Article R5121-183
Pharmacovigilance of blood-derived medicinal products involves monitoring, known as traceability, from the time they are manufactured until they are administered to patients. The purpose of this monit…
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Showing 13801–13810 of 39711 articles for “Art. al. 3”
Pharmacovigilance of blood-derived medicinal products involves monitoring, known as traceability, from the time they are manufactured until they are administered to patients. The purpose of this monit…
When permitted under the provisions of Article L. 5122-6, advertising of a medicinal product to the general public : 1° Is designed in such a way that the advertising nature of the message is obvious…
The declarations and the periodic safety update report referred to in Articles R. 5121-161, R. 5121-168 and R. 5121-170 are drawn up in accordance with the procedures and standard form laid down by th…
When a healthcare professional administers a blood-derived medicinal product outside healthcare establishments or the establishments and organisations mentioned in article R. 5121-192, he/she affixes…
The authorisation may be subject to special conditions requiring the beneficiary of the authorisation to implement a plan for monitoring the efficacy and safety of the medicinal product, including the…
…eduction measures described in the risk management plan or taken in application of Articles R. 5121-36-1, R. 5121-37-3 and R. 5121-43; 3° Keeps the risk management system up to date and monitors pharm…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may, by reasoned decision, refuse to include a medicinal product on the list referred to in Article R. 5…
I.- In addition to the company's distinctive sign, the outer packaging may include signs or pictograms explaining some of the above information, as well as other information compatible with the summar…
…el distribution in France of a proprietary medicinal product within the meaning of Article L. 5124-13-2, it shall inform the marketing authorisation holder of this intention and send the Director Gene…
When, in application of the second paragraph of Article L. 5124-11, the Director General of the Agence nationale de sécurité du médicament et des produits de santé intends to prohibit the export of a…
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