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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.
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.
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