R4BP User Guide Version 2.0

Transcription

1 R4BP User Guide Version Introduction Basics steps How to register under ECAS? How to create your account in the R4BP? How to access the R4BP? How to create a product? Composition of a product Product classification Pack sizes Directions for use Current Status (existing products already placed on the market) What can I do once I have created a product? How can I change some of the information relating to my products? How to create a frame formulation What can I do once I have created a frame formulation? How can I change some of the information relating to my frame formulations? How to create an application? How to create an application without frame formulation? How to create an application with frame formulation Applications for mutual recognition How to submit an application form? How can I modify some of the information relating to my applications? How to delete an application How to print an application form? How to delegate access to a product? How to delegate access to a frame formulation? How to delegate access to an application? Frequently asked questions Can the applicant be different from the future authorisation holder? To be completed... 37

2 1. 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: The R4BP can be accessed at the following address: 2

3 2. 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 address and the password that you will be requested to provide whenever you want to access the R4BP. This address will also be used for every 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. Likewise it is possible to create a frame formulation covering a range of products you have created. Go to R4BP homepage / Register under ECAS Create my R4BP account Create my product / frame formulation Create my application for a first authorisation Create my application for Create mutual my recognition application for Create mutual my recognition application for Create mutual my recognition application for Create mutual my recognition application for mutual recognition 3

4 3. How to register under ECAS? Go to the R4BP homepage, select your language and then click on "Create ECAS account" Introduce the requested data to register under ECAS. This process will allow you to define the address that you will be requested to provide whenever you will want to access the R4BP. You will receive an activation at the address you have provided (check your spambox as well). Follow the instructions to complete your ECAS registration. 4

5 4. 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" Check the domain. It should be external. If not, change the domain by using the link "change it" next to the domain name. 5

6 Then select Neither an institution nor a European body, and click. Back in the initial screen you can enter your ECAS username/password and click on Login You are then connected to the R4BP, Click on the link "Industry user" and complete the creation of your account. Once you will have completed the steps indicated above, you will immediately be able to start using the system for creating applications. 6

7 5. How to access the R4BP? Prerequisite You must already have an ECAS username and password. Process Go to the R4BP homepage Then select your preferred language and then click on "Sign in" (Currently only English is available). Please note that the domain should be external. If this is not the case, change the domain as explained in the previous section. Enter then your ECAS username/password and click on Login. You are now directed to your personal homepage from which you can start the process: 7

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9 On your starting page you can see four different headings allowing you to initiate specific actions: My Products o Under this section you will be invited to enter the information related to your products such as composition, classification, pack sizes and the directions for use. o A list of all your products is drawn up providing a summary of each of them. My Frame formulations o This section offers the possibility to set up frame formulations covering a range of products you have created. o A list of all your frame formulations is drawn up providing a summary of each of them My Applications o Having created a product, and maybe a frame formulation, one can create and submit applications for product authorisation and the establishment of a frame formulation to different Member States. o Furthermore this section presents a portfolio of your applications showing the status in the process and facilitating the management of them. My Delegations o To facilitate actions between R4BP users, functionalities are put in place to exchange information on products, frame formulations and applications in view of submitting new applications.

10 6. How to create a product? When clicking on 'Create product' the screen below will show up. In order to generate a product file in the R4BP, information needs to be entered by going through the different tab pages. 10

11 6.1. 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. The composition of a product must at least contain one active substance. After checking the product type, the relevant 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. To this end you can click 'Add existing active substance' and select in the drop down menu the appropriate active substance: For new active substances click 'Add new active substance' However, in order to facilitate this process, one can as well copy the active substance information either from another product in your portfolio or from the information included in a previously created frame formulation. This in particular can be very useful when creating a number of similar products falling within the same frame formulation. A simple click will show you the available products or frame formulations to pick out. 11

12 The same approach applies when completing the composition with co-formulants. Clicking 'Add co-formulant' will add a new line to be filled in manually. Likewise a copy can be made from the co-formulants included either in a product or in a frame formulation 6.2. Product classification In a next step Risk and Safety phrases as well as GHS Hazard and Precautionary statements must be added Pack sizes A new requirement when creating a product in the R4BP is the indication of the pack types and pack sizes which will be placed on the market. 12

13 All possible container types and respective volumes intended to be sold should be inserted in this list. 13

14 6.4. Directions for use

15 The use directions of a product relate to what will be put on the label of the biocidal product. As products can be placed on the market all over the EU, this information should be provided in different languages depending on the requirements in the Member States. It might be worthwhile contacting the relevant Competent Authorities in order to obtain confirmation on the languages to be introduced. In this page click 'Add directions for use' and select the language for which you want to introduce the instructions. In the next field, a name can be defined so that the language version is retrieved easily at the time of preparing the application. Following the indication of the use categories, one can start completing the information in the chosen language. When finished, the system allows adding extra languages upon clicking 'Add directions for use' and selecting another language. From here the exercise can be repeated as many times as needed Current Status (existing products already placed on the market) By using the button 'Add country' mention can be made about the product already placed on the market within the EU/EEA. 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. Do not forget to 'Save' the product at the end of the process. 7. What can I do once I have created a product? Once you have created a product, you can: Delete the product as long as no application references it; Update the product as long as there is no submitted application referencing it; Create an application for the product; Delegate access to the product to another industry user; Create a frame formulation starting from the product information 8. How can I change some of the information relating to my products? Once an application referencing a product is submitted and the receiving Member State changed the status of the application starting the completeness check, the product cannot be modified anymore.

