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Article R5132-38 of the French Public Health Code

Containers or packaging containing medicinal products covered by the narcotics regulations and not packaged for the public must bear a label of a size appropriate to their volume, affixed in such a way that it cannot be accidentally detached. This label bears the following information in clear, indelible black lettering: 1° The name of the contents ; 2° The gross mass and tare weight corresponding to the packaging used; 3°…

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Article R5132-39 of the French Public Health Code

The provisions of this sub-section may, on public health grounds, be applied, in whole or in part, to medicinal products containing substances or preparations which, although not classified as narcotics, are manufactured from narcotics or give rise to the formation of narcotics during their manufacture. The same applies to medicinal products or products which, in the case of misuse as defined in article R. 5121-153 or in the case of…

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Article R5132-42 of the French Public Health Code

The procedures for applying sections 1 to 3 of this chapter to the establishments mentioned in articles L. 5126-1 and L. 5126-11 shall be laid down, where appropriate, after obtaining the opinion of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by order of the Minister for Health.

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Article R5132-42-3 of the French Public Health Code

Single units of medicinal products may be dispensed, subject to their inclusion on the list established by the order provided for in Article L. 5123-8, for medicinal products which comply with the following packaging rules: 1° Either the medicinal product is presented in the form of a blister pack containing at least the information provided for in Article R. 5121-141, in outer packaging that complies with the provisions of Article…

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Article R5132-42-4 of the French Public Health Code

The pharmacist removes the prescribed dosage units from the original outer packaging by any means that guarantees their integrity. He or she places them in a new outer packaging suitable for transport and storage. All parts of the new outer packaging must be strong enough to prevent any loss of contents. The new outer packaging must not contain medicinal products from different batches.

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Article R5132-42-5 of the French Public Health Code

Without prejudice to the case where the number of units prescribed corresponds to the number of units appearing in an initial outer packaging that complies with the provisions of article R. 5121-138, when the pharmacist dispenses the last units appearing therein, they are, by way of derogation from article R. 5132-42-4, given to the patient in this packaging. Medicinal products dispensed to blind or partially-sighted patients may only be dispensed…

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