Mutual recognition |
Written by DPR Biocides - Anses | ||||||||||||||||||||||||||||
In order to harmonise the European market and simplify the authorisation procedures for making products available on the market, the assessment of a biocidal product can be shared between the Member States concerned. In this case, the decision and, where appropriate, the authorisation conditions are harmonised. These are called " mutual recognition procedures" (described in Chapter VII of the BPR). An application for mutual recognition may be made in several Member States at the time of submitting the first MA application on the European market. In this case, the mutual recognition is known as "simultaneous", and the corresponding procedure is described in Article 34 of Regulation ( EU) No 528/2012. It should be noted that the French version of the Summary of Product Characteristics (Résumé des Caractéristiques du Produit - RCP) must be provided to ANSES within 10 days of the reference Member State sending the SPC in English.
Mutual recognition can also be requested after a marketing authorisation has been granted by a Member State. In this case, the mutual recognition is known as "sequential", and the procedure is described in Article 33 of the BPR.
Regulations
Timeframe
Validity of the MA: Expiry date identical to that of the reference MA. Fees payable to ANSES
Composition of the dossier for a sequential mutual recognition
Composition of the dossier for a parallel mutual recognition
The French summary of product characteristics (Résumé des Caractéristiques du Produit - RCP) must be submitted within 10 days of the reference MA being obtained.
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Last Updated on Wednesday, 09 August 2017 13:32 |