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Article R5121-51-11 of the French Public Health Code

At the end of the Community arbitration procedure implemented in accordance with the provisions of Articles R. 5121-51-8 and R. 5121-51-9, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall grant, vary, suspend or revoke the marketing authorisation within a period of thirty days, in accordance with the decision taken by the European Commission at the end of this procedure.

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Article R5121-51-12 of the French Public Health Code

Each year, the Director General of the Agence nationale de sécurité du médicament et des produits de santé sends the coordination group referred to in Article 27 of Directive 2001/83/EC of the European Parliament and of the Council a list of medicinal products for which he considers it necessary to harmonise the summaries of product characteristics.

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