As Poland is part of the EU they legally have to comply with 2003/94/EC for GMP and 2001/83/EC for marketing a medicine within the EU. Safety, quality and efficiacy are the main principles of drug approval and hence a drug would not be approved within the EU if any of these principals are not met. reversing your statement then would the Polish community consider medicines approved by the MHRA as unsafe? What if a medicine was marketed via decentralised or Mutual recognition in both UK and Poland – would the Polish approval process be inferior to UK approval process?

‘the MHRA explained it is receiving a growing number of reports of unlicensed medicines being sold across the UK’

unlicensed medicines can be sold within the UK providing this is done under MS or WL licenses for unmet clinical needs (as per Art.5 2001/83/EC). In fact the ‘growing number’ is probably due to the increase seen in commercial compounders of unlicensed products for use in the hosptial settings such as TPN and chemotherapy. Without these services patients could potentially be denied treatment for a host of illnesses. Remember there is also the Section 10 exemption to the Medicines Act 68′ which allows for pharmacists to prepared medicines without a marketing authorisation for individual patient use. Hence unlicensed medicines are the cornerstone of cancer treatment within the NHS and private hospital sector.

‘Worryingly, it’s also possible that the demand for foreign medicines could lead to counterfeit products being sold in the UK by criminals seeking to take advantage of this opportunity’

there is also a demand for UK medicines which has already led to counterfeit medicines entering the supply chain (e.g. plavix). Therefore this is not a risk solely for unlicensed medicines.