Application for renewal under transitional law
An authorisation under transitional law is issued for a period of 10 years. The expiration date of an authorisation is listed in the authorisation decision and on the authorisations database on the Ctgb website. After the authorisation expires, the product must be taken off the market. If the authorisation holder wants to keep the product on the market, the authorisation must be renewed. For this purpose an application for renewal of the authorisation (TVB) must be submitted in a timely manner. The renewal is based on the authorised composition and legal conditions for use (WGGA) of the product. An application for renewal cannot include an extended scope of permitted use or a major change. However, authorisation holders can apply for a narrower scope of permitted use than in the original authorisation. An application for renewal can also include a request for administrative changes. Implementing regulation (EU) 354/2013 of 18 April 2013 defines administrative changes.
Procedure
An application for renewal involves a comparison with the previous assessment of the product. The Ctgb checks the original authorisation to determine whether new insights could lead to a different decision. If it can be demonstrated that there are no unacceptable risks to humans and the environment, then the authorisation will be renewed for another 10-year period. However, if any previously authorised use of the product cannot be demonstrated to be safe, then the application for renewal will be rejected and the existing authorisation will be withdrawn. In that case, in order to use up existing stocks on the market, the applicant may request delivery and run-down periods in accordance with the policy decree on derogation periods for biocidal products.
Dossier
An application for renewal must be accompanied by a dossier that contains all the information the Ctgb needs to make a decision. In any case, this includes Application Form B and Application Form C. Because a renewal involves a comparison with the original authorisation, authorisation holders only have to answer the following questions from Application Form C:
- Section A: questions 1 to 7
- Section B: questions 11 to 14
- Section C: questions 1, 11 (optional), 25 and 34
- Section D: question 2
These questions also specify which documents should be included.
Timeline
An application for renewal of the authorisation under transitional law must be submitted to the Ctgb no later than 78 weeks before the expiration date of the original authorisation.
Please note
Under transitional law, decisions on renewal can no longer be made if the active substance and product type combinations from the product have been placed on the Union list of Approved Active Substances according to Regulation 528/2012. In that case, the BPR is in force.
If an application for renewal has been submitted on time, but the Ctgb cannot make a decision before the expiration date of the authorisation, this date will be procedurally extended. In that case, the applicant will be notified of the new expiration date of the authorisation.
For reasons beyond the applicant's control, the expiry date may pass before a decision on its extension has been made. The date will then be postponed again for a period such that there is sufficient time to process the application. You do not need to submit a new application for this.