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Showing 8011–8020 of 17844 articles for “Art. 815-5”
The Chairman of the Disciplinary Board chairs the proceedings. He first gives the floor to the rapporteur to read his report. The chairman then gives the floor to the parties and, where appropriate, t…
The roll for each hearing is drawn up by the Chairman of the Disciplinary Board. The parties are summoned to the hearing. The notice to attend must be sent to the parties by any means that can be reli…
Cases are heard in open court. However, the Chairman may, on his own initiative or at the request of one of the parties, after having obtained the opinion of the rapporteur where appropriate, prohibit…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may, by a reasoned decision setting out the appeal procedures and deadlines, automatically vary, suspend…
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 specific obligations which may be imposed pursuant to the third paragraph of Article L. 5121-9 and which must be mentioned in the risk management system are, in particular, the following: 1° The a…
The marketing authorisation is renewable on application by the holder to the National Agency for the Safety of Medicines and Health Products no later than nine months before its expiry date. The appli…
In the case of blood-derived medicinal products, the Agence nationale de sécurité du médicament et des produits de santé may, when examining the application for marketing authorisation, submit samples…
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