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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.
Registration is a simple and easy process.
No, the clinical trial supply chain sits outside the scope of the Delegated Regulation.
‘Product Not Found’ alerts amount to more than 30% of the total alerts generated when scanning medicines under FMD. Often, this is due to packs which are not part of FMD or are from batches generated prior to FMD coming into effect.
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)*.
Please check which Location(s) are registered with the relevant professional or sectoral body (such as GPhC, CQC, NIS). 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.
MHRA have confirmed with the UK Foreign Office that the Crown Dependencies of Jersey and Guernsey (including the other Channel Islands) and the Isle of Man are included within the FMD implementation. Gibraltar and all other British Overseas Territories e. g.
No. Please contact GS1 directly.
Each Location must be identifiable within the UK MVS. Bulk Registrations can contain one or more Locations from one or more legal entities.
The UK MVS Certificate is only available for download for 60 days. Please store a local copy with your Password.
SecurMed UK’s Blueprint System provider, Arvato Systems, employ a Baseline Testing process where software suppliers must test and verify their own solutions. A package of supporting documentation is available on the NMVS Software Supplier Portal.
If you have successfully logged onto the UK MVS but are having a problem logging onto your FMD software, please contact your Software Supplier.
Bulk Registration is for one or more Locations from one or more legal entities.
The initial Software (TAN) Code and Password are only valid for 60 days.
For more information, please visit the NHS Digital FMD Toolkit for Secondary Care. The NHS Special Pharmacy Service website is also a useful resource for Hospital Pharmacists.