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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.

How will credentials be sent for Bulk Registrations?

Bulk Registration is for one or more Locations from one or more legal entities.

Does the master data (G101 Process) allow the software provider to differentiate between FMD and non-FMD products

The Master Data Download (G101) transaction allows positive confirmation that the product is in the system and is in scope of FMD.

Who can register with SecurMed UKNI MVS?

Registration is a simple and easy process.

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.

How do I change my initial password?

Please refer to the Quick Start Guide:

Quick Start Guide

Further information can be found in the Technical Bulletin:

Technical Bulletin: Certificate and Password Management Issues

Do veterinary Wholesalers need to comply with the FMD regulatory requirements?

Although veterinary medicines fall outside the scope of the Delegated Regulation, veterinary Wholesalers who handle human medicines to supply to veterinary surgeons need to register with SecurMed. Veterinarians and retailers of veterinary medicines were part of the MHRA consultation under Article 23.

One hospital has several ‘goods in’ addresses. Is this a Single or Bulk Registration?

Each Location must be identifiable within the UKNI MVS. Bulk Registrations can contain one or more Locations from one or more legal entities.

Is the Product Code (PC) taken from the Agency or can it 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).

Is aggregation data available in the NMVS/EMVS?

Aggregation data is not available in the NMVS/EMVS. Off-system solutions may be available dependent on the particular supply chain system. Further guidance is expected from the UK NCAs (DHSC/MHRA) who can be contacted at fmd. safetyfeatures@mhra. gov. uk.

Are there technical standards to which the 2D codes should conform?

Data Matrix standard is Higher than ECC200, ISO/IEC 16022:2006 is presumed to conform:

Printed Quality must be rated 1.

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

Northern Ireland does not require the text to appear in any particular order in the 2D matrix or on the pack. Changes to packs need to be submitted to the MHRA in the usual manner for approval.

I am a Manufacturer – where can I find more information?

More information is available from the British Generic Manufacturers Association (BGMA).

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

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

FAQs on Alerts Portal for MAHs

As an MAH I do not have a recent alert ID to submit. Would it be possible to register?You can register using an alert on one of your GTINs / products from the past six weeks. The alert can be any type.

Is it possible for Software Suppliers to register their clients without an agreement for the FMD service?

It is not recommended. It is necessary for the person registering to accept the terms and conditions of the EULA, which could not be justified without an agreement in place.              

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