# The Medicines (Products for Human Use — Fees) Regulations 1995, Paragraph 5: Marketing authorizations


Paragraph 4 shall not apply where the first application for variation of the marketing authorization relates to a therapeutic area, in respect of which the applicant would be entitled (had he not already held a marketing authorization) to apply for a marketing authorization to which Section G of Part 4 of the Annex to Council Directive 75/318/EEC applies.

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Source: https://www.legislation.gov.uk/uksi/1995/1116/schedule/1/part/III/paragraph/5 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/schedule-1/part-III/paragraph-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.