According to the European regulation N°528/2012, industrials who wish to submit a request for the Marketing Authorisation (MA) of a product have to submit a dossier in the country in which they want to market their product, using the European platform R4BP (Register for Biocidal Products). There are several types of MAs. Today, we look into the same product MA.

L'Autorisation de Mise sur le Marché d'un produit biocide identique

What is the "same" biocidal product MA?

The “same” product Marketing Authorisation (MA) allows companies to go from wider to narrower authorisations. That is to say, from a biocidal product family to a subset of one or more “family members” or from wider to narrower markets (from Union authorisation to national authorisation).

Thus, it is possible to request an authorisation for a product if the latter is identical to another authorised biocidal product (reference product) or to another product for which an authorisation request has been submitted (the future reference product).

Nonetheless, both products have to have the same composition and uses. Moreover, the reference product needs to possess a national MA or a Union one (or currently be under evaluation to get it) in order to be able to request a same product MA.

Source : ECHA

For more information, you can take a look at the regulation dealing with same biocidal product MAs.

Dossier submission

According to the Biocidal Product Regulation (BPR), all requests for same biocidal product MA have to be submitted via the R4BP platform, as well as all other MA requests.

In order to be able to benefit from the transitory period, you have to submit your dossier before the approbation date of your substance; just like every other long-term MA request.

The evaluation process

After passing the first round of tests performed by ECHA, the dossier is transferred to the competent authority for validation. It is the latter who will take the final decision.

For more information on the procedure for same product Marketing Authorisation, do not hesitate to visit ECHA’s website and the practical guide on same biocidal product MAs.

Supporting documents

ANSES’s biocides helpdesk gathers the list of all the supporting documents you need for your same product authorisation request. Click here to see it.

Linked fees

The fees linked to national authorisation may vary according to Member States. Therefore, it is the applicant’s responsibility to enquire about this issue to the competent evaluating authority.

Want to know more about biocidal products' regulation in Europe?

 

For more information on REACH Factory software suite, do not hesitate to contact our expert, Mr. Fang Zhou by phone at : +33 1 83 64 20 54 for Europe, or +1 (778) 234 1607 for North America or even send him an email at [email protected]

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