screen contains feat
69. te Authorised PRD1598968 DATest_Bulk Update02 Original Sender AAA Update Authorised PRD1598969 DATest_Bulk Update03 Message Date 28 10 2014 16 31 48 Update Authorised PRD1598970 DATest_Bulk Update04 Authorised Products 100 Update Authorised PRD1598971 DATest_Bulk Update05 Update Authorised PRD1598972 DATest_Bulk Update06 Update Authorised PRD1598973 DATest_Bulk Update07 Update Authorised PRD1598974 DATest_Bulk Update08 Update Authorised PRD1598975 DATest_Bulk Update09 Update Authorised PRD1598976 DATest_Bulk Update10 Update Authorised PRD507683 MIBITEC 1 mg zestaw do sporzdzania pr __ Update Authorised PRD1598966 DATest_Bulk Update Update Authorised PRD1598985 DATest_Bulk Update 1111 Update Authorised PRD1598986 DATest_Bulk Update01 1111 Update Authorised PRD1598987 DATest_Bulk Update02 1111 Update Authorised PRD1598988 DATest_Bulk Update03 1111 Update Authorised PRD1598989 DATest_Bulk Update04 1111 Update Authorised PRD1598990 DATest_Bulk Update05 1111 Update Authorised PRD1598991 DATest_Bulk Update06 1111 Update Authorised PRD1598992 DATest_Bulk Update07 1111 Update Authorised PRD1598993 DATest_Bulk Update08 1111 1 Update Authorised PRD1598994 DATest_Bulk Update09 1111 Update Authorised PRD1598995 DATest_Bulk Update10 1111 4 Update Authorised PRD1598996 DATest_Bulk Update 1 Update Authorised PR
70. te PRD507683 Descrip ion Name Value ae EV Code RBRVS E Update PRD507687 ee ee ee gil Indate PRNSN7AAA peration Type Update 2 e The Authorised Pharmaceutical Form section now contains the value POWDER FOR SOLUTION FOR INJ ECTION e The previously referenced Administrable Pharmaceutical Form now displays SOLUTION FOR INJECTION Authorised Pharmaceutical Forms 1 3 POWDER FOR SOLUTION FOR INJECTION Pharmaceutical Products 1 amp SOLUTION FOR INJECTION You can now further amend the individual product entities validate and send the XEVPRM eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 59 59
71. tended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 27 59 e Element dropdown This contains the various data elements available within the selected section in relation to the xEVMPD hierarchy data structure Figure 21 Element dropdown For every Product selected where this is true Authorised Product Choose an Element 7 Choose an Element Comments EV Code Info Date MAH gt Changes Master File Location PhV enquiry email PhV enquiry Phone QPPV e Predicate dropdown This details the type of operator to be applied on the condition This is an appropriate value which defines the check to be performed i e is is not etc This is filtered depending on the element selection Figure 22 Predicate dropdown For every Product selected where this is true Authorised Product 7 EV Code Choose a Predicate 7 Choose a Predicate Remove Filter Is Missing then execute the s Not Missing e Value field or dropdown This contains the possible values that may be selected or allows for entry of free text For the dropdown the list is populated by matching the conditions entered along with the values in the products contained in the product set Figure 23 Value Field or dropdown For every Product selected where this is true Authorised Product EV Code Is 5 Choose a Value Choose a Value PRD480109 1 e Remove F
72. the active filters area to update the request monitoring and download areas of the screen eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 23 59 7 Manage completed product set requests The download area is provided to allow users to manage completed and failed requests and shows all requests for all users with same organisation HQ as the logged in user The download area is shown in Figure 17 below Figure 17 The downloading of product set area 2Altvenproducts on 28 10 2014 12 45 Bulk Decoded 2 19 KB Completed Aldactoneproducts on 28 10 2014 11 09 Bulk Decoded 2 16 KB Completed Info Date_DA on 28 10 2014 10 54 Bulk Decoded 1 16 KB Completed My2products on 28 10 2014 10 39 Bulk Decoded 2 16 KB Completed My2products on 28 10 2014 10 38 Bulk Decoded 2 16 KB Completed Archived Note Click the Refresh List button in the active filters area to update the request monitoring and download areas of the screen The requests in the list are shown in reverse date time order of the request date each request row contains 5 columns e Request Title The name of the request note this example shows the default name the formats chosen and demonstrates why it is a good idea to name your requests for easier reference later e Size This is a count of the number of products to be exported The figure in brackets shows the file size of the expor
