Timetables for national applications for MAs, ATCs and VHRs
All national applications will be processed on one of six timetables that vary in length depending on the complexity and nature of the application under assessment.
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These timetables apply from 1 January 2021 to national Marketing Authorisations (MAs), Animal Test Certificates (ATCs) and Veterinary Homeopathic Registrations (VHR), as well as renewals and variations to these. It also covers Specific Batch Control (SBC) applications for pharmaceutical products.
Summary of the six new timetables
Complex
Used for complex new MA applications and will be completed within 210 days of receipt of a valid application. It will be determined at the validation stage based on set criterion, such as whether there are novel therapies or new active substances, whether an application is complex or major. It is likely that most biological and immunological applications will be processed on a complex timetable.
Major
Used for non-complex new MA applications including variation-extensions, but excluding MAPIs and Copycats, and will be completed within 180 days of receipt of a valid application.
Standard
Used for MAPIs and Copycats, New VHRs, and Type II variations and will be completed within 120 days of receipt of a valid application.
Shortened
Used for Type IB (non-administrative) variations, MA and VHR renewals, new ATCs (Type B) and conditions. These will be completed within 60 days of receipt of a valid application.
Minor
Used for New ATC (Type A and S), ATC variations and renewals, Type IA variations, and administrative Type IB variations. These will be complete within 30 days of receipt of a valid application.
Batch
Used for Specific Batch Control (SBC) applications and will be completed within 20 days of receipt of an application.
Last updated 27 May 2022 + show all updates
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Changes to Initial Assessment and Second Assessment timeframes.
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Updated timetables applied from 1 January 2021; shortened timescales for Initial assessment and Second assessment
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First published.