the criteria for establishing what is a tiered-priced product;

the conditions under which the customs authorities shall take action;

the measures which shall be taken by the competent authorities in the Member States.

‘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;

‘countries of destination’ means the countries listed in Annex II;

‘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.

‘customs tariff’ is the system provided for in regulations made under section 8 of the Taxation (Cross-border Trade) Act 2018.