73. ther indication The user will need to select the indication element field with a singular reference i e Authorised Product Drug Indication and NOT Authorised Product Drug Indications Figure 6 Example 3a Modify simple repeatable sections Authorised Product Drug Indication Choose a Section Authorised Product Authorised Product Attachment Authorised Product Attachments Authorised Product Authorisation Authorised Product Authorisation Medicinal Product Type Authorised Product Authorisation Medicinal Product Types Authorised Product Authorised Pharmaceutical Forms Authorised Product Drug ATC Authorised Product Drug ATCsS Authorised Product Drug Indication Authorised Product Drug Indications As a result the user can only use the action type change as this is the only applicable action Authorised Product Drug Indication MedDRA Code Change From 10041458 SPECT 1 To 10041480 Remove Change 8 10 4 Example 4 Adding and removing simple repeatable sections This example describes the process whereby a user wishes to either add a new repeatable section and or remove a current repeatable section we will continue to use the drug indications as an example The user will need to select the indication element field with a plural reference i e Authorised Product Drug Indications and NOT Authorised Product Drug Indication Authorised Product Drug Indications Choos
74. uct selected execute the Changes Authorised Product Authorisation Create Filter Authorisation Status Change From 1 Valid 24 To Not Valid Not Submitted for Renewal by Marketing Authorisation Holder Remove Change Create Change Remove Action Add new Action For every Product selected where this is true Authorised Product Authorisation Invalidated Date Assign Authorised Product lue 2014 06 20 MAH lis e ORG2762 ADVANCED ACCELERATOR APPLICATIONS FR SAINT GENIS POUILLY 10 Remove Filter Create Change Remove Change then execute the Changes Create Filter Remove Action Add new Action For every Product selected where this is true Authorised Product Authorisation iain teat invalidated Date Assign lue 4 MAH I is m Value 2014 06 21 Remove Change ORG3190 GIPHARMA IT TORINO 14 Remove Filter Create Change then execute the Changes Title Bulk Update Note that the instruction at the top of the screen is exactly the same as example 1a but in this case the system allows the user to set the value for invalidated date to either 20 or 21 J une depending on the value in the MAH field The instruction can therefore be interpreted as invalidate all products in the set making the value of authorisation status Not valid Not submitted for renewal then set invalidated date 20 June 2014 if the MAH is ORG276
75. ucts_2014 10 27_ 15 59 FOLDER 2014 10 28 11 28 54 pdassep AAA Aldactoneproducts_2014 10 28 __ FOLDER 2014 10 28 11 10 44 pdassep_ AAA 2014 10 27_16 55 49 01 FOLDER 2014 10 28 10 59 08 pdassep_ AAA 2014 10 27_16 55 33 01 FOLDER 2014 10 28 10 59 06 pdassep AAA 2014 10 27_16 55 27 01 FOLDER 2014 10 28 10 59 05 pdassep AAA 2014 10 27_16 55 25 01 FOLDER 2014 10 28 10 59 03 pdassep_AAA Info Date DA 2014 10 28 10 54 FOLDER 2014 10 28 10 54 56 pdassep AAA My2products_2014 10 28 10 39 FOLDER 2014 10 28 10 50 26 pdassep AAA My2products_2014 10 28_10 38 FOLDER 2014 10 28 10 38 39 pdassep_ AAA My2products_2014 10 28_ 10 38 FOLDER 2014 10 28 10 38 08 pdassep_AAA Info Date_DA_2014 10 27_ 14 32 FOLDER 2014 10 27 14 33 50 pdassep AAA CQ36076_2014 10 27_09 51 10 FOLDER 2014 10 27 09 54 01 pdassep AAA My2products_2014 10 27_08 48 FOLDER 2014 10 27 08 51 11 pdassep AAA Comments _DA 2014 10 26 10 FOLDER 2014 10 26 10 44 16 pdassep AAA conditions DA 2014 10 26 09 FOLDER 2014 10 26 09 57 24 pdassep AAA Test Bulk02_2014 10 24 16 12 FOLDER 2014 10 24 15 14 30 pdassep AAA Test Bulk01_2014 10 24_ 15 39 _ FOLDER 2014 10 24 14 59 28 pdassep AAA KO NewProducts_2014 10 24 _ FOLDER 2014 10 24 14 54 37 pdassep_ AAA Perf Data_2014 10 24 15 37 38 FOLDER 2014 10 24 14 37 59 eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 33 59 Figure 33 EVWEB bulk update sub folder view D
76. ures which allow the user to edit some or all of the products in the product set based on the presence of values contained in the fields within the set as well as on the absence of a particular value in the set The bulk update will allow users to perform the following operations on their products Update Nullification and Invalidate MA Once the user has issued all of the edit instructions he indicates that he wishes to save the edit and view the results in EVWEB so that he can view the results of the edit validate the results and submit the message eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 25 59 8 2 General Layout of screen Figure 18 The Bulk Update operations page Conditions Changes O EUROPEAN MEDICINES AGENCY Eudravigilance xEVMPD Bulk Update pdassep 2014 10 21 14 52 23 01 pdassep AAA Actions HUMAN PRODUCTION V 7 9 0 Add new Action For every Product selected execute the Changes Create Change Action NE Set Perform Bulk Title Bulk Update Update e Conditions section The area to the left must be used to define the discrete sets of conditions which are used to identify the subset of products to act upon as part of the bulk update within the initially defined set e Changes section The area to the right must be used to define the edits that are performed on the subset of products meeting this particular set of con
