Closed consultation

Safety feature (Falsified Medicines Directive): ‘black’ and ‘white’ lists

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Original consultation

This consultation ran from to


MHRA seeks views on the listing of prescription medicines exempted from the safety feature and non-prescription medicines that must bear the safety feature (MLX387).


Consultation description

MHRA is consulting on the products that should have the necessary ‘safety features’ in accordance with European law.

Directive 2011/62/EU (the ‘Falsified Medicines Directive’) introduced obligatory ‘safety features’ to verify the authenticity of medicinal products. All prescription medicines will bear the safety features unless they are listed by the European Commission and all non-prescription medicines will not bear the safety features unless they are listed. The MHRA seeks views on products that should be listed.