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Showing 1361113620 of 39711 articles for Art. al. 3

French Public Health CodeIn force
Section 1: Conditions for issuing authorisations

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…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 1: Conditions for issuing authorisations

Article R5139-7

…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…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 3: Import procedures

Article R5138-7

…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…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 2: Certificate of compliance with good practice and Community database.

Article R5138-3

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.…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 1a: Declaration of the manufacture, import and distribution of excipients

Article R5138-2-2

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…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 3: Addictovigilance

Article R5132-103

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…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Subsection 2: Conditions for authorisation and practice

Article D513-11-7

Establishments or organisations authorised under article L. 513-11-1 shall appoint a referral doctor responsible for selecting stool donors.

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 4: National tattoo product vigilance system.

Article R513-10-11

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…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 1: Conditions for issuing authorisations

Article R5139-16

…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…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 1: Conditions for issuing authorisations

Article R5139-6

…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…

AI translation · Updated 1 Nov 2023Open Article
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