<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="eudn"><meta><identification source="#"><FRBRWork><FRBRthis value="http://www.legislation.gov.uk/id/eudn/2014/556"/><FRBRuri value="http://www.legislation.gov.uk/id/eudn/2014/556"/><FRBRdate date="2014-05-15" name="adopted"/><FRBRauthor href=""/><FRBRcountry value="EU"/><FRBRnumber value="556"/><FRBRname value="Decision (EU) 2014/556"/><FRBRprescriptive value="true"/></FRBRWork><FRBRExpression><FRBRthis value="http://www.legislation.gov.uk/eudn/2014/556/2014-05-15"/><FRBRuri value="http://www.legislation.gov.uk/eudn/2014/556/2014-05-15"/><FRBRdate date="2014-05-15" 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Trials Partnership Programme (EDCTP2) jointly undertaken by several Member States</dc:title><dct:alternative>Decision No 556/2014/EU of the European Parliament and of the Council</dct:alternative><dc:description>Decision No 556/2014/EU of the European Parliament and of the Council of 15 May 2014 on the participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme (EDCTP2) jointly undertaken by several Member States</dc:description><dc:modified>2020-12-11</dc:modified><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:32014D0556</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language><dct:valid>2014-05-15</dct:valid><ukm:EUMetadata><ukm:DocumentClassification><ukm:DocumentCategory Value="euretained"/><ukm:DocumentMainType Value="EuropeanUnionDecision"/><ukm:DocumentStatus Value="revised"/></ukm:DocumentClassification><ukm:Year Value="2014"/><ukm:Number Value="556"/><ukm:EURLexIdentifiers xmlns:atom="http://www.w3.org/2005/Atom" xmlns="http://www.legislation.gov.uk/namespaces/legislation"><ukm:Cellar Value="e120a605-ee0f-11e3-8cd4-01aa75ed71a1"/><ukm:CELEX Value="32014D0556"/><ukm:ELI Value="dec:2014:556(2):oj"/><ukm:OfficialJournal Value="JOL_2014_169_R_0004"/></ukm:EURLexIdentifiers><ukm:EnactmentDate Date="2014-05-15"/><ukm:EURLexModified Date="2019-09-08T00:50:08Z"/><ukm:EURLexExtracted Date="2019-09-08T02:52:22Z"/><ukm:XMLGenerated Date="2020-12-11T18:10:18Z"/><ukm:XMLImported Date="2020-12-11T20:56:14Z"/><ukm:Treaty Title="Treaty on the Functioning of the European Union (consolidated version 2008)" Code="TFEU_2008"/><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="EuroVoc" Label="developing countries" URI="http://eurovoc.europa.eu/2295"/><ukm:Subject Scheme="EuroVoc" Label="medicament" URI="http://eurovoc.europa.eu/3813"/><ukm:Subject Scheme="EuroVoc" Label="EU programme" URI="http://eurovoc.europa.eu/5315"/><ukm:Subject Scheme="EuroVoc" Label="EU financing arrangements" URI="http://eurovoc.europa.eu/5844"/><ukm:Subject Scheme="DirectoryCode" Label="Health protection" URI="http://publications.europa.eu/resource/authority/fd_555/1530"/><ukm:Subject Scheme="DirectoryCode" Label="Environment, consumers and health protection" URI="http://publications.europa.eu/resource/authority/fd_555/15"/><ukm:Subject Scheme="EuroVoc" Label="experiment on humans" URI="http://eurovoc.europa.eu/3668"/><ukm:Subject Scheme="SubjectMatter" Label="public health" URI="http://publications.europa.eu/resource/authority/fd_070/SANT"/><ukm:DocumentCurrentStatus><ukm:UKAmended Value="false"/></ukm:DocumentCurrentStatus></ukm:EUMetadata><ukm:Alternatives><ukm:Alternative URI="http://www.legislation.gov.uk/eudn/2014/556/pdfs/eudn_20140556_adopted_en.pdf" Date="2014-05-15" Size="804844"/></ukm:Alternatives><ukm:Statistics><ukm:TotalParagraphs Value="33"/><ukm:BodyParagraphs Value="14"/><ukm:ScheduleParagraphs Value="19"/><ukm:AttachmentParagraphs Value="0"/><ukm:TotalImages Value="0"/></ukm:Statistics></proprietary></meta><body eId="body"><article eId="article-7" uk:target="true"><num>Article 7</num><heading>Agreements between the Union and the EDCTP2-IS</heading><paragraph eId="article-7-1"><num>1.</num><content><p>Subject to a positive <i>ex-ante</i> assessment of the EDCTP2-IS in accordance with Article 61(1) of Regulation (EU, Euratom) No 966/2012, the Commission, on behalf of the Union, shall conclude a delegation agreement and annual transfer of funds agreements with the EDCTP2-IS.</p></content></paragraph><paragraph eId="article-7-2"><num>2.</num><intro><p>The delegation agreement referred to in paragraph 1 shall be concluded in accordance with Article 58(3) and Articles 60 and 61 of Regulation (EU, Euratom) No 966/2012 and Article 40 of Delegated Regulation (EU) No 1268/2012. It shall also set out, inter alia, the following:</p></intro><level class="para1"><num>(a)</num><content><p>the requirements for the EDCTP2-IS contribution regarding the performance indicators set out in Annex II to Decision 2013/743/EU;</p></content></level><level class="para1"><num>(b)</num><content><p>the requirements for the EDCTP2-IS contribution in relation to the monitoring referred to in Annex III to Decision 2013/743/EU;</p></content></level><level class="para1"><num>(c)</num><content><p>the specific performance indicators related to the functioning of the EDCTP2-IS;</p></content></level><level class="para1"><num>(d)</num><content><p>the requirements for the EDCTP2-IS regarding the provision of information on administrative costs and on detailed figures concerning the implementation of the EDCTP2 Programme;</p></content></level><level class="para1"><num>(e)</num><content><p>the arrangements regarding the provision of data necessary to ensure that the Commission is able to meet its dissemination and reporting obligations;</p></content></level><level class="para1"><num>(f)</num><content><p>the arrangements for the approval or rejection by the Commission of the draft EDCTP2 annual work plan, before it is adopted by the EDCTP2-IS; and</p></content></level><level class="para1"><num>(g)</num><content><p>provisions for the publication of calls for proposals by EDCTP2, in particular on the single portal for participants as well as through other Horizon 2020 electronic means of dissemination managed by the Commission.</p></content></level></paragraph></article></body></act></akomaNtoso>