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					<dc:identifier>http://www.legislation.gov.uk/eur/2014/658</dc:identifier><dc:title>Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (Text with EEA relevance) (revoked)</dc:title><dct:alternative>Regulation (EU) No 658/2014 of the European Parliament and of the Council</dct:alternative><dc:description>Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (Text with EEA relevance)</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:02014R0658-20201101</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language><dc:modified>2024-09-03</dc:modified><dc:contributor>Expert Participation</dc:contributor><dct:valid>2020-12-31</dct:valid>
					
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      <EUPrelims DocumentURI="http://www.legislation.gov.uk/eur/2014/658/introduction" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/introduction" RestrictExtent="E+W+S+N.I." Status="Repealed" RestrictStartDate="2020-12-31"><MultilineTitle><Text><Uppercase>Regulation</Uppercase> (EU) No 658/2014 <Uppercase>of the European Parliament and of the Council</Uppercase></Text><Text>of 15 May 2014</Text><Text>on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use</Text><Text>(Text with EEA relevance) (revoked)</Text></MultilineTitle><EUPreamble><P><Text><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P></EUPreamble></EUPrelims>
      <EUBody DocumentURI="http://www.legislation.gov.uk/eur/2014/658/body" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/body" NumberOfProvisions="18" RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><Title>Subject matter and scope</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2014/658/article/1" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/article/1" id="article-1"><Pnumber><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>Article 1</Pnumber><P1para><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P1para></P1></P1group><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><Title>Definitions</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2014/658/article/2" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/article/2" id="article-2"><Pnumber><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>Article 2</Pnumber><P1para><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P1para></P1></P1group><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><Title>Types of fees</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2014/658/article/3" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/article/3" id="article-3"><Pnumber><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>Article 3</Pnumber><P1para><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P1para></P1></P1group><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><Title>Fee for assessment of periodic safety update reports</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2014/658/article/4" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/article/4" id="article-4"><Pnumber><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>Article 4</Pnumber><P1para><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P1para></P1></P1group><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><Title>Fee for assessment of post-authorisation safety studies</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2014/658/article/5" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/article/5" id="article-5"><Pnumber><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>Article 5</Pnumber><P1para><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P1para></P1></P1group><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><Title>Fee for assessments in the context of referrals initiated as a result of the evaluation of pharmacovigilance data</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2014/658/article/6" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/article/6" id="article-6"><Pnumber><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>Article 6</Pnumber><P1para><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P1para></P1></P1group><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><Title>Annual fee for information technology systems and literature monitoring</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2014/658/article/7" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/article/7" id="article-7"><Pnumber><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>Article 7</Pnumber><P1para><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P1para></P1></P1group><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><Title>Fee reductions and fee exemption</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2014/658/article/8" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/article/8" id="article-8"><Pnumber><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>Article 8</Pnumber><P1para><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P1para></P1></P1group><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><Title>Payment of remuneration by the Agency to national competent authorities</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2014/658/article/9" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/article/9" id="article-9"><Pnumber><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>Article 9</Pnumber><P1para><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P1para></P1></P1group><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><Title>Method of payment of the fee</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2014/658/article/10" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/article/10" id="article-10"><Pnumber><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>Article 10</Pnumber><P1para><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P1para></P1></P1group><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><Title>Identification of the payment of the fee</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2014/658/article/11" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/article/11" id="article-11"><Pnumber><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>Article 11</Pnumber><P1para><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P1para></P1></P1group><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><Title>Date of payment of the fee</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2014/658/article/12" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/article/12" id="article-12"><Pnumber><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>Article 12</Pnumber><P1para><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P1para></P1></P1group><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><Title>Refund of fee amounts paid in excess</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2014/658/article/13" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/article/13" id="article-13"><Pnumber><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>Article 