# The Human Medicines Regulations 2012, Paragraph 10


The manufacturer must keep readily available for examination by a person authorised by the licensing authority samples of—
(a) each batch of finished products for at least a period of one year after their expiry date; and
(b) starting materials (other than solvents, gases or water) for at least a period of two years after release of the medicinal product of which those materials formed part,
except where the manufacturer is authorised by the licensing authority to destroy such samples earlier.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/9/paragraph/10 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-9/paragraph-10
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.