The MHRA is seeing a growing number of reports involving unlicensed medicines originating from Poland and other Eastern European countries which are being offered for sale in a number of retail outlets throughout the UK.
74 cases involving Polish and other medicines from Eastern European countries being sold in “corner shops” were investigated by the MHRA last year – these included medicines which fall into the category of pharmacy-only and prescription only medicines.
In an effort to overcome any misunderstanding about product status, the MHRA has produced guidance for consumers, retailers and wholesalers to provide assistance in terms of understanding and complying with the UK regulatory requirements.
Only medicines which have been licensed for sale in the UK and labelled in the English language (with an accompanying Patient Information Leaflet / PIL in English) can be sold and supplied legally in the UK.
Medicines that are licensed only in Poland or other European Member States cannot be sold or supplied in the UK unless a prior MHRA Parallel Import Licence or a Parallel Distribution Notification has been obtained for its supply in the UK.
There are specific consumer safety issues associated with the availability of medicines which are not licensed for UK sale.
The MHRA is also working with the Polish medicines regulator in order to help communities where these medicines are being sold.
Nimo Ahmed, MHRA Acting Head of Enforcement said:
“Polish medicines imported into the UK and sold in Polish language packs have not been approved for sale in the UK and cannot be traded lawfully on the UK market. Medicines offered for sale and supply in the UK must be labelled in English.
“We urge people not to buy medicines that are not labelled in English. Medicines are not ordinary consumer products. There are also specific health concerns with certain medicines that should be prescribed and dispensed under the supervision of a healthcare professional, such as a doctor or a pharmacist. Anyone who self-medicates and buys these medicines from shops that are not registered pharmacies could be endangering their health.
“The medicine may also not be suitable for individual patients and could interact with other medicines being taken and at worst, may cause serious harm.
“We recommend that consumers take note of this guidance to safeguard themselves from potential harm and that suppliers take note of this guidance to avoid committing a criminal offence.”
Notes to Editor
1. In the UK, medicines for human consumption are subject to strict legal control. Medicinal products must be sold and supplied under specified conditions set out in the Human Medicines Regulations 2012.
2. Medicines are not ordinary consumer products and, in the case of prescription-only (POM ) and pharmacy-only (P) medicines, should be taken under the supervision of an appropriate health care provider (for example, a doctor) or a pharmacist.
3. In order to be eligible for legitimate sale in the UK, medicinal products imported from within the EU/EEA must be labelled so that the packaging provides specified statutory information in English and a Patient Information Leaflet must also be provided in English.
4. The importer must apply to MHRA for a specific licence for the importation of each product from each individual country. MHRA examines a sample of the product to be imported and verifies its details against information held by the medicines authority in the source country. If the MHRA is satisfied that the criteria for importation have been met and the labelling and patient information leaflet are satisfactory, a Parallel Import licence will be issued. For products authorised by the European Medicines Agency (EMA) the importer must apply to the EMA who will confirm that the proposed labelling and leaflet meet the requirements of the marketing authorisation and will issue a Parallel Distribution Notification.
5. Repackaging of parallel traded medicines can only be carried out in facilities licensed for this activity by the MHRA or other appropriate body throughout the EU.
6. If an individual is convicted of offences under the Human Medicines Regulations 2012, they can be sentenced to a maximum of two years imprisonment and/or an unlimited fine. Where appropriate the MHRA will use the Proceeds of Crime Act 2002 to determine whether or not benefits were accrued through criminal activity and will recoup illicit earnings if the individual is found guilty. In cases involving counterfeit medicines, the MHRA will use the Fraud Act or Trade Marks Act which both carry a maximum of 10 years imprisonment.
7. To report a counterfeit medicine or device contact the MHRA dedicated 24-hour hotline on 0203 080 6701, or e-mail counterfeit@mhra.gsi.gov.uk or write to: Counterfeits, The Intelligence Unit, MHRA, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ
8. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. All our work is underpinned by robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.
