Each batch of medicinal products or products benefiting from the authorisations or registration provided for in the second paragraph of Article R. 5124-49 is subject, in France, to control of the finished product when it is imported : 1° From a State that is not a member of the European Community and not party to the Agreement on the European Economic Area ; 2° Or from another Member State of…
The manufacturer and importer of medicinal products mentioned in 1° of article L. 4211-1, or of generators, kits or precursors mentioned in 3° of the said article, shall implement a pharmaceutical quality system. This system is managed by a person with the required qualifications in accordance with the good practices mentioned in article L. 5121-5. Within the establishment, the manufacturer and importer mentioned in the previous paragraph, as part of…
The pharmaceutical establishment manufacturing medicinal products mentioned in 1° of article L. 4211-1, generators, kits or precursors mentioned in 3° of this article has a documentation system comprising specifications, manufacturing formulae, procedures and statements, reports and records covering the various operations it carries out. For medicinal products other than investigational medicinal products, generators, kits or precursors mentioned in 3° of article L. 4211-1, the documents relating to each batch are…
Before removing or partially or totally covering the safety features provided for in article R. 5121-138-2, the pharmaceutical establishment which manufactures medicinal products shall check that the medicinal product concerned is genuine and has not been tampered with.
When the pharmacist in charge of a manufacturer, importer or operator of medicinal products other than investigational medicinal products, generators, kits or precursors referred to in 3° of article L. 4211-1 becomes aware, after a batch of medicinal products or products has been marketed, of an incident or accident which has occurred during the manufacture or distribution of this batch and which may result in a risk to public health,…
The provisions of articles R. 5124-49 to R. 5124-55 are applicable to manufacturers and importers of dressing articles or articles presented as complying with the pharmacopoeia mentioned in 2° of article L. 4211-1, or divided officinal products mentioned in 4° of article L. 5121-1. The obligations laid down by these articles are applied by reference to the pharmacopoeia monographs which describe them.
By way of derogation from the provisions of the first sub-section, the provisions of this sub-section apply to the manufacture and importation of investigational medicinal products.
The manufacturer or importer of investigational medicinal products shall ensure that all manufacturing operations are carried out in accordance with the information provided by the sponsor in the application for authorisation referred to in article L. 1123-8 and accepted by the Agence nationale de sécurité du médicament et des produits de santé. The manufacturing methods for a medicinal product are regularly reviewed by the manufacturer in the light of scientific…
Where batches of investigational medicinal products come from another Member State of the European Community or party to the Agreement on the European Economic Area and are manufactured or imported in accordance with the requirements of Directive 2003/94/EC and by an establishment authorised under Article 13-1 of Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001, the batch release certificates signed by the qualified person…
The importing pharmaceutical establishment shall ensure that the investigational medicinal products it imports have been subjected to standards of good manufacturing practice at least equivalent to those laid down in article L. 5121-5 when they are imported : a) From a State that is not a member of the European Community and not party to the Agreement on the European Economic Area ; b) Or from another Member State of…
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75001, Paris France
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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