The European Medicines Agency (EMA) provides guidance in the form of questions and answers (Q&As) to of centrally authorised veterinary medicines about classification of changes to the post-authorisation and certain classification categories.EMA updates the Q&As regularly. Revised topics are marked 'New' or 'Rev.'
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On publication.These Q&As are for guidance only and should be read in conjunction with the, the European Commission and the published on the website of oordination Group for and - Human , which covers /v and EMA human/vet. The update of Part 2C can be submitted as a grouped application, if conditions 5 or 6 of Annex III of the Regulation (EC) 1234/2008 apply.An update or change of a stand-alone ASMF is not foreseen and can only be addressed in connection with a. The type of the (s) is dependent on the type of the single changes introduced in the updated version. The update – including changes to the open and/or restricted part - can be submitted as a grouped application, if condition 5 of Annex III of the Regulation (EC) 1234/2008 applies.However, in case of substantial changes in the updated version of Part 2C or the ASMF it is recommended to submit a single of type II under category B.I.z. In line with the 's (MAH) obligation to keep the dossier up to date, a new or updated Certificate of Suitability (CEP) for an (AS), or starting material/reagent/intermediate used in the manufacturing process of the AS should be submitted as a. It is however understood that only the versions of the CEP (i.e. Updated certificates) which were used in the manufacturing process of a batch of finished product (FP)/ AS need to be included in the dossier.CEP updates should be submitted under the appropriate classification scope within subsection B.III.1.
Each CEP update should be submitted as a scope, i.e. An update covering more than one CEP version should be submitted as a grouped.When applying for an update of an approved CEP, the MAH should refer to the previously agreed version of the CEP within the 'Present/Proposed' section of the application form.If with the submission one or more revisions of the CEP are omitted, the MAH should confirm in the application form (section 'Precise scope and background for change') that substance/material from the omitted CEP version(s) was not used in the manufacture of the FP and/or AS during the validity of this certificate(s). Additionally it should be confirmed that any changes introduced by the omitted CEP update(s), do not affect the quality of the AS and/or FP. In case such confirmation is missing, a negative Type IA notification may be issued.The MAH should also clearly indicate in the 'Present/Proposed' section all changes introduced in the CEP between the latest approved version and the new revision, including all revisions that were not notified. Any changes e.g.
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To manufacturing sites, additional residual solvents introduced in the CEP by subsequent updates should be declared.Example:Submission of an updated CEP version for an already approved manufacturer: R0-CEP-xxxx-xx-rev.02 when the current certificate in the dossier is: R0-CEP-xxxx-xx-rev.00.If, during the validity of R0-CEP-xxxx-xx-rev.01, material of the CEP was used in the manufacture of the FP and/or the AS, then the MAH should submit a of two IA to include both certificates (rev. 02) in the Module 3 or Part 2 (NTA). The foreseen conditions for each of the respective should be met.If, during the validity of R0-CEP-xxxx-xx-rev.01, material of the CEP was not used in the manufacture of the FP and/or AS, the MAH should only submit a single to include the updated certificate R0-CEP-xxxx-xx-rev.02 in Module 3 or Part 2 (NTA). The foreseen conditions for the should be met.The MAH should also confirm in the application form that material/substance from R0-CEP-xxxx-xx-rev.01 was not used in the manufacture of the FP and/or AS during the validity of this certificate and that changes introduced by the revision R0-CEP-xxxx-xx-rev.01 do not affect the quality of the AS and/or the FP. MAH should also clearly list within the 'Present/Proposed' section of the application form all changes introduced to the CEP with revisions 01 and 02.3. How should I submit a new working cell bank (WCB) (Classification category B.I.a.2 a)? New December 2017.
If a new WCB is introduced using the limits/conditions as detailed in an approved qualification protocol, the new WCB is covered by the existing quality assurance system and there is no need to file a.If the documentation of the WCB in the dossier does not include an approved qualification protocol for introducing new WCBs, the MAH should file a B.I.a.2.a) as a type IB (upgraded from type IA as condition 5 (immunological) is not met).To introduce a qualification protocol for preparation of a new WCB, the MAH should file a under B.I.a.2.c. The addition of the new WCB can be covered as part of this single.Changes to an approved standard procedure (protocol) should be filed using a (B.I.a.2.a), or a (B.I.a.2.c), as relevant depending on the complexity of the change. The addition of a new WCB can be covered as part of this single.4.
How should I submit a new reference standard for biological medicinal product? New December 2017.
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