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					<dc:identifier>http://www.legislation.gov.uk/eur/2019/6/article/105</dc:identifier><dc:title>Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)</dc:title><dct:alternative>Regulation (EU) 2019/6 of the European Parliament and of the Council</dct:alternative><dc:description>Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)</dc:description><dc:modified>2020-12-12</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:32019R0006</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language><dct:valid>2018-12-11</dct:valid>
					
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                  <VALUE>Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)</VALUE>
                  <LANG>en</LANG>
               </TITLE>
               <EXPRESSION_TITLE type="data">
                  <VALUE>Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)</VALUE>
                  <LANG>en</LANG>
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                  <VALUE>2019-01-07T00:30:03.816+01:00</VALUE>
                  <YEAR>2019</YEAR>
                  <MONTH>01</MONTH>
                  <DAY>07</DAY>
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					<ukm:Alternatives><ukm:Alternative URI="http://www.legislation.gov.uk/eur/2019/6/pdfs/eur_20190006_adopted_en.pdf" Date="2018-12-11" Size="1782701"/> </ukm:Alternatives>
					
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				</ukm:Metadata><EURetained><EUBody DocumentURI="http://www.legislation.gov.uk/eur/2019/6/body" IdURI="http://www.legislation.gov.uk/id/eur/2019/6/body" NumberOfProvisions="160" RestrictStartDate="2018-12-11" RestrictExtent="E+W+S+N.I."><EUChapter DocumentURI="http://www.legislation.gov.uk/eur/2019/6/chapter/VII" IdURI="http://www.legislation.gov.uk/id/eur/2019/6/chapter/VII" NumberOfProvisions="24" id="chapter-VII" RestrictStartDate="2018-12-11" RestrictExtent="E+W+S+N.I."><Number>
               <Emphasis>CHAPTER VII</Emphasis>
            </Number><Title>
               <Strong>SUPPLY AND USE</Strong>
            </Title><EUSection DocumentURI="http://www.legislation.gov.uk/eur/2019/6/chapter/VII/section/2" IdURI="http://www.legislation.gov.uk/id/eur/2019/6/chapter/VII/section/2" NumberOfProvisions="3" id="chapter-VII-section-2" RestrictStartDate="2018-12-11" RestrictExtent="E+W+S+N.I."><Number>
                  <Expanded>Section 2</Expanded>
               </Number><Title>
                  <Strong>
                     <Expanded>Retail</Expanded>
                  </Strong>
               </Title><P1group RestrictStartDate="2018-12-11" RestrictExtent="E+W+S+N.I."><Title>Veterinary prescriptions</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2019/6/article/105" IdURI="http://www.legislation.gov.uk/id/eur/2019/6/article/105" id="article-105">
                     <Pnumber>Article 105</Pnumber>
                     <P1para>
                        <P2 DocumentURI="http://www.legislation.gov.uk/eur/2019/6/article/105/1" IdURI="http://www.legislation.gov.uk/id/eur/2019/6/article/105/1" id="article-105-1">
                           <Pnumber PuncBefore="" PuncAfter=".">1</Pnumber>
                           <P2para>
                              <Text>A veterinary prescription for an antimicrobial medicinal product for metaphylaxis shall only be issued after a diagnosis of the infectious disease by a veterinarian.</Text>
                           </P2para>
                        </P2>
                        <P2 DocumentURI="http://www.legislation.gov.uk/eur/2019/6/article/105/2" IdURI="http://www.legislation.gov.uk/id/eur/2019/6/article/105/2" id="article-105-2">
                           <Pnumber PuncBefore="" PuncAfter=".">2</Pnumber>
                           <P2para>
                              <Text>The veterinarian shall be able to provide justification for a veterinary prescription of antimicrobial medicinal products, in particular for metaphylaxis and for prophylaxis.</Text>
                           </P2para>
                        </P2>
                        <P2 DocumentURI="http://www.legislation.gov.uk/eur/2019/6/article/105/3" IdURI="http://www.legislation.gov.uk/id/eur/2019/6/article/105/3" id="article-105-3">
                           <Pnumber PuncBefore="" PuncAfter=".">3</Pnumber>
                           <P2para>
                              <Text>A veterinary prescription shall be issued only after a clinical examination or any other proper assessment of the health status of the animal or group of animals by a veterinarian.</Text>
                           </P2para>
                        </P2>
                        <P2 DocumentURI="http://www.legislation.gov.uk/eur/2019/6/article/105/4" IdURI="http://www.legislation.gov.uk/id/eur/2019/6/article/105/4" id="article-105-4">
                           <Pnumber PuncBefore="" PuncAfter=".">4</Pnumber>
                           <P2para>
