The Human Medicines (Amendment) Regulations 2019

Amendment of Schedule 24 (packaging information requirements)

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19.  In schedule 24, after paragraph 18 insert—

18A.  In the case of a medicinal product, other than a radiopharmaceutical, that is required by Article 54a of the 2001 Directive to bear safety features—

(a)a unique identifier which complies with the technical specifications set out in Chapter II of Commission Regulation 2016/161; and

(b)an anti-tampering device allowing verification of whether the packaging of the medicinal product has been tampered with..