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When a substance is used in a medicinal product within the scope of either:
- The Regulation on Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency ((EC) No 726/2004); or
- The Directive on the Community code relating to veterinary medicinal Products (2001/82/EC); or
- The Directive on the Community code for medicinal products for human use (2001/83/EC); the substance does not have to be registered under REACH for that use.
The exemption does not distinguish between active or non-active ingredients as it applies to any substance ‘used in medicinal products'. Excipients used in medicinal products are therefore also exempted from registration.
Amounts of the same substance used for other uses than pharmaceuticals are not exempted. Only the amounts of the substance used in medicinal products are exempted from the registration obligation.
For further information, see chapter 18.104.22.168 of the Guidance on registration: