http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/ADirective 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal productsDirective 2001/82/EC of the European Parliament and of the CouncilDirective 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products2020-12-11King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02001L0082-20090807texttext/xmlen2009-08-07 ANNEX I <Substitution ChangeId="O002001M001" CommentaryRef="c000009">CHEMICAL, PHARMACEUTICAL AND ANALYTICAL STANDARDS, SAFETY AND RESIDUE TESTS, PRE-CLINICAL AND CLINICAL TRIALS IN RESPECT OF TESTING OF VETERINARY MEDICINAL PRODUCTS</Substitution> TITLE IV <Substitution ChangeId="O002001M001" CommentaryRef="c000009">REQUIREMENTS FOR MARKETING AUTHORISATION APPLICATIONS FOR PARTICULAR VETERINARY MEDICINAL PRODUCTS</Substitution> 1. <Substitution ChangeId="O002001M001" CommentaryRef="c000009">IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS</Substitution> A. <Substitution ChangeId="O002001M001" CommentaryRef="c000009">VACCINE ANTIGEN MASTER FILE</Substitution>

For particular immunological veterinary medicinal products and by derogation from the provisions of Title II, Part 2 Section C on active substances, the concept of a Vaccine Antigen Master File is introduced.

For the purpose of this Annex, a Vaccine Antigen Master File means a stand-alone part of the marketing authorisation application dossier for a vaccine, which contains all relevant information on quality concerning each of the active substances, which are part of this veterinary medicinal product. The stand-alone part may be common to one or more monovalent and/or combined vaccines presented by the same applicant or marketing authorisation holder.

Scientific guidelines for the submission and evaluation of a vaccine antigen master file shall be adopted by the Agency. The procedure for the submission and evaluation of a vaccine antigen master file shall follow the guidance published by the Commission in The rules governing medicinal products in the European Union , Volume 6B, Notice to Applicants.

Substituted by Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (Text with EEA relevance).
This XML file does not appear to have any style information associated with it. The document tree is shown below.
<Legislation xmlns="http://www.legislation.gov.uk/namespaces/legislation" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" DocumentURI="http://www.legislation.gov.uk/eudr/2001/82" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82" NumberOfProvisions="108" xsi:schemaLocation="http://www.legislation.gov.uk/namespaces/legislation http://www.legislation.gov.uk/schema/legislation.xsd" SchemaVersion="2.0" RestrictStartDate="2009-08-07" RestrictExtent="E+W+S+N.I.">
<ukm:Metadata xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:dct="http://purl.org/dc/terms/" xmlns:atom="http://www.w3.org/2005/Atom" xmlns:ukm="http://www.legislation.gov.uk/namespaces/metadata">
<dc:identifier>http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/A</dc:identifier>
<dc:title>Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products</dc:title>
<dct:alternative>Directive 2001/82/EC of the European Parliament and of the Council</dct:alternative>
<dc:description>Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products</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:02001L0082-20090807</dc:source>
<dc:type>text</dc:type>
