e-dossier: Guidance on electronic application for transitional authorisation

Transcription

1 Version., /MDA e-dossier: Guidance on electronic application for transitional authorisation AN An application for a transitional authorisation AN can only be submitted for biocidal products that contain at least one notified active substance for which a decision on inclusion in the list in Annex or 2 of the Ordinance on Biocidal Products (OBP; SR 83.2) is still outstanding. Click here for more information about authorisation AN. Click here to see the unofficial, consolidated list of notified active substances. Before you can submit an electronic application, you will need to have access to the product register for chemicals (RPC). To obtain access, follow the instructions for Opening a user account. Go to the following internet page: If the biocidal product only contains active substances in the lists in Annex or 2 of the Ordinance on Biocidal Products, then an application for this biocidal product must be submitted using harmonised European procedure. The following transitional provisions apply to biocidal products that have been placed on the Swiss market under a transitional authorisation.

2 Contents The public product register for chemicals (RPC)... 3 Master data... 4 Classification of the biocidal product...0 Composition...2 GHS labelling of the biocidal product...22 Labelling...27 Information on use...28 Uses...29 Additional information...30 Documents...3 Notes...33 Summary...34 Sending...35 PDF record...37 Supplying documents retroactively...38 General

3 The public product register for chemicals (RPC) Registered user ID Select language Click to submit an electronic biocidal product application A N What s new in and about the public register for chemicals 3

4 General help on all topics Master data Applicant; product name 3 DA TA FIE LD NA VIG ATI ON 2 The name of the applicant, i.e. the person applying in Switzerland, will be entered automatically. 2 Name of the biocidal product; if the product name is different in the languages selected, it must be added for each language by removing the. 3 The information entered must be confirmed by clicking Save. The system will now generate the specific CPID number. Chemical Product IDentificator 4

5 Master data CPID number The CPID number and the main designation have been added to the data set. The specific CPID number must be included in all correspondence concerning the biocidal product. 5

6 Master data Chemical manufacturer (of the product) Clicking on Edit opens a new tab (2) in which the chemical manufacturer can be edited. 3 Companies that are already in the system can be searched for under Search for manufacturer. In exceptional cases, a company that has not been found using the search function can be added in the Add manufacturer section. 4 Search field 6

7 Master data Chemical manufacturer (of the product) Enter the search term and confirm the search by pressing Enter (parts of words can be searched for using *xxx). 2 After a short time, a selection of possible companies is displayed. The required entry must then be marked by clicking on it and confirmed by clicking on Select. The entry will now appear under the Selected manufacturer tab. Only one entry can be put into the system. 3 When you click on Update, the selected entry is automatically transferred to the master data mask (4) to which you will be returned automatically. Important: Only one chemical manufacturer can be stated. 7

8 Master data Product specification, contact information Status In progress Under review Qualified Rights The company can enter/modify all data The company can only add missing documents (see Navigation Documents) because the e-dossier has been sent. The product has been authorised; the company can only enter amendments that have been notified in advance (see Notifications of changes to existing biocidal authorisations A N/A Con our website) Only the Authority may assign and manage authorisation numbers. 2 State the aggregate state of the product. 3 If the product consists of several parts (in situ manufacture), a separate e-dossier Component of a kit must be submitted for each component and an e-dossier (KIT) must be submitted for the commercial product. Select Normal notification for all other cases. 4 Full contact details of the applicant in Switzerland must be given (additional specialists may be named optionally). 8

9 Master data Product identifiers, descriptors 2 3 Internal company identifiers can be entered here. 2 Define descriptors using this tab. 3 Save the master data section, wait for confirmation that the data have been saved and move to the next section on the navigation bar. 9

10 Classification of the biocidal product GHS classification Switch to the GHS section (DSD is no longer required). 2 Select the hazard class(es) and hazard category/ies. As soon as this has been done, the associated H-phrases (3) appear. These can be added by clicking on them. Repeat this process if several phrases are required. 4 If the product has not been classified, a can be inserted here. 0

11 Classification of the biocidal product GHS classification 2 Enter the full classification of the product. 2 Save the Classification section and wait for confirmation that the data have been saved. Entries can be deleted by clicking on X.

