Written question asked by Adrian Flook (Conservative) on Tuesday, 30 November 2004, in the House of Commons. It was due for an answer on Monday, 20 December 2004. It was answered by Baroness Winterton of Doncaster (Labour) on Monday, 20 December 2004 on behalf of the Department of Health.

Dept of Health

Question: To ask the Secretary of State for Trade and Industry, what mechanisms are in place to prevent tamper-proof packaging on medicines being removed by commercial middlemen.

Answer: Mr. Flook: To ask the Secretary of State for Trade and Industry what mechanisms are in place to prevent tamper-proof packaging on medicines being removed by commercial middlemen. [201723] Ms Rosie Winterton: I have been asked to reply. The regulations covering the packaging of medicinal products make no reference to the use of tamper evident presentations. Any decision to use such packaging is for the marketing authorisation holder. If a company authorised to carry out the repackaging of a medicinal product needs to remove tamper evident packaging, or seals, in order to repack the product, he is permitted to do so. However, repacking of medicinal products in the United Kingdom may only be carried out in accordance with relevant process and product-specific licences issued by the Medicines and Healthcare products Regulatory Agency (MHRA)--these permit only the outer packaging to be opened or replaced. The MHRA examines a sample of each product to be repacked and is aware of the instances in which tamper-evident packaging will be opened or replaced. The immediate container may not be opened or replaced so where this uses tamper-evident packaging, it will remain intact.

Secondary information