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


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/ukdsi/2021/9780348224740/regulation/41 (the official version)
Page: https://openlegislation.uk/draft-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.