Personal tools

Sponsorname

Your company could advertise here

www.fla-consulting.eu

Glossary:TAG-00340-Req-nfo

From GxPlex

Revision as of 17:29, 15 July 2026 by gxplex>GxPlexBot (Import from GxPlex Excel)
Jump to: navigation, search


Glossary > Requirements

Requirements
Tag-ID TAG-00340-Req-nfo
English Requirements / Regulatory requirements / Legal requirements / Procedural requirements / Applicable requirements
French Exigences / Exigences réglementaires / Exigences légales / Exigences procédurales / Exigences applicables
German Anforderungen / Regulatorische Anforderungen / Gesetzliche Anforderungen / Verfahrensanforderungen / Geltende Anforderungen

References

 ScopeDocument partLanguageDocument
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40aG§ 40aDEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b-001G§ 40bDEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41bG§ 41bDEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42bHM§ 42bDEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 f Absatz 1 – 3HM§ 63 f Absatz 1 – 3DEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 g Absatz 1 – 2HM§ 63 g Absatz 1 – 2DEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63fHM§ 63fDEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63gHM§ 63gDEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 4NISLeitlinie 4DEDEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.1NISLeitlinie 6 6.1DEDEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.2NIS1.2DEDEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.2NIS3.2DEDEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 4G§ 4DEDEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 5G§ 5DEDEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 28 Absatz 1 – 2MD§ 28 Absatz 1 – 2DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 47-001MD§ 47DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 47-002MD§ 47DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU StrlSchG - Strahlenschutzgesetz 03-Jan-2022 § 32G§ 32DEDEU StrlSchG - Strahlenschutzgesetz 03-Jan-2022
EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-002G2.5ENEU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022
EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) -NIS-ENEU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)
EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.4.3NISVIII.B.4.3ENEU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)
EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 Article 6 Paragraph 1GArticle 6 Paragraph 1ENEU Regulation (EU) 2016/679 (GDPR) 04-May-2016
EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 Article 9 Paragraph 1GArticle 9 Paragraph 1ENEU Regulation (EU) 2016/679 (GDPR) 04-May-2016
EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 Article 9 Paragraph 2GArticle 9 Paragraph 2ENEU Regulation (EU) 2016/679 (GDPR) 04-May-2016
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 1MDArticle 62 Paragraph 1ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 4MDArticle 62 Paragraph 4ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 1MDArticle 63 Paragraph 1ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 69MDArticle 69ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 82MDArticle 82ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 57IVDArticle 57ENEU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 5 (j)IVDArticle 58

Paragraph 5

(j)		ENEU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 5-001IVDArticle 58 Paragraph 5ENEU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 5-002IVDArticle 58 Paragraph 5ENEU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 1IVDArticle 59 Paragraph 1ENEU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 65IVDArticle 65ENEU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 1HMArticle 29 Paragraph 1ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 50HMArticle 50ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 76HMArticle 76ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 9GArticle 9ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble PreambleHMPreambleENEU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble
FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 Article R1121-3-1GArticle R1121-3-1FRFRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025
FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 34GArticle 34FRFRA Constitution du 4 octobre 1958 10-Mar-2024
FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 55GArticle 55FRFRA Constitution du 4 octobre 1958 10-Mar-2024
FRA Infographie - La hiérarchie des normes 22-Mar-2024 N/AGN/AFRFRA Infographie - La hiérarchie des normes 22-Mar-2024
GBR Data Protection Act 2018 06-Jun-2022 Article 2GArticle 2ENGBR Data Protection Act 2018 06-Jun-2022
GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019 -G-ENGBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 7-10HMArticle 7-10ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 16.HMSchedule 1

Part 2

16.		ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020 Article 6 Paragraph 1GArticle 6 Paragraph 1ENGBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020
GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020 Article 9 Paragraph 1GArticle 9 Paragraph 1ENGBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020
GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020 Article 9 Paragraph 2GArticle 9 Paragraph 2ENGBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020
ICH ICH E3 Guideline 1995 -G-ENICH ICH E3 Guideline 1995
ICH ICH E6 Guideline R3 (2025) Appendix AGAppendix AENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 1GIII. Annex 1 1ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8GIII. Annex 1 2.8ENICH ICH E6 Guideline R3 (2025)
INT ISPE - GPP Revision 3 (2015) II.INSII.ENINT ISPE - GPP Revision 3 (2015)
USA 21 CFR Part 11 09-Apr-2025 § 11.100G§ 11.100ENUSA 21 CFR Part 11 09-Apr-2025
USA 21 CFR Part 11 09-Apr-2025 § 11.50G§ 11.50ENUSA 21 CFR Part 11 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.40 (b)HM§ 312.40 (b)ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 320 09-Apr-2025 § 320.22HM§ 320.22ENUSA 21 CFR Part 320 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 Subpart BGSubpart BENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 Subpart CGSubpart CENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 § 56.103G§ 56.103ENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 § 56.109G§ 56.109ENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 § 56.111 - §56.112G§ 56.111

-

§56.112		ENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 Subpart BMDSubpart BENUSA 21 CFR Part 812 09-Apr-2025
USA 42 CFR Part 11 09-Apr-2025 § 11.24G§ 11.24ENUSA 42 CFR Part 11 09-Apr-2025
USA 42 CFR Part 11 09-Apr-2025 § 11.40G§ 11.40ENUSA 42 CFR Part 11 09-Apr-2025
USA 42 CFR Part 11 09-Apr-2025 § 11.54G§ 11.54ENUSA 42 CFR Part 11 09-Apr-2025
USA 42 CFR Part 11 09-Apr-2025 § 11.6G§ 11.6ENUSA 42 CFR Part 11 09-Apr-2025
USA 42 CFR Part 11 09-Apr-2025 § 11.64G§ 11.64ENUSA 42 CFR Part 11 09-Apr-2025
USA 42 CFR Part 11 09-Apr-2025 § 11.8G§ 11.8ENUSA 42 CFR Part 11 09-Apr-2025
USA 45 CFR Part 160 09-Apr-2025 § 164.508G§ 164.508ENUSA 45 CFR Part 160 09-Apr-2025
USA 45 CFR Part 160 09-Apr-2025 § 164.512G§ 164.512ENUSA 45 CFR Part 160 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 Subpart EGSubpart EENUSA 45 CFR Part 46 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 § 46.107 - § 46.112G§ 46.107 - § 46.112ENUSA 45 CFR Part 46 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 § 46.113G§ 46.113ENUSA 45 CFR Part 46 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 § 46.115G§ 46.115ENUSA 45 CFR Part 46 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 § 46.123G§ 46.123ENUSA 45 CFR Part 46 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 § 46.124G§ 46.124ENUSA 45 CFR Part 46 09-Apr-2025
USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 510 (k)GSec 510 (k)ENUSA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - 1.5 Regulatory requirementsHMGlossary - 1.5 Regulatory requirementsENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
Retrieved from "https://gxplex.org/index.php?title=Glossary:TAG-00340-Req-nfo&oldid=20280"