HC Deb 16 July 1986 vol 101 cc556-7W
Mr. McNamara

asked the Secretary of State for Social Services how many abridged product licence applications for medical products were received by his Department in 1985; how many product licences were granted in 1985 on the basis of an abridged application; and if he will provide comparable figures for the years 1981, 1982, 1983 and 1984.

Mr. Hayhoe

The total figures for all product licence applications* of all kinds and licences granted for the years 1981–85 are:

*Applications Received Licences Granted
1981 1,043 765
1982 1,282 934
1983 1,158 783
1984 922 641
1985 1,365 649
* These figures relate to initial applications received and do not take account of applications which are rejected as incomplete at a later stage.

It is estimated that approximately 98 per cent. of applications received and licences granted relate to abridged applications.

Mr. McNamara

asked the Secretary of State for Social Services how many abridged applications for product licences for medical products received by his Department in 1985 remained to be processed at the end of March 1986.

Mr. Hayhoe

Approximately 800.

Mr. McNamara

asked the Secretary of State for Social Services how many applications for exemptions from the need to hold a clinical trial certificate in respect of medical products were received by his Department in 1981, 1982, 1983, 1984 and 1985; and how many of these applications were dealt with in a period in excess of 35 plus 28 days stipulated in the Medicines (Exemptions from Licences) (Clinical Trials) Order 1981 (S.I., 1981, No. 164).

Mr. Hayhoe

The information requested is set out in the table:

Applications for clinical trial exemption Number not dealt with within 35 plus 28 days
1981 208 9
1982 232 8
1983 261 9
1984 263 16
1985 240 15

Mr. McNamara

asked the Secretary of State for Social Services how many product licences were issued by his Department in 1985 for new chemical entity medicinal products; and how many new chemical entities were represented in this number of licences.

Mr. Hayhoe

Nineteen product licences were issued in 1985 for medicinal products involving new active substances — formerly referred to as "new chemical entities"; these represented 14 new active substances.

Mr. McNamara

asked the Secretary of State for Social Services if he will state anonymously the period of time taken to process each product licence application in respect of a new chemical entity medicinal product received by his Department in 1985.

Mr. Hayhoe

Of the 67 product licence applications received in 1985 involving such products, there were 16 applications where a product licence was granted in 1985 and the approximate times taken for processing these are shown in the table. The remaining applications are either still under consideration or have been withdrawn — refused.

Number of applications Time taken in months
1 4.5
9 7
2 8
4 10