<akomaNtoso xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xsi:schemaLocation="http://docs.oasis-open.org/legaldocml/ns/akn/3.0 http://docs.oasis-open.org/legaldocml/akn-core/v1.0/cos01/part2-specs/schemas/akomantoso30.xsd"><act name="eur"><meta><identification source="#"><FRBRWork><FRBRthis value="http://www.legislation.gov.uk/id/eur/2016/793"/><FRBRuri value="http://www.legislation.gov.uk/id/eur/2016/793"/><FRBRdate date="2016-05-11" name="adopted"/><FRBRauthor href=""/><FRBRcountry value="EU"/><FRBRnumber value="793"/><FRBRname value="Regulation (EU) 2016/793"/><FRBRprescriptive value="true"/></FRBRWork><FRBRExpression><FRBRthis value="http://www.legislation.gov.uk/eur/2016/793/2023-05-03"/><FRBRuri value="http://www.legislation.gov.uk/eur/2016/793/2023-05-03"/><FRBRdate date="2023-05-03" 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type="jurisdiction"/><restriction href="#body" refersTo="#period-from-2023-05-03" type="jurisdiction"/><restriction href="#article-2" refersTo="#period-from-2020-12-31" type="jurisdiction"/></restrictions><otherAnalysis source=""><uk:commentary href="#article-2" refersTo="#key-7b85e58ea6a8ae03b005ee601dcc65af"/><uk:commentary href="#article-2" refersTo="#key-fbc75ddb735b4e0c513f0bd9c7630c6d"/><uk:commentary href="#article-2" refersTo="#key-301a0dd095338c8825b06332b0310efe"/><uk:commentary href="#article-2" refersTo="#key-815974d3d93a12c0c548587255911617"/><uk:commentary href="#article-2" refersTo="#key-ef0ca1638e70044ed78d002ef5785238"/><uk:commentary href="#article-2" refersTo="#key-a90bb3b0e197b1ecc1172c61e1305ff5"/><uk:commentary href="#article-2" refersTo="#key-d11a64a4b80d166a2c303c6e39448cae"/></otherAnalysis></analysis><temporalData source="#"><temporalGroup eId="period-from-2020-12-31"><timeInterval start="#date-2020-12-31" refersTo="#"/></temporalGroup><temporalGroup eId="period-from-2023-05-03"><timeInterval start="#date-2023-05-03" refersTo="#"/></temporalGroup></temporalData><references source="#"><TLCEvent eId="adopted" href="" showAs="AdoptedDate"/><TLCLocation eId="extent-e+w+s+ni" href="/ontology/jurisdictions/uk.EnglandWalesScotlandNorthernIreland" showAs="E+W+S+N.I."/></references><notes source="#"><note ukl:Name="Commentary" ukl:Type="F" class="commentary F" eId="key-7b85e58ea6a8ae03b005ee601dcc65af" marker="F1"><p>Words in Art. 2(1) substituted (31.12.2020) by <ref eId="cj7dejmf5-00016" href="http://www.legislation.gov.uk/id/uksi/2020/1354">The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354)</ref>, <ref eId="cj7dejmf5-00017" class="subref" href="http://www.legislation.gov.uk/id/uksi/2020/1354/regulation/1">regs. 1</ref>, <ref eId="cj7dejmf5-00018" class="subref operative" href="http://www.legislation.gov.uk/id/uksi/2020/1354/regulation/2/3/a/i">2(3)(a)(i)</ref></p></note><note ukl:Name="Commentary" ukl:Type="F" class="commentary F" eId="key-fbc75ddb735b4e0c513f0bd9c7630c6d" marker="F2"><p>Word in Art. 2(1) substituted (31.12.2020) by <ref eId="cj7dejmf5-00025" href="http://www.legislation.gov.uk/id/uksi/2020/1354">The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354)</ref>, <ref eId="cj7dejmf5-00026" class="subref" href="http://www.legislation.gov.uk/id/uksi/2020/1354/regulation/1">regs. 1</ref>, <ref eId="cj7dejmf5-00027" class="subref operative" href="http://www.legislation.gov.uk/id/uksi/2020/1354/regulation/2/3/a/ii">2(3)(a)(ii)</ref></p></note><note ukl:Name="Commentary" ukl:Type="F" class="commentary F" eId="key-301a0dd095338c8825b06332b0310efe" marker="F3"><p>Words in Art. 2(1) substituted (31.12.2020) by <ref