Regulation 3 Amendment of Part I of the Medicines Fees Regulations

for the definition of “the 2001 Directive” substitute the following definition—

• ““the 2001 Directive” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use^f1, as amended by—

  1. (a)

     Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components^f2,

  2. (b)

     Commission Directive 2003/63/EC amending Directive 2001/83/EC^f3,

  3. (c)

     Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC^f4,

  4. (d)

     Directive 2004/27/EC of the European Parliament and of the Council also amending Directive 2001/83/EC^f5, and

  5. (e)

     Regulation (EC) No. 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004^f6;”;

after the definition of “EEA State” insert the following definition—

• ““exempt imported product” means a medicinal product, as defined in Article 1(2) of the 2001 Directive, to which paragraph 1 of Schedule 1 to the 1994 Regulations^f7 applies, which was not manufactured in the United Kingdom and in relation to which no marketing authorization has been granted;”; and

after the definition of “relevant fee period” substitute the following definition—

• ““special import notice” means a written notice given to the licensing authority in accordance with paragraph 7(2) of Schedule 2 to, or paragraph 3(2) of Schedule 4 to, the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005^f8;”.