cGVP definition
cGVP or “GVP” means current principles and guidelines of good pharmacovigilance practice for medicinal products for human use, as set forth in EU Directive 2001/83/EC, Commission Implementing Regulation No 520/2012 and the EMA’s Guideline on Good Pharmacovigilance Practice;
cGVP or "GVP" means current principles and guidelines of good pharmacovigilance practice for medicinal products for human use, as set forth in UK Human Medicines Regulation 2012, Directive 2001/83/EC, Commission Implementing Regulation No 520/2012 and the EMA's Guideline on Good Pharmacovigilance Practice; "cGxP" or "GxP" means cGMP, cGCP, cGLP and cGVP; "Clinical Trials" means the clinical trials required to be undertaken for the purposes of securing a Marketing Authorisation for the Product in the Territory for the indication in the Field; "Commercially Reasonable Efforts" means [***]; [***]; "Confidential Information" means any business, commercial or technical information (in whatever form or media) of either Party that is marked or otherwise indicated as
cGVP means current Good Pharmacovigilance Practices applicable to the conduct of specific pharmacovigilance activities by a Person in the European Union based upon Article 108a of Directive 2001/83/EC (until repealed in its entirety), 536/2014/EU, by the European Medicines Agency, all other applicable rules, regulations, orders, guidances, guidelines (including those issued by the International Council on Harmonization or other industry or nongovernmental standards), in the United States pursuant to the Federal Food, Drug, and Cosmetics Act, as may be amended and supplemented from time to time, and implementing regulations, including such extraterritorial jurisdiction as may be applicable to adverse events or experience or medical device reports required to be reported to the USFDA (including access to original data as may be requested from time to time by USFDA), the reporting and data management and storage requirements of the World Health Organisation and the World Health Organisation Collaborating Centre for International Drug Monitoring Centre located in Uppsala Sweden (Uppsala Monitoring Centre) and equivalent or comparable non-United States and non-European Union regulations, rules, orders, guidances and standards, as applicable, including Good Pharmacovigilance Practices (药物警戒质量管理规范) promulgated by NMPA and effective as of December 1, 2021, in each case as may be amended from time to time.