# The Medicines (Products for Human Use) (Fees) Regulations 2016, Paragraph 4: Extension application


An extension application is an application—
(a) for an extension of a marketing authorisation—
(i) in the case of a UKMA(NI) or UKMA(UK), within the meaning of Article 2(4) of Commission Regulation (EC) No 1234/2008; or
(ii) in the case of a UKMA(GB), within the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations; 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/uksi/2016/190/schedule/2/paragraph/4 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.