Essentials of European Medical Device Regulatory Affairs - June 2020

VAR – Variation assessment report VarWP – Working Party on Variation Regulation, also: Variation Working Party VBA – Value-based assessment

VBP – Value-based pricing VCS – Viral challenge study VDD – Veterinary Drugs Directorate (Canada) VeDDRA – Veterinary Dictionary for Drug Related Affairs VF – Ventricular failure VHP – Voluntary harmonisation procedure VICH – International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products VIPP – Verified internet pharmaceutical practice site (US) VMD – Veterinary Medicines Directorate VMP – Veterinary medicinal product VMRFG – Veterinary Mutual Recognition Facilitation Group VNeeS – Veterinary non-eCTD electronic submission VPC – Veterinary Products Committee (UK) VPN – Virtual private network vPvB – Very persistent and very bioaccumulative (biocidal products) VSI – Validation Supplementary Information

VTE – Venous thromboembolism VWP – Vaccines Working Party

WWW WBC – White blood cell WC – Written confirmation (issued by competent authority) WCPB – Women of childbearing potential WDA – Wholesale dealer’s licence WEBAE – Web adverse event(s) WEB-RADR (project) – Recognising Adverse Drug Reactions WEU – Well-established use WG – Working Group WGEO – Working Group of Enforcement Officers (HMA)

WHO – World Health Organization WL – Warning letter – but also: WL – Wholesale dealer’s licence WOCBP – Women of child-bearing potential WoE – Weight of evidence WP – Working Party WRAC – Worldwide Regulatory Affairs Committee WS – Work sharing WTO – World Trade Organisation

XXX XEVIMPD – Extended EudraVigilance Investigational Medicinal Product Dictionary

XEVMPD – Extended EudraVigilance medicinal products dictionary XEVPRM – Extended EudraVigilance product report message XML – Extensible Markup Language XRF – X-ray fluorescence ZZZ ZAPI – Zoonosis Anticipation and Preparedness Initiative ZVA – Zalu Valsts Agentura (State Agency for Medicines) (Latvia)

[Last updated January 2020]