1.For products listed as tiered-priced products in Annex I, an applicant must submit information to the Secretary of State relating to any change which has occurred since the product was added to that list with respect to the information provided in the application specified in Article 4(2). Such information must be sent to the address provided at Article 4(1).
2.The Secretary of State must, from time to time and upon receipt of information under paragraph 1, review whether a product listed as a tiered-priced product in Annex I fulfils the requirements of this Regulation to qualify as a tiered-priced product.
3.The Secretary of State may make regulations to amend the list of tiered-priced products in Annex I to remove any product from that list if the Secretary of State determines, under paragraph 2, that that product no longer fulfils the requirements of this Regulation to qualify as a tiered-priced product.]
Textual Amendments
F1Art. 7 substituted (31.12.2020) by The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354), regs. 1, 2(7)