pharmacovigilance system definition
pharmacovigilance system is a system used by the marketing authorisation holder and by Member States to fulfil the tasks and responsibilities listed in Title IX and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. “Pharmacovigilance system master file” is a detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to one or more authorised medicinal products.
pharmacovigilance system means a system used by the marketing authorisation holder and by Member States to fulfil the tasks and responsibilities set out in Chapter IX and designed to monitor the safety of authorised medicinal products and detect any change to their benefit-risk balance;
pharmacovigilance system or “PVS” means a system used by an organization to fulfill its tasks and responsibilities about detecting, assessing, understanding, and preventing adverse effects or any other drug-related problem and detect any change to their risk-benefit balance.
More Definitions of pharmacovigilance system
pharmacovigilance system. A system used by the marketing authorization holder and by Member States to fulfil the tasks and responsibilities listed in Title IX of Directive 2001/83/EC and designed to monitor the safety of authorized medicinal products and detect any change to their risk-benefit balance [DIR 2001/83/EC Art 1(28d)]. In general, a pharmacovigilance system is a system used by an organization to fulfil its legal tasks and responsibilities in relation to pharmacovigilance and designed to monitor the safety of authorized medicinal products and detect any change to their risk-benefit balance. Receipt Date: Any Calendar Day on which an employee, affiliated company or commercial partner of a Party receives notification of an initial Adverse Event report. The time clock starts again at Day 0 when follow-up information is received by an employee, an affiliated company or a commercial partner of the concerned Party. Day 0: he date the Marketing Authorization Holder (MAH) becomes aware of a case which fulfils the minimum information as criteria for reporting should be considered as Day 0. The clock for expedited reporting starts (Day 0) as soon as the minimum information has been brought to the attention of any personnel of the Marketing Authorization Holder, a contracted agent, or an organization having a contractual arrangement with the MAH, including medical representatives. The determination of Day 0 is predicated on identification of an individual case report which fulfils the minimum information (i.e. identifiable patient, reporter, adverse event, drug). For reports received electronically by the Seller, an agent of the Seller, an Affiliate, a contractor, or a license partner, receipt/awareness/first knowledge is interpreted to mean the date that the report arrives on a server, the date on a facsimile transmission, or the date a voicemail is recorded. It is not the date a report is actually retrieved from a server, fax machine, or from voicemail. For mail received via the postal system, the date of awareness/receipt/first knowledge is the date that is "date stamped" on the letter as being initially received by the Seller, a contractor, an agent of the Seller, an Affiliate, or a license partner. Regulatory Authorities: The competent regulatory authority in the country/territory within the scope of the Agreement. Safety Information: Any of the following event relating to the Products: Adverse Events, reports of overdose, medication error (including dispensing error, accidenta...
pharmacovigilance system. “ means a system to fulfil the tasks and responsibilities listed in Title IX of Directive 2001/83/EC (Pharmacovigilance), as amended, and the requirements under relevant laws of the Territory, including the Drug Administration Law of China and related regulations, such as the China Drug Good Supply Practices, and designed to monitor the safety of authorized medicinal products and detect any change to their risk-benefit balance.
pharmacovigilance system means a system used by the holder of a marketing authorisation, traditional herbal registration or Article 126a authorisation, or by the licensing authority, to fulfil the tasks and responsibilities set out in Part 11 and designed to monitor the safety of authorised or registered medicinal products and detect any change to their risk-benefit balance;