Article R5121-166
Any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 is required to: 1° Record all adverse reactions suspected of being due to a medicinal product o…
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Showing 2551–2560 of 61284 articles for “Art. 151 septies A · CE 16 October 2019 n° 417364 · CE 28 June 2013 · BOI-BIC-PVMV-40-20-20-20”
Any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 is required to: 1° Record all adverse reactions suspected of being due to a medicinal product o…
Any company or organisation exploiting a medicinal product or a product referred to in Article R. 5121-150 has at its disposal on a permanent basis the services of a person responsible for pharmacovig…
The company or organisation exploiting a medicinal product or a product referred to in Article R. 5121-150 may not communicate information relating to pharmacovigilance to the general public about thi…
I.-Any company or organisation exploiting a medicinal product or a product mentioned in article R. 5121-150 is required to transmit electronically to the European Medicines Agency a periodic safety up…
The marketing authorisation holder may, by written reasoned request, refer the matter to the Committee for Medicinal Products for Human Use referred to in Article 56 of Regulation (EC) No 726/2004 of…
Any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 implements procedures to obtain accurate and verifiable information for the scientific evaluati…
The final examination comprises three tests. A general test (duration: specified in the specific decrees; coefficient 4) comprising: a) A written examination covering the technical aspects of the spor…
I.-The services listed under numbers 116 to 136 of the table mentioned in article A. 743-8 give rise to the collection of the following fees:Service number the service (table 2 of article appendix 4-7…
Information relating to a beneficiary of temporary protection which is necessary to examine a transfer application other than that mentioned in articles R. 581-10 and R. 581-11 is requested or provide…
The commissaires [supervisory auditors] responsible for the constitution of the société européenne holding company are appointed and carry out their duties in accordance with the conditions set out in…
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