![]() changes to the active substance specifications or related analytical methods) separate variations have to be submitted under the corresponding B.I.b. It should be noted that in cases where the introduction of the new active substance manufacturer has an impact at the level of the finished product manufacturer (e.g. ![]() The introduction of a new manufacturer of the active substance not supported by an ASMF that requires significant updates to 3.2.S should be submitted under a single Type II scope B.I.a.1.g). The introduction of a new manufacturing site for an active substance supported by an ASMF should be submitted under a single Type II scope B.I.a.1.b. What changes are covered by a single type II scope? (Classification categoryB.I.a.1) Introduction of a new manufacturing site for an active substance. See also question ’Who is my contact at the European Medicines Agency during type II variation, including extension of indications?’.Ģ.2. All the related changes should be listed in the present/proposed table.Ĭhanges affecting the FP not directly related to the introduction of the new manufacturing site such as changes in excipients, specification parameters /limits for the FP, container closure system including suppliers should be submitted as additional variation scopes.Īny pre-submission queries of any intended submission of complex related changes under one single type II scope should be addressed to the Product Lead in charge of Quality Type II variations. The following complex related changes could be considered for submission under a single type II scope B.II.b.1 - Addition of a new finished product (FP) manufacturing site: changes to the manufacturing process, batch size and in-process controls to adapt to the new manufacturing site settings.Ĭomplex related changes submitted under a single type II should always be clearly identified in the application form as following: a clear description of all the related changes should be provided in the precise scope. What changes can I submit under a single type II scope? (Classification category B.II.b.1) 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. 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.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |