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Article R5132-42-6 of the French Public Health Code

By way of derogation from Article R. 5121-138, the label, printed by the pharmacist at the time of dispensing and affixed to the new outer packaging referred to in Article R. 5132-42-4, shall bear the following information, written in such a way as to be easily legible, clearly understandable and indelible: 1° The name of the proprietary medicinal product, the strength and the pharmaceutical form ; 2° Where appropriate, a…

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Article R5132-42-7 of the French Public Health Code

When dispensing a medicinal product by unit, the pharmacist provides the patient with a printed version of the package leaflet referred to in Article R. 5121-148. By way of derogation from the previous paragraph, he may, subject to the patient’s agreement, inform the patient by any means of the arrangements for access to the electronic version of the package leaflet for the medicinal product in question.

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Article R5132-44 of the French Public Health Code

Preparations containing either one or more substances included in lists I and II defined in article L. 5132-6, or one or more narcotic or psychotropic substances, in doses or concentrations too low to justify their being subject to them, may be exempted, by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, from compliance with some or all of the provisions…

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Article R5132-58 of the French Public Health Code

Dangerous substances or preparations classified as very toxic, toxic, carcinogenic, teratogenic or mutagenic may only be transferred, whether free of charge or for consideration, to a natural or legal person known to the transferor or providing proof of his identity. It may only be made against delivery to the transferor of a receipt or an order stating the name of the substances or preparations, their quantity, and the name and…

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Article R5132-59 of the French Public Health Code

The transfer of the substances or preparations referred to in article R. 5132-58, whether free of charge or in return for payment, is recorded using a procedure approved by order of the ministers responsible for agriculture, consumer affairs, industry and health, which allows the competent authorities to monitor the operations carried out. These records indicate the name and quantity of the substances or preparations transferred, the date on which they…

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Article R5132-74 of the French Public Health Code

The production, including cultivation, manufacture, transport, import, export, possession, offering, transfer, acquisition or use and, in general, agricultural, craft, commercial and industrial operations relating to substances or preparations and plants or parts of plants classified as narcotics by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé are prohibited, unless expressly authorised. Where these substances or preparations and these plants or…

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Article R5132-75 of the French Public Health Code

The authorisation provided for in Article R. 5132-74 is issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, after obtaining the opinion of the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, for the pharmaceutical establishments within its remit. The Director General of the Agency will notify the applicant of his decision within…

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Article R5132-76 of the French Public Health Code

I.- By way of derogation from the provisions of the first paragraph of article R. 5132-74, the following shall take the place of authorisation, for professional use only : 1° Registration with the Order of Pharmacists for pharmacists who own a dispensary and for pharmacists who manage mutualist pharmacies; 2° Registration with the Order of Pharmacists of pharmacists managing an in-house pharmacy authorised in application of article L. 5126-7 ;…

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