http://www.legislation.gov.uk/eur/2012/712/article/2Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance)Commission Regulation (EU) No 712/2012Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance)King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32012R0712texttext/xmlen2024-09-06Expert Participation2020-12-31 http://publications.europa.eu/resource/cellar/370e9528-dfb6-11e1-905c-01aa75ed71a1 370e9528-dfb6-11e1-905c-01aa75ed71a1 cellar http://publications.europa.eu/resource/oj/JOL_2012_209_R_0004_01 JOL_2012_209_R_0004_01 oj http://publications.europa.eu/resource/eli/reg_impl/2012/712/oj reg_impl:2012:712:oj eli http://publications.europa.eu/resource/celex/32012R0712 32012R0712 celex http://publications.europa.eu/resource/authority/document-collection/CELEX CELEX document-collection CELEX CELEX CELEX 32012R0712 oj:JOL_2012_209_R_0004_01 http://data.europa.eu/eli/reg_impl/2012/712/oj http://publications.europa.eu/resource/authority/fd_555/133015 133015 fd_555 133015 133015 Proprietary medicinal products http://publications.europa.eu/resource/authority/fd_555/13 13 fd_555 13 13 Industrial policy and internal market http://publications.europa.eu/resource/authority/fd_555/1330 1330 fd_555 1330 1330 Internal market: approximation of laws 2012-08-03 2012 08 03 celex:32012R0712 http://publications.europa.eu/resource/cellar/6af3ed69-c00a-4629-9deb-a7003a30a52d 6af3ed69-c00a-4629-9deb-a7003a30a52d cellar http://publications.europa.eu/resource/oj/JOL_2001_311_R_0067_01 JOL_2001_311_R_0067_01 oj http://publications.europa.eu/resource/celex/32001L0083 32001L0083 celex http://publications.europa.eu/resource/eli/dir/2001/83/oj dir:2001:83:oj eli http://publications.europa.eu/resource/authority/treaty/TFEU_2008 TFEU_2008 treaty TFEU_2008 TFEU_2008 Treaty on the Functioning of the European Union (consolidated version 2008) TFEU (2008) Consolidated version of the Treaty on the Functioning of the European Union (2008) http://publications.europa.eu/resource/authority/fd_070/SANT SANT fd_070 SANT SANT public health 2012-08-24 2012 08 24 {EV|http://publications.europa.eu/resource/authority/fd_335/EV} {DATPUB|http://publications.europa.eu/resource/authority/fd_335/DATPUB} + 20 {V|http://publications.europa.eu/resource/authority/fd_335/V} {ART|http://publications.europa.eu/resource/authority/fd_335/ART} 3 cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2013-08-04 2013 08 04 {MA|http://publications.europa.eu/resource/authority/fd_335/MA} {MA/PART|http://publications.europa.eu/resource/authority/fd_335/MA%2FPART} {ART|http://publications.europa.eu/resource/authority/fd_335/ART} 1 P.10 - P.15 - P.18.A - P.18.C - P.21 - P.22 - P.23 {V|http://publications.europa.eu/resource/authority/fd_335/V} {ART|http://publications.europa.eu/resource/authority/fd_335/ART} 3 cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2012-11-02 2012 11 02 {MA|http://publications.europa.eu/resource/authority/fd_335/MA} {V|http://publications.europa.eu/resource/authority/fd_335/V} {ART|http://publications.europa.eu/resource/authority/fd_335/ART} 3 cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2012-08-03 2012 08 03 http://publications.europa.eu/resource/cellar/6b6ad3b2-5608-499e-882d-0010dd1921e1 6b6ad3b2-5608-499e-882d-0010dd1921e1 cellar http://publications.europa.eu/resource/eli/reg/2008/1234/oj reg:2008:1234:oj eli http://publications.europa.eu/resource/oj/JOL_2008_334_R_0007_01 JOL_2008_334_R_0007_01 oj http://publications.europa.eu/resource/celex/32008R1234 32008R1234 celex 2012-11-02 {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 12 MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2012-11-02 {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 10 MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2012-11-02 {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 2 MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2012-11-02 {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 16 MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2012-11-02 {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 15 MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2012-11-02 {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 18 MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2013-08-04 {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 20 MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2012-11-02 {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 6 MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2012-11-02 {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 3 MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2012-11-02 {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 1 MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2012-11-02 {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 5 MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 http://eurovoc.europa.eu/3813 3813 EUROVOC 3813 medicament medication http://eurovoc.europa.eu/1415 1415 EUROVOC 1415 pharmaceutical industry pharmaceutical production http://eurovoc.europa.eu/100149 100149 EUROVOC 28 28 SOCIAL QUESTIONS http://eurovoc.europa.eu/100215 100215 EUROVOC 2841 2841 health http://publications.europa.eu/resource/authority/fd_555/133015 133015 fd_555 133015 133015 Proprietary medicinal products 2012 http://publications.europa.eu/resource/authority/fd_070/VETE VETE fd_070 VETE VETE Veterinary legislation true http://publications.europa.eu/resource/cellar/795b76ea-b9e5-4e52-abfd-57c8d5994add 795b76ea-b9e5-4e52-abfd-57c8d5994add cellar http://publications.europa.eu/resource/eli/reg/2008/1234/2012-11-02 reg:2008:1234:2012-11-02 eli http://publications.europa.eu/resource/celex/02008R1234-20121102 02008R1234-20121102 celex http://publications.europa.eu/resource/consolidation/2008R1234%2F20121102 2008R1234/20121102 consolidation http://eurovoc.europa.eu/5451 5451 EUROVOC 5451 market approval ban on sales marketing ban sales ban http://eurovoc.europa.eu/13 13 EUROVOC 13 marketing marketing campaign marketing policy marketing structure http://eurovoc.europa.eu/100147 100147 EUROVOC 20 20 TRADE http://eurovoc.europa.eu/100196 100196 EUROVOC 2031 2031 marketing 0712 2012 http://publications.europa.eu/resource/cellar/fb5ac17e-438b-42a6-835b-c1932a322526 fb5ac17e-438b-42a6-835b-c1932a322526 cellar http://publications.europa.eu/resource/eli/dir/2009/53/oj dir:2009:53:oj eli http://publications.europa.eu/resource/oj/JOL_2009_168_R_0033_01 JOL_2009_168_R_0033_01 oj http://publications.europa.eu/resource/celex/32009L0053 32009L0053 celex http://eurovoc.europa.eu/5734 5734 EUROVOC 5734 veterinary drug veterinary medicines http://eurovoc.europa.eu/1415 1415 EUROVOC 1415 pharmaceutical industry pharmaceutical production http://eurovoc.europa.eu/100149 100149 EUROVOC 28 28 SOCIAL QUESTIONS http://eurovoc.europa.eu/100215 100215 EUROVOC 2841 2841 health http://publications.europa.eu/resource/cellar/76810f3f-d7a4-4393-878f-99fff4602ffc 76810f3f-d7a4-4393-878f-99fff4602ffc cellar http://publications.europa.eu/resource/oj/JOL_2004_136_R_0001_01 JOL_2004_136_R_0001_01 oj http://publications.europa.eu/resource/celex/32004R0726 32004R0726 celex http://publications.europa.eu/resource/eli/reg/2004/726/oj reg:2004:726:oj eli http://publications.europa.eu/resource/cellar/c2c47535-c88b-4327-b1cc-037151f17287 c2c47535-c88b-4327-b1cc-037151f17287 cellar http://publications.europa.eu/resource/oj/JOL_2001_311_R_0001_01 JOL_2001_311_R_0001_01 oj http://publications.europa.eu/resource/celex/32001L0082 32001L0082 celex http://publications.europa.eu/resource/eli/dir/2001/82/oj dir:2001:82:oj eli

