Useful FMD Links
Please find below links to public sites which provide useful information for the implementation of the Falsified Medicines Directive.
- A copy of the Delegated Regulation can be found on the European Commission Public Health website:
Delegated Regulation
- MHRA have provided guidance for the implementation and compliance of the Safety Features Regulation:
Implementing the Falsified Medicines Directive: Safety Features. To register for the FMD Safety Features newsletter, or for any queries about the FMD, please contact the
Medicines and Healthcare Products Regulatory Agency (MHRA).
- NHS Digital have developed guidance toolkits for healthcare professionals:
Falsified Medicines Directive Implementation Toolkits.
- National Competent Authorities – Go to GOV.UK for guidance on
FMD Safety Features and
FMD Errors or Alerts.
- European Medicines Verification Organisation (EMVO) – For more information, please visit the
EMVO Website, read the
Annex I and Annex II Delegated Regulation or visit the
European Commission Website.
- Live status of all of the Solidsoft Reply Countries:
Solidsoft Reply Market Status.
Use the links below for tailored guidance:
Department of Health
Community Pharmacy
Hospital Pharmacy
Wholesaler
Software Suppliers
SWS (Arvato Developers Toolkit)