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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 2 CELEX: 32006R0816 Definitions
For the purposes of this Regulation, the following definitions shall apply: (1) ‘pharmaceutical product’ means any product of the pharmaceutical sector, including medicinal products as defined in Article 1(2) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use , active ingredients and diagnostic kits ex vivo; (2) ‘rights-holder’ means the holder of any patent or supplementary protection certificate in relation to which a compulsory licence has been applied for under this Regulation; (3) ‘importing country’ means the country to which the pharmaceutical product is to be exported; (4) ‘competent authority’ for the purposes of Articles 1 to 11, 16 and 17 means any national authority having competence to grant compulsory licences under this Regulation in a given Member State. |