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Showing 4301–4310 of 34765 articles for “Art. R. 210-9”
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…
…es and according to the same procedures as those laid down for a marketing authorisation in Article R. 5121-47. It shall immediately inform the European Medicines Agency. Decisions to refuse, vary, su…
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…
…n up and signed by persons with the necessary qualifications and experience as mentioned in Article R. 5121-33.
…r human use, the applicant is exempt from providing the data mentioned in 5°, 6° and 16° of Article R. 5121-107-4.
…ised procedure under the same conditions as those laid down for marketing authorisation in articles R. 5121-51 to R. 5121-51-7.
…l Agency for the Safety of Medicines and Health Products under the conditions laid down in Articles R. 5121-21 and R. 5121-97 respectively.
…om the list by the Commission, the information and documents mentioned in 5°, 6° and 16° of Article R. 5121-107-4.
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…
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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