# The Medicines (Fees Relating to Medicinal Products for Human Use) Amendment Regulations 1990, Regulation 22: Amendment of Schedule 3 to the principal Regulations


In Schedule 3 to the principal Regulations (waiver, reduction or refund of fees)—
(a) in paragraphs 2(1) and 2(2)—
(i) after “clinical trial certificate” there shall be inserted in each case “or for a variation to or for a renewal of a product licence”; and
(ii) for “3(a) or 4” there shall be substituted in each case “3(a), 4, 6 or 10”;
(b) after paragraph 4 there shall be inserted the following paragraph—
“5 The fee payable in respect of each such application shall be waived where—
(a) a product licence (parallel import) relates to a medicinal product in respect of which a separate marketing authorisation has been granted pursuant to the provisions of Council Directive 65/65/EEC in more than one Member State of the European Economic Community; and
(b) those marketing authorisations are indicated on the product licence (parallel import) as having been validly granted in those Member States; and
(c) the holder of that licence applies for the grant of a separate product licence (parallel import) in respect of each marketing authorisation which has been granted and so indicated.”.

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Source: https://www.legislation.gov.uk/uksi/1990/210/regulation/22 (the official version)
Page: https://openlegislation.uk/medicines-fees-relating-to-medicinal-products-for-human-use-amendment-regulations-1990/regulation-22
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.