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  6. Factsheet - 32020R1043

Factsheet - 32020R1043

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)
Proposed act with possible EEA relevance
Act under scrutiny by EEA EFTA
Draft Joint Committee Decision (JCD) under consideration
Entry into force of Joint Committee Decision (JCD) pending
Incorporated into the EEA Agreement and in force
Incorporated into the EEA Agreement but no longer in force
Legal status
EU legal act incorporated into the EEA Agreement by a Joint Committee Decision (JCD)
Area (EEA Agreement)
II Technical Regulations, Standards, Testing and Certification
II.XIII Medicinal Products
Joint committee decision (JCD)
114/2020
In force in the EEA
Yes
Legal Documents
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)
Joint Committee Decision in English: OJ L 172, 6.7.2023, p. 41
Legal act in EU languages: OJ L 231, 17.7.2020, p. 12
Reglugerð Evrópuþingsins og ráðsins (ESB) 2020/1043 frá 15. júlí 2020 um framkvæmd klínískra prófana með mannalyfjum, sem innihalda eða samanstanda af erfðabreyttum lífverum og eru ætluð til að meðhöndla eða koma í veg fyrir kórónaveirusjúkdóminn (COVID-19), og afhendingu þeirra
Legal act in Icelandic: EEA Suppl. No 62, 24.9.2020, p. 267-271
Joint Committee Decision in Icelandic: EEA Supplement No 51, 6.7.2023, p. 40
Verordnung (EU) 2020/1043 des Europäischen Parlaments und des Rates vom 15. Juli 2020 über die Durchführung klinischer Prüfungen mit genetisch veränderte Organismen enthaltenden oder aus solchen bestehenden Humanarzneimitteln zur Behandlung oder Verhütung der Coronavirus-Erkrankung (COVID-19) und deren Abgabe
Legal act in German: OJ L 231, 17.7.2020, p. 12
Europaparlaments- og rådsforordning (EU) 2020/1043 av 15. juli 2020 om gjennomføring av kliniske utprøvinger og utlevering av legemidler for mennesker som inneholder eller består av genmodifiserte organismer, til behandling eller forebygging av koronavirussykdom (covid-19)
Legal act in Norwegian: EEA Suppl. No 45, 1.7.2021, p. 184-188
Joint Committee Decision in Norwegian: EEA Supplement No 51, 6.7.2023, p. 40
History
06.08.2020 Adopted JCD confirmed entry into force date
06.08.2020 Compliance date in the EEA
06.08.2020 Adoption of Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement
Joint Committee Decision in English: OJ L 172, 6.7.2023, p. 41
Joint Committee Decision in Icelandic: EEA Supplement No 51, 6.7.2023, p. 40
Joint Committee Decision in Norwegian: EEA Supplement No 51, 6.7.2023, p. 40
18.07.2020 Compliance date in the EU
15.07.2020 Adoption date in the EU
Legal act in EU languages: EUR-LEX 1043
Legal act in German: EUR-LEX 1043
13.07.2020 Draft Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement sent to Commission
17.06.2020 Adoption of the proposal in the EU
COM(2020) 261

Disclaimer: EEA-Lex is provided for information purposes only. The information is not guaranteed or promised to be current or complete and is not intended to replace any applicable legal sources.

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