Introduction of a new manufacturing site for the finished product. However, it has to be assured that there is still one approved manufacturing site left in the documentation performing the same function as the one(s) concerned by the deletion.Ģ.1. 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.
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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. New files will be added on a regular basis, so please check back often.1.1. Please note: the content of the files in the Vault encompasses all time periods of Bureau history and do not always reflect the current views, policies, and priorities of the FBI. Note: You need your FOI/PA request number to use this feature.
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Searching for Topics: You can browse or search for specific topics or persons (like Al Capone or Marilyn Monroe) by viewing our alphabetical listing, by using the search tool in the upper right of this site, or by checking the different category lists that can be found in the menu on the right side of this page.The Vault includes several new tools and resources for your convenience: Included here are many new FBI files that have been released to the public but never added to this website dozens of records previously posted on our site but removed as requests diminished files from our previous FOIA Library, and new, previously unreleased files. The Vault is our new FOIA Library, containing 6,700 documents and other media that have been scanned from paper into digital copies so you can read them in the comfort of your home or office.
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