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Showing 2881–2890 of 52277 articles for “Art. 1 ter”
…ean Union pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal pro…
By way of derogation from the provisions of article R. 5121-99, the registration lapses if it appears that it is not followed by the marketing of the medicinal product on the national territory within…
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…
…ay, indicating the scope of the information, any new information which it has or becomes aware of after the application for registration has been submitted or after the registration has been granted,…
…primary packaging on which it is impossible to include all the information specified in Article R. 5121-138 may bear only the following information: 1° The name of the medicinal product or product, th…
After registration, 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 artic…
By way of derogation from the provisions of Article R. 5121-138, when the medicinal products or products are contained in an outer packaging that complies with the requirements of the said Article, th…
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…
…ion of the medicinal product. If these steps are not taken within a timeframe compatible with the interests of public health, the Director General of the Agency will take all appropriate measures. Ind…
…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 packaging of a m…
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