# The Medicines (Products for Human Use-Fees) Regulations 2008, Paragraph 12: Interpretation


In this Part, a reference to—
(a) an application to the licensing authority for regulatory assistance means a reference to—
(i) a single application of that type, or
(ii) a set of applications of that type,
relating to a single United Kingdom marketing authorization; and
(b) an application for a marketing authorization in a concerned member State means a reference to—
(i) a single application of that type, or
(ii) a set of applications of that type in a number of concerned member States,
relating to a single United Kingdom marketing authorization.

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Source: https://www.legislation.gov.uk/uksi/2008/552/schedule/1/paragraph/12 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-12
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.