13</Pnumber><P1para><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P1para></P1></P1group><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><Title>Provisional estimate of Agency budget</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2014/658/article/14" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/article/14" id="article-14"><Pnumber><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>Article 14</Pnumber><P1para><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P1para></P1></P1group><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><Title>Transparency and monitoring</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2014/658/article/15" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/article/15" id="article-15"><Pnumber><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>Article 15</Pnumber><P1para><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P1para></P1></P1group><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><Title>Exercise of the delegation</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2014/658/article/16" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/article/16" id="article-16"><Pnumber><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>Article 16</Pnumber><P1para><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P1para></P1></P1group><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><Title>Transitional provisions</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2014/658/article/17" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/article/17" id="article-17"><Pnumber><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>Article 17</Pnumber><P1para><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P1para></P1></P1group><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><Title>Entry into force and application</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2014/658/article/18" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/article/18" id="article-18"><Pnumber><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>Article 18</Pnumber><P1para><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P1para></P1></P1group><SignedSection DocumentURI="http://www.legislation.gov.uk/eur/2014/658/signature" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/signature" RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><Para><Text><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></Para></SignedSection></EUBody>
      <Schedules RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31" Status="Repealed" Match="false"><Schedule DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex" id="annex" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false" RestrictStartDate="2020-12-31"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>ANNEX</Number><ScheduleBody><EUPart DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex/part/I" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex/part/I" id="annex-part-I" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false" RestrictStartDate="2020-12-31"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>PART I</Number><Title><Strong>FEE FOR ASSESSMENT OF PERIODIC SAFETY UPDATE REPORTS REFERRED TO IN ARTICLE 4</Strong></Title><Division DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex/part/I/division/1" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex/part/I/division/1" id="annex-part-I-division-1" RestrictStartDate="2020-12-31" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>1.</Number><P><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P></Division><Division DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex/part/I/division/2" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex/part/I/division/2" id="annex-part-I-division-2" RestrictStartDate="2020-12-31" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>2.</Number><Title>For the purpose of calculating the amount to be levied on each marketing authorisation holder in application of Article 4(4), the Agency shall calculate the proportion of chargeable units held by each marketing authorisation holder concerned of the total number of chargeable units held by all marketing authorisation holders involved in the procedure.</Title><P><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P></Division><Division DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex/part/I/division/3" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex/part/I/division/3" id="annex-part-I-division-3" RestrictStartDate="2020-12-31" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>3.</Number><P><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P></Division><Division DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex/part/I/division/4" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex/part/I/division/4" id="annex-part-I-division-4" RestrictStartDate="2020-12-31" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>4.</Number><P><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P></Division></EUPart><EUPart DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex/part/II" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex/part/II" id="annex-part-II" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false" RestrictStartDate="2020-12-31"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>PART II</Number><Title><Strong>FEE FOR ASSESSMENT OF A POST-AUTHORISATION SAFETY STUDIES REFERRED TO IN ARTICLE 5</Strong></Title><Division DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex/part/II/division/1" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex/part/II/division/1" id="annex-part-II-division-1" RestrictStartDate="2020-12-31" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>1.</Number><Title>The fee for the assessment of each post-authorisation safety study shall be EUR 
                        45 810 to be paid in two instalments as follows:</Title><P><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P></Division><Division DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex/part/II/division/2" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex/part/II/division/2" id="annex-part-II-division-2" RestrictStartDate="2020-12-31" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>2.</Number><P><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P></Division><Division DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex/part/II/division/3" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex/part/II/division/3" id="annex-part-II-division-3" RestrictStartDate="2020-12-31" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>3.</Number><P><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P></Division><Division DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex/part/II/division/4" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex/part/II/division/4" id="annex-part-II-division-4" RestrictStartDate="2020-12-31" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>4.</Number><P><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P></Division></EUPart><EUPart DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex/part/III" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex/part/III" id="annex-part-III" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false" RestrictStartDate="2020-12-31"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>PART III</Number><Title><Strong>FEE FOR ASSESSMENT IN THE CONTEXT OF REFERRALS INITIATED AS A RESULT OF THE EVALUATION OF PHARMACOVIGILANCE DATA REFERRED TO IN ARTICLE 6</Strong></Title><Division DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex/part/III/division/1" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex/part/III/division/1" id="annex-part-III-division-1" RestrictStartDate="2020-12-31" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>1.</Number><Title>The fee for the assessment of the procedure referred to in Article 6(1) shall be EUR 
