Registration is a simple and easy process. It is required of all organisations and companies that handle or dispense prescriptive medicine, including (but not limited to):
For more information, please visit our End User Registration Guidance page and, for full details, download our End User Registration Process Overview.
This depends upon the terms and conditions of both the Wholesaler and the manufacturer. However, in general, we expect the current returns process will remain valid as long as the stock has not been decommissioned and the anti-tamper device is still intact.
The Delegated Regulation allows for aggregation but does not stipulate the need for pack aggregation. The EMVS / NMVS system does not support aggregation.
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.
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