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Glossary:TAG-00059-Reg-lat

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Glossary > Regulatory submission

Regulatory submission
Tag-ID TAG-00059-Reg-lat
English Regulatory submission / Regulatory application / Regulatory dossier
French Soumission réglementaire / Dossier réglementaire / Demande d'autorisation
German Regulatorische Einreichung / Regulatorischer Antrag / Zulassungsantrag

References

 ScopeDocument partLanguageDocument
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40G§ 40DEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40 Absatz 2G§ 40 Absatz 2DEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 10G§ 10DEDEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 6G§ 6DEDEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 7G§ 7DEDEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 38MD§ 38DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 39MD§ 39DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 70 Paragraph 1MDArticle 70 Paragraph 1ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 70 Paragraph 6 – 7MDArticle 70 Paragraph 6 – 7ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 66 Paragraph 1IVDArticle 66 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 66 Paragraph 6 – 7IVDArticle 66 Paragraph 6 – 7ENEU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 11GArticle 11ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 13GArticle 13ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 14GArticle 14ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 16HMArticle 16ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 17 Paragraph 1-3HMArticle 17 Paragraph 1-3ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 17 Paragraph 4-5HMArticle 17 Paragraph 4-5ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 18 Paragraph 1-3HMArticle 18 Paragraph 1-3ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 19 Paragraph 1HMArticle 19 Paragraph 1ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 19 Paragraph 2-4HMArticle 19 Paragraph 2-4ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 20 Paragraph 1-3HMArticle 20 Paragraph 1-3ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 20 Paragraph 4-7HMArticle 20 Paragraph 4-7ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 21HMArticle 21ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 22HMArticle 22ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 23 Paragraph 1-2HMArticle 23 Paragraph 1-2ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 23 Paragraph 3-6HMArticle 23 Paragraph 3-6ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 24HMArticle 24ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 5GArticle 5ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 6GArticle 6ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 7GArticle 7ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 8GArticle 8ENEU 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
FRA AEC DOC010 V.04 01-Jun-2018 -HM-FRFRA AEC DOC010 V.04 01-Jun-2018
FRA AEC-DM-DMDIV DOC006 v04 AAP RDM Partie II Modalités pratiques 16-May-2025 -MD-FRFRA AEC-DM-DMDIV DOC006 v04 AAP RDM Partie II Modalités pratiques 16-May-2025
GBR IRAS - Integrated Research Application System 28-Jan-2025 IRASGIRASENGBR IRAS - Integrated Research Application System 28-Jan-2025
GBR IRAS - Integrated Research Application System 28-Jan-2025 TemplatesGTemplatesENGBR IRAS - Integrated Research Application System 28-Jan-2025
GBR NIHR - National Institute for Health and Care Research 28-Jan-2025 -G-ENGBR NIHR - National Institute for Health and Care Research 28-Jan-2025
GBR The Human Medicines Regulations 2012 01-Jan-2025 Article 51BHMArticle 51BENGBR The Human Medicines Regulations 2012 01-Jan-2025
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 14HMArticle 14ENGBR 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 Article 15 (1) - (6)HMArticle 15 (1) - (6)ENGBR 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 Article 16HMArticle 16ENGBR 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 Article 17HMArticle 17ENGBR 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 Article 18HMArticle 18ENGBR 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 Article 19 - 20HMArticle 19 - 20ENGBR 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 3 Part 1 1.HMSchedule 3

Part 1

1.		ENGBR 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 3 Part 1 1. ; 3.HMSchedule 3

Part 1

1. ; 3.		ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
USA 21 CFR Part 812 09-Apr-2025 Subpart BMDSubpart BENUSA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.30MD§ 812.30ENUSA 21 CFR Part 812 09-Apr-2025
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.8 - 4.9HM4.8 - 4.9ENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
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