The authorisation of finished medicinal products on the basis of the Medicinal Products Act ("Arzneimittelgesetz", AMG) is one of the main tasks of the BfArM.In the course of these
licensing procedures, it reviews the health benefit, i.e. efficacy, safety, and
pharmaceutical quality of the medicinal products. Furthermore, the BfArM fulfils important tasks in connection with drug
licensing on a ... Process of reviewing and assessing the dossier to support a medicinal
product in view of its marketing (also called
licensing,
registration, approval, etc.), finalized by granting of a document also called
marketing authorization (MA) (equivalent:
product license). This process is performed within a legislative framework which defines the
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requirements in relation to ingredients, manufacturing, labelling and claims. The Food and Drug Administration (FDA) is amending its regulations governing drug establishment
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Requirements & Documentation ' The TARIC is available to help determine if a license is required for a particular
product. In addition, the
European Commission maintains an export helpdesk with information on import restrictions of various products.
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pharmaceutical ingredient is transported unchanged from the site of administration across a bio membrane to the
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product development stage to consistently ensure a predefined quality at the end of the manufacturing process.”
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