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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 CELEX: 32016R0793 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. |