§ Chris GraylingTo ask the Secretary of State for Health (1) how many complaints the Medicines and Healthcare Products Regulatory Agency has received in the past 12 months about changes by pharmaceutical distributors to manufacturers' packaging and related materials; [162005]
(2) whether the Medicines and Healthcare Products Regulatory Agency has received representations about the health risks posed by changes to the packaging of pharmaceutical products during distribution; [162008]
(3) if he will introduce tighter guidelines on the right to change or modify the packaging of pharmaceutical products during the distribution process. [162009]
§ Ms Rosie WintertonA pharmaceutical distributor in the United Kingdom is required to hold a wholesale dealer's licence (WL) issued by the Medicines and Healthcare products Regulatory Agency (MHRA). A WL does not authorise distributors to make changes to the manufacturers' packaging and related materials of licensed medicinal products; these activities require a separate assembly licence, also issued by the MHRA. A number of wholesale dealers hold assembly licences for the purpose of re-packaging licensed parallel imported medicines and this reply relates to this group of products.
931WThe repackaging of licensed medicinal products, such as parallel imports, is controlled by the specification registered in the parallel import licence and may only be carried out by assembly sites licensed and inspected by the MHRA.
Parallel importers are not permitted to change the primary packaging of the product—that is the immediate packaging in contact with the product (for instance the blister packaging). The importer is however required to overlabel the immediate packaging in accordance with the European Union labelling regulations. This operation can be carried out by the importer if the company holds an assembly licence, issued by MHRA after inspecting the site.
Any repackaging and relabelling proposed by a parallel importer is considered by MHRA before a licence is issued. The labelling of all products must meet the Medicines Labelling Regulations as laid down in Title V of Directive 2001/83/EC and each product pack must contain a patient information leaflet in English. Guidelines on the labelling and packaging of medicinal products are also relevant to parallel imports.
In the past 12 months MHRA has received 107 letters or reports relating to medicinal products that have been repackaged and placed on the market in the United Kingdom as licensed parallel imports. These include 18 reports received by the MHRA Defective Medicines Report Centre concerning quality defects in the labelling or leaflets of re-packaged parallel imports, (which represents 6 per cent. of quality defects reported on all products).
A further 66 of the letters received, either directly or via ministerial offices, concern aspects of the labelling, packaging or leaflet of the imported products, of which 14 were from patients, patient carers and health professionals. The remaining 52 were from the UK Marketing Authorisation holders and 47 related to updating of patient information leaflets.