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Showing 2791–2800 of 33338 articles for “Art. para. 4–5”
I. - Substantial changes to the activities authorised in application of this section which relate to: - the preparation of a new pharmaceutical form of an advanced therapy medicinal product prepared o…
I. - Any changes relating to: 1° The name or administrative address of the registered office of the establishment or authorised body; 2° The appointment of a new director of the establishment or autho…
Establishments or authorised organisations shall draw up and keep up-to-date a full list of the agreements they have entered into with third parties whose involvement has an influence on the quality a…
Advanced therapy medicinal products prepared on an ad hoc basis are distributed, under the responsibility of the person in charge referred to in article R. 4211-37 or, where applicable, the person in…
Changes other than those mentioned in articles R. 4211-43 and R. 4211-44 are declared in the annual activity report provided for in article R. 4211-47.
In the event of non-compliance with the legislative and regulatory provisions or the conditions of the authorisation, the suspension, which may not exceed one year, and the withdrawal of the authorisa…
The authorised establishment or body sends the Director General of the Agence nationale de sécurité du médicament et des produits de santé and the Director General of the Agence de la biomédecine, as…
Subject toArticle L. 286 BA of the Book of Tax Procedures, when implementing the powers of investigation, recording and prosecution provided for in this Code or when required on the basis of the Code…
The representative of the Minister for the Economy referred to in Article L. 432-4-1 may object to the decisions of the Chief Executive Officer of the body referred to in Article L. 432-2 in the follo…
Two or more pharmacies are authorised to group together if their original location is situated in a municipality with a number of pharmacies in excess of the thresholds provided for in article L. 5125…
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