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Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems article 19 CELEX: 32006R0816 Review
Three years after the entry into force of this Regulation, and every three years thereafter, the Commission shall present a report to the European Parliament, the Council, and the European Economic and Social Committee on the operation of this Regulation including any appropriate plans for amendments. The report shall cover, in particular: (a) the application of Article 10(9) on determining the remuneration of the rights-holder; (b) the application of the simplified and accelerated procedure referred to in Article 16(4); (c) the sufficiency of the requirements under Article 10(5) to prevent trade diversion, and
(d) the contribution this Regulation has made to the implementation of the system established by the Decision. |