Retailers In Hull Warned About Illegally Selling Polish Medicines, UK

Last Thursday, 12 August, enforcement officers from the Medicines and Healthcare products Regulatory Agency (MHRA) visited six Polish convenience stores in the Hull area.


This followed information received by the MHRA from Trading Standards relating to the suspected sale of unlicensed medicines.


Any medicines that are not labelled in English are unlicensed and therefore unsuitable for sale in the UK.


The officers came across stocks of medicines which were all labelled in Polish and were consequently seized.


The types of products seized included aspirin, ibuprofen and children's cough medications.


One of the shops visited had been the subject of a previous MHRA visit and had been instructed to remove all of their unlicensed medicines from sale. This shop was still selling Polish labelled medicines, leading officers to seize approximately ??1,000 worth of stock. The MHRA is considering further enforcement action against this shop.


The remaining shops had all of their stocks of unlicensed medicines removed and formal warnings were issued to the offending retailers.


MHRA Head of Operations, Danny Lee-Frost, said, "The MHRA wishes to ensure Polish retailers are complying with UK medicines legislation and therefore selling medicines in a safe way.


Polish medicines imported into the UK and sold in Polish packs have not been approved for sale in the UK and are regarded as unlicensed medicines. Medicines on sale in the UK are required to be labelled in English.


Unlicensed medicines present potential risks to patients as there is no assurance that they have been tested to required standards of safety and quality in the UK."


Notes


1. These medicines have not been imported into the UK through the approved supply chain and therefore, if there was a fault with a product, the mechanism in place for recalling medicines would fail to identify them.


2. In order to be eligible for legitimate parallel importation from within the EU/EEA, medicinal products must be labelled so that the packaging provides specified statutory information in English and a Patient Information Leaflet must also be provided in English.


The parallel 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.


Repackaging of parallel traded medicines can only be carried out in the UK in facilities licensed for this activity by the MHRA.


3. If an individual is convicted of offences under the Medicines Act 1968, 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.


Source:

MHRA