                              <Text>By way of derogation from point (33) of Article 4 and paragraph 3 of this Article, a Member State may allow a veterinary prescription to be issued by a professional, other than a veterinarian, who is qualified to do so in accordance with applicable national law at the time of entry into force of this Regulation. Such prescriptions shall be valid only in that Member State and shall exclude prescriptions of antimicrobial medicinal products and any other veterinary medicinal products where a diagnosis by a veterinarian is necessary.</Text>
                           </P2para>
                           <P2para>
                              <Text>Veterinary prescriptions issued by a professional, other than a veterinarian shall be, <Emphasis>mutatis mutandis</Emphasis>, subject to paragraphs 5, 6, 8, 9 and 11 of this Article.</Text>
                           </P2para>
                        </P2>
                        <P2 DocumentURI="http://www.legislation.gov.uk/eur/2019/6/article/105/5" IdURI="http://www.legislation.gov.uk/id/eur/2019/6/article/105/5" id="article-105-5">
                           <Pnumber PuncBefore="" PuncAfter=".">5</Pnumber>
                           <P2para>
                              <Text>A veterinary prescription shall contain at least the following elements:</Text>
                              <P3>
                                 <Pnumber PuncBefore="(" PuncAfter=")">a</Pnumber>
                                 <P3para>
                                    <Text>identification of the animal or groups of animals to be treated;</Text>
                                 </P3para>
                              </P3>
                              <P3>
                                 <Pnumber PuncBefore="(" PuncAfter=")">b</Pnumber>
                                 <P3para>
                                    <Text>full name and contact details of the animal owner or keeper;</Text>
                                 </P3para>
                              </P3>
                              <P3>
                                 <Pnumber PuncBefore="(" PuncAfter=")">c</Pnumber>
                                 <P3para>
                                    <Text>issue date;</Text>
                                 </P3para>
                              </P3>
                              <P3>
                                 <Pnumber PuncBefore="(" PuncAfter=")">d</Pnumber>
                                 <P3para>
                                    <Text>full name and contact details of the veterinarian including, if available, the professional number;</Text>
                                 </P3para>
                              </P3>
                              <P3>
                                 <Pnumber PuncBefore="(" PuncAfter=")">e</Pnumber>
                                 <P3para>
                                    <Text>signature or an equivalent electronic form of identification of the veterinarian;</Text>
                                 </P3para>
                              </P3>
                              <P3>
                                 <Pnumber PuncBefore="(" PuncAfter=")">f</Pnumber>
                                 <P3para>
                                    <Text>name of the prescribed medicinal product, including its active substances;</Text>
                                 </P3para>
                              </P3>
                              <P3>
                                 <Pnumber PuncBefore="(" PuncAfter=")">g</Pnumber>
                                 <P3para>
                                    <Text>pharmaceutical form and strength;</Text>
                                 </P3para>
                              </P3>
                              <P3>
                                 <Pnumber PuncBefore="(" PuncAfter=")">h</Pnumber>
                                 <P3para>
                                    <Text>quantity prescribed, or the number of packs, including pack size;</Text>
                                 </P3para>
                              </P3>
                              <P3>
                                 <Pnumber PuncBefore="(" PuncAfter=")">i</Pnumber>
                                 <P3para>
                                    <Text>dosage regimen;</Text>
                                 </P3para>
                              </P3>
                              <P3>
                                 <Pnumber PuncBefore="(" PuncAfter=")">j</Pnumber>
                                 <P3para>
                                    <Text>for food-producing animal species, withdrawal period even if such period is zero;</Text>
                                 </P3para>
                              </P3>
                              <P3>
                                 <Pnumber PuncBefore="(" PuncAfter=")">k</Pnumber>
                                 <P3para>
                                    <Text>any warnings necessary to ensure the proper use including, where relevant, to ensure prudent use of antimicrobials;</Text>
                                 </P3para>
                              </P3>
                              <P3>
                                 <Pnumber PuncBefore="(" PuncAfter=")">l</Pnumber>
