# The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007, Regulation 3: Amendment of Part I of the Medicines Fees Regulations


In Part I of the Medicines Fees Regulation (general), in regulation 2 (interpretation)—
(a) 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, as amended by—
(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,
(b) Commission Directive 2003/63/EC amending Directive 2001/83/EC,
(c) Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC,
(d) Directive 2004/27/EC of the European Parliament and of the Council also amending Directive 2001/83/EC, and
(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;”;
(b) 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 applies, which was not manufactured in the United Kingdom and in relation to which no marketing authorization has been granted;”; and
(c) 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;”.

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Source: https://www.legislation.gov.uk/uksi/2007/610/regulation/3 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-and-medical-devices-fees-amendments-regulations-2007/regulation-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.