Definitions
Article 2
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 ( 4 ) , 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.