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Showing 561–570 of 1054 articles for “Art. LD-AdIC §§ 51–62”
A joint order by the ministers for labour and agriculture specifies the procedures and methods to be used to check compliance with biological limit values.
I.-In accordance with the provisions of II of Article L. 4211-9-1, an establishment or organisation authorised under this section may have the preparation and distribution of an individually prepared…
In order to obtain recognition, by at least one other Member State of the European Community or party to the Agreement on the European Economic Area, of a marketing authorisation granted by the Direct…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé or the applicant for marketing authorisation may refer the matter to the European Medicines Agency with…
In order to obtain recognition in France of a marketing authorisation issued by another State, known as the reference State, which is a member of the European Community or a party to the Agreement on…
To obtain a marketing authorisation in France and in at least one other Member State of the European Community or party to the Agreement on the European Economic Area, for a medicinal product which is…
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 Europea…
In specific cases of interest to the European Union, the Director General of the National Agency for the Safety of Medicines and Health Products or the applicant shall refer the matter to the European…
In the absence of agreement within the coordination group, the Community arbitration procedure provided for in articles 32 to 34 of Directive 2001/83/EC of the European Parliament and of the Council a…
At the end of the procedures provided for in this sub-section, the marketing authorisation is issued or varied by the Director General of the Agence nationale de sécurité du médicament et des produits…
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