Regulation 4 Amendment of section 18 of the Act

For subsection (3) of section 18 of the Act (applications for licences)^f1 there shall be substituted—

“(3)

Where documents that constitute a dossier for the purposes of Article 9 of the Second Council Directive 75/319/EEC of 20 May 1975 are forwarded to the licensing authority under and in accordance with the said Article, or documents are forwarded to that authority under and in accordance with Article 17 of Council Directive 81/851/EEC of 28 September 1981, such forwarding shall be deemed to be an application for the grant of a product licence under this Part of this Act.”