Version Superseded: 01/10/2006
Point in time view as at 28/02/2002. This version of this provision has been superseded.
Medicines Act 1968, Section 18 is up to date with all changes known to be in force on or before 07 March 2025. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
(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.
[F1(3)Where documents that constitute a dossier for the purposes of [F2Article 28 of the 2001 Directive] 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 M181/851/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.]
Textual Amendments
F1S. 18(3) substituted by S.I. 1983/1724, art. 4
F2Words in s. 18(3) substituted (28.2.2002) by S.I. 2002/236, reg. 2(b)
Modifications etc. (not altering text)
C1Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)
C2S. 18 applied (with modifications)(11.3.1992) by S.I. 1992/605, reg. 2(1)(2), Sch.
C3Definitions 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
Marginal Citations
M1OJ No. L 317. 6.11.81, p. 1.
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