Article 2 Definitions

For the purposes of this Regulation, the following definitions shall apply:

1. (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^f1, active ingredients and diagnostic kits ex vivo;

2. (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. (3)

   ‘importing country’ means the country to which the pharmaceutical product is to be exported;

4. (4)

   F1“competent authority” for the purposes of Articles 1 to 11, 16 and 17 means the Comptroller-General of Patents, Designs and Trade Marks;

5. (5)

   F2“patent” means “a patent under the Patents Act 1977;

6. (6)

   “supplementary protection certificate” means a supplementary protection certificate issued under Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products