<dc:format>text/xml</dc:format>
<dc:language>en</dc:language>
<dct:valid>2009-08-07</dct:valid>
<atom:link rel="self" href="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/A/data.xml" type="application/xml"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/resources" href="http://www.legislation.gov.uk/eudr/2001/82/resources" title="More Resources"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/act" href="http://www.legislation.gov.uk/eudr/2001/82" title="whole act"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/introduction" href="http://www.legislation.gov.uk/eudr/2001/82/introduction" title="introduction"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/body" href="http://www.legislation.gov.uk/eudr/2001/82/body" title="body"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/annexes" href="http://www.legislation.gov.uk/eudr/2001/82/annexes" title="annexes"/>
<atom:link rel="http://www.legislation.gov.uk/def/date/euexitday" href="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/A/2020-01-31" title="2020-01-31"/>
<atom:link rel="http://www.legislation.gov.uk/def/date/euexitTransitionEnd" href="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/A/2020-12-31" title="2020-12-31"/>
<atom:link rel="alternate" type="application/rdf+xml" href="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/A/data.rdf" title="RDF/XML"/>
<atom:link rel="alternate" type="application/akn+xml" href="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/A/data.akn" title="AKN"/>
<atom:link rel="alternate" type="application/xhtml+xml" href="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/A/data.xht" title="HTML snippet"/>
<atom:link rel="alternate" type="text/html" href="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/A/data.htm" title="Website (XHTML) Default View"/>
<atom:link rel="alternate" type="text/csv" href="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/A/data.csv" title="CSV"/>
<atom:link rel="alternate" type="application/pdf" href="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/A/data.pdf" title="PDF"/>
<atom:link rel="alternate" type="application/akn+xhtml" href="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/A/data.html" title="HTML5 snippet"/>
<atom:link rel="http://purl.org/dc/terms/tableOfContents" hreflang="en" href="http://www.legislation.gov.uk/eudr/2001/82/contents" title="Table of Contents"/>
<atom:link rel="http://purl.org/dc/terms/replaces" href="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/A/2009-03-06" title="2009-03-06"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/A/2009-03-06" title="2009-03-06"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/A/2009-07-20" title="2009-07-20"/>
<atom:link rel="up" href="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1" title="Annex I Title IV Division 1"/>
<atom:link rel="next" href="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/B" title="Division; Annex I Title IV Division 1 Division B"/>
<atom:link rel="nextInForce" href="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/B" title="Division; Annex I Title IV Division 1 Division B"/>
<ukm:EUMetadata>
<ukm:DocumentClassification>
<ukm:DocumentCategory Value="euretained"/>
<ukm:DocumentMainType Value="EuropeanUnionDirective"/>
<ukm:DocumentStatus Value="revised"/>
</ukm:DocumentClassification>
<ukm:Year Value="2001"/>
<ukm:Number Value="82"/>
<ukm:EURLexIdentifiers>
<ukm:Cellar Value="4ff0e658-e48a-4e85-8b68-2bfab41fa86e"/>
