Article R5139-13
The Director General of the Agence nationale de sécurité du médicament et des produits de santé keeps an up-to-date list of authorisation holders and authorised persons. These lists are accessible at…
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Showing 13611–13620 of 39711 articles for “Art. al. 3”
The Director General of the Agence nationale de sécurité du médicament et des produits de santé keeps an up-to-date list of authorisation holders and authorised persons. These lists are accessible at…
…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. In urgent cases, the Director General of the Agenc…
…guaranteeing protection of public health at least equivalent to that provided by the European Union;3° In the event of a finding of non-compliance, the information relating to this finding will be imm…
The certificate of compliance with good manufacturing practice referred to in article L. 5138-4 is issued following an inspection of the establishment if the good practices provided for in article L.…
The descriptive file provided for in Article L. 5138-1 and accompanying the declaration shall be sent to the Agence nationale de sécurité du médicament et des produits de santé by any means capable of…
Any company or organisation exploiting a medicinal product or product mentioned in article R. 5132-98 must immediately report any serious case of pharmacodependence, abuse or misuse of this medicinal…
Establishments or organisations authorised under article L. 513-11-1 shall appoint a referral doctor responsible for selecting stool donors.
In the event of a serious adverse reaction likely to be due to a tattooing product, the persons responsible for placing a tattooing product on the market, the health professionals who have observed it…
…General of the Agency when it has been withdrawn in accordance with the provisions of article R. 5139-8 and article R. 5139-11.On expiry of the authorisation or in the event of withdrawal of the auth…
…e de l'alimentation, de l'environnement et du travail, under the conditions laid down inarticle R. 533-8 of the Environment Code, or of the Comité d'expertise des utilisations confinées d'organismes g…
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