# The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992, Regulation 6: Amendment of Schedule 3 to the Principal Regulations


(1) Schedule 3 to the Principal Regulations (standard provisions for wholesale dealer’s licences including wholesale dealer’s licences of right), shall be amended in accordance with the following paragraph.
(2) After paragraph 8 there shall be inserted the following paragraph—
“8A Where the licence relates to imported proprietary products, the licence holder shall in relation to medicinal products for human use—
(a) ensure that all manufacture and assembly operations have been carried out by a duly authorised manufacturer or assembler and that the products have been manufactured and assembled in accordance with the principles and guidelines of good manufacturing practice;
(b) keep readily available for examination by a person authorised by the licensing authority samples of each batch of finished products for at least one year after their expiry date except where the licence holder is authorised by the licensing authority to destroy such samples earlier;
(c) implement a system for recording and reviewing complaints relating to the medicinal products to which his licence relates, together with an effective system for recalling promptly and at any time any such medicinal product in the distribution network; and
(d) record and investigate all such complaints and immediately inform the licensing authority of any defect which could result in a recall from sale, supply or exportation or in an abnormal restriction on such sale, supply or exportation.”.

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Source: https://www.legislation.gov.uk/uksi/1992/2846/regulation/6 (the official version)
Page: https://openlegislation.uk/medicines-standard-provisions-for-licences-and-certificates-amendment-regulations-1992/regulation-6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.