# The Medical Devices (Northern Ireland Protocol) Regulations 2021, Regulation 41: Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016

Extent: E+W+S+N.I.

In the Medicines (Products for Human Use) (Fees) Regulations 2016, in regulation 10(5) (fee for advice for other purposes)—
(a) in paragraph (a), omit the “or” at the end; and
(b) in paragraph (b), at the end insert—
“; or
(c) obtaining an EU technical documentation assessment certificate or EU type-examination certificate of the type mentioned in section 5 of Annex IX and section 6 of Annex X of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, for a medical device incorporating that product or a product of that type.”

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Source: https://www.legislation.gov.uk/uksi/2021/905/regulation/41 (the official version)
Page: https://openlegislation.uk/medical-devices-northern-ireland-protocol-regulations-2021/regulation-41
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.