- Regulatory reference texts:

• Articles R522-26 to R522-27 of the French Environmental Code,
• Article 4 of the Ministerial Order of 19 May 2004 .

- Notes:

The first authorisation must be granted by and for another Member State. The product must contain one or more active substances listed in Annex I of Directive 98/8/EC.

- Deadlines:

4 months with the possibility of a suspension of the evaluation if additional information is necessary.

- Validity of the authorisation:

10 years.

- Fees payable to ANSES:

€4,000

- Composition of the dossier:

• A summary of the dossier (see Annex IIB Section X of the Ministerial Order of 19 May 2004 ),
• Part of the documents listed in the section Dossier Submission - How? (in French): explanatory letter, R4BP form, form specific to France (if applicable), letter(s) of access,
• A certified copy of the first authorisation issued, translated into French,
• The classification, packaging and labelling, including a draft label, in French,
• The Safety Data Sheet(s) in French.

Concerning the mutual recognition of products already on the French market (“existing” products), the procedure is carried out in two phases:

- Initially, the following documents must be sent before the application submission deadline, when submitting the first application for authorisation:

• An explanatory letter (in French) confirming that an application for authorisation has been made in another Member State and that mutual recognition is sought in France,
• Part of the documents listed in the section Dossier Submission - How? (in French), i.e.: letter(s) of access, R4BP form, form specific to France,
• An electronic copy of the dossier summary.

- Subsequently, the following documents must be sent no later than two months after obtaining the first authorisation:

• A certified copy of the first authorisation, translated into French,
• An evaluation report (in electronic format only),
• A summary of the dossier (in electronic format only),
• The labelling, instruction manual(s) and SDS, in French,
• Fees payable to ANSES (fees).