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Regulation [New]

EUV 2024/1381

Commission Implementing Regulation (EU) 2024/1381 of 23 May 2024 laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medicinal products for human use at Union level, as well as templates for those joint clinical assessments
Edition 2024-05-23

Standards [CURRENT]

SN EN ISO 81060-3

Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO 81060-3:2022)
Edition 2023-01

Standards [CURRENT]

SN EN ISO 28057

Clinical dosimetry - Dosimetry with solid thermoluminescence detectors for photon and electron radiations in radiotherapy (ISO 28057:2019)
Edition 2021-06

Standards [CURRENT]

SN EN ISO 8596/A1

Ophthalmic optics - Visual acuity testing - Standard and clinical optotypes and their presentation (ISO 8596:2017/Amd1:2019); Amendment A1
Edition 2020-08

Regulation

EUV 2022/20

Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials
Edition 2022-01-07

Pre-standard

SN ENV 13734

Health informatics - Vital signs information representation
Edition 2001-02

Corrigendum to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Edition 2016-11-17

Regulation

EUV 536/2014

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Edition 2014-04-16

Administrative provision

EUB 2021/1240

Commission Decision (EU) 2021/1240 of 13 July 2021 on the compliance of the EU portal and the EU database for clinical trials of medicinal products for human use with the requirements referred to in Article 82(2) of Regulation (EU) No 536/2014 of the European Parliament and of the Council
Edition 2021-07-13

Communication from the Commission - Guidance on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with Article 41 of Regulation (EC) No 1901/2006
Edition 2009-02-04

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