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Wörterbuch Qualitätsmanagement in der Medizin
Normgerechte Definitionen und Interpretationshilfen
Edition
2012-08
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
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
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
Klinische Prüfung von Medizinprodukten
Kommentar zu DIN EN ISO 14155
Edition
2024-01
Nicht aktive Medizinprodukte
Horizontale Europäische Normen in Anlehnung an entsprechende EU-Richtlinien und -Verordnungen
Edition
2022-06
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