Article R5121-9-10
The request for an opinion from the Agence nationale de sécurité du médicament et des produits de santé by the ministers responsible for health and social security, on the order mentioned in the last…
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Showing 4071–4080 of 24560 articles for “Art. Cass. com. – 21 June 2011 – no. 10-19.902”
The request for an opinion from the Agence nationale de sécurité du médicament et des produits de santé by the ministers responsible for health and social security, on the order mentioned in the last…
…established following a report from one of the organisations mentioned in 1° to 4° of article R. 5121-76-2, in a given therapeutic indication. The list of medicinal products covered by a compassionat…
…ector General of the Agency if the application does not comply with the provisions of Articles L. 5121-14-1, R. 5121-97, R. 5121-107-4 and R. 5121-107-5, or if at least one of the following conditions…
Following the establishment of a new Community herbal monograph or the revision of an existing monograph, the registration holder shall submit a request for amendment of the registration dossier to th…
…ragraph, a change of registration holder is authorised under the conditions set out in Article R. 5121-46.
…and signed by persons with the necessary qualifications and experience as mentioned in Article R. 5121-33.
…an use, the applicant is exempt from providing the data mentioned in 5°, 6° and 16° of Article R. 5121-107-4.
…procedure under the same conditions as those laid down for marketing authorisation in articles R. 5121-51 to R. 5121-51-7.
…e list by the Commission, the information and documents mentioned in 5°, 6° and 16° of Article R. 5121-107-4.
I.-The registration of the medicinal products mentioned in article L. 5121-13 may be refused, amended, suspended or withdrawn by the Director General of the Agency.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…
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