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Showing 10681–10690 of 36632 articles for “Art. al. 5”
…g to medicinal products for human use, the applicant is exempt from providing the data mentioned in 5°, 6° and 16° of Article R. 5121-107-4.
…p and signed by persons with the necessary qualifications and experience as mentioned in Article R. 5121-33.
A medicinal product may only be classified as a prescription-only medicine if the restrictions on prescribing are justified by the constraints involved in implementing the treatment, having regard to…
Once a reference medicinal product, within the meaning of 5° of Article L. 5121-1, or a reference biological medicinal product, within the meaning of 15° of the same Article, is covered by a compassio…
…internal use in the health establishment or of the person responsible as referred to in Article L. 5126-10 ; 2° The initials of the surname and first name of the patient for whom the prescription 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…
…r human use; 2° The batches of this medicinal product have been released in accordance with Article 51 of the aforementioned Directive; 3° Subject to the provisions of Articles R. 5121-117 to R. 5121-…
…medicinal products, in accordance with the amendment envisaged in the version in force on 1 May 2015. Notwithstanding the previous paragraph, a change of registration holder is authorised under the c…
The marketing authorisation, the early access authorisation under 1° of II of article L. 5121-12 or the compassionate access authorisation under II of article L. 5121-12-1 or the compassionate prescri…
…e cases to its marketing authorisation, its early access authorisation under 1° of II of Article L. 5121-12 or the compassionate access authorisation under II of Article L. 5121-12-1 or the compassion…
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