<ukm:ELI Value="dir:2001:82:2009-08-07"/>
<ukm:CELEX Value="02001L0082-20090807"/>
</ukm:EURLexIdentifiers>
<ukm:EnactmentDate Date="2001-11-06"/>
<ukm:EURLexModified Date="2016-06-30T21:20:58Z"/>
<ukm:EURLexExtracted Date="2018-05-18T17:39:01Z"/>
<ukm:XMLGenerated Date="2020-12-11T18:24:08Z"/>
<ukm:XMLImported Date="2020-12-11T20:27:15Z"/>
<ukm:CreatedBy Label="Provisional data" URI="http://publications.europa.eu/resource/authority/corporate-body/OP_DATPRO"/>
<ukm:EURLexMetadata>
<WORK xmlns="">
<URI>
<VALUE>http://publications.europa.eu/resource/cellar/4ff0e658-e48a-4e85-8b68-2bfab41fa86e</VALUE>
<IDENTIFIER>4ff0e658-e48a-4e85-8b68-2bfab41fa86e</IDENTIFIER>
<TYPE>cellar</TYPE>
</URI>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/eli/dir/2001/82/2009-08-07</VALUE>
<IDENTIFIER>dir:2001:82:2009-08-07</IDENTIFIER>
<TYPE>eli</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/celex/02001L0082-20090807</VALUE>
<IDENTIFIER>02001L0082-20090807</IDENTIFIER>
<TYPE>celex</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/consolidation/2001L0082%2F20090807</VALUE>
<IDENTIFIER>2001L0082/20090807</IDENTIFIER>
<TYPE>consolidation</TYPE>
</URI>
</SAMEAS>
<ACT_CONSOLIDATED_CONSOLIDATES_RESOURCE_LEGAL type="link">
<URI>
<VALUE>http://publications.europa.eu/resource/cellar/fb5ac17e-438b-42a6-835b-c1932a322526</VALUE>
<IDENTIFIER>fb5ac17e-438b-42a6-835b-c1932a322526</IDENTIFIER>
<TYPE>cellar</TYPE>
</URI>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/eli/dir/2009/53/oj</VALUE>
<IDENTIFIER>dir:2009:53:oj</IDENTIFIER>
<TYPE>eli</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/oj/JOL_2009_168_R_0033_01</VALUE>
<IDENTIFIER>JOL_2009_168_R_0033_01</IDENTIFIER>
<TYPE>oj</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/celex/32009L0053</VALUE>
<IDENTIFIER>32009L0053</IDENTIFIER>
<TYPE>celex</TYPE>
</URI>
</SAMEAS>
</ACT_CONSOLIDATED_CONSOLIDATES_RESOURCE_LEGAL>
<RESOURCE_LEGAL_INFORMATION_MISCELLANEOUS type="data">
<VALUE>LASTMODIN {32009L0053|http://publications.europa.eu/resource/celex/32009L0053}</VALUE>
</RESOURCE_LEGAL_INFORMATION_MISCELLANEOUS>
<RESOURCE_LEGAL_HAS_TYPE_ACT_CONCEPT_TYPE_ACT type="concept">
<URI>
<VALUE>http://publications.europa.eu/resource/authority/fd_030/VC</VALUE>
<IDENTIFIER>VC</IDENTIFIER>
<TYPE>fd_030</TYPE>
</URI>
<OP-CODE>VC</OP-CODE>
<IDENTIFIER>VC</IDENTIFIER>
<PREFLABEL>Consolidated text</PREFLABEL>
</RESOURCE_LEGAL_HAS_TYPE_ACT_CONCEPT_TYPE_ACT>
<WORK_DATE_DOCUMENT type="date">
<VALUE>2009-08-07</VALUE>
<YEAR>2009</YEAR>
<MONTH>08</MONTH>
<DAY>07</DAY>
</WORK_DATE_DOCUMENT>
<DATE_CREATION_LEGACY type="date">
<VALUE>2010-01-07</VALUE>
<YEAR>2010</YEAR>
<MONTH>01</MONTH>
<DAY>07</DAY>
</DATE_CREATION_LEGACY>
<IDENTIFIER type="data">
<VALUE>http://data.europa.eu/eli/dir/2001/82/2009-08-07</VALUE>
</IDENTIFIER>
<WORK_ID_DOCUMENT type="data">
<VALUE>celex:02001L0082-20090807</VALUE>
</WORK_ID_DOCUMENT>
<IDENTIFIER type="data">
<VALUE>02001L0082-20090807</VALUE>
</IDENTIFIER>
<ID_CELEX type="data">
<VALUE>02001L0082-20090807</VALUE>
</ID_CELEX>
<DATE type="date">
<VALUE>2009-08-07</VALUE>
<YEAR>2009</YEAR>
<MONTH>08</MONTH>
<DAY>07</DAY>
</DATE>
<DATE type="date">
<VALUE>2010-01-07</VALUE>
<YEAR>2010</YEAR>
<MONTH>01</MONTH>
<DAY>07</DAY>
</DATE>
<ACT_CONSOLIDATED_DATE type="date">
<VALUE>2009-08-07</VALUE>
<YEAR>2009</YEAR>
<MONTH>08</MONTH>
<DAY>07</DAY>
</ACT_CONSOLIDATED_DATE>
<RESOURCE_LEGAL_DATE_ENTRY-INTO-FORCE type="date">
