A more recent version of this regulatory record is available. This version is kept only as a historical record. Please see the Record history section for link to the most recent version.
List details
Entry number | 42* |
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Scope |
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Latest application date | 2019-07-04 |
Sunset date | 2021-01-04 |
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Record history
The following timeline shows when we detected changes of this regulatory record (the date might slightly differ from the date of the actual change). Additions between versions are hightlighted in green color, red color shows data removed between versions.
April 26, 2022
- EC: 618-541-1
- Entry number: 42* → 42
- Remarks: By way of derogation from the date mentioned above under ‘latest application date’, 22 June 2022 for uses as follows: ─ for the research, development and production of medicinal products falling within the scope of Directive 2001/83/EC or medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746 of the European Parliament and of the Council (Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176)), in view of their use for the diagnosis, treatment or prevention of the coronavirus disease (COVID-19), ─ in medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID-19. By way of derogation from the date mentioned above under ‘sunset date’, 22 December 2023 for uses as follows: ─ for the research, development and production of medicinal products falling within the scope of Directive 2001/83/EC or medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, in view of their use for the diagnosis, treatment or prevention of COVID-19, ─ in medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID-19.
This version
Dec. 16, 2021
- Entry number: 42 → 42*
- Remarks: By way of derogation from the date mentioned above under ‘latest application date’, 22 June 2022 for uses as follows: ─ for the research, development and production of medicinal products falling within the scope of Directive 2001/83/EC or medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746 of the European Parliament and of the Council (Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176)), in view of their use for the diagnosis, treatment or prevention of the coronavirus disease (COVID-19), ─ in medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID-19. By way of derogation from the date mentioned above under ‘sunset date’, 22 December 2023 for uses as follows: ─ for the research, development and production of medicinal products falling within the scope of Directive 2001/83/EC or medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, in view of their use for the diagnosis, treatment or prevention of COVID-19, ─ in medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID-19.
June 22, 2021
- Name: Polyethylene glycol mono(tert-octylph-enyl) ether9036-19-5 → Poly(oxy-1,2-ethanediyl), α-[(1,1,3,3-tetramethylbutyl)phenyl]-ω-hydroxy-
- EC: 618-541-1
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