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Regulation (EU) 2016/793 of the European Parliament and of the CouncilShow full title
Regulation (EU) 2016/793 of the European Parliament and of the Council of 11 May 2016 to avoid trade diversion into the European Union of certain key medicines (codification)
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Article 1U.K.
1.This Regulation lays down:
(a)the criteria for establishing what is a tiered-priced product;
(b)the conditions under which the customs authorities shall take action;
(c)the measures which shall be taken by the competent authorities in the Member States.
2.For the purposes of this Regulation:
(a)‘tiered-priced product’ means any pharmaceutical product which is used in the prevention, diagnosis or treatment of a disease, referred to in Annex IV, and which is priced in accordance with one of the optional price calculations set out in Article 3, verified by the [F1Secretary of State] or an independent auditor as provided for in Article 4 and entered in the list of tiered-priced products set out in Annex I;
(b)‘countries of destination’ means the countries listed in Annex II;
(c)‘competent authority’ means an authority designated by a Member State to determine whether goods suspended by the customs authorities in the respective Member State are tiered-priced products and to give instructions depending on the outcome of the review.
[F2(d)‘customs tariff’ is the system provided for in regulations made under section 8 of the Taxation (Cross-border Trade) Act 2018.]
Textual Amendments
F1Words in Art. 1(2)(a) substituted (31.12.2020) by The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354), regs. 1, 2(2)(a)
F2Art. 1(2)(d) inserted (31.12.2020) by The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354), regs. 1, 2(2)(b)
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