# The Human Medicines Regulations 2012, Regulation 65C: Variation of a UKMA(GB) or a UKMA(UK)(Category 1)


(1) A UKMA(GB) or a UKMA(UK)(Category 1) holder may apply to vary the authorisation.
(2) Any such application must be made in accordance with Schedule 10A.
(3) Schedule 10A does not apply to the transfer of a UKMA(GB) or a UKMA(UK)(Category 1) from one person to another.
(4) The licensing authority may publish guidance on the details of the various categories of variations, on the operation of the procedures laid down in Schedule 10A, and on the documentation to be submitted pursuant to those procedures.
(5) Any guidance referred to in paragraph (4) must be regularly reviewed and, when necessary, updated.
(6) Unless replaced by guidelines published under paragraph (4), the guidelines published by the Commission under Article 4 of Regulation (EC) No 1234/2008 which applied immediately before IP completion day, insofar only as they concern applications under Chapter IIa of that Regulation, continue to apply to—
(a) applications made under regulation 65C on or after IP completion day; or
(b) applications made before IP completion day to which regulation 65C and Schedule 10A apply by virtue of Parts 3 and 5 of Schedule 33A.
(7) The Ministers may by regulations amend Schedule 10A.

---
Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/65C (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-65C
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.