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

8.  The manufacturer shall inform the holder of the relevant product licence of any material change since the date upon which such licence was granted in respect of—

(a) the facilities and equipment available at each of the premises of the manufacturer for carrying out any stage of the manufacturer or assembly of the medicinal products to which the relevant product licences relate, or

(b) the facilities and equipment available in each of the premises of the manufacturer for the storage of the medicinal products to which the relevant product licences relate on, and distribution of the products from or between, such premises, or

(c) any manufacturing operations, not being operations in relation to the medicinal products to which the relevant product licences relate, which are carried on by the manufacturer on or near any of the premises on which such medicinal products are manufactured or assembled and the substances or articles in respect of which such operations are carried on, or

(d) the arrangements for the identification and storage of materials and ingredients before and during manufacture of the medicinal products to which the relevant product licences relate and the arrangements for the storage of the medicinal products after they have been manufactured or assembled, or

(e) the arrangements for ensuring a satisfactory turnover of stocks of medicinal products to which the relevant product licences relate, or

(f) the arrangements for maintaining production records and records of analytical and other testing procedures applied in the course of manufacture or assembly of the medicinal products to which the relevant product licences relate, or

(g) the arrangements for keeping reference samples of materials used in the manufacture of any medicinal products to which the relevant product licences relate and reference samples of such medicinal products.