GVP definition
GVP means the then-current good pharmacovigilance practice standards, practices and procedures promulgated or endorsed by any applicable Regulatory Authority as set forth in the guidelines imposed by such Regulatory Authority, as may be updated from time to time.
GVP means the principles and guidelines of good pharmacovigilance practice for medicinal products for human use contained in applicable Laws and Orders, including (a) Directive 2001/83/E, (b) Commission Implementing Regulation No. 520/2012, (c) the European Medicines Agency’s Guideline on Good Pharmacovigilance Practice and (d) any equivalent provisions in any market in the Wholesale Distribution Territory.
GVP means the then-current set of measures for: (a) the performance of pharmacovigilance in the EU; and (b) monitoring the safety of medicines on sale to the public in the U.S. and other countries.
Examples of GVP in a sentence
It will, and shall ensure that its Affiliates, comply with all Applicable Laws in connection with the performance of its and its Affiliates’ activities under this Agreement, including, to the extent applicable, GMP, GLP, GCP, GVP and other similar rules, regulations and requirements; the European Data Protection Directive 95/46/EC; the European General Data Protection Regulation (Regulation (EU) 2016/679); and any other applicable national data protection legislation.
More Definitions of GVP
GVP means the then-current set of measures under Applicable Laws for: (a) the performance of pharmacovigilance in the EU and (b) monitoring the safety of medicines on sale to the public in the U.S. and other countries.
1. 105 “GxP” means GMP, GCP, GLP or GVP.
1. 106 “GxP Audit” means a GxP audit, which is comprised of an evaluation of the state of compliance of the systems and sub-systems, applicable to a manufacturing site, non-manufacturing site, investigator site or service provider site or a GxP system or process, with EU and U.S. standards and ICH Guidelines, and the applicable regulations in the countries where a Licensed Product or any component thereof is Manufactured or Commercialized.
GVP means the current good pharmacovigilance practices applicable to the conduct of pharmacovigilance in the European Union based upon Article 108a of Directive 2001/83/EC (until repealed in its entirety), 536/2014/EU, issued by the EMA, and all other applicable rules, regulations, orders, guidance, guidelines (including those issued by the ICH or other Governmental Entities) in the United States pursuant to the FDCA, and its 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 FDA, the reporting and data management and storage requirements of the World Health Organization and the World Health Organization Collaborating Centre for International Drug Monitoring Centre located in Uppsala Sweden, as may be amended from time to time.
GVP means Good Pharmacovigilance Practices for the European Union, a set of guidelines for the conduct of pharmacovigilance in the EU, drawn up based on Article 108a of Directive 2001/83/EC, by the European Medicines Agency in cooperation with competent authorities in Member States and interested parties, and applying to marketing authorization holders in the EU, the Agency and competent authorities in Member States.
GVP or “Good Pharmacovigilance Practices” means, in addition to the provisions under the Pharmacovigilance Agreement, all applicable good pharmacovigilance practices promulgated and published by FDA, EMA or any other Regulatory Authorities having jurisdiction over the Development, Manufacture or Commercialization of the Product , as applicable, pursuant to its regulations, guidelines or otherwise, including as applicable, major pharmacovigilance process and product and/or population specific considerations as defined in (a) European Commission Regulation code relating to medicinal products for human use, Directives 2010/84/EU and 2012/26/EU respectively, as well as by the Commission Implementing Regulation (EU) No 520/2012 on the Performance of Pharmacovigilance Activities Provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC, Title IX of the Directive, Article 108a (a) of Directive 2001/83/EC, and principles detailed in the ICH guidelines for pharmacovigilance as well as (b) principles detailed in the United States 21 CFR and Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiological Assessment.
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
GVP means the then 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;
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;