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Showing 5351–5360 of 47859 articles for “Art. 151 septies · CE plén. 13 June 2018 n° 401942 · CE 17 May 1995 · CE 26 September 2018 · CE 28 April 2006 · CAA Paris 9 November 2011 · BOI-BIC-PVMV-40-10-10-10 et -20”
…authority responsible for supervision on a consolidated basis, the Autorité de contrôle prudentiel et de résolution receives an application for authorisation to use an internal risk assessment approa…
…2° Good Friday in communes with a Protestant temple or a mixed church; 3° Easter Monday ; 4° 1st May 5° 8th May ; 6° Ascension Day ; 7° Whit Monday 8° 14th July 9° Assumption Day 10° All Saints' Da…
The application for authorisation or renewal of authorisation provided for in 12° and 13° of Article L. 5121-1 shall be sent by registered post with acknowledgement of receipt or lodged against receip…
…cts mentioned in 1° of II of article L. 5121-12 and in II of article L. 5121-12-1, the obligations set out in article R. 5121-161 and articles R. 5121-166 to R. 5121-170 are carried out in accordance…
…ded for in Article L. 4211-6 is required to report the following to the Director General of the Agence nationale de sécurité du médicament et des produits de santé: 1° Any serious adverse reaction sus…
…any or organisation exploiting an authorised or registered medicinal product or product, in accordance with the procedure laid down in 1° of Articles R. 5121-26 and R. 5121-28 and in Article R. 5121-9…
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…
Pharmaceutical establishments, including those managed by public health establishments mentioned in articles R. 5124-68 to R. 5124-73 for their production, hospital preparation and magistral preparati…
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…
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