eId="cj7dejmf5-00034" href="http://www.legislation.gov.uk/id/uksi/2020/1354">The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354)</ref>, <ref eId="cj7dejmf5-00035" class="subref" href="http://www.legislation.gov.uk/id/uksi/2020/1354/regulation/1">regs. 1</ref>, <ref eId="cj7dejmf5-00036" class="subref operative" href="http://www.legislation.gov.uk/id/uksi/2020/1354/regulation/2/3/a/iii">2(3)(a)(iii)</ref></p></note><note ukl:Name="Commentary" ukl:Type="F" class="commentary F" eId="key-815974d3d93a12c0c548587255911617" marker="F4"><p>Words in Art. 2(2)(a) substituted (31.12.2020) by <ref eId="cj7dejmf5-00043" href="http://www.legislation.gov.uk/id/uksi/2020/1354">The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354)</ref>, <ref eId="cj7dejmf5-00044" class="subref" href="http://www.legislation.gov.uk/id/uksi/2020/1354/regulation/1">regs. 1</ref>, <ref eId="cj7dejmf5-00045" class="subref operative" href="http://www.legislation.gov.uk/id/uksi/2020/1354/regulation/2/3/b/i">2(3)(b)(i)</ref></p></note><note ukl:Name="Commentary" ukl:Type="F" class="commentary F" eId="key-ef0ca1638e70044ed78d002ef5785238" marker="F5"><p>Words in Art. 2(2)(b) substituted (31.12.2020) by <ref eId="cj7dejmf5-00061" href="http://www.legislation.gov.uk/id/uksi/2020/1354">The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354)</ref>, <ref eId="cj7dejmf5-00062" class="subref" href="http://www.legislation.gov.uk/id/uksi/2020/1354/regulation/1">regs. 1</ref>, <ref eId="cj7dejmf5-00063" class="subref operative" href="http://www.legislation.gov.uk/id/uksi/2020/1354/regulation/2/3/b/ii">2(3)(b)(ii)</ref></p></note><note ukl:Name="Commentary" ukl:Type="F" class="commentary F" eId="key-a90bb3b0e197b1ecc1172c61e1305ff5" marker="F6"><p>Words in Art. 2(2)(b) substituted (31.12.2020) by <ref eId="cj7dejmf5-00052" href="http://www.legislation.gov.uk/id/uksi/2020/1354">The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354)</ref>, <ref eId="cj7dejmf5-00053" class="subref" href="http://www.legislation.gov.uk/id/uksi/2020/1354/regulation/1">regs. 1</ref>, <ref eId="cj7dejmf5-00054" class="subref operative" href="http://www.legislation.gov.uk/id/uksi/2020/1354/regulation/2/3/b/i">2(3)(b)(i)</ref></p></note><note ukl:Name="Commentary" ukl:Type="F" class="commentary F" eId="key-d11a64a4b80d166a2c303c6e39448cae" marker="F7"><p>Art. 2(3) inserted (31.12.2020) by <ref eId="cj7dejmf5-00007" href="http://www.legislation.gov.uk/id/uksi/2020/1354">The Prevention of Trade Diversion (Key Medicines) (EU Exit) Regulations 2020 (S.I. 2020/1354)</ref>, <ref eId="cj7dejmf5-00008" class="subref" href="http://www.legislation.gov.uk/id/uksi/2020/1354/regulation/1">regs. 1</ref>, <ref eId="cj7dejmf5-00009" class="subref operative" href="http://www.legislation.gov.uk/id/uksi/2020/1354/regulation/2/3/c">2(3)(c)</ref></p></note></notes><proprietary xmlns:ukm="http://www.legislation.gov.uk/namespaces/metadata" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:dct="http://purl.org/dc/terms/" source="#"><dc:identifier>http://www.legislation.gov.uk/eur/2016/793/article/2</dc:identifier><dc:title>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 (codification)</dc:title><dct:alternative>Regulation (EU) 2016/793 of the European Parliament and of the Council</dct:alternative><dc:description>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 (codification)</dc:description><dc:publisher>King's Printer of Acts of Parliament</dc:publisher><dc:source>https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0793</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language><dc:modified>2024-10-01</dc:modified><dc:contributor>Expert