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Showing 1411–1420 of 29147 articles for “Art. s. 1832 to 1844-17”
…ocedure laid down in 1° of Articles R. 5121-26 and R. 5121-28 and in Article R. 5121-97 is required to submit a periodic safety update report: 1° Under the conditions determined by the marketing autho…
…that the marketing authorisation should be varied, the marketing authorisation holder shall submit to the Director General of the Agence nationale de sécurité du médicament et des produits de santé a…
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…
…lishments, including those managed by public health establishments mentioned in articles R. 5124-68 to R. 5124-73 for their production, hospital preparation and magistral preparation activities, are s…
The declarations and the periodic safety update report referred to in Articles R. 5121-161, R. 5121-168 and R. 5121-170 are drawn up in accordance with the procedures and standard form laid down by th…
The in-house pharmacies referred to in Article L. 5126-1 shall forward to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, immediately upon request, a r…
The procedures and standard form for the declarations and report mentioned in Articles R. 5121-174 to R. 5121-176 are laid down by decision of the Director General of the Agence nationale de sécurité…
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…
The duration of the practical experience provided for in article R. 5124-16 is reduced to one year for pharmacists whose studies were carried out under a five-year system. It is reduced to six months…
I.-The provision of free samples referred to in article L. 5122-10 is only permitted during the two years following the first effective marketing in France of : 1° a proprietary medicinal product that…
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