# The Medicines (Products for Human Use-Fees) Regulations 2008, Paragraph 29: Interpretation


In this Part—
(a) “clinical particulars”, in relation to a medicinal product, means the clinical particulars contained in the Summary of Product Characteristics for that product as specified in paragraph 4 of Article 11 of the 2001 Directive;
(b) the “BROMI labels and leaflets self-certification guidance” means the document entitled “Guidance on Changes to Labelling and Patient Information Leaflets For Self – Certification” published by the licensing authority on its website on 28th January 2008.

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Source: https://www.legislation.gov.uk/uksi/2008/552/schedule/1/paragraph/29 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-29
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.