The Falsified Medicines Directive (Directive 2011/62/EU) and the Commission Delegated Regulation (EU) 2016/161 on safety features appearing on the packaging of medicinal products, which became applicable on 9 February 2019, lay down detailed rules on safety features for medicinal products for human use. These include the placement of two safety features on the packaging of most medicinal products for human use:
- a unique identifier (a two-dimensional barcode); and
- an anti-tampering device.
No additional national requirements or conditions apply in Latvia regarding the unique identifier or the anti-tampering device. Therefore, marketing authorisation holders are advised to comply with the requirements established by the European Commission:
- European Commission presentation for stakeholders – Medicines Verification in Europe: What to Expect in 2019 (available in English)
- European Commission Guideline – Guideline on the Packaging Information of Medicinal Products for Human Use Authorised by the Union (available in English)
- Questions and Answers (Version 22) – Safety Features for Medicinal Products for Human Use(available in English):
To assist marketing authorisation holders in meeting these requirements, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), established by the Heads of Medicines Agencies (HMA), has prepared an Implementation Plan for the Safety Features on the Packaging of Medicinal Products. The plan provides detailed guidance for marketing authorisation holders (and applicants) on the procedures for implementing the required safety features. The implementation plan is available in English here.
Further explanations and the CMDh responses to frequently asked questions are available on the CMDh website.
Additional Information
State Agency of Medicines (Latvia) video presentation: Regulatory Activities for the Implementation of Safety Features on Medicinal Products
