Article R5121-216
The Agence de la biomédecine is informed of the decisions taken in application of Article R. 5121-212.
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Showing 1361–1370 of 3184 articles for “Art. L232-21”
The Agence de la biomédecine is informed of the decisions taken in application of Article R. 5121-212.
The authorisation may be subject to special conditions requiring the beneficiary of the authorisation to implement a plan for monitoring the efficacy and safety of the medicinal product, including the…
In the event of failure to comply with the legislative and regulatory requirements, the conditions for granting or monitoring the authorisation referred to in Articles R. 5121-212 and R. 5121-213, or…
A request for authorisation must be submitted for any changes which have an impact on the quality, safety and efficacy of the medicinal product. This application must be accompanied by a technical dos…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within a maximum of one hundred and twenty days from the date…
With the exception of pharmacists covered by the provisions of article L. 4138-2 of the Defence Code, a pharmacist providing a replacement must, in order to do so, apply for registration on the roll o…
The following information is exempt from advertising approval when it appears on labels, leaflets or brochures relating to the products referred to in Article L. 5122-14: 1° The name and composition o…
Subject to the provisions of article R. 5125-24, the exclusion of a member of a société d'exercice libéral de pharmaciens d'officine may be decided, when he contravenes the operating rules of the comp…
The constraint is served on the debtor by registered letter with acknowledgement of receipt or by bailiff's deed. On pain of nullity, the bailiff's writ or the registered letter shall mention :1° The…
Professional advisory committees may be set up, by a decree which specifies their composition and defines the organisational and operational procedures, under one or more certifying ministers, accordi…
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