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.
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.
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.
Used for MAPIs and Copycats, New VHRs, and Type II variations and will be completed within 120 days of receipt of a valid application.
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.
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.
Used for Specific Batch Control applications and will be completed within 20 days of receipt of an application.