Medicines Control Agency

HC Deb 14 December 1989 vol 163 c791W

Mr. Rowlands

To ask the Secretary of State for Health whether he will list the outstanding applications for a licence before the Medicines Control Agency; and how long each application has been awaiting approval.

Mrs. Virginia Bottomley

We are unable to list the outstanding licence applications held by the Medicines Control Agency because this information is, in accordance with the Medicines Act 1968, treated as confidential.

We can however say that the number of applications for new licences awaiting a decision as at 30 November 1989 was:

	Number
Product licences	1,766
Product licences (parallel imports)	1,006
Manufacturers licences	21
Wholesale dealers licences	32
Non orthodox practitioner licences	3

The average time taken^* to grant product licences and product licences (parallel imports) as at 30 June 1989 (latest available figure) was:

	Months
for new active substances	24
for abridged applications referred to Committees under the Medicines Act	32
for other abridged applications	16
for parallel imports	19

The estimated time taken to grant the following licences is currently:

	Days
for manufacturers licences	80–90
for wholesale dealers licences	80–90
for non orthodox practitioner licences	40

Note:

It should be noted that all times quoted are gross processing times and take no account of delays while companies prepare their replies to queries raised on applications.