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FMD Case Studies

FMD Case Studies

NHS Digital have collected case studies to demonstrate how Community and Hospital Pharmacies have implemented the FMD.

What is Peppol?

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.

What is the MHRA FMD guidance?

Visit the MHRA FMD guidance. To sign up to the MHRA’s FMD Safety Features Newsletter, please contact the MHRA.

Are out-of-hours GP services within the scope of FMD?

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.

Dispensing Doctor and GPs have been informed by the DDA not to commit to any SSPs currently. Is this correct?

“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.

How do MAHs onboard to the FMD?

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.

I am a Hospital Pharmacist. Where can I find more information on FMD tailored to my sector?

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.

I operate within the Secondary Care sector; where can I find information about FMD specifically related to my sector?

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

Can Pharmacies and Wholesalers sell data to IMS?

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 from one nominated site to another, does the receiving site have to conduct full checks of the stock?

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.

Why is the ‘mixed bulk transaction’ not available to Wholesalers?

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.

Is it possible to convert EAN codes to GTIN?

Please refer to the European Pack Coding Guidelines at the European Federation of Pharmaceutical Industries and Associations (EFPIA).

Is the Product Code (PC) taken obligatory from the Agency or it can be taken from MAH internal database assigned by GS1?

Please refer to the European Pack Coding Guidelines at the European Federation of Pharmaceutical Industries and Associations (EFPIA).

Are EMA MAs the same as UK MHRA MAs?

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.

Does the EMVS and UK MVS cater for multi-market packs labelled and supplied to UK and Ireland?

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.

Does the WDA holder need to connect to the EMVS?

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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