Paragraph 3

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

Sch. 6 para. 6 inserted by Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) 2010 Sch. 5 para. 4
Sch. 6 para. 4A inserted by Medicines (Marketing Authorisations and Miscellaneous Amendments) 2004 reg. 3(5)
Sch. 6 para. 4B inserted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(15)

(1)

Subject to sub-paragraph (2), any application for a product licence made before the date when these Regulations come into force but not then determined shall from that date be treated as an application for a marketing authorization, and the provisions of Schedule 2 shall apply accordingly.

(2)

Where any act has been done in relation to an application to which sub-paragraph (1) applies before the date when these Regulations come into force, nothing in that sub-paragraph requires that act to be repeated.