§ Mr. Simon HughesTo ask the Secretary of State for Health if he will list for(a) 1993, (b) 1994 and (c) 1995 the mean and range of the delays between advice being issued by the Committee on Safety of Medicines relating to compulsory variation of a product licence and a letter in terms of paragraph 6 of schedule 2 of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 or previous equivalent legislation begin issued; and what assessment he had made of the performance of the Medicines Control Agency and Committee on Safety of Medicines in this regard. [35090]
§ Mr. MaloneIn 1993 and 1994 there were no compulsory variations.
In 1995 there were three compulsory variations, two of which related to the same safety issue. The times between advice being formulated by the Committee on Safety of Medicines and a letter being issued under paragraph 6 of schedule 2 of the Medicines for Human Use (Marketing Authorisations, etc.,) Regulations 1994 were on2, 82 and 84 days.
No specific assessment has been made of this issue.