Participation</dc:contributor><dct:valid>2023-05-03</dct:valid><ukm:EUMetadata><ukm:DocumentClassification><ukm:DocumentCategory Value="euretained"/><ukm:DocumentMainType Value="EuropeanUnionRegulation"/><ukm:DocumentStatus Value="revised"/></ukm:DocumentClassification><ukm:Year Value="2016"/><ukm:Number Value="793"/><ukm:EURLexIdentifiers xmlns:atom="http://www.w3.org/2005/Atom" xmlns="http://www.legislation.gov.uk/namespaces/legislation"><ukm:Cellar Value="8d8273dc-216c-11e6-86d0-01aa75ed71a1"/><ukm:OfficialJournal Value="JOL_2016_135_R_0003"/><ukm:CELEX Value="32016R0793"/><ukm:ELI Value="reg:2016:793:oj"/></ukm:EURLexIdentifiers><ukm:EnactmentDate Date="2016-05-11"/><ukm:EURLexModified Date="2017-02-01T20:01:19Z"/><ukm:EURLexExtracted Date="2018-04-23T17:10:14Z"/><ukm:XMLGenerated Date="2020-12-11T21:53:01Z"/><ukm:XMLImported Date="2020-12-12T06:50:23Z"/><ukm:Treaty Title="Treaty on the Functioning of the European Union (consolidated version 2012)" Code="TFEU_2012"/><ukm:CreatedBy Label="Council of the European Union" URI="http://publications.europa.eu/resource/authority/corporate-body/CONSIL"/><ukm:CreatedBy Label="European Parliament" URI="http://publications.europa.eu/resource/authority/corporate-body/EP"/><ukm:Subject Scheme="SubjectMatter" Label="Development cooperation" URI="http://publications.europa.eu/resource/authority/fd_070/CDEV"/><ukm:Subject Scheme="EuroVoc" Label="import (EU)" URI="http://eurovoc.europa.eu/3191"/><ukm:Subject Scheme="EuroVoc" Label="import restriction" URI="http://eurovoc.europa.eu/3579"/><ukm:Subject Scheme="EuroVoc" Label="customs inspection" URI="http://eurovoc.europa.eu/4079"/><ukm:Subject Scheme="EuroVoc" Label="third country" URI="http://eurovoc.europa.eu/2300"/><ukm:Subject Scheme="EuroVoc" Label="export (EU)" URI="http://eurovoc.europa.eu/3190"/><ukm:Subject Scheme="SubjectMatter" Label="External relations" URI="http://publications.europa.eu/resource/authority/fd_070/EXT"/><ukm:Subject Scheme="EuroVoc" Label="medicament" URI="http://eurovoc.europa.eu/3813"/><ukm:Subject Scheme="EuroVoc" Label="discriminatory price" URI="http://eurovoc.europa.eu/2666"/><ukm:Subject Scheme="DirectoryCode" Label="General" URI="http://publications.europa.eu/resource/authority/fd_555/117010"/><ukm:Subject Scheme="DirectoryCode" Label="External relations" URI="http://publications.europa.eu/resource/authority/fd_555/11"/><ukm:Subject Scheme="DirectoryCode" Label="Development policy" URI="http://publications.europa.eu/resource/authority/fd_555/1170"/><ukm:Subject Scheme="EuroVoc" Label="export restriction" URI="http://eurovoc.europa.eu/3577"/><ukm:Subject Scheme="SubjectMatter" Label="public health" URI="http://publications.europa.eu/resource/authority/fd_070/SANT"/><ukm:DocumentCurrentStatus><ukm:UKAmended Value="true"/></ukm:DocumentCurrentStatus></ukm:EUMetadata><ukm:Alternatives><ukm:Alternative URI="http://www.legislation.gov.uk/eur/2016/793/pdfs/eur_20160793_adopted_en.pdf" Date="2016-05-24" Size="462009"/></ukm:Alternatives><ukm:Statistics><ukm:TotalParagraphs Value="106"/><ukm:BodyParagraphs Value="16"/><ukm:ScheduleParagraphs Value="90"/><ukm:AttachmentParagraphs Value="0"/><ukm:TotalImages Value="0"/></ukm:Statistics></proprietary></meta><body eId="body"><article eId="article-2" uk:target="true"><num>Article 2</num><paragraph eId="article-2-1"><num>1.