I will be issuing a series of blog posts regarding the implementation of FMD: Safety Features and how it is progressing over the next few months. This is the first and looks at robustness of incoming checks.
The safety features element of the Falsified Medicines Directive (FMD) [EU Directive 2011/62/EU transposed into the Human Medicines Regulations (as amended) and Delegated Regulation 2016/161] came into force across the EU on 9 February 2019.
Since implementation, MHRA has been inspecting for the required new elements and we have seen some excellent examples of robust systems that have been brought in line with the FMD safety features requirements. We have also seen some systems that required improvement and examples of systems that failed to identify falsified stock as part of the pharmaceutical quality system requirements.
The definition of a falsified medicine is as follows:
[The Human Medicines Regulations (as amended by SI 2013;1855 Regulation 8 (a)(vi))]
“Falsified medicinal product” means any medicinal product with a false representation of:
(a) its identity, including its packaging and labelling, its name or its composition (other than any unintentional quality defect) as regards any of its ingredients including excipients and the strength of those ingredients;
(b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or
(c) its history, including the records and documents relating to the distribution channels used.
Checking your systems comply
As part of the new measures your systems should be able to identify decommissioned, stolen or recalled stock. This should include not just using the new FMD 2D barcode unique identifier (UI) scanning systems but also identifying stock from the two countries (Greece and Italy) that are yet to implement the 2D barcode UI system.
Where the 2D barcode UI is not yet in use, the MHRA are clear that it is still your responsibility to identify falsified, stolen or recalled stock received into your systems, including those that have already been decommissioned. Inspectors will be looking for this step as part of your incoming goods checks.
We have published specific guidance from Italian and Greek regulatory agencies on how to check incoming stock from these countries is compliant on our GOV.UK guidance page. Please visit this page to find out more about Safety Features.
If you have any questions with regards to this blog post, please contact FMD.GMPenquiries@mhra.gov.uk
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