Article R5121-213
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…
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Showing 3811–3820 of 33006 articles for “Art. CJEU – C-48/16 – 17 May 2017”
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…
…y and patient safety;11° The public or private health establishments in which the medicinal product may be administered;12° Where the medicinal product is prepared, distributed and administered in acc…
…laimed therapeutic effect is lacking, or in the event of danger to public health, the authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicam…
A request for authorisation must be submitted for any changes which have an impact on the quality, safety and efficacy of the medicinal product. This application must be accompanied by a technical dos…
…rs that additional information is required to enable him to reach a decision on the application, he may suspend consideration of the application until the missing information has been received, up to…
The guardian may not, even with authorisation: 1° Perform acts which involve a gratuitous alienation of the property or rights of the protected person except as stated in relation to gifts, such as th…
Sont exemchis de la retenue à la source prévue au 2 de Article 119 bis, insofar as they derive from profits exempt from corporation tax pursuant to 3° ter of article 208, dividends and other income di…
…8 of the Forestry Code. From 1st January 2005, the departmental councils and the municipal councils may each exempt their share of the acquisitions mentioned in the first paragraph and evidenced by a…
The Minister for Labour may issue recommendations on the specific procedures for applying this chapter to situations of long-term exposure resulting from a radiological emergency. These recommendation…
…zones in which, due to a radiological emergency, measures to reduce exposure to ionising radiation may be prescribed, the employer shall assess, in accordance with the provisions of Section 4, the ri…
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