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Showing 9361–9370 of 33456 articles for “Art. al. 3”
Without prejudice to the provisions of articles L. 8114-1 and L. 8114-2, refusal to submit to the checks provided for in this chapter shall give rise to automatic assessment by the administration of t…
In order to be able to continuously assess the benefit/risk balance of the medicinal product as defined in the first paragraph of Article L. 5121-9, the Agence nationale de sécurité du médicament et d…
…c medicinal product that may be substituted for this medicinal product pursuant to Article L. 5125-23 from having an identical or similar appearance and texture.
Any holder of a marketing authorisation for a medicinal product or any operator of such a medicinal product is required, within one year of the promulgation of Act 2011-2012 of 29 December 2011 on rei…
…mentioned in articles L. 5121-12 and L. 5121-12-1, its registration mentioned in articles L. 5121-13 or L. 5121-14-1, its authorisation mentioned in article L. 5121-9-1 or its parallel import authori…
…port. It may not sell medicinal products of major therapeutic interest mentioned in article L. 5121-30 outside the national territory or to wholesale export distributors.
To meet specific defence requirements, the medical supply establishments of the armed forces health service may repackage and repackage health products in accordance with the rules laid down by the Ag…
The provisions of articles L. 5121-29 to L. 5121-32 and of the I of article L. 5121-33 do not apply to the Pharmacie centrale des armées, when the latter holds a marketing authorisation or exploits a…
The Director General of the Regional Health Agency defines the district of a municipality on the basis of its geographical unit and the presence of a resident population. The geographical unit is dete…
When carrying out their activity on national territory, the qualified person in pharmacovigilance referred to in paragraph 8 of Article 77 of Regulation (EU) 2019/6 of 11 December 2018 shall have prof…
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