Guidance

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.

Documents

Details

These timetables apply from 1 April 2019 to national Marketing Authorisations (MAs), Animal Test Certificates (ATCs) and Veterinary Homeopathic Registrations (VHR) and variations to or renewals of these. It also covers specific batch control 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 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 variations, MA and VHR renewals, new ATCs (Type B) and conditional data. 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 applications and will be completed within 20 days of receipt of an application.

Published 28 March 2019