16 In practice, as long as the withdraw button is available in your application list you can withdraw your application and amend the product provided that no other applications are referencing it. Or, you can ask the Member State to put your application in draft mode allowing you to make the changes. 16

17 9. How to create a frame formulation 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. In any event, all Member States want to know the composition of the different products to be placed on their market. Process Click on 'Create frame formulation' and you will be directed to the window below Fill in the frame formulation code, a description or name of your frame and select the concentration unit. 17

18 In the next tab the process continues and the approach followed is quite similar to the creation of a product: Either you click on 'Add existing active substance' and you select from one of the fields below the appropriate active substance. Or you copy in the active substance information from a product or frame formulation already created in your portfolio. The same applies for the addition of new active substances Please note that for a frame formulation the concentration range needs to be indicated. Be sure that this covers all the individual product concentrations intended to go under this frame. Do not forget to 'Save' the frame formulation at the end of the process. It has now been added to your list of frame formulations, visible when clicking 'My frame formulations' 10. What can I do once I have created a frame formulation? Once you have created a frame formulation, you can: Delete the frame as long as no application references it; Update the frame formulation as long as there is no submitted application referencing it; Create an application for the frame formulation; Delegate access to the frame formulation to another industry user; Create a product starting from the frame formulation information 11. How can I change some of the information relating to my frame formulations? Once an application referencing a frame formulation is submitted and the receiving Member State changed the status of the application starting the completeness check, the frame formulation cannot be modified simply. 18

19 In practice as long as the withdraw button is available in your application list you can withdraw your application and amend the frame formulation provided that no other applications are referencing it. Or, you can ask the Member State to put your application in draft mode allowing you to make any changes. 19

20 12. How to create an application? In this new version of the R4BP distinction is made between an application for the authorisation of a single product and an application for the authorisation of a product including a frame formulation. Depending on the situation please select 'Create application' or 'Create application with frame formulation' 13. How to create an application without frame formulation? 1) Click on Create application 2) Select the type of application. Currently 8 possible application types are available (low risk and non-low risk). Please be aware that applications for a first authorisation and mutual recognition thereof require a separate form to be generated and sent to the relevant Competent Authorities. You will need to fill a specific form for each and every Member State where you will apply for mutual recognition. 20

21 3) Fill in the Receiving Member State and product details if available/requested. 21

22 4) In the next step you will then be invited to: select in your portfolio of products, the product for which you want to create the application form, and include the name For the concerned product, select from the list those pack size(s) for which you wish an authorisation When clicking on the tab Pack sizes, check the relevant pack sizes which were included at the time of product creation For the concerned product, select from the list those directions for use valid in this specific application. When clicking on the tab Directions for use, check the relevant languages. 22

23 5) The following steps in the process aim to: provide information on the applicant (a company) and the applicant representative (a person); the relevant fields can easily be prefilled by clicking or. Alternatively one can select the appropriate company or person from the list at the right side of the window provide information on the future authorisation holder (a company) and the future authorisation holder representative (a person); provide information on the implementation of Article 13(2) of the Biocides Directive provide administrative information on documents annexed to the application dossier sent to the Competent Authorities. After completion of the electronic application form don't forget to save it. You can then either click on Save 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. In both cases the application will show up in your applications list accessible via The list of applications provides an overview of all your applications and indicates the status in the authorisation process. For example 'DRAFT' or 'SUBMITTED' or 23

24 At the front of each line one can see different functional icons as shown in the picture. In particular it should be noted that as soon an application has been submitted to the R4BP, the printer icon is available to print the application form to be submitted with the rest of your dossier to the competent authorities in the receiving Member State. 14. How to create an application with frame formulation 1) Click on Create application with frame formulation 2) Select the type of application. Currently 5 possible application types are available (low risk and non-low risk). Please be aware that applications for a first authorisation and mutual recognition thereof require a separate form to be generated and sent to the relevant Competent Authorities. You will need to fill a specific form for each and every Member State where you will apply for mutual recognition. 24

25 3) Fill in the Receiving Member State and product details. 4) Differently from building an application for a single product, the concept for this type of application is to choose first a previously defined frame formulation. Secondly you need to link the reference product and the related products in your portfolio to that frame formulation. So you will be invited to select in your portfolio of frame formulations, the one for which you want to create the application form; 25

