# The Medicines (Products for Human Use) (Fees) Regulations 2012, Paragraph 4: Extension application


An extension application is an application—
(a) for an extension of a marketing authorization within the meaning of Article 2(4) of EC Regulation No. 1234/2008; and
(b) which includes the result of pre-clinical tests or clinical trials as specified in Article 8(3)(i) of the 2001 Directive.

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Source: https://www.legislation.gov.uk/nisr/2012/134/schedule/2/paragraph/4 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.