# The Human Medicines Regulations 2012, Regulation 52: Application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etc


(1) This regulation applies where—
(a) an application is made for a UKMA(NI) by reference to another medicinal product as reference medicinal product; and
(b) one or more of the circumstances listed in Article 10(3) of the 2001 Directive applies in respect of the application.
(2) The applicant must provide information in accordance with Article 10(3) and (6) of the 2001 Directive.
(3) Paragraph (2) of regulation 51 applies to the application as it applies in relation to an application made in accordance with paragraph (1) of that regulation.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/52 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-52
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.