French Public Health CodeIn force
Section 1: General provisions.
Article R5112-1
…ented under a scientific or common name in the current pharmacopoeia complies with its specifications.
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Showing 2751–2760 of 52406 articles for “Art. s. 387-1”
…ented under a scientific or common name in the current pharmacopoeia complies with its specifications.
When a medicinal product is the subject of a marketing authorisation granted by the European Union pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 200…
…uct, previously marketed on the national territory, is no longer marketed for three consecutive years. The three-year period is counted from the date of issue of the registration. For registrations is…
The information provided for in Articles R. 5121-138 and R. 5121-139 is written in French. They may also be written in other languages, provided that the same information appears in all the languages…
I. - The applicant or the holder of the registration shall forward to the Agency without delay, indicating the scope of the information, any new information which it has or becomes aware of after the…
…ation, manufacturing methods and control techniques take account of scientific and technical progress. Any resulting changes must first be registered under the conditions set out in article R. 5121-10…
Pharmacovigilance is carried out :1° For medicinal products and for products which must be covered by the marketing authorisation provided for in article L. 5121-8, after this authorisation has been i…
…the interests of public health, the Director General of the Agency will take all appropriate measures. Independently of suspension or withdrawal decisions and for the reasons that justify them, the Di…
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…
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