12 Composition Search for components 2 Search for reference substances: Standard setting, the search is only performed in the ideal Search for products: The search is limited to the preparations database. To be used only in exceptional cases. Substances and preparations can be searched for under the heading Select components. 2 Use Search term to enter the name of a product or preparation and start the search by pressing Enter or clicking on Search. We recommend searching for reference substances (to enter the composition) by CAS or EC numbers as chemical names often produce no hits. 2

13 Composition Search for components, search results 2 If the search was successful, all the hits will be shown in the list (which may comprise several pages; 2). Select the required component by clicking on it; a new tab will open automatically: 3

14 Composition Individual components, Content section Selected substance or preparation Headings that manage data entry for the selected substance or preparation 2 The operator must be = for normal applications for authorisation A N because the composition to 00% is required (exception: application for authorisation A N for a biocidal product family) Enter the content and normally the unit g /00 g (percentage unit) as standard. Separate decimal places with a point (e.g ). 5 Select the function of the substance or preparation. If none of the predefined functions applies, you can select normal composition. Important: The product needs at least one component designated as a biocidal active substance 6 All biocidal active substances and hazard-determining substances in the end product must be declared ( ). 4

15 Composition Individual components, Chemical manufacturer (of the biocidal active substance as stipulated in Article 62d OBP, Article 95 BPR) section Clicking on Edit will open a new tab named Edit manufacturer. Important: Active substance manufacturer(s) and/or active substance supplier(s) must only be stated for the biocidal active substance(s). It is not essential to name the manufacturer(s) of all the other components. 5

16 Composition Individual components, Chemical manufacturer (of the biocidal active substance as stipulated in Article 62d OBP, Article 95 BPR) section 2 3 Please note your obligations under Article 62d OBP. Click here for more information. Companies that are already in the system can be searched for under Search for manufacturer. A company that has not been found using the search function can be added in the Add manufacturer section. 2 Enter the search term and confirm by pressing Enter. 3 After a short time, a selection of possible companies is displayed. The required entry must then be marked by clicking on it and confirmed by clicking on Add. The entry will now appear under the Manufacturer tab. Several manufacturers can be entered. 6

17 Composition Individual components, Chemical manufacturer (of the biocidal active substance as stipulated in Article 62d OBP, Article 95 BPR) section Once all the active substance suppliers for the biocidal active substance have been selected, click on Update. This will add the information to the substance or preparation and you will be automatically returned to the overview of headings for the selected substance or preparation. 7

18 Composition Individual components, Chemical manufacturer (of the biocidal active substance as stipulated in Article 62d OBP, Article 95 BPR) section The active substance manufacturer(s) is/are now shown and can be modified as required by clicking on Edit. 8

19 Composition Individual components, GHS classification heading 2 3 Select the hazard class and category for the substance or preparation as shown in the CLP Regulation EC 272/ The corresponding H-phrases will now appear and can be selected by inserting a. 3 Click on Add to transfer the selected classification into the lower field. Important: It is no longer essential to state the DSD classification. 9

20 Composition Individual components, GHS classification heading 2 3 If the substance or preparation has not been classified, or if the relevant data are not available, this can confirmed by inserting a. 2 The GHS classification is shown here; entries can be deleted by clicking on X or modified by clicking on the corresponding line. 3 Once the full GHS classification has been entered, confirm by clicking on Update. You will be automatically returned to the overview of headings for the selected substance or preparation. 20

21 Composition Other components 2 Relevant information about the composition can be entered here 3 You are now back in the Select component section, where you can search for further components. 2 All the components that have already been selected are shown together here. The symbol in the C/D column shows you that this component has been defined as declared. 3 Save your entries at the end of the process. Important: The full composition to 00% must be given. It is not permitted to use ranges. 2

22 GHS labelling of the biocidal product H-phrases 2 2 Select the H-phrases drop-down list in the H-phrases section. 2 You can select the required H-phrase by searching in the appropriate field (you can search by number) or by scrolling through the list. Click on the required phrase to confirm it and click on Add. Important: It is no longer essential to use DSD labelling. 22

23 GHS labelling of the biocidal product H-phrases, variables as a special case The special case of H-phrases with variables: The corresponding text must be stated analogously in all selected languages 23

