The Falsified Medicines Directive 2011/62/EU, which is due for adoption in February 2019, will require pharmaceutical companies to apply serialisation codes to every applicable pack (OTC and some minor exemptions). As a consequence, artwork changes will be required, which all too often are treated as a rushed afterthought. The impending legislation will affect all prescription medicines for the European market. In this article, Gill Wright from Westrock MPs advises the first step to comply with this legislation is to get your artwork amended and approved.