Article R5138-7
Active substances may only be imported for the manufacture of medicinal products for human use from a third country into the European Union if they are accompanied by written confirmation from the com…
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Showing 3871–3880 of 12836 articles for “Art. 7 mars 2012”
Active substances may only be imported for the manufacture of medicinal products for human use from a third country into the European Union if they are accompanied by written confirmation from the com…
When the application for authorisation concerns all or part of the micro-organisms or toxins or products containing them, intended for veterinary use, the Director General of the Agence nationale de s…
The decision to administer emergency contraception is preceded by an interview with the student, whether she is a minor or an adult. The purpose of this interview is to enable the nurse to assess whet…
The registration of a homeopathic veterinary medicinal product mentioned in Article L. 5141-9 may be refused, suspended or withdrawn by the Director General of the Agency. Decisions to refuse, suspend…
Decisions to register homeopathic veterinary medicinal products or to suspend or cancel these registrations are made public in an extract on the website of the Agence nationale de sécurité sanitaire d…
Medicinal products subject to clinical trials, on the one hand, and any reference medicinal products and placebos, on the other, are prepared in accordance with good manufacturing practice, defined in…
…of use and on which it is impossible to include all the information provided for in Article R. 5141-74, the information provided for in Article R. 5141-73 appears only on the outer packaging.
…packaging of a medicinal product is compulsory, unless the information mentioned in article R. 5141-77 appears directly on the outer packaging or the immediate packaging. When an information leaflet i…
…packagings on which it is impossible to include all the particulars provided for in Article R. 5141-73 may include only the following information: 1° The name of the medicinal product ; 2° The quantit…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail shall inform the Prefect of the département in which the establishment is located…
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