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Showing 4751–4760 of 52609 articles for “Art. 13 §1”
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…
…ary 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, the st…
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…
When registration is suspended or withdrawn, the holder informs the stockholders without delay. They must take all necessary steps to stop the distribution of the medicinal product. If these steps are…
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…
…146 may be used in advertising for the homeopathic medicinal products mentioned in article L. 5121-13.
The duration of the practical experience provided for in article R. 5124-16 is reduced to one year for pharmacists whose studies were carried out under a five-year system. It is reduced to six months…
The head pharmacist and the delegate pharmacist(s) of the companies or organisations mentioned in 1° and 2° of article R. 5124-2 must provide evidence of at least two years' practical experience in on…
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