Data Matrix standard is Higher than ECC200, ISO/IEC 16022:2006 is presumed to conform:
The United Kingdom Transition Period ended on 31st December 2020 and the UK became a third country in relation to the EU.
You can find the Delegated Regulation here.
Please consult the UK government website.
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.
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.
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.