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Written by DPR Biocides - Anses
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Thursday, 08 April 2010 15:14 |
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Special submission procedures apply if:
- the product contains substances registered for the European revision programme, not yet included in Annex I or IA of Directive 98/8/EC, and is not currently on the French market. In this case, the product may still be sold but must be declared on the inventory database of the French Ministry of Ecology and on the INRS database. Depending on its type and uses, the product will follow the transitional period scheme pending inclusion of its component active substances in Annex I or IA of Directive 98/8/EC.
- the product contains substances listed in Annex I or IA of Directive 98/8/EC. The deadline for submitting applications is given by the instructions for inclusion of the active substances composing the product. Applications should be submitted no later than the day before the inclusion deadline for the active substance in the biocidal product.
- the product is already on the French market ("existing" products). This concern the transitional period during which a manufacturer can continue to sell its product on the French market, without special procedures. Nevertheless, some restrictions apply depending on the product type and uses as indicated in "regulation - transitional period" section
- the product contains new substances. Applications may be submitted, at the earliest, at the same time as the registration dossier for the active substance. The placing on the market of these products is prohibited before authorisation has been granted.
- the product contains more than one active substance belonging to the same product type. The deadline for submission is given by the Inclusion Directive for the last active substance listed.
- the product contains active substances included or pending inclusion for different product types. An authorisation is issued for each product type, separately over time if the substances have not been included at the same time in Annex I or IA of Directive 98/8/EC.
The submission deadlines are also indicated in the Ministerial Orders transposing the Inclusion Directives for the active substances.
When submitting the first application for authorisation, it is necessary to register any intentions to submit other applications, such as for mutual recognition, at the same time.
WARNING: If no dossier has been submitted before the deadline for an existing product, its marketing shall be prohibited six months after the deadline for submitting applications, and its use shall be prohibited twelve months after that same date.
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Last Updated on Friday, 25 March 2011 16:00 |