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Showing 3221–3230 of 40713 articles for “Art. R 211-9-7”
Containers or packaging containing narcotics and used for their import or export, transport or possession must bear a label of a size appropriate to their volume, affixed in such a way that it cannot…
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…
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…
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 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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