Good Pharmacovigilance Practice definition
Good Pharmacovigilance Practice means the applicable principles and guidelines for good pharmacovigilance practice for drugs and medicinal products, as such principles and guidelines are amended, implemented and supplemented from time-to-time, including without limitation those set out in the European Medicines Agency’s GVP modules I to XVI.”
Good Pharmacovigilance Practice means the guideline on good pharmacovigilance practice published by the European Medicines Agency under Regulation (EU) 1235/2010, as amended by Regulation (EU) 1027/2012, and Directive 2010/84/EU, as amended by Directive 2012/26/EU, and the principles laid down in Commission Implementing Regulation (EU) 520/2012; [***] means as is defined in Clause 12.5(a); Improvement(s) means any analogue, modification, prodrug, salt, polymorph, metabolite, isomer or synthetic intermediate of a Licensed Compound (i) discovered solely by Nuvectis, its Affiliates or Sub-Licensees during the Term; or (ii) that was discovered solely by the University or jointly by Nuvectis and the University pursuant to the Development Collaboration Agreement. Improvements licensed under this Agreement as part of the Collaboration IP shall be detailed in Schedule 5 as updated from time to time under the heading Improvement Compound Know-How and/or Improvement Compound Patent as the case may be; Improvement Compound IP means Improvement Compound Know-How and Improvement Compound Patent;
Good Pharmacovigilance Practice means the Guidelines on Pharmacovigilance for Medicinal Products for Human Use published by the European Commission under Article 108a of the 2001 Directive;
Examples of Good Pharmacovigilance Practice in a sentence
Member States shall ensure the effective functioning of the national pharmacovigilance system in accordance with the Good Pharmacovigilance Practice approved by the Commission and the legislation of the Member States.
Under EU legislation Bayer and its contracted partners are obliged to fulfil certain Pharmacovigilance responsibilities stated in the Good Pharmacovigilance Practice (GVP) and relevant guidelines.
The competent authorities of the Member States ensure the control of fulfillment of pharmacovigilance obligations by the holders of registration certificates of medicinal products that are in circulation in the territories of the Member States in accordance with the Good Pharmacovigilance Practice and the legislation of the Member States.
Regular safety data exchange will occur according to current guidelines on Good Pharmacovigilance Practice, FDA and Health Canada requirements and in accordance with the Pharmacovigilance Agreement.
More Definitions of Good Pharmacovigilance Practice
Good Pharmacovigilance Practice means the then current standards, practices and procedures for pharmacovigilance promulgated or endorsed by any applicable Governmental Entity, including those of the United States, as set forth in the FDCA, 21 C.F.R. § 314.80, or other comparable Law of any comparable foreign Governmental Entity;
Good Pharmacovigilance Practice means the Guidelines on Pharmacovigilance for Medicinal Products for Human Use published by the European Commission pursuant to Article 106 of the 2001 Directive;
Good Pharmacovigilance Practice or “GPP” the then current “good pharmacovigilance practice as such term is defined from time to time by the FDA, EMA or other Regulatory Authority of competent jurisdiction pursuant to its regulations, guidelines or otherwise, as applicable;
Good Pharmacovigilance Practice means the then current standards, practices and procedures for pharmacovigilance promulgated or endorsed by any applicable Governmental Entity, including those of the United States, as set forth in the FDCA, 21 C.F.R. § 314.80, or other comparable Law of any comparable foreign Governmental Entity; “Governmental Entity”, (i) any Relevant Authority, (ii) any company, business, enterprise, or other entity owned, in whole or in part, or controlled by any Relevant Authority, or (iii) any political party;
Good Pharmacovigilance Practice or “GVP” means the current applicable principles and guidelines of good pharmacovigilance practice for medicinal products for human use, including, as applicable, as provided for in (a) the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use (Codes, E2A, E2B, E2C, E2D), (b) the EMA’s Guideline on Good Pharmacovigilance Practices and any analogous guidelines in the United Kingdom, (c) the United States Code of Federal Regulations 21 C.F.R. as it applies to pharmacovigilance practices, as supplemented by relevant FDA guidance, compliance guides, and other relevant regulatory materials, and (d) the equivalent Applicable Law in any relevant country, each as may be amended and applicable from time to time.