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Showing 6271–6280 of 16903 articles for “Art. CE 23-6-1986 n° 50655”
Professionals who have obtained authorisation to practise part of the profession concerned appear on a separate list containing the professional title under which they are authorised to practise and t…
The competent authority's assessment of the applicant's command of the French language results in a decision that may be appealed to the administrative court with territorial jurisdiction.
…to patients' health, proprietary medicinal products which fulfil the conditions for being a reference proprietary medicinal product in an existing hybrid group may, by decision of the Director Genera…
I.-The early access authorisation may be renewed. Renewal is the subject of an application by the holder of this authorisation addressed to the Haute Autorité de santé, the ministers responsible for h…
When the application for early access authorisation concerns a medicinal product composed, in whole or in part, of genetically modified organisms, the holder of the exploitation rights, or his authori…
…t of the application referred to in Article R. 5121-68, where applicable on a proposal from the Agence nationale de sécurité du médicament et des produits de santé or the Ministers responsible for hea…
…mentioned in III of Article L. 5121-12 is set at one year from the date of granting of the early access authorisation mentioned in this article, renewable, where applicable, for a maximum of one addi…
At the end of the procedures provided for in this sub-section, the marketing authorisation is issued or varied by the Director General of the Agence nationale de sécurité du médicament et des produits…
I. - Except when the Agence nationale de sécurité du médicament et des produits de santé makes use of the derogation mentioned in V of article L. 5121-12-1, the compassionate prescription framework is…
…es, the holder of the exploitation rights for a medicinal product benefiting from a compassionate access authorisation or, where applicable, his authorised representative, sends the Director General o…
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