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Showing 4381–4390 of 42053 articles for “Art. L 332-7 s.”
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…
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…
In the case of small immediate packaging other than ampoules containing only one dose of use and on which it is impossible to include all the information provided for in Article R. 5141-74, the inform…
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…
Ampoules and other small primary 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 m…
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…
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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