Skip to main content

Research and Innovation Binding Text and Guidance

For GTMP

For Cell Therapy and Tissue Engineered Products

Genetically Modified Organisms (GMOs) 

  • Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19), OJ L 231, 17.7.2020, p. 12–16, CELEX number: 32020R1043 
    • Proposal (Proposal for a Regulation of the European Parliament and of the Council on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease, COM/2020/261 final, CELEX number: 52020PC0261) 
    • Original text 
  • Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (Text with EEA relevance), OJ L 125, 21.5.2009, p. 75–97, CELEX number: 32009L0041 
    • Proposal (Proposal for a Directive of the European Parliament and of the Council on the contained use of genetically modified micro-organisms (Recast), COM/2007/0736 final - COD 2007/0259, CELEX number: 52007PC0736) 
    • Original text 
    • Document summary 
  • 2000/608/EC: Commission Decision of 27 September 2000 concerning the guidance notes for risk assessment outlined in Annex III of Directive 90/219/EEC on the contained use of genetically modified micro-organisms (notified under document number C(2000) 2736) (Text with EEA relevance), OJ L 258, 12.10.2000, p. 43–48, CELEX number: 32000D0608 
  • Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (Text with EEA relevance), OJ L 287, 5.11.2003, p. 1–10, CELEX number: 32003R1946 
    • Proposal (Proposal for a Regulation of the European Parliament and of the Council on the transboundary movement of genetically modified organisms, COM/2002/0085 final - COD 2002/0046, OJ C 151 E, 25.6.2002, p. 121–128, CELEX number: 52002PC0085) 
    • Original text 
    • Document summary 
  • Commission Implementing Decision (EU) 2021/1161 of 13 July 2021 amending Decision 2011/891/EU and Implementing Decisions (EU) 2017/1211, (EU) 2017/1212, (EU) 2017/2449, (EU) 2019/2085 and (EU) 2019/2086 as regards the authorisation holder and its representative in the Union for the placing on the market of products containing, consisting of, or produced from certain genetically modified organisms (notified under document C(2021) 5148) (Text with EEA relevance) (Only the Dutch text is authentic), C/2021/5148, OJ L 252, 15.7.2021, p. 1–6, CELEX number: 32021D1161 
  • Commission Implementing Decision (EU) 2021/184 of 12 February 2021 amending Decisions 2009/813/EC, 2009/814/EC and 2010/429/EU and Implementing Decisions 2012/82/EU, 2012/83/EU, 2012/347/EU, 2013/649/EU, (EU) 2015/683, (EU) 2015/684, (EU) 2015/685, (EU) 2015/686, (EU) 2015/687, (EU) 2015/688, (EU) 2015/689, (EU) 2015/693, (EU) 2015/695, (EU) 2015/696, (EU) 2015/700, (EU) 2015/701, (EU) 2015/2279, (EU) 2015/2281, (EU) 2016/1216, (EU) 2016/1217, (EU) 2017/1207, (EU) 2018/1111, (EU) 2018/2045, (EU) 2018/2046, (EU) 2019/1307, (EU) 2019/1308, (EU) 2019/1309, (EU) 2019/2083 and (EU) 2020/1360 as regards the authorisation holder and its representative in the Union for the placing on the market of products containing, consisting of or produced from certain genetically modified organisms (notified under document C(2021) 826) (Only the Dutch text is authentic) (Text with EEA relevance), C/2021/826, OJ L 55, 16.2.2021, p. 4–23, CELEX number: 32021D0184 
  • Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC (Text with EEA relevance.), OJ L 231, 6.9.2019, p. 1–28, CELEX number: 32019R1381 
    • Proposal (Proposal for a Regulation of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain amending Regulation (EC) No 178/2002 [on general food law], Directive 2001/18/EC [on the deliberate release into the environment of GMOs], Regulation (EC) No 1829/2003 [on GM food and feed], Regulation (EC) No 1831/2003 [on feed additives], Regulation (EC) No 2065/2003 [on smoke flavourings], Regulation (EC) No 1935/2004 [on food contact materials], Regulation (EC) No 1331/2008 [on the common authorisation procedure for food additives, food enzymes and food flavourings], Regulation (EC) No 1107/2009 [on plant protection products] and Regulation (EU) No 2015/2283 [on novel foods], COM/2018/0179 final - 2018/088 (COD), CELEX number: 52018PC0179) 
    • Original text 
    • Document summary 

 

