The safety features legislation sits within Article 54 of Council Directive 2001/83/EC.
The expectation therefore is that the 2D data matrix code and associated information, along with the anti-tampering device, must be applied to packaging components which meet the full labelling provisions in Article 54 of the Directive. This has been considered by the European Commission. See this link for further information.
The United Kingdom formally departed from the European Union on 31st January 2020, entering into a Transition Period lasting until 31st December 2020.
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.
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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.