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Showing 4911–4920 of 64181 articles for “Art. II-1° ter”
Articles R. 4127-36, R. 4127-37, R. 4127-37-1, R. 4127-37-3 and R. 4127-37-4 are applicable in New Caledonia in the version resulting from Decree no. 2016-1066 of 3 August 2016.Article R. 4127-37-2 is…
…may be useful to the pharmacist for pharmaceutical practice. The pharmacopoeia indicates the characteristics of medicinal products, the means by which they can be identified, the testing and analysis…
…wn Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, the labelling of its outer packaging or,…
…ses if it appears that it is not followed by the marketing of the medicinal product on the national territory within three years of registration or that the medicinal product, previously marketed on t…
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,…
Ampoules or other small 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 medicina…
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…
…he 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, the primary packaging in blis…
…products which must be covered by the marketing authorisation provided for in article L. 5121-8, after this authorisation has been issued;2° For the medicinal products mentioned in article L. 5121-12…
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