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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Details
These timetables apply from 1 January 2021 to national Marketing Authorisations (MAs), Animal Test Certificates (ATCs) and Veterinary Homeopathic Registrations (VHR). 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 (excluding copycats) including variation-extensions, and will be completed within 180 days of receipt of a valid application.
Standard
Used for Copycats, New VHRs, Variations Requiring Assessment - Standard (VRA-S) and will be completed within 120 days of receipt of a valid application.
Shortened
Used for Variations Requiring Assessment - Reduced (VRA-R), VHR renewals, all ATC applications and conditions. These will be completed within 60 days of receipt of a valid application.
Minor
Used for Variations Not Requiring Assessment (VNRA) and administrative VRA-R. 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.
Updates to this page
Published 28 March 2019Last updated 12 December 2024 + show all updates
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Changes made under Major, Standard, Shortened and Minor headings. In table, Validation row, Minor column updated.
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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.