The Medicines (Manufacturer's Undertakings for Imported Products) Regulations 1977

7.  The manufacturer shall keep readily available for inspection by a person authorised by the licensing authority durable records of the details of manufacture and assembly of each batch of every medicinal product to which each relevant product licence relates and of the tests carried out thereon in such a form that the records will be easily identifiable from the number of the batch as shown on each container in which the medicinal product is exported from the country where it has been manufactured or assembled; the manufacturer shall permit the person authorised to take copies of or make extracts from such records. Such records shall not be destroyed for a period of five years from the date when the manufacture or assembly of the relevant batch of the medicinal product occurred.