<VALUE>2009-08-07</VALUE>
<YEAR>2009</YEAR>
<MONTH>08</MONTH>
<DAY>07</DAY>
</RESOURCE_LEGAL_DATE_ENTRY-INTO-FORCE>
<ACT_CONSOLIDATED_CONSOLIDATES_RESOURCE_LEGAL type="link">
<URI>
<VALUE>http://publications.europa.eu/resource/cellar/8bfc649d-79b3-4525-83d2-aeda82ec91fb</VALUE>
<IDENTIFIER>8bfc649d-79b3-4525-83d2-aeda82ec91fb</IDENTIFIER>
<TYPE>cellar</TYPE>
</URI>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/oj/JOL_2004_136_R_0058_01</VALUE>
<IDENTIFIER>JOL_2004_136_R_0058_01</IDENTIFIER>
<TYPE>oj</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/celex/32004L0028</VALUE>
<IDENTIFIER>32004L0028</IDENTIFIER>
<TYPE>celex</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/eli/dir/2004/28/oj</VALUE>
<IDENTIFIER>dir:2004:28:oj</IDENTIFIER>
<TYPE>eli</TYPE>
</URI>
</SAMEAS>
</ACT_CONSOLIDATED_CONSOLIDATES_RESOURCE_LEGAL>
<WORK_SUMMARIZED_BY_SUMMARY type="link">
<URI>
<VALUE>http://publications.europa.eu/resource/cellar/1c36625f-c9c8-4943-a721-2b45cc655ede</VALUE>
<IDENTIFIER>1c36625f-c9c8-4943-a721-2b45cc655ede</IDENTIFIER>
<TYPE>cellar</TYPE>
</URI>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/uriserv/l21231</VALUE>
<IDENTIFIER>l21231</IDENTIFIER>
<TYPE>uriserv</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/legissum/l21231</VALUE>
<IDENTIFIER>l21231</IDENTIFIER>
<TYPE>legissum</TYPE>
</URI>
</SAMEAS>
</WORK_SUMMARIZED_BY_SUMMARY>
<ACT_CONSOLIDATED_CONSOLIDATES_RESOURCE_LEGAL type="link">
<URI>
<VALUE>http://publications.europa.eu/resource/cellar/49bddfd2-6ee5-400e-bf90-f09e7298c7ef</VALUE>
<IDENTIFIER>49bddfd2-6ee5-400e-bf90-f09e7298c7ef</IDENTIFIER>
<TYPE>cellar</TYPE>
</URI>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/celex/32009R0470</VALUE>
<IDENTIFIER>32009R0470</IDENTIFIER>
<TYPE>celex</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/oj/JOL_2009_152_R_0011_01</VALUE>
<IDENTIFIER>JOL_2009_152_R_0011_01</IDENTIFIER>
<TYPE>oj</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/eli/reg/2009/470/oj</VALUE>
<IDENTIFIER>reg:2009:470:oj</IDENTIFIER>
<TYPE>eli</TYPE>
</URI>
</SAMEAS>
</ACT_CONSOLIDATED_CONSOLIDATES_RESOURCE_LEGAL>
<ACT_CONSOLIDATED_CONSOLIDATES_RESOURCE_LEGAL type="link">
<URI>
<VALUE>http://publications.europa.eu/resource/cellar/e474fe78-b6bf-4305-8f23-811c876fa891</VALUE>
<IDENTIFIER>e474fe78-b6bf-4305-8f23-811c876fa891</IDENTIFIER>
<TYPE>cellar</TYPE>
</URI>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/eli/dir/2001/82/2009-07-20</VALUE>
<IDENTIFIER>dir:2001:82:2009-07-20</IDENTIFIER>
<TYPE>eli</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/celex/02001L0082-20090720</VALUE>
<IDENTIFIER>02001L0082-20090720</IDENTIFIER>
<TYPE>celex</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/consolidation/2001L0082%2F20090720</VALUE>
<IDENTIFIER>2001L0082/20090720</IDENTIFIER>
<TYPE>consolidation</TYPE>
</URI>
</SAMEAS>
</ACT_CONSOLIDATED_CONSOLIDATES_RESOURCE_LEGAL>
<RESOURCE_LEGAL_YEAR type="data">
<VALUE>2001</VALUE>
</RESOURCE_LEGAL_YEAR>
<CREATED_BY type="concept">
<URI>
<VALUE>http://publications.europa.eu/resource/authority/corporate-body/OP_DATPRO</VALUE>
<IDENTIFIER>OP_DATPRO</IDENTIFIER>
<TYPE>corporate-body</TYPE>
</URI>
<OP-CODE>OP_DATPRO</OP-CODE>
<IDENTIFIER>OP_DATPRO</IDENTIFIER>
<PREFLABEL>Provisional data</PREFLABEL>
</CREATED_BY>
<RESOURCE_LEGAL_TYPE type="data">
<VALUE>L</VALUE>
</RESOURCE_LEGAL_TYPE>
<RESOURCE_LEGAL_NUMBER_NATURAL type="data">
<VALUE>82</VALUE>
</RESOURCE_LEGAL_NUMBER_NATURAL>
