HC Deb 10 January 1989 vol 144 cc597-8W
Mr. David Nicholson

To ask the Secretary of State for Health what arrangements exist for the inspection of overseas manufacturing sites for products that are licensed under the Product Licences (Parallel Imports) Scheme in those European Community countries that are not a party to the pharmaceutical inspection convention.

Mr. Mellor

Overseas manufacturing sites for products which are the subject of the product licences (parallel imports) scheme are subject to inspection by the member state concerned. Where the pharmaceutical inspection convention does not apply, United Kingdom inspectors have made some informal visits in association with the local inspectorate.

Mr. David Nicholson

To ask the Secretary of State for Health how many holders of licences granted under the Product Licences (Parallel Imports) Scheme also hold manufacturers' licences which enable them to re-package and re-assemble products the original packs of which are in a foreign language.

Mr. Mellor

Sixteen.

Mr. David Nicholson

To ask the Secretary of State for Health what information he has as to how many products granted product licences (parallel imports) are (a) dispensed in the manufacturer's original packs which contain information for patients in a foreign language and (b) have to be re-packaged by the importing wholesaler or dispensing pharmacist to overcome language problems.

Mr. Mellor

Holders of product licences (parallel imports) are required to remove any instructions containing information for patients in a foreign language unless such instructions form part of an approved multilingual leaflet including English.

Licence holders must also arrange for all products to be relabelled to comply with the United Kingdom statutory requirements for labelling of medicinal products.

All information received about alleged breaches of the above requirements will be followed up.