                                 <P3para>
                                    <Text>if a medicinal product is prescribed in accordance with Articles 112, 113 and 114, a statement to that effect;</Text>
                                 </P3para>
                              </P3>
                              <P3>
                                 <Pnumber PuncBefore="(" PuncAfter=")">m</Pnumber>
                                 <P3para>
                                    <Text>if a medicinal product is prescribed in accordance with Article 107(3) and (4), a statement to that effect.</Text>
                                 </P3para>
                              </P3>
                           </P2para>
                        </P2>
                        <P2 DocumentURI="http://www.legislation.gov.uk/eur/2019/6/article/105/6" IdURI="http://www.legislation.gov.uk/id/eur/2019/6/article/105/6" id="article-105-6">
                           <Pnumber PuncBefore="" PuncAfter=".">6</Pnumber>
                           <P2para>
                              <Text>The quantity of the medicinal products prescribed shall be limited to the amount required for the treatment or therapy concerned. As regards antimicrobial medicinal products for metaphylaxis or prophylaxis, they shall be prescribed only for a limited duration to cover the period of risk.</Text>
                           </P2para>
                        </P2>
                        <P2 DocumentURI="http://www.legislation.gov.uk/eur/2019/6/article/105/7" IdURI="http://www.legislation.gov.uk/id/eur/2019/6/article/105/7" id="article-105-7">
                           <Pnumber PuncBefore="" PuncAfter=".">7</Pnumber>
                           <P2para>
                              <Text>Veterinary prescriptions issued in accordance with paragraph 3 shall be recognised throughout the Union.</Text>
                           </P2para>
                        </P2>
                        <P2 DocumentURI="http://www.legislation.gov.uk/eur/2019/6/article/105/8" IdURI="http://www.legislation.gov.uk/id/eur/2019/6/article/105/8" id="article-105-8">
                           <Pnumber PuncBefore="" PuncAfter=".">8</Pnumber>
                           <P2para>
                              <Text>The Commission may, by means of implementing acts, set a model format for the requirements set in paragraph 5 of this Article. That model format shall also be made available in electronic version. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).</Text>
                           </P2para>
                        </P2>
                        <P2 DocumentURI="http://www.legislation.gov.uk/eur/2019/6/article/105/9" IdURI="http://www.legislation.gov.uk/id/eur/2019/6/article/105/9" id="article-105-9">
                           <Pnumber PuncBefore="" PuncAfter=".">9</Pnumber>
                           <P2para>
                              <Text>The medicinal product prescribed shall be supplied in accordance with applicable national law.</Text>
                           </P2para>
                        </P2>
                        <P2 DocumentURI="http://www.legislation.gov.uk/eur/2019/6/article/105/10" IdURI="http://www.legislation.gov.uk/id/eur/2019/6/article/105/10" id="article-105-10">
                           <Pnumber PuncBefore="" PuncAfter=".">10</Pnumber>
                           <P2para>
                              <Text>A veterinary prescription for antimicrobial medicinal products shall be valid for five days from the date of its issue.</Text>
                           </P2para>
                        </P2>
                        <P2 DocumentURI="http://www.legislation.gov.uk/eur/2019/6/article/105/11" IdURI="http://www.legislation.gov.uk/id/eur/2019/6/article/105/11" id="article-105-11">
                           <Pnumber PuncBefore="" PuncAfter=".">11</Pnumber>
                           <P2para>
                              <Text>In addition to the requirements set out in this Article, Member States may lay down rules on record-keeping for veterinarians when issuing veterinary prescriptions.</Text>
                           </P2para>
                        </P2>
                        <P2 DocumentURI="http://www.legislation.gov.uk/eur/2019/6/article/105/12" IdURI="http://www.legislation.gov.uk/id/eur/2019/6/article/105/12" id="article-105-12">
                           <Pnumber PuncBefore="" PuncAfter=".">12</Pnumber>
                           <P2para>
                              <Text>Notwithstanding Article 34, a veterinary medicinal product classified as subject to veterinary prescription under that Article may be administered without a veterinary prescription by a veterinarian personally, unless otherwise provided for under applicable national law. The veterinarian shall keep records of such personal administration without prescription in accordance with applicable national law.</Text>
                           </P2para>
                        </P2>
                     </P1para>
                  </P1></P1group></EUSection></EUChapter></EUBody></EURetained></Legislation>