Paragraph 2 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)

(1)

Subject to paragraphs 3 and 4 below, this Schedule applies to any application for the grant or renewal of a marketing authorization for a relevant medicinal product where, throughout the period beginning with the date on which the application is made and ending with the date on which the licensing authority give a decision on the application, either—

(a)

there is no other marketing authorization in force in respect of the product anywhere in the Community; or

(b)

any day in that period falls within the period beginning with 1st January 1995, and ending with 31st December 1997.

(2)

Subject to paragraphs 3 and 4 below, this Schedule also applies to every proposal to revoke, vary or suspend an authorization for a relevant medicinal product where there is no such other authorization in force at the time of the proposal.