SERIALISATION

9 February 2019 saw the entry into force in Poland of Commission Delegated Regulation (EU) 2016/161 which requires medicinal product manufacturers to use certain safety features on their products. This posed a serious challenge to pharmaceutical and contract manufacturers who had to bring their manufacturing processes and their technical and computer infrastructure in line with the new regulatory standards.

Directive 2011/62/EU (“Anti-Counterfeiting Directive”) introduced new standards under which pharmaceutical manufacturers must make sure that individual packs bear anti-counterfeiting safety features. While these regulations apply exclusively to prescription drugs, there are some exceptions where safety features may be additionally required for other products, including over-the-counter drugs.

The anti-counterfeiting law requires that individual packs cannot be opened unless they are physically interfered with (ATD – anti-tampering device) and that each pack has a unique identifier to ensure that a medicinal product is fully traceable across its distribution chain.