# The Human Medicines Regulations 2012, Regulation 65A: Validity of parallel import licence


(1) Unless paragraph (2) applies, a parallel import licence remains in force for a period of 5 years from the date it is granted or renewed.
(2) A parallel import licence will cease to be valid if—
(a) the information supplied in the application for a licence no longer matches the information currently approved for the reference product by the licensing authority;
(b) details about the product imported under the licence are not consistent with the details supplied in the application; or
(c) the patient information leaflet supplied with the product is not consistent with latest version of the leaflet that is required to be issued with the product by the licensing authority, and
an application to vary the licence to update any details in relation to sub-paragraph (a) to (c) has not been granted by the licensing authority because the condition in regulation 68(11) has not been met.

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