Article R5121-171
If the coordination group agrees, at the end of the single assessment procedure for periodic safety update reports provided for in Article 107g(1) of Directive 2001/83/EC of the European Parliament an…
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Showing 2421–2430 of 8303 articles for “Art. CJEU – C-452/17 – 21 Nov. 2018”
If the coordination group agrees, at the end of the single assessment procedure for periodic safety update reports provided for in Article 107g(1) of Directive 2001/83/EC of the European Parliament an…
…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 patients or healthcare profession…
…al preparation and magistral preparation activities, are subject to the provisions of articles R. 5121-162, R. 5121-163 with the exception of 4°, R. 5121-164 with the exception of 3° and 5° and R. 512…
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…
…t the procedures for collecting, verifying and evaluating the information mentioned in Article R. 5121-151. It is published on the Agency's website.
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…
Subject to the provisions of article R. 5125-12, a pharmacist who is a partner in one or more private companies operating a pharmacy may only practise his profession within the company operating the p…
For the application of article R. 5134-171 in Mayotte, 1° to 3° are replaced by 1° and 2° as follows: " 1° The director of the Mayotte university training and research centre, or his representative; "…
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