Article R5121-62
Exceptionally, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may, at the reasoned request of the marketing authorisation holder, authorise him to pres…
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Showing 8591–8600 of 67437 articles for “Art. I-5° bis and Art. 35 bis”
Exceptionally, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may, at the reasoned request of the marketing authorisation holder, authorise him to pres…
…the declared formulation. The samples taken are placed in bags bearing a label specifying the name and batch number of the medicinal product, the date of sampling, the reason for sampling and the nam…
…e, free transfer or wholesale distribution of investigational medicinal products, dressing articles and articles presented as complying with the pharmacopoeia mentioned in 2° of article L. 4211-1 or d…
…ation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules concerning safety features on the packaging of medi…
…le L. 5121-5, applicable to these activities, sets out the respective obligations of the depository and the operator, manufacturer or importer on whose behalf it is acting. They may only distribute ba…
Wholesalers of medicinal plants shall, with regard to the operations they carry out and prior to marketing, check the identification of the plants and release the batches defined during the operations…
I.-The pharmaceutical establishment of a company or organisation mentioned in 1° to 5° and 8° of article R. 5124-2 engaged in wholesale, free transfer or wholesale distribution checks the safety devic…
…administrative authority, pursuant to Article 77 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human…
…e with good practice in the donation of medicinal products, set by order of the Minister for Health and relating in particular to the quality, shelf life and storage of products.
…ted by the Minister for Health, after obtaining the opinion of the Minister for Humanitarian Action and, depending on the location of the proposed pharmaceutical establishment, of the Central Council…
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