# The Human Medicines Regulations 2012, Paragraph 10: Measures to close the procedures specified in paragraphs 6 to 8


Where reference is made to this paragraph, the licensing authority must take the following measures—
(a) inform the holder as to whether the variation is accepted or rejected;
(b) where the variation is rejected, inform the holder of the grounds for the rejection; and
(c) where necessary, amend the decision granting the UK marketing authorisation in accordance with the accepted variation within the time limit laid down in paragraph 15.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/10A/paragraph/10 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-10A/paragraph-10
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.