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Showing 1165111660 of 38939 articles for Art. al. 4

French Public Health CodeIn force
Paragraph 4: Provisions common to both procedures.

Article R5141-47-7

…uct characteristics and the summary report of the assessment carried out, mentioned in article R. 5141-28, including the reasons justifying the decision, excluding any information of an industrial or…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Subsection 3: Authorisation procedures.

Article R5141-42

…roduct where it appears, in particular following evaluation of the data referred to in article R. 5141-90, that the medicinal product no longer meets the conditions referred to in article L. 5141-6. I…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 2: Experimentation.

Article R5141-11

As stated in article R. 234-4 of the French Rural and Maritime Fishing Code, which reads as follows:"I. - Foodstuffs derived from an animal that has undergone a clinical trial on veterinary medicinal…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Paragraph 2: Application to vary a marketing authorisation requiring an assessment

Article D5141-56

I.-The amount of the fee provided for in 2° of 1 of I of Article L. 5141-8 for a variation to a marketing authorisation requiring an assessment as part of a national procedure or a mutual recognition…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Paragraph 5: Other applications of the Community arbitration procedure.

Article R5141-47-11

When the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail considers that the variation, suspension or withdrawal of a marketing author…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Paragraph 1: General provisions.

Article R5141-47-1

…ing authorisation procedure issued by the European Commission pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, in more than one Member State of t…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 5: Public information.

Article R513-10-14

…angerous substances included in the composition of the tattoo product and mentioned in article L. 1342-2 of this code, the quantity expressed as a percentage, in the form of a concentration range or a…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 1a: Additional dispensing of oral contraceptives by pharmacists

Article R5134-4-2

Where the pharmacist dispenses contraceptives pursuant to article R. 5134-4-1 : 1° He may not, in application of article R. 5132-12 and under the conditions set out in paragraph 1 of article R. 5132-1…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 1: Dispensing to minors of medicinal products indicated in emergency contraception and not subject to compulsory medical prescription.

Article D5134-1

…d not subject to compulsory medical prescription by virtue of the second paragraph of article L. 5134-1 is carried out in conditions of confidentiality allowing a conversation to take place without th…

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

Article R5138-4

The application for the certificate provided for in the second paragraph of Article L. 5138-4 is sent to the Agence nationale de sécurité du médicament et des produits de santé by a person authorised…

AI translation · Updated 1 Nov 2023Open Article
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Mariela Petrova

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