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Showing 8271–8280 of 20753 articles for “Art. CA Paris 13-6-2024 n° 22/08263”
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.
…ng hybrid group may, by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, be entered in the register of hybrid groups in the same group, unti…
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…
…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 nationale d…
…date of granting of the early access authorisation mentioned in this article, renewable, where applicable, for a maximum of one additional year at each renewal.
…uthorisation is issued or varied by the Director General of the Agence nationale de sécurité du médicament et des produits de santé within thirty days of notification of the agreement by the reference…
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…
…rights for a medicinal product benefiting from a compassionate access authorisation or, where applicable, his authorised representative, sends the Director General of the Agence nationale de sécurité…
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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