  • Commission Directive (EU) 2018/350 of 8 March 2018 amending Directive 2001/18/EC of the European Parliament and of the Council as regards the environmental risk assessment of genetically modified organisms, OJ L 67, 9.3.2018, p. 30–45, CELEX number: 32018L0350 
  • Commission Implementing Regulation (EU) No 120/2014 of 7 February 2014 amending Regulation (EC) No 1981/2006 on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and the Council as regards the Community reference laboratory for genetically modified organisms Text with EEA relevance, OJ L 39, 8.2.2014, p. 46–52, CELEX number: 32014R0120 
  • 2009/770/EC: Commission Decision of 13 October 2009 establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council (notified under document C(2009) 7680) (Text with EEA relevance), OJ L 275, 21.10.2009, p. 9–27, CELEX number: 32009D0770 
  • Directive 2008/27/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, as regards the implementing powers conferred on the Commission, OJ L 81, 20.3.2008, p. 45–47, CELEX number: 32008L0027 
    • Proposal (Proposal for a Directive of the European Parliament and of the Council Amending Directive 2001/18/CE concerning the deliberate release into the environment of genetically modified organisms, as regards the implementing powers conferred to the Commission, COM/2006/0920 final - COD 2006/0296, CELEX number: 52006PC0920) 
    • Original text 
  • Commission Regulation (EC) No 1981/2006 of 22 December 2006 on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the Community reference laboratory for genetically modified organisms (Text with EEA relevance), OJ L 368, 23.12.2006, p. 99–109, CELEX number: 32006R1981 
  • Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms, OJ L 10, 16.1.2004, p. 5–10, CELEX number: 32004R0065 
  • 2002/813/EC: Council Decision of 3 October 2002 establishing, pursuant to Directive 2001/18/EC of the European Parliament and of the Council, the summary notification information format for notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than for placing on the market, OJ L 280, 18.10.2002, p. 62–83, CELEX number: 32002D0813 
  • 2002/812/EC: Council Decision of 3 October 2002 establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the summary information format relating to the placing on the market of genetically modified organisms as or in products, OJ L 280, 18.10.2002, p. 37–61, CELEX number: 32002D0812 
  • 2002/811/EC: Council Decision of 3 October 2002 establishing guidance notes supplementing Annex VII to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, OJ L 280, 18.10.2002, p. 27–36, CELEX number: 32002D0811 
    • Proposal (Proposal for a Council Decision establishing guidance notes supplementing Annex VII to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC /* COM/2002/0359 final */ OJ C 262E , 29.10.2002, p. 325–335) 
    • Original text 
  • Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC - Commission Declaration, OJ L 106, 17.4.2001, p. 1–39, CELEX number: 32001L0018 
    • Proposal (Proposal for a European Parliament and Council Directive amending Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms, COM/98/0085 final - COD 98/0072, OJ C 139, 4.5.1998, p. 1, CELEX number: 51998PC0085) 
    • Amended proposal (Amended proposal for a European Parliament and Council Directive amending Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms, COM/99/0139 final - COD 98/0072, OJ C 139, 19.5.1999, p. 7, CELEX number: 51999PC0139) 
    • Original text 
    • Consolidated text 
    • Document summary 
  • 96/134/EC: Commission Decision of 16 January 1996 amending Decision 91/448/EEC concerning guidelines for classification referred to in Article 4 of Council Directive 90/219/EEC on the contained use of genetically modified micro-organisms (Text with EEA relevance), OJ L 31, 9.2.1996, p. 25–27, CELEX number: 31996D0134 
  • 93/572/EEC: Commission Decision of 19 October 1993 concerning the placing on the market of a product containing genetically modified organisms pursuant to Article 13 of Council Directive 90/220/EEC, OJ L 276, 9.11.1993, p. 16–17, CELEX number: 31993D0572 
  • 91/596/EEC: Council Decision of 4 November 1991 concerning the Summary Notification Information Format referred to in Article 9 of Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms, OJ L 322, 23.11.1991, p. 1–16, CELEX number: 31991D0596 
    • Proposal (Proposal For A Council Decision Concerning The Summary Notification Information Format Referred To In Article 9 Of Directive 90/220/Eec/* Com/91/282final */) 
    • Original text 
    • Consolidated text 

Medical Devices (MD) 

