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Showing 5081–5090 of 14454 articles for “Art. 6 nov. 2001”
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.
Unless there is a risk 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…
…plication for renewal is addressed in accordance with the procedures defined in I of Article R 5121-68 no later than three months before the expiry date of the authorisation.Applications for renewal m…
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…
…the Haute Autorité de santé during the assessment 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 produi…
I.-The maximum value of the period referred to in 1° of II of Article L. 5121-12 is set at two years from the date on which the authorisation referred to in this Article is granted. II.-The maximum va…
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…
…s up a draft summary of each report, with a view to publication as provided for in Article R. 5121-76-10, and sends it to the Agency with the report. III. - Prescribers and pharmacists are required to…
…doctors who prescribed the medicinal product, the pharmacists or persons mentioned in article L. 5126-10 who dispensed it, the regional pharmacovigilance centres and, where appropriate, the poison con…
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