3. What are your obligations under the European authorization?
Your obligations will depend on the date on which the SA is listed.
The PB must be considered as a new PB. An application for marketing authorization (MA) must therefore be filed in a European country, along with mutual recognition in other European countries where the PB will be marketed, or an MA directly at European level to cover several member states at once.
No marketing authorization is granted until the MA has been approved.
Once the product has been placed on the market, it must comply with French obligations relating to various declarations:
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What are your obligations under the European authorization?