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Article R5138-8 of the French Public Health Code

The written confirmation referred to in article R. 5138-7 is not required when the active substances imported come from a country on the list provided for in article 111b of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.

Original in French 🇫🇷
Article R5138-8

La confirmation écrite mentionnée à l’article R. 5138-7 n’est pas à fournir lorsque les substances actives importées proviennent d’un pays mentionné sur la liste prévue à l’article 111 ter de la directive 2001/83/ CE du Parlement européen et du Conseil du 6 novembre 2001 instituant un code communautaire relatif aux médicaments à usage humain.


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