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National Competent Authorities

GOV. UK guidance on:

FMD Safety Features
FMD Errors or Alerts
To register for the FMD Safety Features newsletter, or for any queries about the FMD, please contact the Medicines and Healthcare products Regulatory Agency (MHRA).

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.

What happens to medicines that are intended for one market when they are then sold to a new market under an Art.126a/Exceptional MA?

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.

Will manufacturers and wholesalers be able to see data on products I have dispensed?

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.

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.

Where can I find the EU Commission Q&A on FMD?

The EU Commission Q&A on FMD can be found on the European Commission site.

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

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

Does the WDA holder need to connect to the EMVS?

No. Unless the WDA holder is also an MAH or a Parallel Distributor, there is no need to connect to the EMVS.

Does the UK GTIN product code require 13 or 14 characters?

GTIN product codes require 14 characters. For more information, please refer to the EMVS Pack Coding Guidelines.

How should serialisation be implemented for ‘titration’ packs, only to outer box or it should also be applied to the inner boxes too?

Serialisation should be applied to the pack which is the unit of sale and to which the labelling provisions in Article 54 of Council Directive 2001/83/EC apply.

What is the EMVO and how can I contact them?

The European Medicines Verfication Organsiation (EMVO) is a Belgian non-profit organisation representing stakeholders united in securing the legal supply chain from falsified medicines. For more details go to their website.

How many manufacturers are now supplying codes to SecurMed UK?

Product, Batch and Pack data started being transmitted to the UKNI MVS when SecurMed UK was connected to the European Hub (EMVS) on 31st October 2018. Data for millions of packs is already downloaded.

Do MAHs interact with the UKNI national hub for downloading pack data?

No. The MAH should upload the pack data to the EMVS, which will determine which packs need to be sent to the UKNI national hub. The EMVS is the master system of record for MAH pack data.

Where the MAH or Manufacturer has a separate WDA, how will packs be decommissioned?

Each Manufacturer who also holds a WDA needs to review their business operations and wholesaling processes and, where applicable, connect to SecurMed for medicines verification and decommissioning as a Wholesaler.  

It is up to each MAH or Manufacturer to perform this assessment.

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