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Normgerechte Definitionen und Interpretationshilfen
Edition 2012-08

Regulation

EUV 2022/2239

Commission Delegated Regulation (EU) 2022/2239 of 6 September 2022 amending Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards labelling requirements for unauthorised investigational and unauthorised auxiliary medicinal products for human use
Edition 2022-09-06

Regulation

EUV 2017/1569

Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections
Edition 2017-05-23

Administrative provision

2005/28/EG

Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
Edition 2005-04-08

Kommentar zu DIN EN ISO 14155
Edition 2024-01

Horizontale Europäische Normen in Anlehnung an entsprechende EU-Richtlinien und -Verordnungen
Edition 2022-06

Regulation

EUV 2022/641

Regulation (EU) 2022/641 of the European Parliament and of the Council of 12 April 2022 amending Regulation (EU) No 536/2014 as regards a derogation from certain obligations concerning investigational medicinal products made available in the United Kingdom in respect of Northern Ireland and in Cyprus, Ireland and Malta
Edition 2022-04-12

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