Section 4: Manufacture and import.

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…

Where manufacturers and importers of investigational medicinal products entrust certain quality control operations to a laboratory in accordance with Article R. 5124-47 (2°), the biomedical research sponsor ensures that this laboratory complies with the elements relating to investigational medicinal products in the application for authorisation referred to in Article L. 1123-8 accepted by the Agence nationale de sécurité du médicament et des produits de santé.

For investigational medicinal products, the documents relating to each batch are kept by the pharmaceutical establishment which manufactures it, for at least five years after the end of the trial or the early termination of the last clinical trial during which the batch was used. Establishments importing investigational medicinal products under the conditions set out in articles R. 5124-57-3 and R. 5124-57-4 hold these documents and keep them for the…