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Are you looking for some specific information? Please use the search options below. Either type key words into the 'How can we help you?' box, then choose a category and your user type, or simply use the Category / User type selections. Then press the search icon and a series of articles will be generated for you.

Is there any order that the text has to appear in the 2D Matrix or as ‘human readable’ on the pack?

The UKNI MVS does not require the text to appear in any particular order in the 2D matrix or on the pack.

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.

Can the 'Sub User ID' be used if each location has a separate User ID?

The 'Sub-user ID' is not applicable to the UKNI MVS.

What are the UKNI pack labelling requirements?

The Northern Ireland pack labelling requirements are: – Product code in GTIN format – Batch Number – Expiry Date – Unique serialisation number – 2D matrix.

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.

I am a biopharmaceutical manufacturer operating within the research sector; where can I find more information about FMD?

The Association of the British Pharmaceutical Industry (ABPI) is the trade association for the research-based pharmaceutical industry in the UK. Please visit their website. www. abpi. org. uk. Alternatively you can contact the British Generic Manufacturers Association (BGMA): www. britishgenerics. co.

Will the Certificate renewal email be sent to the Requestor or the Location?

The renewal email is sent automatically from the UKNI MVS to the MVS System Contact email address, provided at the time of registration, unless this has since been changed.

Do we need to implement bulk transactions in our Wholesaler software?

We expect Wholesaler solutions to include bulk transactions and the baseline testing process includes single and bulk transactions. If you feel that your use case does not warrant bulk transactions contact tech@securmed. org. uk to confirm.

Where can Doctors and GPs get further information about the FMD?

For more information, please visit the NHS Digital GP FMD Toolkit

Further information can be found on the NI GOV UK Department of Health Falsified Medicines Directive

The BMA, DDA and MHRA websites also have useful resources for Doctors and GPs.

Who will have to decommission homecare supplied drugs?

Where medicines are dispensed for a named patient as a homecare supplied drug, the medicine will be decommissioned by the homecare service provider ‘at the time of supply’ to that patient.

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 a legal entity with multiple Locations require a unique Username, Password and User Certificate per Location?

Each Location needs to be registered uniquely. Please check which Locations are registered with the relevant professional or sectoral body (such as PSNI). SecurMed will provide individual credentials for each Location that is individually registered with the relevant body.

Do Wholesalers performing QP batch release need to register with SecurMed?

Wholesalers are not allowed to perform QP batch release. All Wholesalers need to register with SecurMed to verify and decommission medicines as required under the Delegated Regulation. Only MAHs and holders of parallel import authorisations will be expected to pay fees to SecurMed.

Two Year Certificate Expiry

SituationUKNI Medicines Verification users may receive system generated emails advising their certificate will expire soon and requesting them to download a new certificate. Users will be unable to access the UKNI MVS if the existing certificate expires.

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.