Article R5121-37-1
…nefit balance of the medicinal product or product as defined in the first paragraph of Article L. 5121-9. It shall forward the results of all studies, in particular safety and efficacy studies, and th…
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Showing 4001–4010 of 42420 articles for “Art. 1873-3 · Cass. 1re civ. 21 July 1987”
…nefit balance of the medicinal product or product as defined in the first paragraph of Article L. 5121-9. It shall forward the results of all studies, in particular safety and efficacy studies, and th…
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.
…h an application for registration has been submitted under the conditions laid down in Article L. 5121-14-1, for which the three-year period is only counted from the date of notification of the decisi…
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…
Elderly patients requiring geriatric care because of their polypathology and risk of dependency are cared for : 1° As a matter of priority, subject to the availability of permanent medical care, by di…
Authorisation for cancer treatment by complex oncology surgery with grade B as referred to in II of Article R. 6123-87-1 may only be granted if the applicant has an organisation enabling it to: 1° Org…
…acilities providing outpatient anaesthesia or surgery provide the care provided for in article R. 6121-4, lasting twelve hours or less and not including accommodation, for patients whose state of heal…
The consultation provided for in Article L. 6143-7 takes place on the initiative and in accordance with the procedures defined by the Chairman of the Executive Board. In addition, the latter shall con…
…a) in the case of a market located in a Member State, a regulated market as defined inArticle L. 421-1 of the Monetary and Financial Code ; b) In the case of a market located in a third country, a f…
…aphs of II of Article L. 1245-5, the first paragraph of II of Article L. 1245-5-1, and Articles L. 4211-9-1, L. 4211-9-2, L. 5124-3 and L. 5124-9-1 ; 2° Ensuring the implementation, information and mo…
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