<ACT_CONSOLIDATED_CONSOLIDATES_RESOURCE_LEGAL type="link">
<URI>
<VALUE>http://publications.europa.eu/resource/cellar/c2c47535-c88b-4327-b1cc-037151f17287</VALUE>
<IDENTIFIER>c2c47535-c88b-4327-b1cc-037151f17287</IDENTIFIER>
<TYPE>cellar</TYPE>
</URI>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/oj/JOL_2001_311_R_0001_01</VALUE>
<IDENTIFIER>JOL_2001_311_R_0001_01</IDENTIFIER>
<TYPE>oj</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/celex/32001L0082</VALUE>
<IDENTIFIER>32001L0082</IDENTIFIER>
<TYPE>celex</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/eli/dir/2001/82/oj</VALUE>
<IDENTIFIER>dir:2001:82:oj</IDENTIFIER>
<TYPE>eli</TYPE>
</URI>
</SAMEAS>
</ACT_CONSOLIDATED_CONSOLIDATES_RESOURCE_LEGAL>
<WORK_CREATED_BY_AGENT type="concept">
<URI>
<VALUE>http://publications.europa.eu/resource/authority/corporate-body/OP_DATPRO</VALUE>
<IDENTIFIER>OP_DATPRO</IDENTIFIER>
<TYPE>corporate-body</TYPE>
</URI>
<OP-CODE>OP_DATPRO</OP-CODE>
<IDENTIFIER>OP_DATPRO</IDENTIFIER>
<PREFLABEL>Provisional data</PREFLABEL>
<ANNOTATION>
<BUILD_INFO>cdm:CDM_3.2.3 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:5.6.0 builddate:11/08/2015 16:49:57</BUILD_INFO>
<QUALITY_ISSUE>DATMIS</QUALITY_ISSUE>
<ERROR_MESSAGE>Data missing</ERROR_MESSAGE>
</ANNOTATION>
</WORK_CREATED_BY_AGENT>
<ACT_CONSOLIDATED_BASED_ON_RESOURCE_LEGAL type="link">
<URI>
<VALUE>http://publications.europa.eu/resource/cellar/c2c47535-c88b-4327-b1cc-037151f17287</VALUE>
<IDENTIFIER>c2c47535-c88b-4327-b1cc-037151f17287</IDENTIFIER>
<TYPE>cellar</TYPE>
</URI>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/oj/JOL_2001_311_R_0001_01</VALUE>
<IDENTIFIER>JOL_2001_311_R_0001_01</IDENTIFIER>
<TYPE>oj</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/celex/32001L0082</VALUE>
<IDENTIFIER>32001L0082</IDENTIFIER>
<TYPE>celex</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/eli/dir/2001/82/oj</VALUE>
<IDENTIFIER>dir:2001:82:oj</IDENTIFIER>
<TYPE>eli</TYPE>
</URI>
</SAMEAS>
</ACT_CONSOLIDATED_BASED_ON_RESOURCE_LEGAL>
<ACT_CONSOLIDATED_CONSOLIDATES_RESOURCE_LEGAL type="link">
<URI>
<VALUE>http://publications.europa.eu/resource/cellar/9ca604be-c950-11e4-bbe1-01aa75ed71a1</VALUE>
<IDENTIFIER>9ca604be-c950-11e4-bbe1-01aa75ed71a1</IDENTIFIER>
<TYPE>cellar</TYPE>
</URI>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/immc/20150310-011%3ASN%201753%202015%20INIT</VALUE>
<IDENTIFIER>20150310-011:SN 1753 2015 INIT</IDENTIFIER>
<TYPE>immc</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/oj/JOL_2015_068_R_0026</VALUE>
<IDENTIFIER>JOL_2015_068_R_0026</IDENTIFIER>
<TYPE>oj</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/eli/dir/2004/28/corrigendum/2015-03-13/oj</VALUE>
<IDENTIFIER>dir:2004:28:corrigendum:2015-03-13:oj</IDENTIFIER>
<TYPE>eli</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/celex/32004L0028R%2802%29</VALUE>
<IDENTIFIER>32004L0028R(02)</IDENTIFIER>
<TYPE>celex</TYPE>
</URI>
</SAMEAS>
</ACT_CONSOLIDATED_CONSOLIDATES_RESOURCE_LEGAL>
<YEAR type="data">
<VALUE>2001</VALUE>
</YEAR>
<RESOURCE_LEGAL_ID_CELEX type="data">
<VALUE>02001L0082-20090807</VALUE>
</RESOURCE_LEGAL_ID_CELEX>
<BASED_ON type="link">
<URI>
<VALUE>http://publications.europa.eu/resource/cellar/c2c47535-c88b-4327-b1cc-037151f17287</VALUE>
<IDENTIFIER>c2c47535-c88b-4327-b1cc-037151f17287</IDENTIFIER>
<TYPE>cellar</TYPE>
</URI>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/oj/JOL_2001_311_R_0001_01</VALUE>
