Article R5121-149
The package leaflet is drawn up in accordance with the summary of product characteristics. It includes a standard text, expressly inviting patients to report any suspected adverse reaction to their do…
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Showing 1751–1760 of 47971 articles for “Art. L 113-14 · loi n° 2019-733 du 14 juillet 2019”
The package leaflet is drawn up in accordance with the summary of product characteristics. It includes a standard text, expressly inviting patients to report any suspected adverse reaction to their do…
The change of holder of part of the authorisation to open a pharmaceutical establishment is subject to a modification of the initial authorisation to open under the conditions set out in article R. 51…
The design, surface area, layout and layout of the premises of the internal-use pharmacy are appropriate to the tasks and activities for which the pharmacy is responsible. These premises are easily ac…
Renewal of the supply of a medicinal product or preparation covered by this section may only take place after a specific period of time resulting from the dosage and quantities previously supplied. Re…
Advertising aimed at healthcare professionals, for a product or object defined in article R. 5134-11, is adapted to its target audience. It specifies the date on which it was drawn up or last revised…
The application for marketing authorisation for a veterinary medicinal product contains the following information: 1° The name or corporate name and address of the future holder of the marketing autho…
The change of ownership or management lease of part of a veterinary pharmaceutical establishment is subject : 1° A modification of the initial opening authorisation under the conditions set out in art…
Monitoring self-vaccines for veterinary use consists of the authorisation holder recording the following information in chronological order: 1° The name and address of the owner of the animal or farm…
I.-The National Council of the Order of Veterinary Surgeons has two months from the date of receipt of the application to give its opinion. If the National Council of the Order of Veterinary Surgeons…
The CE marking may be affixed to a medical device only if it complies with the essential health and safety requirements referred to in Section 5 of this Chapter and has undergone the certification pro…
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