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 1.5 or better according to ISO/IEC 15415:2011
  • Coding of the Unique Identifier conforms to ISO/IEC 15418:2009
  • For multiple coding schemes, Unique Identifiers conform to  ISO/IEC 15434:2006
  • Coding of the Product code conforms to ISO/IEC 15459-3:2014 or ISO/IEC 15459-4:2014

https://barcode.tec-it.com/en/DataMatrix?data=This%20is%20a%202%20D%20Matrix%20Code

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EU Exit and UK MVS

The United Kingdom Transition Period ended on 31st December 2020 and the UK became a third country in relation to the EU.

Where can I find a copy of the Delegated Regulation?

You can find the Delegated Regulation here.

Which medicines are in scope of FMD?

For details of the scope of the regulation please check: FMD Delegated Regulation 2016_161

Where stakeholders are unclear on the legislation, for example whether types of medicine are in/out of scope, please contact DHSC/MHRA at fmd. safetyfeatures@mhra. gov. uk.

Will anti-tamper devices be allowed on OTCs and other out-of-scope products after February 2019?

The MHRA has confirmed that subject to the outcome of a public consultation anti-tamper devices may continue to be placed on out-of-scope products after 9th February 2019 if the relevant manufacturer considers that it is necessary to do so in the interests of patient safety.

My company has not yet submitted to the MHRA White List of products exempt from FMD charges. Can products still be added to the White List?

Yes. Article 46 of the Delegated Regulation (DR) notifies the commission of additional medicinal products that are at risk or not at risk of falsification. All submissions must be made by the MHRA. Please contact the MHRA for information on how to submit.