Article R5121-100-1
…s laid down in Chapters I and IIa of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing authorisation for medicinal produc…
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Showing 2931–2940 of 29080 articles for “Art. CE 4-10-2013 n° 351065”
…s laid down in Chapters I and IIa of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing authorisation for medicinal produc…
…e application for registration and the expert reports are drawn up and signed by persons with the necessary qualifications and experience as mentioned in Article R. 5121-33.
…rbal 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 Commission of the Eur…
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 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…
…d, suspended or withdrawn by the Director General of the Agency. The period of suspension may not exceed one year. Decisions to refuse, amend, suspend or cancel registration shall state the reasons on…
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 Board comprises : 1° Four representatives of the State, including the Regional Prefect and three representatives appointed by him from among those mentioned in 2° of Article R. 6123-3-3, including…
…ranting of the career transition leave requested by an employee: 1° When it considers that the absence of the person concerned could have consequences prejudicial to the production and running of the…
An employee who has benefited from a professional transition leave may not claim, in the same company, the benefit of a new professional transition leave before a period, expressed in months, equal to…
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