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Showing 8751–8760 of 59890 articles for “Art. R 330-1”
The declaration and reporting obligations laid down in this section apply without prejudice to those laid down for veterinary medicinal products authorised by the European Medicines Agency in Regulati…
The creation, organisation and funding of veterinary pharmacovigilance centres, as well as the conditions under which they carry out the tasks entrusted to them by the Agence nationale de sécurité san…
Decisions to authorise, modify, renew, suspend or withdraw authorisation for the preparation of autovaccines are made public in an extract on the website of the Agence nationale de sécurité sanitaire…
The authorisation holder shall inform the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail of the date on which the activity of prepar…
Autovaccines are prepared under the responsibility of a qualified person, who has obtained the authorisation provided for in article L. 5141-12, in facilities which may, where appropriate, be made ava…
The authorisation provided for in Article L. 5141-10 is issued by the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail.
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail will notify the applicant of his decision within one hundred and twenty days from…
The CE mark is affixed under the responsibility of the manufacturer or his authorised representative. Its form and dimensions are laid down by order of the Minister for Health. The CE marking must be…
The affixing of marks or inscriptions on a medical device, on its packaging or on the instructions for use which are likely to mislead as to the meaning or form of the CE marking is prohibited. Any ot…
Where a medical device is not intended for use in a specific part of the body, it must be considered and classified according to the most critical use as specified. Where more than one rule applies to…
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