  • Commission Implementing Decision (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment, C/2022/9, OJ L 1, 5.1.2022, p. 11–13, CELEX number: 32022D0006 
  • Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices, C/2021/8984, OJ L 448, 15.12.2021, p. 32–38, CELEX number: 32021R2226 
  • Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed), C/2021/8447, OJ L 426, 29.11.2021, p. 9–15, CELEX number: 32021R2078 
  • Commission Delegated Directive (EU) 2021/1978 of 11 August 2021 amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices (Text with EEA relevance), C/2021/5866, OJ L 402, 15.11.2021, p. 65–68, CELEX number: 32021L1978 
  • Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council, C/2021/5210, OJ L 256, 19.7.2021, p. 100–102, CELEX number: 32021D1182 
  • Commission Implementing Decision (EU) 2021/611 of 14 April 2021 amending Implementing Decision (EU) 2020/438 as regards harmonised standards on biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products and clinical investigation of medical devices for human subjects, C/2021/2434, OJ L 129, 15.4.2021, p. 158–160, CELEX number: 32021D0611 
  • Commission Implementing Decision (EU) 2021/610 of 14 April 2021 amending Implementing Decision (EU) 2020/437 as regards harmonised standards on medical vehicles and their equipment, anaesthetic and respiratory equipment, biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products, clinical investigation of medical devices for human subjects, non-active surgical implants, medical devices utilising animal tissues and their derivatives, electroacoustics and medical electrical equipment, C/2021/2439, OJ L 129, 15.4.2021, p. 153–157, CELEX number: 32021D0610 
  • Commission Implementing Decision (EU) 2021/609 of 14 April 2021 amending Implementing Decision (EU) 2020/439 as regards harmonised standards on packaging for terminally sterilised medical devices and sterilisation of health care products, C/2021/2432, OJ L 129, 15.4.2021, p. 150–152, CELEX number: 32021D0609 
  • Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions (Text with EEA relevance), OJ L 130, 24.4.2020, p. 18–22, CELEX number: 32020R0561 
    • Proposal (Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions (Text with EEA relevance), COM(2020) 144 final, 2020/0060(COD) 
    • Original text 
  • Commission Implementing Decision (EU) 2020/439 of 24 March 2020 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Directive 98/79/EC of the European Parliament and of the Council, C/2020/1903, OJ L 90I, 25.3.2020, p. 33–39, CELEX number: 32020D0439 
  • Commission Implementing Decision (EU) 2020/438 of 24 March 2020 on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC, C/2020/1902, OJ L 90I, 25.3.2020, p. 25–32, CELEX number: 32020D0438 
  • Commission Implementing Decision (EU) 2020/437 of 24 March 2020 on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC, C/2020/1901, OJ L 90I, 25.3.2020, p. 1–24, CELEX number: 32020D0437 
  • Commission Implementing Decision (EU) 2019/1396 of 10 September 2019 laying down the rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the designation of expert panels in the field of medical devices (Text with EEA relevance.), C/2019/6414, OJ L 234, 11.9.2019, p. 23–30, CELEX number: 32019D1396 
  • Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices (Text with EEA relevance.), C/2019/4068, OJ L 149, 7.6.2019, p. 73–75, CELEX number: 32019D0939 
  • Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council (Text with EEA relevance. ), C/2017/7779, OJ L 309, 24.11.2017, p. 7–17, CELEX number: 32017R2185 
  • Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance), OJ L 117, 5.5.2017, p. 1–175, CELEX number: 32017R0745 
    • Proposal (Proposal for a Regulation of the European Parliament and the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, COM/2012/0542 final, 2012/0266 (COD), CELEX number: 52012PC0542) 
    • Original text 
    • Consolidated text 
    • Document summary 
  • Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices Text with EEA relevance, OJ L 253, 25.9.2013, p. 8–19, CELEX number: 32013R0920 
  • Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices Text with EEA relevance, OJ L 72, 10.3.2012, p. 28–31, CELEX number: 32012R0207 
  • 2010/227/: Commission Decision of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (notified under document C(2010) 2363) (Text with EEA relevance), OJ L 102, 23.4.2010, p. 45–48, CELEX number: 32010D0227 
  • Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance), OJ L 210, 12.8.2005, p. 41–43, CELEX number: 32005L0050 
  • Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices (Text with EEA relevance), OJ L 28, 4.2.2003, p. 43–44, CELEX number: 32003L0012 
  • Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance), OJ L 117, 5.5.2017, p. 176–332, CELEX number: 32017R0746 
  • 2011/869/EU: Commission Decision of 20 December 2011 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (notified under document C(2011) 9398) Text with EEA relevance, OJ L 341, 22.12.2011, p. 63–64, CELEX number: 32011D0869 
  • 2009/886/EC: Commission Decision of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (notified under document C(2009) 9464) (Text with EEA relevance), OJ L 318, 4.12.2009, p. 25–40, CELEX number: 32009D0886 
  • 2002/364/EC: Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (Text with EEA relevance) (notified under document number C(2002) 1344), OJ L 131, 16.5.2002, p. 17–30, CELEX number: 32002D0364 
  • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, OJ L 331, 7.12.1998, p. 1–37, CELEX number: 31998L0079 
  • Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (Text with EEA relevance), OJ L 212, 9.8.2012, p. 3–12, CELEX number: 32012R0722 

Fundamental research

Discovery phase leading to Proof of concept

Pre-clinical model

Good Laboratory practices

Non-clinical development (safety and efficacy studies)

Research on existing collections of samples

Biobanks

Registries

 

Research on new collections of samples

 

Manufacturing phase

Good manufacturing practices

Chemistry Manufacturing Controls (CMC)

 

Clinical research

Clinical trial

Good Clinical Practices

Funding

  • Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014, OJ L 107, 26.3.2021, pp. 1–29, CELEX number: 32021R0522 

ATMP certification procedure by CAT

Intellectual Property rights

Patentability

 

Early interactions with regulators

EMA- Innovation Task Force Briefing meetings

EMA- Scientific advice and Protocol Assistance

Early support from national competent authorities

Parallel advices (EMA/HTA, EMA/FDA)

 

War der Inhalt dieser Seite nützlich? Teilen Sie Ihre Gedanken und Eindrücke mit uns.