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Bulk Registration is for one or more Locations from one or more legal entities.
The Master Data Download (G101) transaction allows positive confirmation that the product is in the system and is in scope of FMD.
Registration is a simple and easy process.
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.
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
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.
Please consult the UK government website.
Each Location must be identifiable within the UKNI MVS. Bulk Registrations can contain one or more Locations from one or more legal entities.
Please refer to the European Pack Coding Guidelines at the European Federation of Pharmaceutical Industries and Associations (EFPIA).
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.
Data Matrix standard is Higher than ECC200, ISO/IEC 16022:2006 is presumed to conform:
Printed Quality must be rated 1.
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.
More information is available from the British Generic Manufacturers Association (BGMA).
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.
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.
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.