Track & Trace: Are We Talking Mars Flight When We Can't Get to the Moon?

Hedley Rees, Managing Consultant, PharmaFlow
Wednesday, October 30, 2013 11:00 EDT

This interview appears in CPhI's Annual Report, Part 2, which was formally released last week at CPhI 2013 in Frankfurt.

CPhI: What impact do you expect the EU Falsified Medicines Act and US FDASIA to have on the industry?

HR: The EU was first to legislate on adulteration and counterfeit issues in 2011. The subsequent consultation on the associated GDP/GMP tightening was fraught with issues raised by supply chain actors that would be impacted.

For example, one area of confusion was the requirement to apply for a wholesale dealer license for any company storing materials for more than 24 hours, and in the case of cold chain, licenses would be required if they were handled at all. The ensuing uproar (especially from the third party logistics providers) resulting in that requirement being abandoned, as happened to a number of the initial proposals.

Even now, there are still practical issues with the new regulations, such as the requirement for materials sourced from third countries (outside EU) to assure EU GMP equivalence. That is still a moving feast, as is the requirement to assure transparency of materials right the way up to original source -- how many Pharma companies can claim they have that?

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