# 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), Article 3

Extent: E+W+S+N.I.

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.

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Source: https://www.legislation.gov.uk/eur/2016/793/article/3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2016-793/article-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.