#AGRG2107649AOrder of April 12, 2021 on the Implementation of the National Catalogue of Phytopharmaceutical Uses in Marketing Authorization Decisions and Parallel Trade Permits for Phytopharmaceutical Products and Adjuvants
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This French law establishes a national catalog of phytopharmaceutical uses to regulate marketing authorizations and parallel trade permits for related products. It affects agricultural producers, regulatory agencies, and companies by defining conditions under which these products can be marketed and used. Amendments and updates to existing permits are required, and the law outlines clear timelines for these updates.
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Key Changes
- Establishment of a national catalogue for phytopharmaceutical uses
- Regulation of marketing authorizations and parallel trade permits
- Timeline for updating existing permits and AMMs
Obligations
What this law requires
Phytopharmaceutical product manufacturers and distributors must align marketing authorizations (AMM) with the National Catalogue of Phytopharmaceutical Uses, using only the approved crop categories and OEPP codes listed in Annex 1
Companies holding parallel trade permits for phytopharmaceutical products must update permits to reflect the approved uses defined in the National Catalogue of Phytopharmaceutical Uses
Regulatory agencies must reference only the culture codes and uses specified in the National Catalogue when issuing or amending marketing authorizations and parallel trade permits
Amendments and updates to existing permits must be completed within the timelines established by this Order
Phytopharmaceutical products and adjuvants (TTGX classification) must comply with the scope of use definitions specified in the Catalogue for each crop category