§ Mr. BerminghamTo ask the Secretary of State for Health what is the average length of delay in the issue of approvals for pharmaceutical products on application; and if he will make a statement.
§ Mr. FreemanThe mean average time to grant product licences for established drug substances for the 12 months ending 31 December 1988, the latest date for which statistics are available, was 15 months. The corresponding time for new active substances was 21 months. These periods include the time taken by applicants to respond to inquiries from Medicines Act section 4 committees of the licensing authority.