R4BP User Guide Version 1.0 Introduction
Contents
1. cccccceeeeeeeeees 28 Do I need to worry if in my list of applications the status of some of my applications for mutual recognition indicates Clock stopped missing data requested ceeeeeeeeeeeeeees 28 You have forgotten your PaSSWOTd 00 cccccsssessseeececceceeeseseeeecceceeesaeeeseeeeeeeeesaaaaesseeseeseeeaaas 29 You tried to login to the R4BP and got the message Your password has expired 30 T gt a 4 S lt Register for Biocidal Products Introduction One of the purposes of the R4BP is to allow industry users of the R4BP to create application forms to be attached to the applications to be submitted to the relevant competent authorities of the Member States and to follow the statuses of these different applications after their submission The purpose of this user guide is to explain to industry users the key features of the R4BP Further questions should be addressed to ENV R4BP BIOCIDAL REGISTER ec europa eu The R4BP can be accessed at the following address https webgate ec europa eu env r4bp T o j 4 T W 4 gt os Register for Brocidal Products Basics steps To access the R4BP you must first register under ECAS the European Commission Authentification Service This is the starting point for any data submission to the R4BP This process will allow you to define the email address and the password that you will be requested to provide whenever2. How can I modify some of the information relating to my applications Once an application has been submitted this application cannot be modified anymore unless its status is reverted to draft To have the status of a submitted application reverted to draft you will need to submit a request to the functional mailbox ENV R4BP BIOCIDAL REGISTER ec europa eu How to delete an application Prerequisite The application must be in draft mode Process 1 Go to your list of applications by clicking on Modify application 2 Click on the icon of the application that you want to delete 18 gi t Register for Biocidal Products How to print an application form Prerequisite The application must have been submitted Process 1 Go to your list of applications by clicking on Modify application 2 Click on the icon a of the application that you want to print 3 Select the language in which you want the application to be printed Select language for the print form ETETE 19 4 a i Register for Biocidal Products How to delegate access to a product The user who has created a product can delegate access to 1t to another user already registered in the R4BP The delegation can be given with full or restricted consultation access e Restricted access means that the user to whom access is granted will not be able to see the detailed composition of the product The user will
3. You tried to login to the R4BP and got the message Your password has expired The system does not automatically propose to renew your password You need to execute the change password procedure as explained below You click on Change password under the login section Authentication requested by R4BP 2 R 4 B f tC S Domain European Commission Username E Remember my username ECAS password F Warn me each time an application asks ECAS for my identity E View my ECAS account details after logging me in Don t yet have an ECAS password Is the selected domain correct If not please change it or else your username or e mail will not be recognised Forgot your password lt gt Privacy Statement Contact Help ft The European Commission s Authentication Service ECAS is managed by DIGIT A 1 UAA Version 1 12 0 Processing You will need to provide your email address in the field Username your current password and your new password Change ECAS password Username nchorapi Domain External ECAS password The new ECAS password Confirm new ECAS password Click then on Submit to proceed with the password change Make also sure that you have selected the right domain 30
4. Mutual Recognition of Product Authorisation A Mutual Recognition of Product Registration oo A Product Provisional Authorization 3 Click on confirm and continue Confirm and continue 14 ee AE li Register for Brocidal Products P select the one required for your application Do you want to continue rt may last some time if you have more than 200 products TE Click on OR 4 You will then be invited to e select in your portfolio of products the product for which you want to create the application form e select in your portfolio of applications the applications for a first authorisation for the selected product e provide information on the applicant a company and on the applicant representative a person e indicate the name of the receiving Member State e indicate the product name e provide information on the future authorisation holder a company and the future authorisation holder representative a person All this information must be submitted before the user can generate and print the application form to be sent to the receiving Member state In the case of an application for mutual recognition one and only one future authorisation holder and product name can be specified If the product is to be placed on the market under different names and or by different future authorisation holders in the receiving Member State separate application forms will have to be sub
5. ar DIGIT the domain selection page alternatively you can achieve this by deleting the cookies of your brovser Enter then your ECAS username password and click on Submit A gt Fa Register for Biocidal Products How to create a product The composition of a product must at least contain one active substance The active substance can be either selected from the list of substances already included in Annex I or typed in manually if it is a new active substance not yet included in Annex I Composition of a product All the components should be indicated If some components have no ISO or IUPAC name you can simply indicate in the corresponding field Product placed on the market The information whether and where the product is placed on the market is advisory This information could be useful for the Rapporteur Member State should they wish to contact other Member States where the product is placed on the market to discuss a specific issue What can I do once I have created a product Once you have created a product you can e Delete the product as long as no application references it e Update the product as long as there is no submitted application referencing it e Create an application for the product e Delegate access to the product to another industry user e Transfer the product to another industry user How can I change some of the information relating to my products Once an ap
