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Showing 2921–2930 of 46956 articles for “Art. 219 I b”
The marketing authorisation provided for in Article L. 5121-8 may only be granted for a blood-derived medicinal product when it is prepared from blood or blood components collected under the condition…
For a similar biological medicinal product defined in a of 15° of Article L. 5121-1, the marketing authorisation may be granted before the expiry of the intellectual property rights attached to the re…
The following definitions apply 1° "Investigational medicinal product" means a medicinal product which has been tested or used as a reference, including as a placebo, in a clinical trial; 2° "Authoris…
The prescription of a proprietary medicinal product shall mention its active ingredients, designated by their international non-proprietary name recommended by the World Health Organisation or, failin…
The holder of a marketing authorisation for a medicinal product shall immediately inform the Agence nationale de sécurité du médicament et des produits de santé, specifying the reasons, of any action…
Any medicinal product intended for magistral preparations in pharmacies and identified by a special name is subject to the provisions of this chapter and those of article L. 5124-6.
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…
The holder of an intellectual property right protecting the appearance and texture of the oral pharmaceutical forms of a reference medicinal product within the meaning of Article L. 5121-1 may not pro…
I. - Without prejudice to decisions to vary, suspend or withdraw marketing authorisations, the Agence nationale de sécurité du médicament et des produits de santé may, in the interests of public healt…
The authorisation provided for in article L. 5121-8 is refused if it appears that the assessment of the positive therapeutic effects of the medicinal product or product with regard to the risks to pat…
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