24 GHS labelling of the biocidal product H-phrases All the selected H-phrases are shown here. They can be deleted again by clicking on the X. The Variables column also shows whether there is an entry that you can read or modify by clicking on the appropriate line. 24

25 GHS labelling of the biocidal product P-phrases You can enter P-phrases in the same way as H-phrases. Note: Since the P-phrases stated for biocidal products are determined independently by the future authorisation holder, and are accordingly not imposed, it is the responsibility of the future authorisation holder to ensure that the entries are correct (i.e. they will not be checked by the Authority). 25

26 GHS labelling of the biocidal product Hazard pictograms 2 3 You can select the pictograms you require by inserting a symbol under the relevant pictograms in the Hazard pictograms section. 2 Select the appropriate signal word. If no signal word will be used, select No signal word. 3 Confirm your entries by clicking on Save. 26

27 Labelling User categories, container sizes 2 Select user category/ies When selecting the container sizes, you can select all the entries in the column by inserting a in the grey area at the top. Otherwise you can add the manually. 2 Confirm your entries by clicking on Save. 27

28 Information on use Note: The Authority completes this section once the product has been evaluated. This information also forms part of the official decision. 28

29 Uses Uses, areas of use, methods of use, objectives of use Select the appropriate subsections of the biocidal product type(s) here. You can modify the selection options on the right Select the required use(s). 5 If a use does not feature under any of the headings, note the fact here, stating the heading concerned. 6 Confirm your entries by clicking on Save. 29

30 Additional information Note: This area is not available yet. 30

31 Documents Uploading documents 2 Documents relevant for an application for authorisation A N: Signed printout of the the last page of the record (see chapter on PDF record and Sending section) A draft of the label (including information and instructions for use) Safety data sheet If appropriate, documentation of efficacy (disinfectants and wood preservatives) Where appropriate, documentation of the product labelling The completed supplementary document Click on Select to navigate to your personal files, which you can then mark and add to the submission by clicking on Upload (2). Most common formats (such as Word, Excel, PDF, ZIP etc.) can be used. We recommend using self-explanatory file names (such as SDB_D, SDB_F, Study_EN650, Label_Front etc.). 3

32 Documents Uploading documents Once documents have been uploaded successfully, they can be renamed. 2 Select document type. 3 Mark to show whether the document should be available to the public (this is the applicant s responsibility). The document can be deleted by clicking on X. 4 All uploaded documents are shown together here. 5 Once all the documents have been uploaded, confirm your entries by clicking on Save. 32

33 Notes Note: This is where you can enter additional information about the biocidal product that is connected to the application for authorisation A N. 33

34 Summary Note: The summary shows all the information that has been entered so far on a single page in a clear, concise form. 34

35 Sending You can send the product as soon as you have entered all the relevant data. The status will then change from In progress to Under review and the data will be sent to the Notification Authority for Chemicals. Important: After you have sent the data, you can only Send documents retroactively ; all the other sections are in read-only mode and can no longer be edited. If you get any error messages you will not be able to send the product. Eliminate all the errors, which will be clearly listed, and send the product again. 35

36 Sending The following information will appear if you have sent the product successfully: The following information must now be sent by to the Notification Authority for Chemicals: Proprietary name and CPID number of the biocidal product Confirmation that this is the first application for an authorisation A N Excel template providing information on the active substance supplier (click here for more information) The last page of the scanned product record (see PDF record section) To the address: cheminfo@bag.admin.ch 36

37 PDF record Click on the words PDF record The PDF record will now be generated automatically Save the document and print out at least the last page Select the language in which you wish to receive the official decision and sign where indicated. Important: for legal reasons, only the signature of the applicant in Switzerland can be accepted Scan this page 37

38 Supplying documents retroactively Supplying documents retroactively (PDF record etc.) Please note that documents uploaded to the Documents tab (where these exist) can be read by other sub-users. As described in the Documents section, you can add the PDF record subsequently to the product documents that have already been uploaded. 38

39 General Do not add any other documents while the review is ongoing or after you have received the official decision unless you are requested to do so by the Authority. You are likely to incur additional charges if dossiers are incomplete. Please do not hesitate to contact us if you have any questions or anything is unclear: +4 (58) (Mon - Fri: am am (noon)) 39