Please find below links to public sites which provide useful information for the implementation of the Falsified Medicines Directive. MHRA have provided guidance for the implementation and compliance of the Safety Features Regulation: Implementing the Falsified Medicines Directive: Safety Features.
What is an AMPP code?
Actual Medicinal Product Pack (AMPP) codes uniquely identify a packaged product. An AMPP is the packaged product which is supplied for direct patient use.
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.
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 error code occurs because the UKNI MVS cannot find the User Certificate. Problem
Solution
UKNI MVS Certificate has expired (two years)
Contact the SecurMed Service Desk to request a new User Certificate.
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.
GTIN product codes require 14 characters. For more information, please refer to the EMVS Pack Coding Guidelines.
No. European Marketing Authorisations (EMA) Marketing Authorisations (MAs) are issued by the EMA under the Centralised Procedure (CP) process. Once granted, this enables the MAH to market and distribute medicines within all EU member states.
Please consult the UK government website.
Please check which surgeries are registered with the relevant professional or sectoral body (such as NI Direct). SecurMed will provide individual credentials for each Location that is individually registered with the relevant body.
Guidance has been issued about how to manage alerts on the Community Pharmacy FMDsource website and on the NHS Digital FMD site.
If you have successfully logged onto the UKNI MVS but are having a problem logging onto your FMD software, please contact your Software Supplier.
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.
Refer to your SOP and/or guidance on FMD Source or RPS. To progress the investigation of an Alert with SecurMed UK please click here.