26 Go to the 'Product information' tab, and select from the list of products those for which you request the establishment of a frame formulation. o At this stage you need to determine which product is the reference product, and which are the additional products through clicking the appropriate checkboxes o Following the addition of the products, you need to identify for both reference and additional products the pack sizes and the directions for use. 26

27 Therefore, select first the appropriate product with the so-called radio button in front of the line Click on the 'Pack sizes' tab and select the relevant pack size o Then click the 'Directions for use' tab and select the appropriate languages from the available directions for use. 27

28 5) The following steps in the process aim to: provide information on the applicant (a company) and the applicant representative (a person); the relevant fields can easily be prefilled by clicking or. Alternatively one can select the appropriate company or person from the list at the right side of the window provide information on the future authorisation holder (a company) and the future authorisation holder representative (a person); provide information on the implementation of Article 13(2) of the Biocides Directive provide administrative information on documents annexed to the application dossier sent to the Competent Authorities. After completion of the electronic application form don't forget to save it. You can then either click on Save 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. 28

29 In both cases the application will show up in your applications list accessible via The list of applications provides an overview of all your applications and indicates the status in the authorisation process. For example 'DRAFT' or 'SUBMITTED'r At the front of each line one can see different functional icons as shown in the picture. In particular it should be noted that as soon as an application has been submitted to the R4BP, the printer icon is available to print the application form to be submitted with the rest of your dossier to the competent authorities in the receiving Member State. 29

30 15. Applications 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. See an example below. Upon selection of the appropriate application, the authorisation information automatically filled in (Authorisation number and date only when the authorisation has been granted).

31 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. 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 submitted. You can only apply for the mutual recognition of a first product authorisation or product registration with or without the establishment of a frame formulation. Note that it is not possible to use an authorisation granted on the basis of a mutual recognition procedure to apply for another mutual recognition procedure. 16. 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 My applications 2) Click on the icon of the application that you want to submit 3) Click on the icon Submit 17. 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. In practice as long as the withdraw button is available in your application list you can withdraw your application and make changes to it. This is only possible as the application status is 'SUBMITTED'. When it is no longer in this status, you can contact the relevant evaluating Member State who has the tools to unlock the application..

32 It is also possible to send a request to the functional mailbox: ENV-R4BP-BIOCIDAL- REGISTER@ec.europa.eu Do not forget to re-submit the application afterwards 18. How to delete an application Prerequisite The application must be in draft mode. Process 1) Go to your list of applications by clicking on My applications 2) Click on the icon of the application that you want to delete. 19. How to print an application form? Prerequisite The application must have been submitted. Process 1) Go to your list of applications by clicking on My applications 2) Click on the icon of the application that you want to print. 32

33 20. How to delegate access to a product? The user who has created a product can delegate access to it to another user already registered in the R4BP. The delegation can be given with full or restricted consultation access. 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 only be able to see the name and concentration of the active substance. 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. 33

34 Process 1) Start the process by clicking on 'Delegate Products' 2) Click on 'New delegation' and indicate the address of the beneficiary Click 'Add Product' and select the product for which you want to delegate access. It is possible to add more then one product, to be delegated in one time. 3) New in the system is that for every product also the pack sizes and direction for use are part of the delegation. So these need to be defined as well before being able to proceed with the delegation. address of the user to whom you want to delegate access to the product and 4) Indicate whether you want to give a full or a limited access. 5) Click on Save 34

35 21. How to delegate access to a frame formulation? The user who has created a frame formulation can delegate access to it to another user already registered in the R4BP. The delegation can be given with full or restricted consultation access. Restricted access means that the user to whom access is granted will not be able to see the detailed composition of the frame. The user will only be able to see the name and concentration of the active substance. Full access means that the user to whom access is granted will be able to see the detailed composition of the frame. 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 frame can not be further delegated. The user who has been delegated access to a frame formulation will see that the frame is included in its list of frame formulations. The user can then use that frame formulation to create an application for a first authorisation or for mutual recognition. The user can however not edit or modify the details of that frame. Prerequisite You must have one frame formulation 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) Start the process by clicking on 'Delegate Frame Formulations' 2) Click on 'New delegation' and indicate the address of the beneficiary Click 'Add Frame Formulation' and select the frame for which you want to delegate access. 35

36 It is possible to add more then one frame formulation, to be delegated in one time. 3) Indicate whether you want to give a full or a limited access. 4) Click on Save 22. How to delegate access to an application? 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) Start the proces by clicking on Delegate applications. 2) Click on 'New delegation' and indicate the address of the beneficiary Click 'Add Application' and select the frame for which you want to delegate access. 3) Indicate whether you want to give a full or a limited access. 4) Click on Save 36

37 23. Frequently asked questions 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 To be completed 37