Article R5121-103
…is suspended or withdrawn, the holder informs the stockholders without delay. They must take all necessary steps to stop the distribution of the medicinal product. If these steps are not taken within…
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Showing 3641–3650 of 52948 articles for “Art. CE 27-1-2017 n° 391817”
…is suspended or withdrawn, the holder informs the stockholders without delay. They must take all necessary steps to stop the distribution of the medicinal product. If these steps are not taken within…
Without prejudice 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…
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…
…ictogram, the model of which is determined, after consultation with the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by order of the Minister for Health…
The information contained in advertising 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 therape…
…t comply with the marketing authorisation or registration or with the recommendations of good practice; 5° "Abuse": intentional, persistent or sporadic excessive use of medicines or products mentioned…
Pharmacovigilance includes: 1° The reporting of adverse reactions suspected to be due to a medicinal product or a product mentioned in article R. 5121-150, including cases of overdose, misuse, abuse a…
The duration of the practical experience provided for in article R. 5124-16 is reduced to one year for pharmacists whose studies were carried out under a five-year system. It is reduced to six months…
…s) of the companies or organisations mentioned in 1° and 2° of article R. 5124-2 must provide evidence of at least two years' practical experience in one or more establishments authorised to manufactu…
…12°, 13°, 14° and 15° of article R. 5124-2 provide proof of at least six months' practical experience in a pharmaceutical establishment of a company or organisation mentioned in the same article; The…
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