Article L5145-5
…nt of a pharmacovigilance system master file, in accordance with Article 77 of the same Regulation; 13° The obligation for the marketing authorisation or registration holder to produce, at the request…
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Showing 9431–9440 of 9503 articles for “Art. CJEU – C-593/21 – 13 Oct. 2022”
…nt of a pharmacovigilance system master file, in accordance with Article 77 of the same Regulation; 13° The obligation for the marketing authorisation or registration holder to produce, at the request…
…or's opinion of the failure of the legal representative to provide the requested written statements 13. Where the legal representative refuses to provide or confirm one or more of the written statemen…
…y auditor shall ensure that relevant information is given in the notes to the financial statements. 13. If this is the case, and pursuant to the provisions of article R. 823-7 of the French Commercial…
The judicial police officers and, on their orders and under their responsibility, the judicial police officers and deputy judicial police officers mentioned in articles 20 and 21-1° may ask any person…
…anages and calculated in accordance with Article 2 of Commission Delegated Regulation (EU) No 231/2013 of 19 December 2012, is below the thresholds mentioned in IV of Article L. 532-9, these AIFs do n…
I.-The Minister for Health or, by delegation, the Director General of the Centre National de Gestion may, following the opinion of a committee comprising, in particular, delegates from the national co…
…ive substances: -are not authorised to be administered to them, pursuant to paragraph 4 of Article 113 or paragraph 6 of Article 114 of Regulation (EU) 2019/6 of 11 December 2018;-and, in the case of…
I.- Where the person concerned establishes in a particular case that he is not at fault or negligent, the period of suspension provided for in articles L. 232-23-3-3 to L. 232-23-3-9 shall not apply.…
I.-In order to provide one or more of the services referred to in Article L. 54-10-2 on a regular professional basis, service providers established in France may apply for authorisation from the Autor…
I. - In each department, based on an assessment of the coherence of the perimeters and an inventory of the distribution of the competences of the existing groupings and their exercise, a departmental…
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