Renewal of PT8 products
When to apply for product renewal?
An application for renewal of a product according to the Biocidal Product Regulation (BPR) must be submitted 550 days before the expiry date of the first expiring active substance. For a large number of existing authorizations the products have the same expiry date as the active substance in the products. For these wood preservatives the existing product authorizations will for most cases be prolonged administratively using Article 31(7). This means that product evaluations can take place after the re-evaluation of the active substances. More information is available in the document: CA-May18-Doc.4.1.
What to include in an application for product renewal?
An application for renewal of a product must be submitted 550 days before the expiry date of the first expiring active substance. At the time of submission an application should include data requested under Article 31(3); i.e. (a) all relevant data required under Article 20 that has been generated by the applicant since the initial authorization and (b) an assessment of whether the conclusions of the initial assessment still remain valid and any supporting information. However, as the active substances contained in a product have not been renewed, any new information from the evaluation of active substances must await a final conclusion before it can be included in a product evaluation. Any new guidance or other new information that is relevant for the product evaluation must however be considered in the application for renewal that is submitted. At this point a cursory completeness check will be performed, however it should be noted that based on the active substance evaluation, then further data and updates of the application might be requested. After the validation the evaluation will be administratively initiated and then put on hold until the final decision for the active substance(s) is available.
An IUCLID file should be submitted with the renewal application. In the IUCLID file argumentation should be provided for each data point on whether studies from the first authorization are applied or if new data is enclosed. There might be updated safety data sheets for constituents, new efficacy studies and stability studies etc. An updated SPC should be generated.
An overview of changes made to the authorization since the original authorization was granted.
An overview of all assets in R4BP covered by the renewal in the concerned member states, including all trade names.
Which format to use for the Product Assessment Report for renewal?
At the renewal stage for wood preservatives, applicants are encouraged to use the new template for product assessment reports (PAR). In the PAR it should be clearly indicated what is copied from the former PAR and what is new information. For wood preservatives new guidance is available for a number of areas and this is one of the major reasons for choosing an updated PAR instead of creating an addendum to the PAR from the former authorization. E.g. for stability formerly a deviation of 15% was accepted while now maximum 10% is accepted based on new harmonized guidance. For the wood preservatives that are authorized generally a number of changes have been applied. These must be incorporated in the updated PAR in the application for renewal.
New requirements for storage stability studies
At the renewal of PT8 wood preservative products the guidance on the BPR: Volume I, Part A Chapter III: Requirements for Biocidal Products will replace the previous guidance stating an acceptable degradation of 15% according to WHO/FAO. New as well as existing storage stability documentation must comply with the new guidance for the renewal process and products will be assessed and authorized accordingly.
According to Section 3.4.2, Guidance on the BPR: Volume I. Part A Chapter III: Requirements for Biocidal Products. “The active substance content should be determined using a validated method of analysis. It is generally recognised that a decrease in the active content of ≤10 % should not adversely affect the efficacy and risk assessment of the product. Where the degradation of the active content is >10%, or in cases where a decrease of <10% may impact on the efficacy and/or the risk assessment, then a justification for the acceptability of the decrease should be provided. This may require an assessment of the degradation on the efficacy and risk assessment. The fate (degradation products) of the active substance may have to be assessed. Alternatively, a more appropriate shelf life, in which the degradation of the active content is considered acceptable, should be proposed. For this reason, particularly when the active is known to degrade, it is advantageous to perform ambient storage studies in which the active content is assessed at interim time periods.”
Fees for renewal applications – when to pay and how much?
The fees are set to cover the costs for the Danish Environmental Protection Agency for handling and evaluating applications. A list of the fees levied with effect from 1 February 2018 can be found here.
A fee of 15.000 DKK must be paid at the time of submission of the application. Remaining fee will be invoiced after the renewal of the active substances, when the product renewal is about to begin. Fees for 2018 apply no matter when the actual product evaluations begin.
DEPA can choose to charge a reduced fee, if the amount of work expected is less than a full evaluation.
Comparative assessment – what should be submitted?
If one of the active substances contained in the product for renewal meets at least one of the exclusion criteria listed in Article 5(1), then evidence that Article 5(2) is applicable should be contained in the application.
If one of the active substances contained in the product is a candidate for substitution, a comparative assessment must be performed as a part of the re-evaluation process. Any relevant information for this assessment can be submitted as a part of the application.
An authorisation for biocidal products containing candidates for substitution can be granted (and renewed) for a maximum period of five years.
When can mutual recognition in parallel be used?
The process for mutual recognition in parallel can be used only for authorizations having the same term and conditions (apart from limited exceptions) in all the relevant Member States at the time of the application for renewal. If authorizations in different Member States are no longer the same these authorizations are to be considered as different products, and should be evaluated separately through national authorizations in the Member States, rather than through mutual recognition. Therefore, it is important for the applicant to have a clear outline of changes made for the products in each Member State.
Product authorizations must also have the same terms and conditions after the renewal of the active substances, i.e. that any changes applied for during this period should contain all concerned member states.