§ Mr. Tony Lloydasked the Secretary of State for Social Services if he will publish the number of applications (a) he has received and (b) he has granted for parallel product licences for pharmaceuticals; and if he will make a statement.
§ Mr. WhitneyThe current position on applications for pharmaceutical product licences (parallel importing) is as follows:
Number Applications received 2,500 Applications cleared 1,825 Licences granted 900 The outstanding applications await assessment, but a large proportion of them cannot be determined until information is received from regulatory authorities in other European Community member states.
All applications for product licences (parallel importing) are subject to detailed medical and pharmaceutical assessment and following appropriate inquiries are granted where the licensing authority is satisfied that the imported product is therapeutically equivalent to that which is the subject of the United Kingdom product licence.
The conditions for the grant of PL(PI) licences are set out in Medicines Act leaflet MAL2(PI), a copy of which is in the Library.