# The Human Medicines Regulations 2012, Paragraph 41A: Transitional provision in relation to global marketing authorisations under the 2001 Directive


Where a relevant medicinal product is subject to a global marketing authorisation as described in Article 6 of the 2001 Directive before IP completion day, a paediatric investigation plan does not need to be carried out in relation to that product.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/33A/paragraph/41A (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-33A/paragraph-41A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.