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Showing 8291–8300 of 18228 articles for “Art. 5° ter”
…t transpires that: 1° That it is not followed by the marketing of the medicinal product on national territory within three years of its issue; 2° That the medicinal product, previously marketed on nat…
…cision must state the reasons on which it is based and, except in an emergency, may only be taken after the proprietor has been invited to present his observations. For a proprietary medicinal product…
After the marketing authorisation has been granted, the authorisation holder must, with regard to the manufacturing and control methods, take account of scientific and technical progress and introduce…
…icinal product may only be dispensed to healthcare professionals authorised to prescribe and administer them by virtue of article R. 5121-80. Where applicable, it sets out the restrictions or prohibit…
…horisation in accordance with Article L. 5121-8, any variation or extension, as provided for in Chapter I of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of v…
…n or restriction intended to ensure the safe and effective use of the medicinal product or product; 5° The existence of an adequate pharmacovigilance system; 6° The performance of post-authorisation e…
1° In the interests of patients or for any other public health reason and, where appropriate, at the request of the Minister for Health, the Director General of the Agence nationale de sécurité du méd…
…ement system, together with a detailed description of this system, within a period which he shall determine. This decision may only be taken after the holder has been invited to submit its observation…
…authorisation was subject and, in particular, to comply with the manufacturing and testing methods;5° Reports on the controls carried out by the applicant in compliance with the said methods;6° The p…
…he grounds mentioned in Article L. 5121-9. The application for authorisation may only be rejected after the applicant has been invited to present his observations. Rejection decisions must state the r…
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