Article R5121-107-9
…f the application does not comply with the provisions of Articles L. 5121-14-1, R. 5121-97, R. 5121-107-4 and R. 5121-107-5, or if at least one of the following conditions is met: 1° The qualitative o…
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Showing 5361–5370 of 59015 articles for “Art. 10 and 11”
…f the application does not comply with the provisions of Articles L. 5121-14-1, R. 5121-97, R. 5121-107-4 and R. 5121-107-5, or if at least one of the following conditions is met: 1° The qualitative o…
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…
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…
…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…
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