6. in Login aving created your ECAS account you can sign in to enter or consult your data in the Community Register for Biocidal Products R46P Check the domain It should be external If not change the domain by using the link change it at the bottom of the connexion screen gt gt Intracomm gt Authentication Service gt Login Authentication requested by R4BP ste RBP ERegisterfonBiocidal Products Domain European Commission Username Remember my username ECAS password Warn me each time an application asks ECAS for my identity View my ECAS account details after logging me in Don t yet have an ECAS password Is the selected domain correct If not plea gt else your username or e mail will not be recognised Forgot your password Change Password Privacy Statement Contact Help wac ea D G j T gt tet rid The European Commission s Authentication Service ECAS is managed by DIGIT A 1 UAA Version 1 12 0 Processing 9 milliseconds European Commission Authentication Service gt gt EUROPA gt Authentication Service Where Are You From Please choose your domain European Economic and Social Committee the Regions U OT A Court of Justice of the European Communities hange it or else your username or e mail will not be recognised European Parliament European Commission Council of the European Union voc
7. of those co formulants which composition qualitatively or quantitatively differs from that of the reference product In all cases you should also provide the details of the frame formulation to be established To that effect you should use the form provided hereafter fill it and send it to the R4BP administrator to be uploaded in the R4BP so that it can be easily accessed by all Member States The form could also be joined to your application to support the establishment of the frame formulation 26 Composition of the frame formulation NB This information is confidential and should not be disclosed to third parties Add rows as necessary Common name IUPAC name Function CAS EC number Concentratio Unit w w Concentratio Unit w w Classification Substance of concern number n n te z P yes L no Add rows as necessary 3 Indicate the common name Trade names alone are not accepted For biological products indicate the scientific name strain serovar as appropriate 4 Select from pre defined list e g g l g kg other Select from pre defined list e g g l g kg other For biological products the concentration should state the number of activity units units of potency as appropriate per defined unit of formulation e g per gramme or per litre 5 If the source is different information should be provided on the technical equivalence of the two sources For further guidance see note for guidance on the a
8. you will want to access the R4BP This email address will also be used for every email that the R4BP will be sending to you Once you have registered under ECAS you can create your account in the R4BP On your first visit to the R4BP you will be asked to provide a number of information to complete the creation of your R4BP account You will then be able to use the R4BP to create application forms to be attached to the applications to be submitted to the relevant competent authorities of the Member States and to follow the statuses of these different applications after their submission However before being able to create application forms you will first need to give the details of the product for which you want to apply for authorisation Go to R4BP homepage https webgate ec europa eu env r4bp Register under ECAS Create my R4BP account Create my product Create my application for a first authorisation Create my application for mutual recognition 7 a Register for Biocidal Products How to register under ECAS Go to the R4BP homepage select your language and then click on Create ECAS account First Visit Before submitting data to the Community Register for Biocidal Products R4BP you must open an account in ECAS the European Commission authentification Service his is the starting point for any data submission to the R4BP Introduce the requested data to registe
9. The following message will then appear to confirm that the data have been successfully submitted to the R4BP 16 eer AE gt a Register for Brocidal Products The data have have been been successfully submitted to the system Industry reference code 2010 1970 3266 NO AA MS reference code 3665 Please do not forget to print the application form to sign it and to join it to your application Do you wish to print the application form now 5 Yes I want to print the application form now No 1 wil print the application form later If you decide to print your application form you will be asked to choose the language in which the form should be printed Select language for the print form Ee Remember that a written version of the application form must be submitted with the rest of your dossier to the competent authorities in the receiving Member State 17 ne p AE ta Register for Biocidal Products How to submit an application form As explained previously you can submit your data to the R4BP directly after having created your application form You may also decide to create all your application forms before submitting them to the R4BP in which case you will need to come back to the R4BP and to do the following 1 Go to your list of applications by clicking on Modify application 2 Click on the icon of the application that you want to submit 3 Click on the icon Submit
