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No. The Delegated Regulation asserts that all parties that are connected to the repositories system, including manufacturers, wholesalers and pharmacies, have sole responsibility, ownership and access to any data that they generate.
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
The UK MVS Certificate is only available for download for 60 days. Please store a local copy with your Password.
FMD Case Studies
NHS Digital have collected case studies to demonstrate how Community and Hospital Pharmacies have implemented the FMD.
The initial Software (TAN) Code and Password are only valid for 60 days.
Each healthcare institution, pharmacy and wholesaler will need to purchase the equipment required to enable it to scan the unique identifier and undertake verification and decommissioning.
The UK 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.
Yes, this service is available. Useful resources:
Technical Bulletin: Certificate and Password Management Issues
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.
Your UK MVS Certificate must be installed locally to be able to reset your Password. You can only reset your Password using the UK MVS GUI.
Software suppliers may register for the SDK on the NMVS Software Supplier Portal.
Data Matrix standard is Higher than ECC200, ISO/IEC 16022:2006 is presumed to conform:
Printed Quality must be rated 1.
First, the pharmacist scans the medicine to decommission. This sends a message to the relevant NMVS of the new market. As this NMVS will not yet contain pack data, they will then query the number with the EMVO.
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 refer to the European Pack Coding Guidelines at the European Federation of Pharmaceutical Industries and Associations (EFPIA).
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