title: The importance of regulatory data protection or exclusive use and other forms of intellectual property rights in the crop protection industry.
abstract: In order for a chemical plant protection product to be authorised for sale a registration dossier has to be assembled to demonstrate safety and efficacy to the satisfaction of government regulators. These studies and tests are protected for a period of 10 years in Europe, North America and some other jurisdictions from the date of first product authorisation so that only the data owner can gain commercial benefit from the data. Subsequent regulatory reviews which require new studies should not result in further periods of regulatory data protection exclusive use for the new data but compensation should be payable to the data generator. © 2016 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.
authors.affiliation: Arysta Life Science, Slough, Berkshire, UK.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Carroll
mesh_terms: D016494:Computer Security / Q000331:legislation & jurisprudence*; D000069601:Crop Protection / Q000331:legislation & jurisprudence*; D005060:Europe; D018973:Intellectual Property; D009656:North America
keywords: compensation; data call-in; registration; regulatory data protection exclusive use period