Glossary:TAG-00340-Req-nfo

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

	Scope	Document part	Language	Document
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40a	G	§ 40a	DE	DEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b-001	G	§ 40b	DE	DEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41b	G	§ 41b	DE	DEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42b	HM	§ 42b	DE	DEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 f Absatz 1 – 3	HM	§ 63 f Absatz 1 – 3	DE	DEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 g Absatz 1 – 2	HM	§ 63 g Absatz 1 – 2	DE	DEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63f	HM	§ 63f	DE	DEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63g	HM	§ 63g	DE	DEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 4	NIS	Leitlinie 4	DE	DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.1	NIS	Leitlinie 6 6.1	DE	DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.2	NIS	1.2	DE	DEU 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 3.2	NIS	3.2	DE	DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 4	G	§ 4	DE	DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 5	G	§ 5	DE	DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 28 Absatz 1 – 2	MD	§ 28 Absatz 1 – 2	DE	DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 47-001	MD	§ 47	DE	DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 47-002	MD	§ 47	DE	DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU StrlSchG - Strahlenschutzgesetz 03-Jan-2022 § 32	G	§ 32	DE	DEU 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 2.5-002	G	2.5	EN	EU 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	-	EN	EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)
EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.4.3	NIS	VIII.B.4.3	EN	EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)
EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 Article 6 Paragraph 1	G	Article 6 Paragraph 1	EN	EU Regulation (EU) 2016/679 (GDPR) 04-May-2016
EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 Article 9 Paragraph 1	G	Article 9 Paragraph 1	EN	EU Regulation (EU) 2016/679 (GDPR) 04-May-2016
EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 Article 9 Paragraph 2	G	Article 9 Paragraph 2	EN	EU Regulation (EU) 2016/679 (GDPR) 04-May-2016
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 1	MD	Article 62 Paragraph 1	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 4	MD	Article 62 Paragraph 4	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 1	MD	Article 63 Paragraph 1	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 69	MD	Article 69	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 82	MD	Article 82	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 57	IVD	Article 57	EN	EU 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)	IVD	Article 58 Paragraph 5 (j)	EN	EU 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 5-001	IVD	Article 58 Paragraph 5	EN	EU 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 5-002	IVD	Article 58 Paragraph 5	EN	EU 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 1	IVD	Article 59 Paragraph 1	EN	EU 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 65	IVD	Article 65	EN	EU 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 1	HM	Article 29 Paragraph 1	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 50	HM	Article 50	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 76	HM	Article 76	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 9	G	Article 9	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble Preamble	HM	Preamble	EN	EU 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 R1121-3-1	G	Article R1121-3-1	FR	FRA 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 34	G	Article 34	FR	FRA Constitution du 4 octobre 1958 10-Mar-2024
FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 55	G	Article 55	FR	FRA Constitution du 4 octobre 1958 10-Mar-2024
FRA Infographie - La hiérarchie des normes 22-Mar-2024 N/A	G	N/A	FR	FRA Infographie - La hiérarchie des normes 22-Mar-2024
GBR Data Protection Act 2018 06-Jun-2022 Article 2	G	Article 2	EN	GBR 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	-	EN	GBR 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 7-10	HM	Article 7-10	EN	GBR 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.	HM	Schedule 1 Part 2 16.	EN	GBR 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 1	G	Article 6 Paragraph 1	EN	GBR 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 1	G	Article 9 Paragraph 1	EN	GBR 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 2	G	Article 9 Paragraph 2	EN	GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020
ICH ICH E3 Guideline 1995 -	G	-	EN	ICH ICH E3 Guideline 1995
ICH ICH E6 Guideline R3 (2025) Appendix A	G	Appendix A	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 1	G	III. Annex 1 1	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8	G	III. Annex 1 2.8	EN	ICH ICH E6 Guideline R3 (2025)
INT ISPE - GPP Revision 3 (2015) II.	INS	II.	EN	INT ISPE - GPP Revision 3 (2015)
USA 21 CFR Part 11 09-Apr-2025 § 11.100	G	§ 11.100	EN	USA 21 CFR Part 11 09-Apr-2025
USA 21 CFR Part 11 09-Apr-2025 § 11.50	G	§ 11.50	EN	USA 21 CFR Part 11 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.40 (b)	HM	§ 312.40 (b)	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 320 09-Apr-2025 § 320.22	HM	§ 320.22	EN	USA 21 CFR Part 320 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 Subpart B	G	Subpart B	EN	USA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 Subpart C	G	Subpart C	EN	USA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 § 56.103	G	§ 56.103	EN	USA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 § 56.109	G	§ 56.109	EN	USA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 § 56.111 - §56.112	G	§ 56.111 - §56.112	EN	USA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 Subpart B	MD	Subpart B	EN	USA 21 CFR Part 812 09-Apr-2025
USA 42 CFR Part 11 09-Apr-2025 § 11.24	G	§ 11.24	EN	USA 42 CFR Part 11 09-Apr-2025
USA 42 CFR Part 11 09-Apr-2025 § 11.40	G	§ 11.40	EN	USA 42 CFR Part 11 09-Apr-2025
USA 42 CFR Part 11 09-Apr-2025 § 11.54	G	§ 11.54	EN	USA 42 CFR Part 11 09-Apr-2025
USA 42 CFR Part 11 09-Apr-2025 § 11.6	G	§ 11.6	EN	USA 42 CFR Part 11 09-Apr-2025
USA 42 CFR Part 11 09-Apr-2025 § 11.64	G	§ 11.64	EN	USA 42 CFR Part 11 09-Apr-2025
USA 42 CFR Part 11 09-Apr-2025 § 11.8	G	§ 11.8	EN	USA 42 CFR Part 11 09-Apr-2025
USA 45 CFR Part 160 09-Apr-2025 § 164.508	G	§ 164.508	EN	USA 45 CFR Part 160 09-Apr-2025
USA 45 CFR Part 160 09-Apr-2025 § 164.512	G	§ 164.512	EN	USA 45 CFR Part 160 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 Subpart E	G	Subpart E	EN	USA 45 CFR Part 46 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 § 46.107 - § 46.112	G	§ 46.107 - § 46.112	EN	USA 45 CFR Part 46 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 § 46.113	G	§ 46.113	EN	USA 45 CFR Part 46 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 § 46.115	G	§ 46.115	EN	USA 45 CFR Part 46 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 § 46.123	G	§ 46.123	EN	USA 45 CFR Part 46 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 § 46.124	G	§ 46.124	EN	USA 45 CFR Part 46 09-Apr-2025
USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 510 (k)	G	Sec 510 (k)	EN	USA 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 requirements	HM	Glossary - 1.5 Regulatory requirements	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995