Written question asked by Stephen O'Brien (Conservative) on Tuesday, 25 July 2006, in the House of Commons. It was due for an answer on Monday, 9 October 2006. It was answered by Andy Burnham (Labour) on Tuesday, 7 November 2006 on behalf of the Department of Health.

Medicine Re-packaging

Question: To ask the Secretary of State for Health what her policy is on the re-packaging of medicines for parallel trade; and what assessment she has made of the effect of re-packaging on the (a) quality and (b) integrity of the product.

Answer: The majority of parallel imported medicines are marketed in the original packaging which has been over-labelled in accordance with the Medicines Labelling Regulations. In the cases where re-packaging occurs, the primary packaging which is in contact with the drug product and which is primarily responsible for maintaining the quality and integrity of the drug product, is not modified in any way, thus the original quality and integrity of the product are maintained. Any re-packaging and re-labelling proposed by a parallel importer must be assessed as satisfactory by the Medicines and Healthcare products Regulatory Agency (MHRA) for a parallel import licence to be granted. Each batch of product must be released by a qualified person. The MHRA has systems in place to receive and investigate reports of packaging and labelling problems with medicines, including parallel traded products.

Secondary information