http://www.legislation.gov.uk/eur/2016/793/article/3Regulation (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)Regulation (EU) 2016/793 of the European Parliament and of the CouncilRegulation (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)King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0793texttext/xmlen2024-10-01Expert Participation2023-05-03
Article 3

The tiered price referred to in Article 4(2)(b) shall, at the option of the applicant, be either:

(a)

no higher than the percentage set out in Annex III of the weighted average ex factory price charged by a manufacturer in markets of the Organisation for Economic Cooperation and Development (OECD) for the same product at the time of application; or

(b)

a manufacturer's direct production costs, with the addition of the maximum percentage which is set out in Annex III.