Notification of a simplified authorisation
A biocidal product authorised according to the simplified procedure may be placed on the market in all Member States by a declaration (Art. 13c OBP), without the need for mutual recognition.
Requirements Basics
A biocidal product authorised through a simplified authorisation in an EU or EFTA country can be made available on the market in Switzerland without the need for a mutual recognition. The notification must be issued at least 30 days prior to the first placing on the market via the Register for Biocidal Products (R4BP3).
The notification of a simplified authorisation is not an actual authorisation: Following a review of the application and its documentation and a positive decision, Switzerland merely provides the applicant with a «Confirmation» and the corresponding «authorisation number». After a positive decision has been issued by the authority, the biocidal product may be placed on the market.
Please refer to the document on the restriction of misleading trade names.
Procedure
At the latest, 30 days prior to the first placing on the market, the authorisation holder must notify the Notification Authority Chemicals, via the European Register for Biocidal products R4BP 3, of the biocidal product that was simply authorised in another Member State.
For registration in R4BP3 we recommend the Guide issued by the European Chemicals Agency (ECHA) «ECHA Accounts Manual for Industry Users» for drafting and managing the accounts in R4BP3, and the following guidance document: How to use R4BP 3 for the general concepts and functions in the Chemicals portal.
Detailed instructions on how to submit a notification of a simplified authorisation can be found in a subchapter (‘Notification for placing on the market’) of the following guidelines:
- Simplified authorisations - ECHA (europa.eu)
- Practical guide on simplified authorisation of biocidal products
- BSM: How to submit an application for Simplifies Authorisation; Kapitel 10 ff: Notification for placing on the market
Application
The application for recognition must include the following:
In addition to the documents/information required in R4BP 3, a draft label and a safety data sheet would have to be uploaded under «documents» in R4BP 3. If the biocidal product for which authorisation is being requested using the harmonised European procedure is already on the market in Switzerland under a transitional authorisation: its authorisation number (CHAN or CHAC) and proprietary name (IMPORTANT: additional costs will be charged if queries arise).
Provided the application documents are complete, the application is reviewed within the next 30 days. The applicant must monitor the status of its submission and react to requests of the authorities in R4BP 3. If the applicant misses a deadline, e.g. for the payment of fees or for a subsequent request for a statement, etc., the notification can be rejected or declined or the processing can be concluded irrespective of the deadline. After a positive decision has been issued by the Chemicals Notification Authority, the biocidal product may be placed on the market.
Period of Validity
The OBP does not explicitly define the period of validity of the simplified authorisation. The active substances in Annex 1 also are no longer limited in regard to their inclusion as they were in the past. According to the general principles of EU Biocidal Products Regulation No. 528/2012 (art. 17, para. 4 BPR), a simplified authorisation is therefore granted for a maximum period of 10 years. The validity period of a notification is based on the validity period of the reference authorisation granted according to the simplified procedure.
Fees
A fee of 500 CHF is charged for the notification of a simplified authorised biocidal product.
Biocidal product families
Entire biocidal product familes cannot be notified as a whole, only the individual members thereof.
Change requests
Apart from administrative changes, notifications cannot be amended. If a change is made to the simplified authorisation, it must be withdrawn and a new application submitted.
Extension of the authorisation
Notifications of simplified authorisations cannot be extended beyond their expiry dates. After the simplified authorisation has been extended, a new notification for placing on the market must be submitted.