LegislationLegislation
- Directive 2011/62/EU – Falsified Medicines Directive (FMD)
- Commission Delegated Regulation (EU) 2016/161
- European Commission Q&A on Safety Features
- Medicinal Products (Safety Features on Packaging) Regulations 2019 (S.I. No. 36 of 2019)
- Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2013 (S.I. No. 162 of 2013) – these regulations implemented the Falsified Medicines Directive in Irish law.
- Medicinal Products (Safety Features on Packaging) Regulations 2022 (SI No 270 of 2022) – these regulations support the implementation of the Commission Delegated Regulation in Ireland.