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Showing 5981–5990 of 24499 articles for “Art. 4 Dec 2013”
…opean Community when the competent authority of that Member State has already checked the batch and declared it to comply with the approved specifications. The Minister for Health may, on a proposal f…
…tary medicinal product and withdraw it from the market on the grounds mentioned in Article L. 5121-14-2. The decision must state the reasons on which it is based and, except in an emergency, may only…
…on may only be rejected after the applicant has been invited to present his observations. Rejection decisions must state the reasons on which they are based and indicate the appeal procedures and time…
…nts to the summary of product characteristics. If the Director General of the Agency has not made a decision within ninety days of the date of submission of the application, the applicant may proceed…
The committee responsible for proposing the list of approved products for public authorities, in accordance with the provisions of articles L. 5123-2 and L. 5123-3, is the Transparency Committee, the…
…produits de santé a report on their establishment, the form and content of which are determined by decision of the Director General of the Agency.
Manufacturers, importers, operators, stockists, wholesaler-distributors, wholesale distributors of pharmaceutical products other than medicinal products, wholesale distributors of medicinal plants, di…
For the purposes of calculating the number of staff referred to in Articles R. 5124-38 and R. 5124-39, account is taken of persons engaged in the following operations: 1° Manufacturing and import oper…
…r a period exceeding one month, an assistant pharmacist, recruited in application of articles R. 5124-38 or R. 5124-39, is absent or replaces the responsible or delegated pharmacist, he is replaced.
Nor do the provisions of article R. 5124-42 prevent the companies or organisations mentioned in article R. 5124-43 from selling directly, provided that batches are individually monitored and, if neces…
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