Paragraph 4 Scope and application of the procedural provisions

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

sch 2 am (1.1.2010) by Medicines for Human Use (Marketing Authorisations Etc.) 2009 reg 2
Sch. 2 para. 1 words substituted by Medicines (Products for Human Use) (Amendments to Fees for Variations) 2009 reg. 9(3)
Sch. 2 para. 3 words substituted by Medicines (Marketing Authorisations and Miscellaneous Amendments) 2004 reg. 3(3)
Sch. 2 para. 2(a) substituted by Medicines (Advisory Bodies) 2005 Sch. 2 para. 1(2)
Sch. 2 para. 14(8)(a) word substituted by Medicines (Advisory Bodies) 2005 Sch. 2 para. 1(3)
Sch. 2 substituted by Medicines (Advisory Bodies) 2005 Sch. 2 para. 4
Sch. 2 para. 3 words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 8(g)(i)
Sch. 2 para. 4(a) words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 8(g)(ii)
Sch. 2 para. 4(b) words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 8(g)(iii)

This Schedule does not apply—

(a)

if the licensing authority make a decision in relation to the application in accordance with Article 7.2 of the 1965 Directive (suspension of detailed examination of an application under active examination in another Member State); or

(b)

the application or proposal relates to the renewal or variation of a marketing authorization which has been granted in accordance with the provisions of Chapter III of Council Directive 75/319 EEC or which has been granted by Member States in accordance with Article 4 of Council Directive 87/22/EEC before 1st January 1995; or

(c)

to the variation of an authorization on the application of holder.