                        190 740 where one or two active substances and/or combinations of active substances are included in the assessment. That fee shall be increased by EUR 
                        41 350 per each additional active substance or combination of active substances as of the third active substance or combination of substances. That fee shall not exceed EUR 
                        314 790 irrespective of the number of active substances and/or combinations of active substances.</Title><P><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P></Division><Division DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex/part/III/division/2" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex/part/III/division/2" id="annex-part-III-division-2" RestrictStartDate="2020-12-31" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>2.</Number><Title>For the purpose of calculating the amount to be levied on each marketing authorisation holder in application of Article 6(4), the Agency shall calculate the proportion of chargeable units held by each marketing authorisation holder concerned of the total number of chargeable units held by all marketing authorisation holders involved in the procedure.</Title><P><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P></Division><Division DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex/part/III/division/3" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex/part/III/division/3" id="annex-part-III-division-3" RestrictStartDate="2020-12-31" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>3.</Number><Title>In application of Article 6(5), the amount payable by the marketing authorisation holder shall be two thirds of the applicable fee laid down in point 1 of this Part. Small and medium-sized enterprises shall pay 60 % of that amount.</Title><P><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P></Division><Division DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex/part/III/division/4" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex/part/III/division/4" id="annex-part-III-division-4" RestrictStartDate="2020-12-31" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>4.</Number><P><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P></Division></EUPart><EUPart DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex/part/IV" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex/part/IV" id="annex-part-IV" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false" RestrictStartDate="2020-12-31"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>PART IV</Number><Title><Strong>ANNUAL FEE FOR INFORMATION TECHNOLOGY SYSTEMS AND LITERATURE MONITORING REFERRED TO IN ARTICLE 7</Strong></Title><Division DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex/part/IV/division/1" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex/part/IV/division/1" id="annex-part-IV-division-1" RestrictStartDate="2020-12-31" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>1.</Number><P><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P></Division><Division DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex/part/IV/division/2" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex/part/IV/division/2" id="annex-part-IV-division-2" RestrictStartDate="2020-12-31" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>2.</Number><P><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P></Division><Division DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex/part/IV/division/3" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex/part/IV/division/3" id="annex-part-IV-division-3" RestrictStartDate="2020-12-31" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>3.</Number><P><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P></Division></EUPart><EUPart DocumentURI="http://www.legislation.gov.uk/eur/2014/658/annex/part/V" IdURI="http://www.legislation.gov.uk/id/eur/2014/658/annex/part/V" id="annex-part-V" RestrictStartDate="2020-12-31" RestrictExtent="E+W+S+N.I." Status="Repealed" Match="false"><Number><CommentaryRef Ref="key-0b8144e27bde94d8dbe19442681cb6a3"/>PART V</Number><Title><Strong>PERFORMANCE INFORMATION</Strong></Title><P><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P></EUPart></ScheduleBody></Schedule></Schedules>
   </EURetained><Commentaries><Commentary id="key-0b8144e27bde94d8dbe19442681cb6a3" Type="F"><Para><Text>Regulation revoked (31.12.2020) by <Citation URI="http://www.legislation.gov.uk/id/uksi/2019/775" id="chqgv83u5-00003" Class="UnitedKingdomStatutoryInstrument" Year="2019" Number="775" Title="The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019">The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775)</Citation>, <CitationSubRef CitationRef="chqgv83u5-00003" id="chqgv83u5-00004" SectionRef="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/775/regulation/1">reg. 1</CitationSubRef>, <CitationSubRef CitationRef="chqgv83u5-00003" id="chqgv83u5-00005" SectionRef="schedule-9-paragraph-1-dd" URI="http://www.legislation.gov.uk/id/uksi/2019/775/schedule/9/paragraph/1/dd" Operative="true">Sch. 9 para. 1(dd)</CitationSubRef> (subject to transitional provisions in <Citation URI="http://www.legislation.gov.uk/id/uksi/2012/1916" id="chqgv83u5-00006" Class="UnitedKingdomStatutoryInstrument" Year="2012" Number="1916">S.I. 2012/1916</Citation>, <CitationSubRef CitationRef="chqgv83u5-00006" id="chqgv83u5-00007" SectionRef="schedule-33A" URI="http://www.legislation.gov.uk/id/uksi/2012/1916/schedule/33A">Sch. 33A</CitationSubRef>); <Citation URI="http://www.legislation.gov.uk/id/ukpga/2020/1" id="chqgv83u5-00008" Year="2020" Class="UnitedKingdomPublicGeneralAct" Number="1">2020 c. 1</Citation>, <CitationSubRef CitationRef="chqgv83u5-00008" id="chqgv83u5-00009" SectionRef="schedule-5-paragraph-1-1" URI="http://www.legislation.gov.uk/id/ukpga/2020/1/schedule/5/paragraph/1/1">Sch. 5 para. 1(1)</CitationSubRef></Text></Para></Commentary></Commentaries></Legislation>