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Showing 1591–1600 of 59300 articles for “Art. 9° and 10°”
Following the establishment of a new Community herbal monograph or the revision of an existing monograph, the registration holder shall submit a request for amendment of the registration dossier to th…
The detailed summaries of the tests accompanying the application for registration and the expert reports are drawn up and signed by persons with the necessary qualifications and experience as mentione…
…the European Communities pursuant to Article 16f of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human…
…the European Communities pursuant to Article 16f of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human…
…on for a marketing authorisation or registration to the National Agency for the Safety of Medicines and Health Products under the conditions laid down in Articles R. 5121-21 and R. 5121-97 respectivel…
…y providing, within three months of the withdrawal from the list by the Commission, the information and documents mentioned in 5°, 6° and 16° of Article R. 5121-107-4.
…cy for an opinion, as referred to in Article 16h of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human…
Where the application for registration concerns a product which has been the subject of a Community herbal monograph established by the Committee for Herbal Medicinal Products of the European Medicine…
The registration application file includes the following information and documents, presented in accordance with the order referred to in Article R. 5121-11 : 1° The name and address of the applicant…
I-The purpose of the professional training course referred to in articles R. 512-9 and R. 512-10 is to enable trainees to acquire legal, technical, commercial and administrative skills prior to engagi…
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