Regulation (EC) No 816/2006

means the country to which the pharmaceutical product is to be exported;

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;

means the holder of any patent or supplementary protection certificate in relation to which a compulsory licence has been applied for under this Regulation;