<IDENTIFIER>JOL_2001_311_R_0001_01</IDENTIFIER>
<TYPE>oj</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/celex/32001L0082</VALUE>
<IDENTIFIER>32001L0082</IDENTIFIER>
<TYPE>celex</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/eli/dir/2001/82/oj</VALUE>
<IDENTIFIER>dir:2001:82:oj</IDENTIFIER>
<TYPE>eli</TYPE>
</URI>
</SAMEAS>
</BASED_ON>
<DATE_DOCUMENT type="date">
<VALUE>2009-08-07</VALUE>
<YEAR>2009</YEAR>
<MONTH>08</MONTH>
<DAY>07</DAY>
</DATE_DOCUMENT>
<IDENTIFIER type="data">
<VALUE>celex:02001L0082-20090807</VALUE>
</IDENTIFIER>
<ELI type="data">
<VALUE>http://data.europa.eu/eli/dir/2001/82/2009-08-07</VALUE>
</ELI>
<LASTMODIFICATIONDATE type="date">
<VALUE>2016-06-30T23:20:58.377+02:00</VALUE>
<YEAR>2016</YEAR>
<MONTH>06</MONTH>
<DAY>30</DAY>
</LASTMODIFICATIONDATE>
<ACT_CONSOLIDATED_CONSOLIDATES_RESOURCE_LEGAL type="link">
<URI>
<VALUE>http://publications.europa.eu/resource/cellar/cae34a17-17da-40b8-a900-1f4dd07ec89f</VALUE>
<IDENTIFIER>cae34a17-17da-40b8-a900-1f4dd07ec89f</IDENTIFIER>
<TYPE>cellar</TYPE>
</URI>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/oj/JOL_2012_086_R_0025_01_REG_2009_596_25</VALUE>
<IDENTIFIER>JOL_2012_086_R_0025_01_REG_2009_596_25</IDENTIFIER>
<TYPE>oj</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/eli/reg/2009/596/corrigendum/2012-03-24/oj</VALUE>
<IDENTIFIER>reg:2009:596:corrigendum:2012-03-24:oj</IDENTIFIER>
<TYPE>eli</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/celex/32009R0596R%2801%29</VALUE>
<IDENTIFIER>32009R0596R(01)</IDENTIFIER>
<TYPE>celex</TYPE>
</URI>
</SAMEAS>
</ACT_CONSOLIDATED_CONSOLIDATES_RESOURCE_LEGAL>
<ID_SECTOR type="data">
<VALUE>0</VALUE>
</ID_SECTOR>
<ACT_CONSOLIDATED_CONSOLIDATES_RESOURCE_LEGAL type="link">
<URI>
<VALUE>http://publications.europa.eu/resource/cellar/7e1c2c74-d24a-4f9e-8e09-6cc5fc19b98a</VALUE>
<IDENTIFIER>7e1c2c74-d24a-4f9e-8e09-6cc5fc19b98a</IDENTIFIER>
<TYPE>cellar</TYPE>
</URI>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/oj/JOL_2009_188_R_0014_01</VALUE>
<IDENTIFIER>JOL_2009_188_R_0014_01</IDENTIFIER>
<TYPE>oj</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/celex/32009R0596</VALUE>
<IDENTIFIER>32009R0596</IDENTIFIER>
<TYPE>celex</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/eli/reg/2009/596/oj</VALUE>
<IDENTIFIER>reg:2009:596:oj</IDENTIFIER>
<TYPE>eli</TYPE>
</URI>
</SAMEAS>
</ACT_CONSOLIDATED_CONSOLIDATES_RESOURCE_LEGAL>
<ACT_CONSOLIDATED_CONSOLIDATES_RESOURCE_LEGAL type="link">
<URI>
<VALUE>http://publications.europa.eu/resource/cellar/74a33fde-b1b4-437c-9487-af216132699d</VALUE>
<IDENTIFIER>74a33fde-b1b4-437c-9487-af216132699d</IDENTIFIER>
<TYPE>cellar</TYPE>
</URI>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/oj/JOL_2009_044_R_0010_01</VALUE>
<IDENTIFIER>JOL_2009_044_R_0010_01</IDENTIFIER>
<TYPE>oj</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/celex/32009L0009</VALUE>
<IDENTIFIER>32009L0009</IDENTIFIER>
<TYPE>celex</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/eli/dir/2009/9/oj</VALUE>
<IDENTIFIER>dir:2009:9:oj</IDENTIFIER>
<TYPE>eli</TYPE>
</URI>
</SAMEAS>
</ACT_CONSOLIDATED_CONSOLIDATES_RESOURCE_LEGAL>
<RESOURCE_LEGAL_ELI type="data">
<VALUE>http://data.europa.eu/eli/dir/2001/82/2009-08-07</VALUE>
</RESOURCE_LEGAL_ELI>
<RESOURCE_LEGAL_NUMBER_NATURAL_CELEX type="data">
<VALUE>0082</VALUE>
</RESOURCE_LEGAL_NUMBER_NATURAL_CELEX>
<WORK_HAS_RESOURCE-TYPE type="concept">
<URI>
