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Showing 91–100 of 2192 articles for “Art. art. 107”
…ist by the Commission, the information and documents mentioned in 5°, 6° and 16° of Article R. 5121-107-4.
…use, the applicant is exempt from providing the data mentioned in 5°, 6° and 16° of Article R. 5121-107-4.
…presence of vitamins or minerals in the medicinal product as provided for in III of Article R. 5121-107-3, data on the traditional use of the combination, in particular those relating to the safety of…
Where, following the establishment of a new Community herbal monograph, the revision of an existing monograph or the revision of the list drawn up by the European Commission in application of Article…
The Director General of the Agency may automatically vary, suspend or cancel a registration in the same cases and according to the same procedures as those laid down for a marketing authorisation in A…
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…
Where a Community herbal monograph has been established or where the herbal medicinal product consists of herbal substances, preparations or combinations thereof included in the list drawn up by the C…
If, after a traditional herbal medicinal product has been registered, the proprietor considers, on the basis of new data available to him, that, given its characteristics, the medicinal product is now…
I.-The period of traditional medical use provided for in 4° of Article L. 5121-14-1 is thirty years, including at least fifteen years in a Member State of the European Community or in another State pa…
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