27

A27 TER cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 http://publications.europa.eu/resource/authority/corporate-body/COM COM corporate-body COM COM European Commission Commission of the European Communities European Commission Commission http://publications.europa.eu/resource/authority/resource-type/REG_IMPL REG_IMPL resource-type REG_IMPL REG_IMPL Implementing regulation http://eurovoc.europa.eu/5916 5916 EUROVOC 5916 drug surveillance supervision of pharmaceutical drugs supervision of medicinal products pharmaceutical surveillance http://eurovoc.europa.eu/2479 2479 EUROVOC 2479 health policy health health protection http://eurovoc.europa.eu/100149 100149 EUROVOC 28 28 SOCIAL QUESTIONS http://eurovoc.europa.eu/100215 100215 EUROVOC 2841 2841 health <table-of-contents> <p>0004 - 0014</p> <p>ANX P 0014 - 0014</p> </table-of-contents> R 712 http://publications.europa.eu/resource/authority/treaty/TFEU_2008 TFEU_2008 treaty TFEU_2008 TFEU_2008 Treaty on the Functioning of the European Union (consolidated version 2008) TFEU (2008) Consolidated version of the Treaty on the Functioning of the European Union (2008) http://publications.europa.eu/resource/cellar/6b6ad3b2-5608-499e-882d-0010dd1921e1 6b6ad3b2-5608-499e-882d-0010dd1921e1 cellar http://publications.europa.eu/resource/eli/reg/2008/1234/oj reg:2008:1234:oj eli http://publications.europa.eu/resource/oj/JOL_2008_334_R_0007_01 JOL_2008_334_R_0007_01 oj http://publications.europa.eu/resource/celex/32008R1234 32008R1234 celex 2012-11-02 {AN|http://publications.europa.eu/resource/authority/fd_370/AN} MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2012-11-02 {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 23 BI MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2012-11-02 {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 9 P.5 MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2013-08-04 {CHA|http://publications.europa.eu/resource/authority/fd_370/CHA} II BI MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 http://publications.europa.eu/resource/authority/fd_030/REGIMP REGIMP fd_030 REGIMP REGIMP Implementing regulation 32012R0712 1035448 http://publications.europa.eu/resource/cellar/fdee20e5-926e-4df9-9142-8a05efa0e0fd fdee20e5-926e-4df9-9142-8a05efa0e0fd cellar http://publications.europa.eu/resource/eli/reg/2008/1234/2013-08-04 reg:2008:1234:2013-08-04 eli http://publications.europa.eu/resource/celex/02008R1234-20130804 02008R1234-20130804 celex http://publications.europa.eu/resource/consolidation/2008R1234%2F20130804 2008R1234/20130804 consolidation http://eurovoc.europa.eu/5734 5734 EUROVOC 5734 veterinary drug veterinary medicines 9999-12-31 9999 12 31 http://eurovoc.europa.eu/5916 5916 EUROVOC 5916 drug surveillance supervision of pharmaceutical drugs supervision of medicinal products pharmaceutical surveillance 3 http://publications.europa.eu/resource/cellar/faf04c11-20d5-4f82-a967-b24dfdc9b008 faf04c11-20d5-4f82-a967-b24dfdc9b008 cellar http://publications.europa.eu/resource/oj/JOL_2012_209_R JOL_2012_209_R oj 2013-08-04 2013 08 04 2012-11-02 2012 11 02 2012-08-24 2012 08 24 http://data.europa.eu/eli/reg_impl/2012/712/oj http://publications.europa.eu/resource/cellar/6af3ed69-c00a-4629-9deb-a7003a30a52d 6af3ed69-c00a-4629-9deb-a7003a30a52d cellar http://publications.europa.eu/resource/oj/JOL_2001_311_R_0067_01 JOL_2001_311_R_0067_01 oj http://publications.europa.eu/resource/celex/32001L0083 32001L0083 celex http://publications.europa.eu/resource/eli/dir/2001/83/oj dir:2001:83:oj eli 1

