Part II Licences and Certificates Relating to Medicinal Products
C1Applications for, and grant and renewal of, licences
18 Application for licence. C2
1
Any application for the grant of a licence under this Part of this Act shall be made to the licensing authority and shall be made in such form and manner, and shall contain, or be accompanied by, such information, documents, samples and other material, as may be prescribed.
2
Any such application shall indicate the descriptions of medicinal products in respect of which the licence is required, either by specifying the descriptions of medicinal products in question or by way of an appropriate general classification.
F13
Where documents that constitute a dossier for the purposes of Article 9 of the Second Council Directive M175/319/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 M281/851/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.
Definitions in ss. 18-22 applied (N.I.) (1.4.1992) by S.I. 1991/194 (N.I. 1), art. 7(2), Sch. 2 para. 5(4); S.R. 1991/131, art. 2(e), Sch. Pt.III