<VALUE>http://publications.europa.eu/resource/authority/resource-type/CONS_TEXT</VALUE>
<IDENTIFIER>CONS_TEXT</IDENTIFIER>
<TYPE>resource-type</TYPE>
</URI>
<OP-CODE>CONS_TEXT</OP-CODE>
<IDENTIFIER>CONS_TEXT</IDENTIFIER>
<PREFLABEL>Consolidated text</PREFLABEL>
</WORK_HAS_RESOURCE-TYPE>
<TYPE>cdm:act_consolidated</TYPE>
<TYPE>cdm:work</TYPE>
<TYPE>cdm:resource_legal</TYPE>
<TYPE>L</TYPE>
</WORK>
<EXPRESSION xmlns="">
<URI>
<VALUE>http://publications.europa.eu/resource/cellar/4ff0e658-e48a-4e85-8b68-2bfab41fa86e.0006</VALUE>
<IDENTIFIER>4ff0e658-e48a-4e85-8b68-2bfab41fa86e.0006</IDENTIFIER>
<TYPE>cellar</TYPE>
</URI>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/celex/02001L0082-20090807.ENG</VALUE>
<IDENTIFIER>02001L0082-20090807.ENG</IDENTIFIER>
<TYPE>celex</TYPE>
</URI>
</SAMEAS>
<SAMEAS>
<URI>
<VALUE>http://publications.europa.eu/resource/consolidation/2001L0082%2F20090807.ENG</VALUE>
<IDENTIFIER>2001L0082/20090807.ENG</IDENTIFIER>
<TYPE>consolidation</TYPE>
</URI>
</SAMEAS>
<LANG type="data">
<VALUE>en</VALUE>
</LANG>
<EXPRESSION_USES_LANGUAGE type="concept">
<URI>
<VALUE>http://publications.europa.eu/resource/authority/language/ENG</VALUE>
<IDENTIFIER>ENG</IDENTIFIER>
<TYPE>language</TYPE>
</URI>
<OP-CODE>ENG</OP-CODE>
<IDENTIFIER>ENG</IDENTIFIER>
<PREFLABEL>English</PREFLABEL>
<ALTLABEL>English</ALTLABEL>
</EXPRESSION_USES_LANGUAGE>
<LASTMODIFICATIONDATE type="date">
<VALUE>2014-10-10T13:48:23.271+02:00</VALUE>
<YEAR>2014</YEAR>
<MONTH>10</MONTH>
<DAY>10</DAY>
</LASTMODIFICATIONDATE>
<EXPRESSION_TITLE type="data">
<VALUE>Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products </VALUE>
</EXPRESSION_TITLE>
<LANG type="data">
<VALUE>eng</VALUE>
</LANG>
<TITLE type="data">
<VALUE>Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products </VALUE>
</TITLE>
<TITLE type="data">
<VALUE>CELEX1</VALUE>
</TITLE>
</EXPRESSION>
</ukm:EURLexMetadata>
</ukm:EUMetadata>
<ukm:Alternatives>
<ukm:Alternative URI="http://www.legislation.gov.uk/eudr/2001/82/pdfs/eudr_20010082_adopted_en.pdf" Date="2001-11-06" Size="400822"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eudr/2001/82/pdfs/eudr_20010082_2004-04-30_en.pdf" Date="2004-04-30" Size="362009" Revised="2004-04-30"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eudr/2001/82/pdfs/eudr_20010082_2009-03-06_en.pdf" Date="2009-03-06" Size="390300" Revised="2009-03-06"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eudr/2001/82/pdfs/eudr_20010082_2009-07-20_en.pdf" Date="2009-07-20" Size="423937" Revised="2009-07-20"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eudr/2001/82/pdfs/eudr_20010082_2009-08-07_en.pdf" Date="2009-08-07" Size="933319" Revised="2009-08-07"/>
</ukm:Alternatives>
<ukm:Statistics>
<ukm:TotalParagraphs Value="546"/>
<ukm:BodyParagraphs Value="108"/>
<ukm:ScheduleParagraphs Value="438"/>
<ukm:AttachmentParagraphs Value="0"/>
<ukm:TotalImages Value="0"/>
</ukm:Statistics>
</ukm:Metadata>
<EURetained>
<Schedules RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I.">
<Schedule DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I" id="annex-I" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I.">
<Number>
<Substitution ChangeId="O002001M001" CommentaryRef="c000009">ANNEX I</Substitution>
</Number>
<TitleBlock>
<Title>
<Substitution ChangeId="O002001M001" CommentaryRef="c000009">CHEMICAL, PHARMACEUTICAL AND ANALYTICAL STANDARDS, SAFETY AND RESIDUE TESTS, PRE-CLINICAL AND CLINICAL TRIALS IN RESPECT OF TESTING OF VETERINARY MEDICINAL PRODUCTS</Substitution>