77. urngancrraneunperindanssninpancantaitesontadureanseidaseniequmerassqeseadad 11 4 2 4 Free text compound CONTIOIS cccccccccce cece esse ee eee eee eeeeeeeeeeeeeaeeeeeeeeeseeeeeeegaaaeeeey 13 Dees Ve Dre View e PE A eter tianutancsgseteteuanw tates ant E sade oie be E 13 4 2 6 List of filter fields available cccc cece cece cece cece eee cece sees eeeeeeeeeeee eee eeeeeeseeeeeenegneneey 15 Tapie 1 Filter fields TEIEreNCe secicrnirereacirivier aia rnatina ernie ease woe 15 5 Submitting a request to create the product Set ssssssss2us222 2222 2222 20 5 1 1 Examine the preview and prepare a COUNL s ssssssrerrererrererrerrerrerrrrerrrrrrrrrrrrerrrr 20 5 1 2 Temporarily remove fIterS ccsarevecedisduawrnarergerdiktvannievinasi aaia a ria ae asiaa iaaa 20 5 1 3 Making a request to create the product Set sessersrrererrrrerrrrrrrerrrrerrrrerrrrrrrsrr gt 21 6 Monitor the progress of pending request ssss2ss2 22 22 7 Manage completed product Set requests sssssssuss22u2 24 8 Bulk Update operations sssss 2 2222222u222 22u2 22u2 2u22 0 25 8 General Principles icsse a a E A EAER 25 6 2 Genelal Layout OF SCl Ce hsrs rnrn eanna aa ON aS 26 8 3 Conditions screen Sectio eesresiriirri nii reira r irr nE Ea EEA EE AEE EE 27 8 4 Steps to create a condition sesessererrsrrrrsrrrrrrrrrrrrsrrrrsrrrrerrrrsrrrrerrer
78. uthorisation Holder Remove Change Create Change Remove Action Add new Action For every Product selected where this is true Authorised Product Authorisation pP EREE invalidated Date Assign lue 2014 06 20 MAH 1s eaa Remove Change ORG2762 ADVANCED ACCELERATOR APPLICATIONS FR SAINT GENIS POUILLY 10 _Remove Filter Create Change then execute the Changes Create Filter Remove Action Add new Action For every Product selected where this is true Authorised Product Authorisation PRE invalidated Date Assign lue 4 MAH is Value 2014 06 21 Remove Change ORG3190 GIPHARMA IT TORINO 14 Remove Filter Create Change Remove Action Add new Action For every Product selected where this is true Authorised Product Authorisation invalidated Date Assign Value 2014 06 22 Remove Change _Remove Filter Create Change then execute the Changes Create Filter Title Bulk Update Authorised Product Authorisation invalidated Date Is Missing This demonstrates an important concept in the solution which is designated by the horizontal grey bars between sections In essence each grey bar separates a discrete action to be taken from the next action the action s in the first section between horizontal breaks must be carried out on the loaded export then the action s from the second horizontal area
79. w open eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 56 59 Eudravigilance xEVMPD Bulk Update CD cen minions scency pdassep AAA Pharm Form change 2014 11 04 12 58 40 01 pdassep AAA Actions HUMAN PRODUCTION V 7 12 1 Add new Action Create Change For every Product selected execute the Changes Create Filter 6 Click on Create Change and select the section in which you wish to perform the change Authorised Product Authorised Pharmaceutical Forms BE Choose an Element Remove Change Create Change 7 Choose an Element which you wish to change Authorised Pharmaceutical Form 8 Choose an Action you wish to perform on the selected element Authorised Product Authorised Pharmaceutical Forms Authorised Pharmaceutical Form ad 9 Specify which value which should be added Authorised Product Authorised Pharmaceutical Forms Authorised Pharmaceutical Form x Add B Pharmaceutical Form EV Code PHFOO2Z01MIG Remove Change Create Change To change the value currently referenced in the Administrable Pharmaceutical Form Name from POWDER FOR SOLUTION FOR INJECTION to SOLUTION FOR INJECTION create another change by performing Steps 6 9 again eXtended EudraVigilance Medicinal Product Dictionary XEVMPD Bulk Update Manager EMA 623491 2014 Page 57 59 Authorised Product Authorised Pharmaceutical For
80. with a new value o Add This type of action will add a new element in a repeatable section o Remove This type of action will remove an element from a repeatable section or a data field o Prepend This type of action is only applicable on free text fields This will add text in front of the current text value o Append This type of action is only applicable on free text fields This will add text at the end of the current text value o Assign Overwrites a Value or Creates the field if not there This type of action will overwrite a value if present or create a new field if not present e Old Value From dropdown This contains the possible values that may be selected The list IS populated by matching the conditions entered along with the values in the products contained in the product set This is only displayed if the Change or Remove action type is selected Figure 28 Old Value From dropdown From Choose a Value T Choose a Value BOX OF 5 VIALS 5 46 e New Value To field or dropdown This contains the possible values that may be selected or allows for entry of free text For the dropdown the list is populated with all the values allowed for that filed Figure 29 New Value To dropdown To Enter a value e Remove Change button This clears and removes the current change e Create Change button This adds a new change dependent on the related condition 8 6 Steps to create a change

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