Chapter IV: Manufacturing and wholesale distribution

For batches of medicinal products or products benefiting from authorisation or registration which are imported from another Member State of the European Community or party to the Agreement on the European Economic Area, the French authorities will recognise the control reports corresponding to these batches held by the manufacturing establishment located in the Member State or party concerned, which holds a manufacturing or import authorisation for such medicinal products or…

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.