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Showing 5101–5110 of 14378 articles for “Art. 815-6”
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…
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…
In the event of an additional request by 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 national…
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…
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…
Where the therapeutic use and patient monitoring protocol so provides, the holder of the exploitation rights for a medicinal product benefiting from a compassionate access authorisation or, where appl…
The pharmaceutical establishment of a company or organisation mentioned in Article R. 5124-2 engaged in wholesale, free transfer or wholesale distribution shall verify that the medicinal products rece…
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