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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.

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.

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.

Will the existing endpoints be available following the release of new endpoints?

Yes the existing endpoints will be available for a period, but you should develop your software at the earliest opportunity to the new version. Two versions of endpoints will be available at all times for backwards compatibility

Is multi-factor authentication required?

Yes. The use of multi-factor authentication is mandated by the Delegated Regulation and has been implemented in the UKNI MVS using an X509 Certificate.

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.

Who can see/use FMD information in a Pharmacy?

All Pharmacy staff involved in the dispensing process must be trained to follow FMD protocols on verification and/or decommissioning of products.

Will the endpoints be different for new versions of the interfaces?

Yes. New interfaces will have different endpoints, URLs may be subject to change but will remain on the same domain.

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

Which professional or sectoral registers are used to verify End User Locations?

SecurMed will provide individual credentials for each Location that is individually registered with the relevant body. This includes, (but is not limited to):

Pharmaceutical Society of Northern Ireland (PSNI)
MHRA (EudraGDMP)
NI Direct
For more information, please visit our End User Registration Guidance page.

Can a single location have multiple sets of credentials for different software solutions?

Yes. Duplicate credentials can be requested for the same location. SecurMed UK will validate the request.

Why is it essential to present a unique certificate as well as a unique username and password?

The use of multi-factor authentication is mandated by the Delegated Regulation.

How do I logon to the UKNI MVS for the first time?

For instructions on how to login to the UKNI MVS please see our quick start guides.

End User Registration Guidance - Updated

Registering with SecurMed for Access to the UKNI MVS

New Registration

Registration is required of all organisations and companies that handle or dispense prescription medicine, located in Northern Ireland, including (but not limited to):

Community Pharmacies
Hospital Pharmacies
GP Practices and Health Centres
Dispensing Doctors
Inpatient/Outpatient Clinics
Wholesalers
Multiple Functions
If your End User...

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