The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020
| Jurisdiction | UK Non-devolved |
| Citation | SI 2020/1354 |
| Year | 2020 |
2020 No. 1354
Exiting The European Union
International Development
Medicines
Trade
The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020
Made 25th November 2020
Coming into force in accordance with regulation 1
The Secretary of State makes these Regulations in exercise of the powers conferred by section 8(1) of, and paragraph 21 of Schedule 7 to, the European Union (Withdrawal) Act 20181.
In accordance with paragraph 1(1) of Schedule 7 to that Act, a draft of this instrument was laid before and approved by a resolution of each House of Parliament.
PART 1
Introduction
Citation and commencement
1. These Regulations may be cited as the Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 and come into force on IP completion day.
PART 2
Amendments to retained direct EU legislation: Great Britain
Amendment of Regulation (EU) 2016/793 of the European Parliament and of the Council to avoid trade diversion into the European Union of certain key medicines
2.—(1) Regulation (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, as it applies in Great Britain on and after IP completion day, is amended as follows.
(2) In Article 1 in paragraph 2—
(a)
(a) in point (a), for “Commission”, substitute “Secretary of State”;
(b)
(b) after point (c), insert—
“(d)
“(d) ‘customs tariff’ is the system provided for in regulations made under section 8 of the Taxation (Cross-border Trade) Act 20182.”.
(3) In Article 2—
(a)
(a) in paragraph 1—
(i) for “the Union”, substitute “Great Britain”;
(ii) for “re-export”, substitute “export”;
(iii) for “placing under suspensive procedures or placing in a free zone or free warehouse”, substitute “or a special Customs procedure”;
(b)
(b) in paragraph 2—
(i) in points (a) and (b), for “re-export”, substitute “export of the tiered-priced products”;
(ii) in point (b), for “customs warehouse procedure or in a free zone or free warehouse”, substitute “storage procedure”;
(c)
(c) after paragraph 2, insert—
“3. In this Article—
(a) ‘special Customs procedure’ has the meaning given by section 3(4) of the Taxation (Cross-border Trade) Act 2018;
(b) ‘storage procedure’ has the meaning given by paragraph 2(1) of Schedule 2 to the Taxation (Cross-border Trade) Act 2018.”.
(4) In Article 4—
(a)
(a) in paragraph 1—
(i) for “Commission”, substitute “Secretary of State”;
(ii) at the end insert—
“Applications must be sent to the Department for International Trade, 3 Whitehall Place, London SW1A 2AW.”;
(b)
(b) in paragraph 2—
(i) for “Commission”, in each place where it occurs, substitute “Secretary of State”;
(ii) for point (d), substitute—
“(d)
“(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”;
(iii) in point (e), for “the Union”, substitute “Great Britain”;
(c)
(c) For paragraph 3 substitute—
“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.”;
(d)
(d) after paragraph 3, insert—
“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.”;
(e)
(e) in paragraphs 4 and 5, for “Commission”, substitute “Secretary of State”;
(f)
(f) omit paragraph 7;
(g)
(g) for paragraph 8, substitute—
“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.”.
(5) For Article 5, substitute—
“Article 5. (1) The Secretary of State must from time to time—
(a)
(a) carry out a review of this Regulation;
(b)
(b) set out the conclusions of the review in a report; and
(c)
(c) publish the report.
(2) The report must in particular—
(a)
(a) set out the use of the powers to make regulations at Article 4(3A), Article 4(8), Article 7 and Article 8;
(b)
(b) set out any other matters the Secretary of State considers relevant in respect of the powers referred to at paragraph 2(a).
(3) The first report must be published before the end of the period of five years beginning with the date on which the Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 come into force.”.
(6) Omit Article 6.
(7) For Article 7, substitute—
“Article 7. (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...
To continue reading
Request your trial