The Human Medicines Regulations 2012

[F1Exception to Article 25 of Commission Regulation 2016/161: health care institutionsU.K.
This section has no associated Explanatory Memorandum

255B.  Article 25(1) of Commission Regulation 2016/161 does not apply to a person authorised or entitled to supply medicinal products to the public [F2in Northern Ireland] if—

(a)the person authorised or entitled to supply medicinal products to the public is operating within a healthcare institution;

(b)the person authorised or entitled to supply medicinal products to the public obtains the medicinal product bearing the unique identifier through a wholesaler belonging to the same legal entity as the healthcare institution;

(c)the wholesaler that supplies the product to the healthcare institution has verified the safety features and decommissioned the unique identifier in accordance with the requirements laid down in Commission Regulation 2016/161;

(d)no sale of the medicinal product takes place between the wholesaler supplying the product and that healthcare institution; and

(e)the medicinal product is supplied to the public within that healthcare institution.]

Textual Amendments

F1Regs. 255A-255C inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 10 and regs. 255A-255C inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 10