Regulation (EU) 2016/793 of the European Parliament and of the CouncilDangos y teitl llawn

Article 4 U.K.

1. In order for products to benefit from this Regulation, manufacturers or exporters of pharmaceutical products shall submit applications to the [F1 Secretary of State]. [F2 Applications must be sent to [F3 the Department for Business and Trade, Old Admiralty Building, Admiralty Place, London SW1A 2DY].]

2. Any application addressed to the [F4 Secretary of State] shall contain the following information:

(a) the product name and active ingredient of the tiered-priced product and sufficient information to verify which disease it prevents, diagnoses or treats;

(b) the price offered in relation to either of the optional price calculations set out in Article 3 in sufficient detail to enable verification. Instead of submitting such detailed information, the applicant may submit a certificate, issued by an independent auditor, stating that the price has been verified and corresponds to one of the criteria set out in Annex III. The independent auditor shall be appointed in agreement between the manufacturer and the [F4 Secretary of State]. Any information submitted by the applicant to the auditor shall remain confidential;

(c) the country or countries of destination to which the applicant intends to sell the product concerned;

[F5 (d) the goods classification code for the goods based on the equivalent goods classification code that is in the customs tariff, as it applies at the time of the application, to identify unambiguously the goods concerned; and]

(e) any measures taken by the manufacturer or exporter to make the tiered-priced product easily distinguishable from identical products offered for sale within [F6 Great Britain].

[F7 3. The Secretary of State must determine whether a product, which is the subject of an application under paragraph 2 or a notification under paragraph 6, fulfils the requirements of this Regulation to qualify as a tiered-priced product. The Secretary of State must inform the applicant of the decision before the end of the period of 15 days, beginning with the date on which the decision was made.]

[F8 3A. The Secretary of State must, from time to time, make regulations to amend Annex I to add any product to the list set out in that Annex if the Secretary of State determines, under paragraph 3, that that product fulfils the requirements of this Regulation to qualify as a tiered-priced product.]

4. If an application is not sufficiently detailed for a review as to substance, the [F9 Secretary of State] shall request the applicant in writing to submit such missing information. If the applicant does not complete the application within the time period set out in that written request, the application shall be null and void.

5. If the [F10 Secretary of State] finds that the application does not fulfil the criteria set out in this Regulation, the application shall be rejected and the applicant shall be informed within 15 days of the date of the decision. Nothing shall prevent the applicant from submitting a modified application for the same product.

6. Products destined to be donated to recipients in one of the countries listed in Annex II may be the subject of a notification to that effect for the purposes of approval and insertion in Annex I.

F11 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F12 8. The Secretary of State may by regulations amend Annexes II, III and IV to revise—

(a) the list of diseases,

(b) the countries of destination covered by this Regulation, or

(c) the formulae used to identify tiered-priced products,

if the Secretary of State considers that it is necessary to do so in light of the experience gained from the application of this Regulation or in order to respond to a health crisis.]

Textual Amendments

F1 Words in Art. 4(1) substituted (31.12.2020) by The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354), regs. 1, 2(4)(a)(i)

F2 Words in Art. 4(1) inserted (31.12.2020) by The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354), regs. 1, 2(4)(a)(ii)

F3 Words in Art. 4(1) substituted (3.5.2023) by The Secretaries of State for Energy Security and Net Zero, for Science, Innovation and Technology, for Business and Trade, and for Culture, Media and Sport and the Transfer of Functions (National Security and Investment Act 2021 etc) Order 2023 (S.I. 2023/424), art. 1(2), Sch. para. 80 (with art. 17)

F4 Words in Art. 4(2) substituted (31.12.2020) by The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354), regs. 1, 2(4)(b)(i)

F5 Art. 4(2)(d) substituted (31.12.2020) by The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354), regs. 1, 2(4)(b)(ii)

F6 Words in Art. 4(2)(e) substituted (31.12.2020) by The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354), regs. 1, 2(4)(b)(iii)

F7 Art. 4(3) substituted (31.12.2020) by The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354), regs. 1, 2(4)(c)

F8 Art. 4(3A) inserted (31.12.2020) by The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354), regs. 1, 2(4)(d)

F9 Words in Art. 4(4) substituted (31.12.2020) by The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354), regs. 1, 2(4)(e)

F10 Words in Art. 4(5) substituted (31.12.2020) by The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354), regs. 1, 2(4)(e)

F11 Art. 4(7) omitted (31.12.2020) by virtue of The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354), regs. 1, 2(4)(f)

F12 Art. 4(8) substituted (31.12.2020) by The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354), regs. 1, 2(4)(g)