§ Suspected Adverse Reactions Surveillance Scheme reports:
§ enter human reports onto the database within 2 working days
212WA§ enter serious animal reports onto the database within 2 working days
§ enter non-serious animal reports onto the database within 10 working days.
§ Centralised Procedures:
§ All assessments (including Maximum Residues Limits) to be submitted within timetables agreed with the European Medicines Evaluation Agency.
§ Decentralised Procedures:
§ All authorisations to be determined within the regulatory timetables.
§ UK Procedures:
§ 93 per cent of new marketing authorisations to be determined or referred to the Veterinary Products Committee within 120 clock days; all to be determined within 210 clock days.
§ 95 per cent of valid variation applications to have first assessment within 70 clock days; all to be determined within 150 clock days.
§ 95 per cent of valid renewal applications to have first assessment within 85 clock days; all to be determined within 180 clock days.