</Title>
</TitleBlock>
<ScheduleBody>
<Division DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/IV" id="annex-I-title-IV" Type="EUTitle" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I.">
<Number>
<Substitution ChangeId="O002001M001" CommentaryRef="c000009">TITLE IV</Substitution>
</Number>
<Title>
<Substitution ChangeId="O002001M001" CommentaryRef="c000009">REQUIREMENTS FOR MARKETING AUTHORISATION APPLICATIONS FOR PARTICULAR VETERINARY MEDICINAL PRODUCTS</Substitution>
</Title>
<Division DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/IV/division/1" id="annex-I-title-IV-division-1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I.">
<Number>
<Substitution ChangeId="O002001M001" CommentaryRef="c000009">1.</Substitution>
</Number>
<Title>
<Substitution ChangeId="O002001M001" CommentaryRef="c000009">IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS</Substitution>
</Title>
<Division DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/A" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/IV/division/1/division/A" id="annex-I-title-IV-division-1-division-A" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I.">
<Number>
<Substitution ChangeId="O002001M001" CommentaryRef="c000009">A.</Substitution>
</Number>
<Title>
<Substitution ChangeId="O002001M001" CommentaryRef="c000009">VACCINE ANTIGEN MASTER FILE</Substitution>
</Title>
<P>
<Text>
<Substitution ChangeId="O002001M001" CommentaryRef="c000009">For particular immunological veterinary medicinal products and by derogation from the provisions of Title II, Part 2 Section C on active substances, the concept of a Vaccine Antigen Master File is introduced.</Substitution>
</Text>
</P>
<P>
<Text>
<Substitution ChangeId="O002001M001" CommentaryRef="c000009">For the purpose of this Annex, a Vaccine Antigen Master File means a stand-alone part of the marketing authorisation application dossier for a vaccine, which contains all relevant information on quality concerning each of the active substances, which are part of this veterinary medicinal product. The stand-alone part may be common to one or more monovalent and/or combined vaccines presented by the same applicant or marketing authorisation holder.</Substitution>
</Text>
</P>
<P>
<Text>
<Substitution ChangeId="O002001M001" CommentaryRef="c000009">Scientific guidelines for the submission and evaluation of a vaccine antigen master file shall be adopted by the Agency. The procedure for the submission and evaluation of a vaccine antigen master file shall follow the guidance published by the Commission in </Substitution>
<Emphasis>
<Substitution ChangeId="O002001M001" CommentaryRef="c000009">The rules governing medicinal products in the European Union</Substitution>
</Emphasis>
<Substitution ChangeId="O002001M001" CommentaryRef="c000009">, Volume 6B, Notice to Applicants.</Substitution>
</Text>
</P>
</Division>
</Division>
</Division>
</ScheduleBody>
</Schedule>
</Schedules>
</EURetained>
<Commentaries>
<Commentary Type="F" Source="EU" id="c000009">
<Para>
<Text>
Substituted by
<Citation Class="EuropeanUnionDirective" Year="2009" Number="9" URI="http://www.legislation.gov.uk/id/eudr/2009/9" Title="Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (Text with EEA relevance)">Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (Text with EEA relevance)</Citation>
.
</Text>
</Para>
</Commentary>
</Commentaries>
</Legislation>