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Showing 8211–8220 of 18228 articles for “Art. 5° ter”
…edure provided for in articles R. 4221-15-4 to R. 4221-15-6, in order, in particular, to define the terms and conditions of the training ordered by the Disciplinary Board and to pronounce, where appro…
…ate that the hearing was public unless the provisions of article R. 4234-25 were applied. In the latter case, it is stated that the hearing took place or continued without the public being present. Th…
Where an application for marketing authorisation in France is made for a medicinal product which has already been authorised or is the subject of an application for marketing authorisation currently b…
The applicant is responsible for the accuracy and truthfulness of the documents and data supplied to the Agency when the application for marketing authorisation is submitted and during its examination…
…components of the system likely to affect the composition or quality of the preparation of the daughter nuclide; 2° The qualitative and quantitative characteristics of the eluate or sublimate.
…ommon names of its constituents. The application is accompanied by a draft summary of product characteristics, the presentation and content of which are laid down in accordance with article 11 of Dire…
…ed, accompanied by its summary;4° Therapeutic indications, contraindications and adverse reactions; 5° Dosage, pharmaceutical form, method and route of administration and presumed duration of stabilit…
When an application for authorisation concerns a generic medicinal product of a reference medicinal product which has not been authorised in France, the applicant must indicate the Member State of the…
…on Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal pro…
The dossiers provided in support of the application for authorisation of the medicinal products mentioned in articles R. 5121-25 and R. 5121-26 are considered to contain all the necessary and sufficie…
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