Article R5121-103
…ion of the medicinal product. If these steps are not taken within a timeframe compatible with the interests of public health, the Director General of the Agency will take all appropriate measures. Ind…
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Showing 4921–4930 of 64181 articles for “Art. II-1° ter”
…ion of the medicinal product. If these steps are not taken within a timeframe compatible with the interests of public health, the Director General of the Agency will take all appropriate measures. Ind…
…to the information required by other legislative and regulatory provisions, the labelling of the outer packaging or, where there is no outer packaging, the labelling of the immediate packaging of a m…
Registration of homeopathic medicinal products and traditional herbal medicinal products, as well as suspension and withdrawal of registration, are made available to the public by the Director General…
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…
…sing for a medicinal product must comply with the information given in the summary of product characteristics referred to in article R. 5121-21 and with the therapeutic strategies recommended by the H…
For the purposes of this chapter, the following definitions shall apply 1° "Adverse reaction": a noxious and unintended response to a medicinal product or to a product mentioned in Article R. 5121-150…
…ng authorisation or registration, this includes cases of use which comply or do not comply with the terms of this authorisation or registration; 2° The collection, recording, evaluation and use of thi…
…en this diploma and the title of the training course appear on a list drawn up by order of the ministers responsible for higher education and health.
…an Economic Area; all or part of this experience may, where applicable, have been acquired during internships beyond the first year in these establishments.In order to carry out his duties in a compan…
The pharmacist in charge and the interim pharmacist in charge of the companies or organisations mentioned in 4°, 5°, 6°, 7°, 8°, 10°, 11°, 12°, 13°, 14° and 15° of article R. 5124-2 provide proof of a…
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