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The United Kingdom Transition Period ended on 31st December 2020 and the UK became a third country in relation to the EU.
Useful Links
National Competent Authorities
GOV. UK guidance on:
FMD Safety Features
FMD Errors or Alerts
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).
Date of Change
30 June 2020
The Actual Medicinal Product Pack (AMPP) code has been defined as the NHRN for the UK.
For those organisations who do not have an IT software provider, or who seek to find companies providing solutions, SecurMed has published the following list of providers.
For details of the scope of the regulation please check: FMD Delegated Regulation 2016_161
Where stakeholders are unclear on the legislation, for example whether types of medicine are in/out of scope, please contact DHSC/MHRA at fmd. safetyfeatures@mhra. gov. uk.
The End User Password is valid for 365 days after registration or a reset. In the 30 days prior to the Password expiry date, the UKNI MVS generates a message to inform the End User Location Contact that the Password must be changed.
To register, please read our guidance below and the End User Licence Agreement (EULA) carefully. For more detailed information, please see our End User Registration Process Overview.
Yes. Article 46 of the Delegated Regulation (DR) notifies the commission of additional medicinal products that are at risk or not at risk of falsification. All submissions must be made by the MHRA. Please contact the MHRA for information on how to submit.
Guidance has been issued about how to manage alerts on the Community Pharmacy FMDsource website and on the NHS Digital FMD site.
What is the FMD?
Since 9th February 2019, the Falsified Medicines Directive (FMD) and associated Delegated Regulation (DR) have imposed new regulatory obligations on all organisations that manufacture and/or dispense prescription-only medicines (POMs)*.
This depends upon the terms and conditions of both the Wholesaler and the manufacturer. However, in general, we expect the current returns process will remain valid as long as the stock has not been decommissioned and the anti-tamper device is still intact.
Please check which surgeries are registered with the relevant professional or sectoral body (such as PSNI). SecurMed will provide individual credentials for each Location that is individually registered with the relevant body.
The use of the term “provide for” in Article 37(d) of Commission Delegated Regulation (EU) 2016/161 means that an NMVO has to ensure that the National Competent Authorities (NCA), the EMA and the Commission are informed.
Please login to the Jira Service Desk and select ‘Service Request’ if your query relates to any of the following:
Software developer toolkit
Sandbox environment
Technical queries to support your software solution development activities
Software Supplier baseline testing
Alternatively, please contact the NMVS Helpdesk.
If you can't find what you're looking for, please use the link below to get in touch.