10. ck on Submit You asked for submitting the product delegation Do you want to ce continue Yes no Click on OK if you want to proceed 21 nF e L T 4 oe a Register for Biocidal Products How to delegate access to an authorisation Prerequisite You must have one product that you created yourself in your list of products You must have one application that you created yourself in your list of applications You must have first delegated full or limited access to the product referenced in the application to which you want to grant access The user to whom you want to delegate access must already have an R4BP account Process 1 Go to your list of applications by clicking on Delegate authorization Delegate authorization 2 Select the authorisation s for which you want to delegate access and click on Delegate product 3 Indicate the e mail address of the user to whom you want to delegate access to the authorisation s Do not modify the date proposed by default 4 Click on Submit 22 Message from webpage C You asked for submitting the authorization delegation Do you want to continue Yes No Click on OK if you want to proceed 23 Re Ai ll Register for Brocidal Products How to transfer of a product The Transfer product facility allows you to move one or several of your product s with associated application s to another user alread
11. eer Ai J ae Register for Biocidal Products R4BP User Guide Version 1 0 Taroa TIO e E EE E E E E E E E E vanes 2 BE E E E EE eee E eareceeteaneaoeceees 3 How 10 fe cister unde ECAS srengeni E EE EES 4 How to Create your account in the R4BP serccais lt cesssxaneindocendeeuesstevednedusnsunnstetecsatnusasinneianedacdeweaneds 5 How CO CHC AUS Cl prodi espa a 9 How to create an application form for a first authOrisatiOn cc ceeeeeccccceecssseeeeeeceeeeeeaaeeeeees 10 How to create an application form for mutual recognition essessseeeeeesssssseerrrssssssseeerrsssss 14 How to submit an application form 0 0 0 sceeeeecccccecceeeessseecceeeeeeaeeesseeeeecesseaeeeeeeeeeeseeaeeenses 18 How to print an application form 00 0 ccceeeseeccceccceeeeeeseeecceeeeeaaaaesseeeceeeeeeseaasneeeeeeeeesaaaeasees 19 How 10 delegate ACCESS 10 ALO CUCL riergaciieaia en a 20 How to delegate access to an authorisation ccccccssseessecceecceeeeesseeeceeeeeeaaeeseeeeeeeeesaeaeenses 22 How to iranstor ofta PrOdUC esien E E E EOE 24 How to create applications forms for frame formulations ccceccccccceceeeeseeseeeeeeeeeeeeeeeees 26 Frcguoniiy asked gus HONS senseo eE Ar EE 28 Why do I have problems when using Internet Explorer 8 cccccccccccccccsseeeeeeceeeeeeeaeeeeees 28 Whatisthepipose ol My dleris T orses e ier a NEn NES EEE ara E EEE 28 Can the applicant be different from the future authorisation holder
12. his product to the portfolio of malcolm fairclough skynet be Do you confirm Click on OK if you want to proceed 25 E F r p Fu Register for Biocidal Products How to create applications forms for frame formulations Preliminary consideration A frame formulation is a group of products with limited variations in their composition which do no affect their efficacy and risk profiles However it is not the frame formulation which is going to be authorised but the products covered by the frame formulation Some Member States might then authorise all the products covered by a frame formulation through one decision others might grant separate authorisations for each and every product covered by the frame formulation You will therefore need to create applications for first authorisations or mutual recognition of the different products covered by the frame formulation Process As in any event all Member States want to know the composition of the different products to be placed on their market you should therefore first create the different products to be covered by the frame formulation Where frame formulations potentially covers a high number of products e g more than 10 it is recognised that it could become a rather burdensome exercise In those cases you should at least enter the full composition of one product the reference product and for the other products only the details of the active substance and
13. mitted When doing so the system will ask you for the reference code of the product This information is however not essential as it is only used to filter your list of products and select directly the one you want to apply for If you do not indicate a code the system will display all the products in your portfolio of products and you will then have to choose the one you want to apply for 15 aTe 1 a ra J a Register for Biocidal Products An separate application form for mutual recognition will need to be submitted for each and every Member State where the product will need to be authorised through mutual recognition of the first authorisation to be granted by the Reference Member State You can only apply for the mutual recognition of a first product authorisation or product registration It is thus not possible to use an authorisation granted on the basis of a mutual recognition procedure to apply for another mutual recognition procedure 5 You can then either click on Save and quit if you only want to save your application and submit it to the R4BP at a later time or directly click on Submit if you directly want to submit your application to the R4BP If you decide to submit your application you will no longer be able to modify it nor the details the product referenced in it If you click on Submit the following message will then appear Message from webpage Click on ORK
14. only be able to see the name and concentration of the active substance e Full access means that the user to whom access is granted will be able to see the detailed composition of the product The user will only be able to see the name and concentration of the active substance and of the other components of the product Access to a product can not be further delegated The user who has been delegated access to a product will see that the product is included in its list of products The user can see either the full composition of the product or only some parts of it depending on the type of delegation granted full vs restricted The user can then use that product to create an application for a first authorisation or for mutual recognition The user can however not edit or modify the details of that product Prerequisite You must have one product that you created yourself in your list of products The user to whom you want to delegate access must already have an R4BP account Process 1 Go to your list of products by clicking on Delegate product 2 Select the product s for which you want to delegate access and click on Delegate product Daeg podaci 20 4 T Register for Biocidal Products 3 Indicate the e mail address of the user to whom you want to delegate access to the product and indicate whether you want to give a full or a limited access Do not modify the date proposed by default 4 Cli
