Paragraph 1

Where the manufacture, assembly, sale or supply of medicinal products of a particular class or description will be, or is likely to be, interrupted for a period and in consequence thereof the health of the community will be, or is likely to be, put at risk, any fees otherwise payable under these Regulations in connection with an application for the grant of a product licence or a manufacturer’s licence relating to a medicinal product falling within that class or description shall be waived during that period or, if the period will, or is likely to, exceed 3 months, during the first 3 months of that period.