Art. 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)

http://www.legislation.gov.uk/eur/2016/793/article/7Regulation (EU) 2016/793 of the European Parliament and of the Council of 11 May 2016 to avoid trade diversion into the European Union of certain key medicines (codification)Regulation (EU) 2016/793 of the European Parliament and of the CouncilRegulation (EU) 2016/793 of the European Parliament and of the Council of 11 May 2016 to avoid trade diversion into the European Union of certain key medicines (codification)King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0793texttext/xmlen2024-10-01Expert Participation2023-05-03
Article 71.

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.