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Showing 2841–2850 of 8562 articles for “Art. 10 mars 2004”
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…
…use, the applicant is exempt from providing the data mentioned in 5°, 6° and 16° of Article R. 5121-107-4.
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…
…ist 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…
I.-The Director General of the Agence nationale de sécurité du médicament et des produits de santé publishes, on the Agency's website, a reference database of medicinal products which are the subject…
…ntation and information provided do not comply with the application file defined in article R. 5121-106. III - Registration may be amended, suspended or withdrawn if it appears that the assessment of…
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…
The following changes to the authorisation to open a pharmaceutical establishment must be declared, pursuant to the second paragraph of Article L. 5124-3: 1° Change in the corporate name of the compan…
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