Section 4: Manufacture and import.

Manufacturers of medicinal products mentioned in 1° of article L. 4211-1 and manufacturers of generators, kits or precursors mentioned in 3° of the same article must justify, at all times, that all the products they use, manufacture and supply comply with the characteristics they must meet and that the necessary controls have been carried out. Manufacturers of medicinal products or products covered by a marketing authorisation referred to in article…

I.-A supply shortage is defined as the inability of a dispensing pharmacy or a pharmacy for internal use as defined in article L. 5126-1 to dispense a medicinal product to a patient within 72 hours, after having requested supplies from two companies engaged in the distribution of medicinal products as referred to in article R. 5124-2. This 72-hour period may be reduced at the pharmacist’s initiative, depending on compatibility with…

Manufacturers of medicinal products referred to in article R. 5124-2 shall check that the active substances used come from manufacturers, importers or distributors either authorised by the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) when the latter carry out their activity on national territory, or registered with the competent authority of the Member State in…

Manufacturers of medicinal products must be able to document the measures they have taken to ensure that their supplier of excipients complies with good practice under the conditions set out in article L. 5138-3.

I.-Any marketing authorisation holder and any pharmaceutical company exploiting a medicinal product in France shall build up a safety stock intended for the national market referred to in article L. 5121-29, in accordance with the procedures defined in this article. Safety stock means the stocking of a number of units of finished product of a medicinal product ready for distribution on French territory, at least equivalent to the period of…

I.-For the medicinal products of major therapeutic interest referred to in article L. 5111-4, marketing authorisation holders and pharmaceutical companies exploiting medicinal products shall, under their responsibility, draw up and implement the shortage management plans referred to in article L. 5121-31 in accordance with the guidelines defined by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé. These shortage management plans…

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…