Article R5141-7
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…
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Showing 3961–3970 of 28297 articles for “Art. Cass. 3e civ. 7-7-2016 n° 15-12370”
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…
The inclusion of an information leaflet for the user in the packaging of a medicinal product is compulsory, unless the information mentioned in article R. 5141-77 appears directly on the outer packagi…
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…
In each region, a commission is responsible for issuing an opinion on animal health programmes and proposing the approval of the groups designated in the first paragraph of article L. 5143-6.
For the purposes of this Title, medical devices other than active implantable medical devices are divided into four classes known as Class I, Class IIa, Class IIb and Class III. Whether a device belon…
The regional material vigilance and reactovigilance coordinators carry out their vigilance duties under the conditions defined in article R. 1413-61-4.
When the prescription includes the information provided for in 1°, subject to adaptation of the country information, to 3° of Article R. 5211-70, persons legally authorised to supply medical devices m…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision on prior authorisation within two months of the date of receip…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his prior authorisation decision within two months of the date of receipt o…
In carrying out checks on the application of the provisions of Title II of Book I of Part I and the regulatory measures taken for its application falling within the remit of the Agence nationale de sé…
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