Business

European Commission (EC) proposals to introduce a unique seal to packaging to combat counterfeiting will cause problems with the insertion of patient leaflets and labelling, according to the UK's medicines watchdog.

The Medicines and Healthcare products Regulatory Agency (MHRA), responding to an EC consultation on combating counterfeit medicines that closed last week, said requiring packs to be sealed in this way would not enable importers of products from other European countries to comply with UK leaflet and labelling rules.

These rules state that products for the UK market should contain an English leaflet and labelling on the primary and secondary packaging.

The EC also wants to ban repackaging, but the MHRA called for the repackaging of medicinal products licensed for clinical trials to be allowed.

Under current EU rules, products can be re-boxed, re-labelled, over-stickered and tablets removed from their blisters and reconditioned. Such repackaging can involve removing the security seal and damaging unique identification codes by which a medicine can be traced.

MHRA director of policy Shaun Gallagher said the agency would be interested to know how introducing a unique seal to packaging would operate and who would make the decision about the products to which it should apply.

Other concerns include the EC’s definition of the “market authorisation holders” and “end users” who are allowed to open the packaging.

More information is available about the consultation here.