Article R733-16
…the right-hand column of the same table:Applicable articlesIn the wording resulting from the decreeR. 162-1 to R. 162-3n° 2005-1007 of 2 August 2005R. 162-4n° 2007-259 of 27 February 2007R. 162-5n° 2…
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Showing 8631–8640 of 39773 articles for “Art. R. 145-5”
…the right-hand column of the same table:Applicable articlesIn the wording resulting from the decreeR. 162-1 to R. 162-3n° 2005-1007 of 2 August 2005R. 162-4n° 2007-259 of 27 February 2007R. 162-5n° 2…
…the right-hand column of the same table:Applicable articlesIn the wording resulting from the decreeR. 162-1 to R. 162-3n° 2005-1007 of 2 August 2005R. 162-4n° 2007-259 of 27 February 2007R. 162-5n° 2…
…y applicable in French Guyana, subject to the adaptations provided for in this title: 1° In Article R. 610-1, the reference to Article R. 614-1 is deleted; 2° Article R. 614-1 is not applicable; 3° In…
…peration of law in Guadeloupe, subject to the adaptations provided for in this title: 1° In Article R. 610-1, the reference to Article R. 614-1 is deleted; 2° Article R. 614-1 is not applicable; 3° In…
After the marketing authorisation has been granted, the marketing authorisation holder must immediately forward to the National Agency for the Safety of Medicines and Health Products, indicating the s…
After a marketing authorisation has been granted, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may require the marketing authorisation holder to carr…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may require samples and mock-ups to be submitted when the medicinal product is marketed.
The marketing authorisation issued by the Agence nationale de sécurité du médicament et des produits de santé lapses if it transpires that: 1° That it is not followed by the marketing of the medicinal…
…n particular for the purposes of applying b of 5° of Article L. 5121-1 and 1°, 2° and 3° of Article R. 5121-28. Variations and extensions to a marketing authorisation are submitted and examined under…
The marketing authorisation may impose one or more of the following conditions, which must be mentioned in the risk management system: 1° The implementation of measures to ensure the safe use of the m…
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