15. pean Commission s Authentication Service ECAS is managed by DIGIT A 1 UAA Version 1 12 0 Processing 9 mi European Commission Authentication Service gt gt EUROPA gt Authentication Service Where Are You From Please choose your domain European Economic and Social Committee External Translation Centre ammittee of the Regions European COUT OT ATG Court of Justice of the European Communities European Parliament European Commission Council of the European Union European GNSS Supervisory Authori wo a DIGIT Qf This Website is managed by the European Commission s Informatics DG Version 1 12 0 Processing 6 milliseconds ange it or else your username or e mail will not be recognised he domain selection page alternatively you can achieve this by deleting the cookies of your broveer Enter your ECAS username password and click on Submit You are then connected to the R4BP Click on the link Industry user and complete the creation of your account Once you will have follow the steps indicated above you will then immediately be able to start using the system for creating applications Register for Brocidal Products How to access the R4BP Prerequisite You must already have an ECAS username and password Process Go to the R4BP homepage https webgate ec europa eu env r4bp Then select your preferred language and then click on Sign
16. plication referencing a product is submitted the product cannot be modified anymore How to create an application form for a first authorisation 1 Click on Create application 2 Select the type of application PLEASE CHOOSE THE TYPE OF YOUR APPLICATION Product Authorisation 9 Product Registration 9 Mutual Recognition of Product Authorisation E Mutual Recognition of Product Registration S0000 Product Provisional Authorization 3 Click on confirm and continue Confirm and continue The following message will then appear Message from webpage oe select the one required for your application Do you want to continue it may last some time if you have more than 200 products The system will retrieve all products from your portfolio to allow you to Click on OK 10 4 You will then be invited to e select in your portfolio of products the product for which you want to create the application form e provide information on the applicant a company and on the applicant representative a person e indicate the name of the receiving Member State e indicate the product name e provide information on the future authorisation holder a company and the future authorisation holder representative a person e indicate the countries in which mutual recognition of the future authorisation might be applied for To add the information on the product name and on the f
17. r under ECAS This process will allow you to define the email address that you will be requested to provide whenever you will want to access the R4BP You will receive an activation email at the email address you have provided check your spambox as well Follow the email instructions to complete your ECAS registration Register for Brocidal Products How to create your account in the R4BP Prerequisite You must already be registered under ECAS Process Go to the R4BP homepage select your language and then click on Sign in Login aving created your ECAS account you can sign into enter or consult your data in the Community Register for Biocidal Products R46P Check the domain It should be external If not change the domain by using the link change it at the bottom of the connexion screen gt gt Intracomm gt Authentication Service gt Login Authentication requested by R4BP r RJB rERegistenfonBiocidal Products Domain European Commission Username Remember my username ECAS password Warn me each time an application asks ECAS for my identity E View my ECAS account details after logging me in Don t yet have an ECAS password Is the selected domain correct If not ples SS else your username or e mail will not be recognised s yor Forgot your password Change Password Privacy Statement Contact Help wor D Gl if tet iseconcs ie rtd The Euro
18. ssessment of technical equivalence CA May08 Doc 6 7 available at http ec europa eu environment biocides index htm 6 Select from pre defined list e g antioxidant emetic dispersing agent other E F r p Fu Register for Biocidal Products Frequently asked questions Why do I have problems when using Internet Explorer 8 Some of problems are due to the fact that the R4BP does not support Internet Explorer version 8 In such cases try using an earlier version or a different browser What is the purpose of My alerts My alerts is intended to keep you informed of status changes of applications submitted in the R4BP Every time the status of an application changes the application will be referenced in the list available under My alerts The list does however only include applications which statuses have been updated since your last visit to the R4BP Can the applicant be different from the future authorisation holder Yes the applicant can be any company and the future authorisation holder can be the same company or any other one Do I need to worry if in my list of applications the status of some of my applications for mutual recognition indicates Clock stopped missing data requested There is nothing to worry about It 1s what appears after updating of the status of the application by the Receiving Member States in the system for all applications for mutual recognition submitted to Member S
