EMA- European Network of Paediatric Research at the European Medicines Agency- Informed Consent for Paediatric Trials in Europe 2015 (revision 06 June 2023)

https://www.ema.europa.eu/en/documents/other/informed-consent-paediatric-clinical-trials-europe-2015_en.pdf

EUDRALEX Volume 10

https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-10_en#set-of-documents-applicable-to-clinical-trials-authorised-under-regulation-eu-no-5362014

EU Regulation No. 910/2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (eIDAS)

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2014.257.01.0073.01.ENG

Regulation (EU) 2016/679- General Data Protection Regulation- (GDPR)

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32016R0679

Sweden

Swedish Medical Products Agency/Lakemedelsverket (“MPA”)

https://www.lakemedelsverket.se/en

Swedish Ethical Review Authority/Etikprövningsmyndigheten (“ERA”)

https://www.government.se/government-agencies/the-swedish-ethics-review-authority-etikprovningsmyndigheten/

Swedish Work Environment Authority

https://www.av.se/en/health-and-safety/genetic-engineering--contained-use-of-gmms/?hl=GMO

Swedish Regulations:

The Medical Products Agency’s regulations (LVFS 2004:6) on good manufacturing practice for pharmaceuticals.

https://www.lakemedelsverket.se/sv/lagar-och-regler/foreskrifter/2004-6

The Medical Products Agency's regulations and general guidelines (LVFS 2004:7) on permits for the manufacture and import of pharmaceuticals.

https://www.lakemedelsverket.se/sv/lagar-och-regler/foreskrifter/2004-7

Swedish Medical Products Agency’s regulations (HSLF-FS 2021:2019) on supplementary provisions to the EU Regulation on clinical trials of medicinal products of human use

https://www.lakemedelsverket.se/sv/lagar-och-regler/foreskrifter/2021-109

New Biobank Act

https://biobanksverige.se/wp-content/uploads/2023/06/the-biobank-act-2023-38.pdf

Medicinal Products Act (2015:315)

https://www.riksdagen.se/sv/dokument-och-lagar/dokument/svensk-forfattningssamling/lakemedelslag-2015315_sfs-2015-315/#K7

Medicinal Product Ordinance (2015:458)

https://www.riksdagen.se/sv/dokument-och-lagar/dokument/svensk-forfattningssamling/lakemedelsforordning-2015458_sfs-2015-458/#K4

Swedish Data Protection Act (2018:218)

https://www.riksdagen.se/sv/dokument-och-lagar/dokument/svensk-forfattningssamling/lag-2018218-med-kompletterande-bestammelser_sfs-2018-218/

Patient Injury Act (1996:799)

https://www.riksdagen.se/sv/dokument-och-lagar/dokument/svensk-forfattningssamling/patientskadelag-1996799_sfs-1996-799/

MPA- Decentralized Clinical Trials