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 3921–3930 of 12454 articles for “Art. 7 Oct 2004”
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…
In the absence of observations or in the event of an inadequate response to the complaints within the time limit mentioned in the previous article, the Director General of the Agence nationale de sécu…
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…
In the event of disagreement on the application of the classification rules between the manufacturer of an in vitro diagnostic medical device and an authorised body involved in the conformity assessme…
The regional material vigilance and reactovigilance coordinators carry out their vigilance duties under the conditions defined in article R. 1413-61-4.
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