Batch Text Replacer 2.15 instal the new2/28/2024 ![]() ![]() In case more than one manufacturer in one MA has to be deleted a single variation of type IA under classification category A.7 to delete all manufacturing sites may be submitted. How to apply for the deletion of more than one manufacturing site? This is the same as manufacturing sites which are required to provide a qualified person declaration, where a single declaration may be acceptable under certain circumstances – see note below under section on Quality Changes – Classification category B.II.b.1.ġ.2. Manufacturer of finished product (as referred under documentation requirement 1 of classification category A.8) means any registered EEA manufacturers of medicinal products (finished product and batch release) which hold a valid manufacturing authorisation. However, the change has to be mentioned in the scope of the application form as well as under "present/proposed" but not in the section “ variations included in this application.” In these cases, no separate variation application for the change in the audit date has to be submitted. Otherwise transmitted means that the information has been provided to the competent authorities within any formal regulatory procedure e.g. How should I submit changes to date of the audit to verify GMP compliance of the manufacturer of the active substance? (Classification category A.8)Īccording to the 'Variations Guidelines’ 2013/C 223/01, this variation does not apply when the information has been otherwise transmitted to the authorities (e.g. ![]()
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