Pharmaceutical Trade (Hansard, 10 December 2003)

§ Dr. Tonge
To ask the Secretary of State for Health what inspection mechanisms are in place in the United Kingdom for short line wholesalers in the parallel pharmaceutical trade. [141700]

§ Ms Rosie Winterton
Short line wholesalers distribute a limited range of medicinal products and often specialise in parallel traded pharmaceuticals known as "parallel imports". They are licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) and are inspected for compliance with good distribution practice at regular intervals.
Wholesalers who assemble parallel imported products are also required to hold assembly licences granted by the MHRA and are inspected for compliance with good manufacturing practice at regular intervals.

§ Dr. Tonge
To ask the Secretary of State for Health what representations he has had from, and what discussions he has had with, patients' groups concerning the repackaging of medicines from the parallel trade in pharmaceutical products. [141701]

§ Miss Melanie Johnson
To date, the Medicines and Healthcare products Regulatory Agency (MHRA) has not received any representations from, nor had any discussions with, patient groups about the repackaging of medicines from the parallel trade in pharmaceuticals.
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The MHRA has received some letters from patients, patient carers and health professionals on this matter. In these cases the product labelling has been reviewed and, where appropriate, the parallel importer asked to address the concerns raised.
In licensing parallel imports, the MHRA ensures the products comply with the appropriate regulations.

§ Dr. Jenny Tonge
To ask the Secretary of State for Health what recent action he has taken to maintain safeguards for patients taking medicines emanating from short line wholesalers. [142200]

§ Ms Rosie Winterton
In order to assure the quality of medicines stored and distributed by wholesalers and safeguard patients, the Inspection and Enforcement Division of the Medicines and Healthcare Products Regulatory Agency (MHRA), on behalf of the Secretary of State for Health, licences all pharmaceutical wholesalers in the United Kingdom and inspects their premises and procedures for compliance with good distribution practice.
The same standards of licensing and inspection are applied to full-line wholesalers, who deal in the full range of medicinal products available in the United Kingdom and short-line wholesalers, who deal in a more limited range of products. MHRA inspectors in the financial year 2003–04 have, to date, inspected over 250 wholesale sites. The inspections have confirmed compliance by these wholesalers with good distribution practice. There has been no recent necessity for additional action to maintain the safeguards to patients taking medicines emanating from short-line, or full-line wholesalers.