# The Human Medicines Regulations 2012, Paragraph 7: Notification procedure for minor variations of type IB


(1) The holder must for minor variations of type IB submit to the licensing authority a notification containing the elements listed in paragraph 9, and if the notification contains those elements, the licensing authority must acknowledge receipt of a valid notification.
(2) If within 30 days beginning with the date on which the licensing authority acknowledges receipt of a valid notification, the licensing authority has not sent the holder an unfavourable opinion, the notification is deemed to be accepted by the licensing authority.
(3) Where the notification is accepted by the licensing authority, the measures provided for in paragraph 10 are to be taken.
(4) Where the licensing authority is of the opinion that the notification cannot be accepted, it must inform the holder, stating the grounds on which its unfavourable opinion is based.
(5) Within 30 days beginning with the date on which the holder receives the unfavourable opinion, the holder may submit to the licensing authority an amended notification in order to take due account of the grounds laid down in that opinion.
(6) If the holder does not amend the notification in accordance with sub-paragraph (5), the notification is deemed to be rejected.
(7) Where an amended notification has been submitted, the licensing authority must assess it within 30 days beginning with the date on which it receives the amended notification, and the measures provided for in paragraph 10 are to be taken.
(8) This paragraph does not apply where—
(a) a type IB variation request is submitted in a grouping that includes a variation type II and does not contain an extension: in such a case, the prior approval procedure in paragraph 8 applies; or
(b) a type IB variation request is submitted in a grouping that includes an extension: in such a case, the procedure in paragraph 11 applies.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/10A/paragraph/7 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-10A/paragraph-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.