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FMD Case Studies
NHS Digital have collected case studies to demonstrate how Community and Hospital Pharmacies have implemented the FMD.
Pan-European Public Procurement OnLine (PEPPOL) enables government organisations such as the NHS, and private companies, to exchange electronic trading documents over an interoperable, European-wide network. It offers a standardised network connection for electronic ordering, invoicing and shipping. For more information, please visit NHS Scan4Safety.
Visit the MHRA FMD guidance. To sign up to the MHRA’s FMD Safety Features Newsletter, please contact the MHRA.
Yes. The Department of Health and Social Care agreed in July 2016 that all GP Surgeries, Practices and Health Centres, including out-of-hours GP services, are considered healthcare institutions, and are therefore within the scope of FMD.
“Article 3 of the Delegated Regulation lists a number of definitions including a ‘healthcare institution’ as meaning ‘a hospital, in-or outpatient clinic or health centre’. The UK has classed General Practitioners (GPs) and Dispensing Doctors as health centres and therefore healthcare institutions.
There are two processes MAHs must complete to onboard for FMD:
1. Onboard to the European Medicines Verification Organisation(EMVO)
All MAHs must onboard to the EMVO to be able to upload pack information to the UK MVS.
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.
NHS Digital have published a Toolkit for Secondary care functions. The NHS publish information, including frequently asked questions about FMD on their Specialist Pharmacy website: www. sps. nhs. uk
Pharmacies and Wholesalers will be able to sell dispensing data generated by their PMR and Wholesaler systems in the normal way.
If stock is transferred within the same designated Wholesaler or to another designated Wholesaler, then there is no need for packs to be verified under FMD. Normal GDP rules apply.
The ‘mixed bulk transaction’ is a bulk of individual transactions, as opposed to a single transaction applied to a bulk of packs. It should only be used to enable cached individual transactions when connectivity has been interrupted.
Please refer to the European Pack Coding Guidelines at the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Please refer to the European Pack Coding Guidelines at the European Federation of Pharmaceutical Industries and Associations (EFPIA).
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 without an additional local UK MA.
Yes. Multi-market packs can be supplied to the UK, Ireland and Malta. The EMVS will know when multi-market packs are uploaded, which systems to send the pack data to, and will also manage the decommissioning activity between them.
No. Unless the WDA holder is also an MAH or a Parallel Distributor, there is no need to connect to the EMVS.
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