Article R5121-100-1
Amendments to the terms of the registration decision and the registration dossier are submitted and examined under the conditions laid down in Chapters I and IIa of Commission Regulation (EC) No 1234/…
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Showing 1211–1220 of 34588 articles for “Art. R 561-10”
Amendments to the terms of the registration decision and the registration dossier are submitted and examined under the conditions laid down in Chapters I and IIa of Commission Regulation (EC) No 1234/…
Where the application for registration concerns a herbal substance, a herbal preparation or a combination thereof included in the list drawn up for use in traditional herbal medicinal products by the…
When the holder of the surgical oncology authorisation implements a hybrid practice of surgical oncology management with the administration of a systemic cancer drug treatment intraoperatively or in t…
The holder of the authorisation ensures that patients are diagnosed and treated on a permanent basis, in liaison with the emergency medicine structures mentioned in article R. 6123-1, including via te…
I.-The registration of the medicinal products mentioned in article L. 5121-13 may be refused, amended, suspended or withdrawn by the Director General of the Agency. The period of suspension may not ex…
The athlete passport management unit carries out an initial review of all profiles.In the light of the successive data integrated into the predictive statistics algorithm concerning an athlete, the he…
The jury, which is sovereign in its deliberations, informs the rector of the academic region, or the minister responsible for sports for the activities mentioned in c of 5° of article R. 212-7 and for…
The file referred to in 2° of Article R. 123-30-9 includes:1° All the information declared;2° The supporting documents required under the legislative or regulatory provisions in force that have been d…
In companies whose securities are admitted to trading on a regulated market, the corporate governance report provided for in the last paragraph of Article L. 225-37 in addition to the information ment…
The Agence nationale de sécurité du médicament et des produits de santé publishes on its website : 1° The initial compassionate prescribing framework, the protocol for therapeutic use and patient foll…
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