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Showing 4311–4320 of 41721 articles for “Art. L. 223-7”
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…
…ral of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail. The absence of a response from the latter within 30 days is considered to be a favourable opinion…
…ite of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail. Registration decisions include the information provided for in Article R. 5141-63.
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…
…ral of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail. In the case of vaccines, mention of other vaccines may be authorised where this is necessary to d…
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…
…he terms and conditions for payment of these sums, as well as the channels and time limits for appeal.The decision to impose a financial penalty may be published on the Agency's website for a period n…
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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