# The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1977, Paragraph 11


(1) Notwithstanding the provisions of paragraph 10 above, where the medicinal product is—
(a) required in an emergency and the licence holder has no filled containers in stock,
(b) so unstable that the delay occasioned by the completion of the tests for sterility on filled containers would render its sale, supply or exportation in active form impossible, or
(c) declared by the relevant product licence to be a product to which this paragraph applies,
and, in the case of sub-paragraphs (a) and (b) above, the licensing authority has directed that the provisions of this paragraph shall apply to the medicinal product, the medicinal product may be regarded as having satisfied the tests for sterility if and so long as the conditions specified in the following sub-paragraph are satisfied.
(2) The conditions referred to in the preceding sub-paragraph are—
(i) in a case to which sub-paragraph (1)(a) of this paragraph applies, the medicinal product is not sold, supplied or exported unless, before it is filled into containers, the following amounts of the medicinal product are tested for sterility in accordance with the foregoing provisions of this Part of this Schedule—
(a) where the medicinal product is in liquid form, not less than 10 millilitres if the contents of the batch are over 10 litres, not less than 0.1 per cent of the batch if the contents of the batch are between 1 and 10 litres and not less than 1 millilitre if the contents of the batch are less than 1 litre,
(b) where the medicinal product is in solid form, 1 gramme if the weight of the batch is over 1 kilogramme, 0.1 per cent of the contents of the batch if the weight of the batch is between 1 kilogramme and 100 grammes and not less than 100 milligrammes if the weight of the batch is less than 100 grammes;
(ii) in a case to which sub-paragraphs (1)(b) or (1)(c) of this paragraph applies, the medicinal product is not sold, supplied or exported before a sample is taken and after the sale, supply or exportation the sample is tested in accordance with the foregoing provisions of this Part of this Schedule;
(iii) if at any examination made during the testing of a sample taken in accordance with the foregoing provisions of this paragraph any growth of micro-organisms is found, the licensing authority and any person to whom the medicinal product was sold, supplied or exported shall be notified forthwith.

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Source: https://www.legislation.gov.uk/uksi/1977/675/schedule/5/paragraph/11 (the official version)
Page: https://openlegislation.uk/medicines-standard-provisions-for-licences-and-certificates-amendment-regulations-1977/schedule-5/paragraph-11
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.