</num><content><p>The importation into  <ins class="substitution first last" ukl:ChangeId="key-7b85e58ea6a8ae03b005ee601dcc65af-1727462095673" ukl:CommentaryRef="key-7b85e58ea6a8ae03b005ee601dcc65af"><noteRef uk:name="commentary" href="#key-7b85e58ea6a8ae03b005ee601dcc65af" class="commentary"/>Great Britain</ins>  of tiered-priced products for the purposes of release for free circulation,  <ins class="substitution first last" ukl:ChangeId="key-fbc75ddb735b4e0c513f0bd9c7630c6d-1727462596983" ukl:CommentaryRef="key-fbc75ddb735b4e0c513f0bd9c7630c6d"><noteRef uk:name="commentary" href="#key-fbc75ddb735b4e0c513f0bd9c7630c6d" class="commentary"/>export</ins>, <ins class="substitution first last" ukl:ChangeId="key-301a0dd095338c8825b06332b0310efe-1727465226439" ukl:CommentaryRef="key-301a0dd095338c8825b06332b0310efe"><noteRef uk:name="commentary" href="#key-301a0dd095338c8825b06332b0310efe" class="commentary"/>or a special Customs procedure</ins>  shall be prohibited.</p></content></paragraph><paragraph eId="article-2-2"><num>2.</num><intro><p>The following shall be exempted from the prohibition regarding tiered-priced products as set out in paragraph 1:</p></intro><level class="para1" eId="article-2-2-a"><num>(a)</num><content><p><ins class="substitution first last" ukl:ChangeId="key-815974d3d93a12c0c548587255911617-1727465294697" ukl:CommentaryRef="key-815974d3d93a12c0c548587255911617"><noteRef uk:name="commentary" href="#key-815974d3d93a12c0c548587255911617" class="commentary"/>export of the tiered-priced products</ins>  to countries of destination;</p></content></level><level class="para1" eId="article-2-2-b"><num>(b)</num><content><p>placing under a transit or  <ins class="substitution first last" ukl:ChangeId="key-ef0ca1638e70044ed78d002ef5785238-1727465400137" ukl:CommentaryRef="key-ef0ca1638e70044ed78d002ef5785238"><noteRef uk:name="commentary" href="#key-ef0ca1638e70044ed78d002ef5785238" class="commentary"/>storage procedure</ins>  for the purpose of  <ins class="substitution first last" ukl:ChangeId="key-a90bb3b0e197b1ecc1172c61e1305ff5-1727465339890" ukl:CommentaryRef="key-a90bb3b0e197b1ecc1172c61e1305ff5"><noteRef uk:name="commentary" href="#key-a90bb3b0e197b1ecc1172c61e1305ff5" class="commentary"/>export of the tiered-priced products</ins>  to a country of destination.</p></content></level></paragraph><paragraph eId="article-2-3"><num><ins class="first" ukl:ChangeId="key-d11a64a4b80d166a2c303c6e39448cae-1727462263602" ukl:CommentaryRef="key-d11a64a4b80d166a2c303c6e39448cae"><noteRef uk:name="commentary" href="#key-d11a64a4b80d166a2c303c6e39448cae" class="commentary"/>3.</ins></num><intro><p><ins ukl:ChangeId="key-d11a64a4b80d166a2c303c6e39448cae-1727462263602" ukl:CommentaryRef="key-d11a64a4b80d166a2c303c6e39448cae">In this Article—</ins></p></intro><level class="para1" eId="article-2-3-a"><num><ins ukl:ChangeId="key-d11a64a4b80d166a2c303c6e39448cae-1727462263602" ukl:CommentaryRef="key-d11a64a4b80d166a2c303c6e39448cae">(a)</ins></num><content><p><ins ukl:ChangeId="key-d11a64a4b80d166a2c303c6e39448cae-1727462263602" ukl:CommentaryRef="key-d11a64a4b80d166a2c303c6e39448cae">‘special Customs procedure’ has the meaning given by section 3(4) of the Taxation (Cross-border Trade) Act 2018;</ins></p></content></level><level class="para1" eId="article-2-3-b"><num><ins ukl:ChangeId="key-d11a64a4b80d166a2c303c6e39448cae-1727462263602" ukl:CommentaryRef="key-d11a64a4b80d166a2c303c6e39448cae">(b)</ins></num><content><p><ins class="last" ukl:ChangeId="key-d11a64a4b80d166a2c303c6e39448cae-1727462263602" ukl:CommentaryRef="key-d11a64a4b80d166a2c303c6e39448cae">‘storage procedure’ has the meaning given by paragraph 2(1) of Schedule 2 to the Taxation (Cross-border Trade) Act 2018.</ins></p></content></level></paragraph></article></body></act></akomaNtoso>