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.
No. Please contact GS1 directly.
The use of the term “provide for” in Article 37(d) of Commission Delegated Regulation (EU) 2016/161 means that an NMVO has to ensure that the National Competent Authorities (NCA), the EMA and the Commission are informed.
You can find the Delegated Regulation here.
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.
For those organisations who do not have an IT software provider, or who seek to find companies providing solutions, SecurMed has published the following list of providers.
What is the FMD?
Since 9th February 2019, the Falsified Medicines Directive (FMD) and associated Delegated Regulation (DR) have imposed new regulatory obligations on all organisations that manufacture and/or dispense prescription-only medicines (POMs)*.