National authorisation

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Biocidal Product Authorization Process

The basic principle in the Biocidal Products Regulation ((EU) No 528/2012 (BPR)) is that a biocidal product (BP) must be authorised before it can be made available on the market or used in the European Union (EU)/European Economic Area (EEA). This takes place in two consecutive steps.

Evaluation and Approval of Active Substances

As the first step, the active substance is evaluated and provided the criteria are fulfilled, is then approved in a specified product-type (PT).

Product-Type Approval and Active Substance Authorization

The second step is the authorisation of each BP consisting of, containing or generating the approved active substance(s). This document concerns the second step, the authorisation of a BP.

National Authorization and Mutual Recognition

The national authorisation (NA) of a BP is granted by the competent authority of the Member State (MSCA) where the BP will be made available on the market (receiving MS) and is only valid for the approved terms and conditions stated therein. To avoid duplication of the evaluation procedure, the product authorisation granted in one MS can be recognised in other MS through the mutual recognition procedure.

Authorization for Biocidal Product Families

The same rules as for a single BP apply also for a biocidal product family (BPF).

Union Level Authorization

Some BPs might gain Union-level authorization, eliminating the necessity for individual national permits.

Application Process and Timing

An application for NA can be made by, or on behalf of, the prospective authorisation holder (AH). The AH is the person/entity established within the EU/EEA who is responsible for the placing on the market of a BP in a particular MS.

Timing of Application

In general, the NA application can follow active substance approval. Apply for BP before approval; else, remove products in 180 days. Use existing BP stocks until 365 days post-approval. Also, seek product authorization later, but hold off market until authorized.

Multi-Active Substance Biocidal Products

Where that BP contains more than one active substance for the same PT. The application for NA must be submitted no later than the date of approval of the last active substance for that PT. If the BP belongs to several PTs it is only necessary to apply for NA when the active substance(s) contained in it has/have been approved for all relevant PTs before the deadline of the last approved.

Proactive Application Strategy

To ensure a smooth process, make NA applications well ahead of the deadline. This prevents rejections from submission or payment issues.