# The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003, Regulation 4: Amendment of the Product Licences Regulations 1993


In the Medicines (Applications for Grant of Product Licences—Products for Human Use) Regulations 1993 —
(a) in regulation 1 (citation, commencement and interpretation), in paragraph (2), in the definition of “the 2001 Directive”, after “human use” insert “ , as amended ”; and
(b) in Schedule 1 (information, documents etc. required in respect of applications)—
(i) in paragraph 17, for “Part 3, paragraph 1.1, second sub-paragraph of the Annex I to the 2001 Directive” substitute “ paragraph (9) of the Introduction and general principles of Annex I to the 2001 Directive ”, and
(ii) in paragraph 18, for “Part 4, paragraph B.2 of the Annex I to the 2001 Directive” substitute “ paragraph 5.2(a) of Part I of Annex I to the 2001 Directive ”.

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Source: https://www.legislation.gov.uk/uksi/2003/2321/regulation/4 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-fees-and-miscellaneous-amendments-regulations-2003/regulation-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.