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Showing 4701–4710 of 24915 articles for “Art. Cass. com. – 10 Nov. 2015 – no. 14-14.820”
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…
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…
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…
The detailed summaries of the tests accompanying the application for registration and the expert reports are drawn up and signed by persons with the necessary qualifications and experience as mentione…
…use, the applicant is exempt from providing the data mentioned in 5°, 6° and 16° of Article R. 5121-107-4.
Where a Community herbal monograph has been established or where the herbal medicinal product consists of herbal substances, preparations or combinations thereof included in the list drawn up by the C…
If, after a traditional herbal medicinal product has been registered, the proprietor considers, on the basis of new data available to him, that, given its characteristics, the medicinal product is now…
…ist by the Commission, the information and documents mentioned in 5°, 6° and 16° of Article R. 5121-107-4.
…ntation and information provided do not comply with the application file defined in article R. 5121-106. III - Registration may be amended, suspended or withdrawn if it appears that the assessment of…
Where the application for registration concerns a product which has been the subject of a Community herbal monograph established by the Committee for Herbal Medicinal Products of the European Medicine…
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