19. stry reference code 2010 1970 3266 NO AA MS reference code 3665 Please do not forget to print the application form to sign it and to join it to your application Do you wish to print the application form now i Yes I want to print the application form now X No I will print the application form later If you wish to print your application form you will be asked to choose the language in which the form should be printed Select language for the print form C Remember that a written version of the application form must be submitted with the rest of your dossier to the competent authorities in the receiving Member State 13 1 se Pe L T ra a Register for Biocidal Products How to create an application form for mutual recognition Pre requisite You should have for the product for which you want to apply for mutual recognition an application for a first authorisation in your portfolio of applications This application for a first authorisation can be either in draft or already submitted This application for a first authorisation might be one that you have created yourself or one that might have been delegated to you by another user so that you can cross refer to it when creating an application for mutual recognition Process 1 Click on Create application 2 Select the type of application PLEASE CHOOSE THE TYPE OF YOUR APPLICATION Product Authorisation C Product Registration
20. tates in the context of the post Annex I authorisation process As the first authorisation has not been granted yet and until it is granted and transmitted to the Member States where you have applied for mutual recognition your applications for mutual recognition are considered as incomplete Missing data 1 e a copy of the first authorisation will have to be transmitted to these Member States whithin two months of obtaining your first authorisation in the first Member State 4 a Register for Biocidal Products You have forgotten your password Start on the R4BP homepage and chose your language Click on Sign in and then on Forgot your password Authentication requested by R4BP gie R4BP to Domain European Commission Username Fi Remember my username ECAS password _ Warn me each time an application asks ECAS for my identity F View my ECAS account details after logging me in Don t yet have an ECAS password Security notice Is the selected domain correct If not please change it or else your username or e mail will not be recognised gt avon orgot your password Change Password Privacy Statement Contact Help vec ee D G l 4 a tei conds Introduce the email address that you have provided when first registering under ECAS Click on Request ECAS password Check your email account 29 4 ee Register for Biocidal Products
21. tfolio of products and you will then have to choose the one you want to apply for 1 a O 1 a ra 6 ta Register for Biocidal Products The list of countries in which mutual recognition might be applied for is only indicative This means that you may eventually decide not to apply for mutual recognition in a country indicated in your list or conversely you may decide to apply for mutual recognition in a country that is not included in the list Be also aware that indicating in this list that you intend to apply for mutual recognition in a given Member State is not an application for mutual recognition You will need to fill a specific form for each and every Member State where you will apply for mutual recognition 5 You can then either click on Save and quit if you only want to save your application and submit it to the R4BP at a later time or directly click on Submit if you directly want to submit your application to the R4BP If you decide to submit your application you will no longer be able to modify it nor the details of the product referenced in it If you click on Submit the following message will then appear Message from webpage Click on ORK The following message will then appear to confirm that the data have been successfully submitted to the R4BP 12 eer AE gt a Register for Brocidal Products The data have have been been successfully submitted to the system Indu
22. uture authorisation holder and future authorisation holder representative click on Add Add Once you have added information on the product name and on the future authorisation holder and future authorisation holder representative make sure that you click on Save entry Save entry If you forget to save the entry this information will be lost and your application will remain incomplete If the product is to be placed on the market under different names and or by different future authorisation holders in the receiving Member State additional entries can be added here 1f the receiving Member State accepts that such request can be made through the same application Some Member States will however request separate applications to be submitted To navigate from one section to another click on Next step or Previous step Next step gt lt Previous step All the requested information with the exception of the information concerning the countries in which mutual recognition might be applied for must be submitted before the user can generate and print the application form to be sent to the receiving Member state When doing so the system will ask you for the reference code of the product This information is however not essential as it is only used to filter your list of products and select directly the one you want to apply for If you do not indicate a code the system will display all the products in your por
23. y registered in the R4BP You have to indicate which product s and the e mail of the person to whom you want to transfer the product This facility is used when you do not need a product and associated application s anymore in your portfolio and someone else will become in charge of the product and your related applications Once the transfer is finished you cannot request the reverse operation Make therefore sure that you transfer the right product to the right person Before using this function you are invited to contact the R4BP administrator at the following address ENV R4BP BIOCIDAL REGISTER ec europa eu Prerequisite You must have at least one product in your portfolio The user to whom you want to transfer the product and its related applications must already have an R4BP account Process 1 Go to your list of products by clicking on Transfer product 2 A message will alert you that the operation can not be reversed and will invite you to contact the R4BP administrator before proceeding If you have contacted the R4BP administrator click on OK if you want to proceed 3 Select the product s that you want to transfer and click on Transfer selected 3 Indicate the e mail address of the user to whom you want to transfer the product s 4 Click on Submit 24 ge This transfer action is IRREVERSIBLE and will move your products and ce your applications related to t
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