No, the clinical trial supply chain sits outside the scope of the Delegated Regulation. However, if a pack of medicines within the scope of the Delegated Regulation is to enter the clinical trial supply chain and intended to be used as an investigational medicinal product, it must be decommissioned before it leaves the ‘commercial’ supply chain and becomes part of the trial medication stock.
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.
Ready to log in to the UK MVS? Please follow the links to instructions below.
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.
MHRA have confirmed with the UK Foreign Office that the Crown Dependencies of Jersey and Guernsey (including the other Channel Islands) and the Isle of Man are included within the FMD implementation. Gibraltar and all other British Overseas Territories e. g.
You can find the Delegated Regulation here.