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Showing 2911–2920 of 58235 articles for “Art. n° 10-10095 and n° 10-30215”
Amendments to the terms of the registration decision and the registration dossier are submitted and examined under the conditions laid down in Chapters I and IIa of Commission Regulation (EC) No 1234/…
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…
…here applicable, the criteria for granting compassionate access authorisation in a given indication and any information necessary for the use of the medicinal product; 2° The therapeutic use and patie…
…tate the reasons on which they are based. They are notified to the applicant or registration holder and state the appeal procedures and deadlines applicable. Such decisions may only be taken after the…
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…
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