Article R5121-107-13
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…
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Showing 2921–2930 of 51396 articles for “Art. Cass. com. 2 novembre 2011 n° 10-15887”
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…
…and signed by persons with the necessary qualifications and experience as mentioned in Article R. 5121-33.
…ncy for the Safety of Medicines and Health Products under the conditions laid down in Articles R. 5121-21 and R. 5121-97 respectively.
…e list by the Commission, the information and documents mentioned in 5°, 6° and 16° of Article R. 5121-107-4.
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…
Tattoo products are subject to vigilance designed to monitor undesirable effects occurring under normal conditions of use of the product or resulting from misuse. This vigilance is applied to all thes…
…y or be associated with a holder of this authorisation under the conditions set out in article R. 6123-90-1. A protocol for the patient's care pathway undergoing systemic cancer drug treatment is draw…
Authorisation may only be granted if the holder can provide cerebral and vascular exploration by scanner and MRI, on site, twenty-four hours a day, seven days a week.The holder of the medical imaging…
…follow-up of the patient after treatment provided for in 3° and the fifth paragraph of article R. 6123-93 are recorded in the patient's medical record.
…rug treatments close to their home within the framework of an association mentioned in Article R. 6123-90-1 and any initial prescriptions for significant changes in treatment made within this framewor…
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