Article R5121-179
A decision by the Director General of the Agence nationale de sécurité du médicament et des produits de santé defines the principles of good pharmacovigilance practice. This decision also sets out the…
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Showing 2421–2430 of 8432 articles for “Art. CJEU – Pierre Fabre – 13 Oct. 2011 – C-439/09”
A decision by the Director General of the Agence nationale de sécurité du médicament et des produits de santé defines the principles of good pharmacovigilance practice. This decision also sets out the…
In Article R. 713-13 : a) The first paragraph reads as follows: "The commission provided for in Article L. 713-17, known as the election organisation commission, competent to organise, in the constitu…
This article applies to the post-authorisation safety studies referred to in Article R. 5121-178 which are carried out either voluntarily by the holder of the marketing authorisation referred to in Ar…
…rry out vigilance missions relating to health products under the conditions defined in article R. 1413-61-4.
I.-This article applies to the post-authorisation studies referred to in article R. 5121-178 which are carried out by the holder of the authorisation referred to in article L. 5121-8 in order to compl…
This sub-section applies to post-authorisation safety studies of a non-interventional nature within the meaning of Article R. 1121-2, which give rise to the collection of safety information from patie…
The articles L. 2113-1 to L. 2113-22 and the articles L. 2224-12-3-1, L. 2224-12-4 and L. 2224-12-5 as well as the third, fourth, fifth and sixth paragraphs of article L. 2143-3 are not applicable to…
This Part of the Code is applicable to the communes of the archipelago of Saint-Pierre-et-Miquelon. For this application it shall read: 1° "Collectivité territoriale" instead of: "département"; 2° "Co…
…ctivity, the following provisions of this Code shall apply to the territorial collectivity of Saint-Pierre-et-Miquelon: 1° Part One: Books II, III, IV and V; 2° Part Three: Book II; 3° Part Four: Book…
…re II) ;2° Cinquième partie : livres IV, VI et VII.For the application of these provisions to Saint-Pierre-et-Miquelon:- the reference to the départements, the regions, the territorial collectivity or…
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