23

A23 TER P1 cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2012-08-03 2012 08 03 2016-06-10T22:10:05.467+02:00 2016 06 10 http://publications.europa.eu/resource/authority/fd_070/SANT SANT fd_070 SANT SANT public health http://eurovoc.europa.eu/5451 5451 EUROVOC 5451 market approval ban on sales marketing ban sales ban LIE {P/EEE|http://publications.europa.eu/resource/authority/fd_400/P%2FEEE} http://publications.europa.eu/resource/authority/fd_070/VETE VETE fd_070 VETE VETE Veterinary legislation http://publications.europa.eu/resource/cellar/6b6ad3b2-5608-499e-882d-0010dd1921e1 6b6ad3b2-5608-499e-882d-0010dd1921e1 cellar http://publications.europa.eu/resource/eli/reg/2008/1234/oj reg:2008:1234:oj eli http://publications.europa.eu/resource/oj/JOL_2008_334_R_0007_01 JOL_2008_334_R_0007_01 oj http://publications.europa.eu/resource/celex/32008R1234 32008R1234 celex 2013-08-04 TXT {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 23 MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2012-11-02 TXT {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 21 P.1 MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2013-08-04 {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 24 MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2013-08-04 TIT {AN|http://publications.europa.eu/resource/authority/fd_370/AN} III MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2012-11-02 TXT {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 4 MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2012-11-02 TXT {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 17 MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2012-11-02 TXT {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 7 MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2012-11-02 TXT {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 22 P.1 MS cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 http://eurovoc.europa.eu/3813 3813 EUROVOC 3813 medicament medication http://publications.europa.eu/resource/cellar/c2c47535-c88b-4327-b1cc-037151f17287 c2c47535-c88b-4327-b1cc-037151f17287 cellar http://publications.europa.eu/resource/oj/JOL_2001_311_R_0001_01 JOL_2001_311_R_0001_01 oj http://publications.europa.eu/resource/celex/32001L0082 32001L0082 celex http://publications.europa.eu/resource/eli/dir/2001/82/oj dir:2001:82:oj eli http://publications.europa.eu/resource/cellar/76810f3f-d7a4-4393-878f-99fff4602ffc 76810f3f-d7a4-4393-878f-99fff4602ffc cellar http://publications.europa.eu/resource/oj/JOL_2004_136_R_0001_01 JOL_2004_136_R_0001_01 oj http://publications.europa.eu/resource/celex/32004R0726 32004R0726 celex http://publications.europa.eu/resource/eli/reg/2004/726/oj reg:2004:726:oj eli 4

16

A16P4 cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 6

41

A41P6 cdm:CDM_2.1.7 tdm:1523 xslt:3945 saxon:9.0.0.1J JVM:1.6.0_29 metaconvJar:1.2.0 builddate:11/04/2014 15:17:05 2012-08-03 2012 08 03 celex:32012R0712 http://publications.europa.eu/resource/cellar/54da7b1e-ffdc-4ae2-af32-91caa329fd74 54da7b1e-ffdc-4ae2-af32-91caa329fd74 cellar http://publications.europa.eu/resource/oj/JOL_1987_015_R_0038_026 JOL_1987_015_R_0038_026 oj http://publications.europa.eu/resource/celex/31987L0022 31987L0022 celex http://publications.europa.eu/resource/eli/dir/1987/22/oj dir:1987:22:oj eli 32012R0712 http://publications.europa.eu/resource/authority/corporate-body/COM COM corporate-body COM COM European Commission Commission of the European Communities European Commission Commission 9999-12-31 9999 12 31 http://publications.europa.eu/resource/cellar/197cddb4-58e7-11e3-a8cb-01aa75ed71a1 197cddb4-58e7-11e3-a8cb-01aa75ed71a1 cellar http://publications.europa.eu/resource/oj/DD_2013_13_064_HR DD_2013_13_064_HR oj http://publications.europa.eu/resource/uriserv/DD.HRV.13.064.FULL DD.HRV.13.064.FULL uriserv http://publications.europa.eu/resource/authority/document-collection/JO JO document-collection JO JO JO MAN2 http://data.europa.eu/eli/reg_impl/2012/712/oj oj:JOL_2012_209_R_0004_01 cdm:resource_legal R cdm:regulation cdm:regulation_implementing cdm:legislation_secondary cdm:work http://publications.europa.eu/resource/cellar/370e9528-dfb6-11e1-905c-01aa75ed71a1.0006 370e9528-dfb6-11e1-905c-01aa75ed71a1.0006 cellar http://publications.europa.eu/resource/oj/JOL_2012_209_R_0004_01.ENG JOL_2012_209_R_0004_01.ENG oj http://publications.europa.eu/resource/uriserv/OJ.L_.2012.209.01.0004.01.ENG OJ.L_.2012.209.01.0004.01.ENG uriserv http://publications.europa.eu/resource/celex/32012R0712.ENG 32012R0712.ENG celex en Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products Text with EEA relevance 2014-11-20T07:18:01.666+01:00 2014 11 20 eng http://publications.europa.eu/resource/authority/language/ENG ENG language ENG ENG English English Article 2From 2 November 2012, the following changes shall apply:in Article 23(1) of Regulation (EC) No 1234/2008, the reference to ‘Chapters II and III’ is replaced by ‘Chapter II’;in Article 23(1) of Regulation (EC) No 1234/2008, subparagraph (a) is deleted.