National Marketing Authorisation
The national procedure is a Marketing Authorisation (MA) process for a product affecting only one State. In France, it is granted by the following national authorities: ANSM for medicine and ANSES for biocides.
National authorisation can then be recognised by other Member States (MSs) via a request for mutual recognition in sequence or in parallel.
You can find the list of competent authorities per state on ECHA’s website.
Mutual recognition in sequence
This one can only be requested once the national authorisation is granted by the competent authority (CA) of a reference MS. The applicant then submits a translation of the national authorisation in the official languages requested by the MSs concerned.
Mutual recognition in parallel
It consists in submitting a national authorisation application to the reference MS by indicating the list of all MSs concerned. The reference MS assesses the application at the same time as the concerned MSs assess the mutual recognition application. The latter must contain two elements:
- reference and concerned MSs names
- summary of the biocidal product's characteristics (Art.20, 1, a, ii) in the official languages required by the MSs concerned
NB : The mutual recognition process will take approximatively 5 months starting from the validation of the application by the evaluating competent authority.
The applicants have to submit their request for national MA and mutual recognition to the competent authority of the country in which they wish to sell their product (or family of products), using the Register for Biocidal Products (R4BP).
The dossier is submitted to the CA via the R4BP platform.
If need be, the CA can ask for further information. Then, there is a period of questions and evaluation via R4BP. The applicant has 180 days to answer to the CA (still using R4BP).
After the evaluation, the CA drafts the biocidal product’s risk assessment and sends it back to the applicant. The latter is given 30 days to make his own comments before the CA finalises the evaluation.
After that, the CA chooses whether to grant the national marketing authorisation or not.
For a national marketing authorisation request in France, ANSES’ biocides helpdesk gathers the complete list of support documents to provide. Click here to see the list.
For the list of supporting document related to your request for mutual recognition in sequence or in parallel, click here.
The fees linked to national authorisation may vary according to MSs.
For more information on the costs related to a national authorisation request, it is the applicant’s responsibility to enquire about this issue to the competent evaluating authority.
Finally, ECHA has published a detailed guide on national MAs. You can read it by clicking here.
Want to learn more about biocidal products' regulation in Europe?
For more information on biocidal products, do not hesitate to contact our expert M. Fang Zhou by phone : +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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