White List/Black List: The requirement for safety features applies to all prescription medicines placed on the market in Europe on or after 9th February 2019. Non-prescription medicines, unlicensed products and “specials” are excluded. Certain other products or product categories normally subject to prescription are excluded under Article 45(1) and are listed in Annex 1 of the DR, commonly referred to as the White List. Examples include medical gases, homoeopathic medicines, radionuclide kits and generators and some parenteral nutrition products. These are all normally subject to specialist handling and logistics and are not considered to be at high risk of falsification. The European Commission can also require under Article 45(2) that some non-prescription medicine packs to bear safety features, particularly if they have been subject to falsification. These are listed in Annex 2, commonly referred to as the Black List.
White List / Black List (FMD)
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