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.
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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;
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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.
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Examples of Pharmacovigilance system in a sentence

  • The Pharmacovigilance system described fulfils the requirements and provides adequate evidence that the applicant has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the identification and notification of any potential risks occurring either in the Community or in a third country.

  • The Pharmacovigilance system described fulfils the requirements and provides adequate evidence that the applicant has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the identification and notification of any a potential risks occurring either in the Community or in a third country.

  • The CHMP considered that the Pharmacovigilance system as described by the applicant fulfils the legislative requirements.

  • IV.2 Risk management plan & Pharmacovigilance system Montelukast was first approved in 1997, and there is now more than 10 years post-authorisation experience with the active substance.

  • IV.2 Risk management plan & Pharmacovigilance system There is now more than 10 years post-authorisation experience with the active substance.

  • Pharmacovigilance system and pharmacovigilance system master file(1) The pharmacovigilance system is a system used by a marketing authorisation holder and the State Agency of Medicines to fulfil pharmacovigilance tasks and responsibilities, which is designed to monitor the safety of authorised medicinal products and detect changes to their risk-benefit balance.

  • The MAH has a pharmacovigilance system at their disposal, which is based on the current European legislation.The Pharmacovigilance system described fulfils the requirements and provides adequate evidence that the applicant has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the identification and notification of any potential risks occurring either in the Community or in a third country.

  • IV.2 Risk management plan & Pharmacovigilance system Olanzapine was first approved in 1996, and there is now more than 10 years post-authorisation experience with the active substance.

  • Detailed description of the pharmacovigilance system The CHMP considered that the Pharmacovigilance system as described by the applicant fulfils the legislative requirements.

  • Pharmacovigilance system The CHMP considered that the pharmacovigilance system summary submitted by the applicant fulfils the requirements of Article 8(3) of Directive 2001/83/EC.


More Definitions of Pharmacovigilance system

Pharmacovigilance system means a system used by the marketing authorisation holder and by the Agency for Medicinal Products and Medical Devices to fulfil the tasks and responsibilities laid down by provisions of the Pharmacovigilance Act and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance,
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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.
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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;
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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...
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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.
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Related to Pharmacovigilance system

  • Pharmacovigilance Agreement has the meaning set forth in Section 4.3.

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Development Plan has the meaning set forth in Section 3.2.

  • Collaborative pharmacy practice means a practice of pharmacy whereby one or

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Collaborative pharmacy practice agreement means a written and signed

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components;

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Quality Agreement has the meaning set forth in Section 9.6.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Development Program means the implementation of the development plan.

  • Protocols means written directions and orders, consistent with the department’s standard of care, that are to be followed by an emergency medical care provider in emergency and nonemergency situations. Protocols must be approved by the service program’s medical director and address the care of both adult and pediatric patients.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Protocol means, in respect of any category of object and associated rights to which this Convention applies, the Protocol in respect of that category of object and associated rights;

  • Analytical x-ray system means a group of components utilizing x-rays to determine the elemental composition or to examine the microstructure of materials.

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.