Paragraph 2

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)

Accordingly any right conferred or obligation imposed by these Regulations shall be conferred or imposed on the holder of such a product licence, except that the provisions of regulation 7(6) (which requires the holder of a marketing authorization to be established in the Community) and the provisions of Schedule 5 (labels) shall not apply.