Due implementation of the regulations counteracting trade in fake drugs poses a challenge for market participants, writes Adam Kraszewski.

Dealing in fake medicinal products has become a major problem. Alas, the issue is not limited to sources with respect to which a reasonable buyer may harbour some suspicions, such as the internet – fake medicines have permeated into the legal supply chain. A fake drug may contain inferior ingredients, be devoid of the active substance, or contain active substances and other ingredients in incorrect doses or proportions, the long and short being that they constitute a threat to life and limb. This problem has been duly noted at European Union level, leading to implementation – effective 9 February 2019 – of Directive 2011/62/EU of 8 June 2011 amending Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use as regards preventing fake medicines from entering the legal distribution chain, and of the Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use. The new regulations provide a basis for establishment of a system enabling monitoring of drugs in legal circulation. Subject to some minor exceptions, duties in this respect shall apply to all drugs requiring a prescription as well as some over-the-counter drugs. Proper implementation of these new regulations presents a challenge for market participants in that it will require creation of a cohesive system which takes into account operation of the single market across the European Union (...)

The entire article available in Rzeczpospolita.