Question of the Week
Who checks that a imported active substance is accompanied by the written confirmation?
This should be checked by the receiving manufacturer of the finished medicinal product. It may also be checked by the importer of the active substance upon its importation.The verification whether such checks take place depends on the transposing law of the Member State where the active substance is imported.It may be verified- by the relevant authority upon importation; and/or- in the context of an inspection of the importer of the active substance, and/or
- in the context of an inspection of the manufacturer of the medicinal product that uses the imported active substance.[GMP MANUAL
Chapter C.8.5.1 Importation of Active Substances for Medicinal Products for Human Use Questions and Answers]