Post Marketing Surveillance definition

Post Marketing Surveillance means systematic process to collect and analyse information gained from medical device that have been placed in the market;
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Post Marketing Surveillance means a procedure implemented after a drug has been licensed for public use. The procedure is designed to provide information on the actual use of the drug for a given indication and on the occurrence of side effects, adverse reactions, etc. This is a method for identifying adverse drug reactions, especially rare (< 1% incidence) ones.
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Post Marketing Surveillance means the set of activities carried out by the Authority to monitor quality of medicines and allied substances when they are in distribution, warehouses, pharmacies, clinics, medicine stores, and hospitals;
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Examples of Post Marketing Surveillance in a sentence

  • Post Marketing Surveillance of Fortified Foods in Tanzania Mainland: Large Scale Producers of wheat and Edible oil.

  • The dossier should contain the Post Marketing Surveillance/ Vigilance Reporting procedures and Data collected by the manufacturer encompassing the details of the complaints received and corrective and Preventive actions taken for the same.

  • The dossier should contain the Post Marketing Surveillance or Vigilance Reporting procedures and Data collected by the manufacturer encompassing the details of the complaints received and corrective and Preventive actions taken for the same.

  • Takeda shall conduct and fund all Post Marketing Surveillance on the Products for the Initial Indications and, if applicable, Additional Indications and/or New Formulations in the Initial Territory.

  • All Suspected Unexpected Serious Adverse Reactions (SUSARs) occurring in all post authorization safety studies in Ghana of which the Local Representative or Marketing Authorization Holder is aware and includes the design and conduct of company-sponsored Post Marketing Surveillance (PMS) Studies (i.e Phase IV clinical trials) should be reported within 7 days.

  • A new era of regulatory approved and commercially available therapeutics for NMD is upon us and this requires a comprehensive and academic approach to generating real world evidence related to new therapies to inform regulatory decisions and Post Marketing Surveillance.

  • These regulations may be cited as the Regulations Governing the Post Marketing Surveillance of Products Regulated under Law No 003/2018 of 09/02/2018 and shall come into operation on the date of publication.

  • Post Marketing Surveillance of Anti-malarial Medicines in Tanzania.

  • Only patients being treated for approved indi- cations of the product are to be included in the Post- Marketing Surveillance Study.

  • During the Transition Period you will be responsible for performing those assignments you currently perform, and have responsibilities substantially similar to such responsibilities you currently have, including responsibility for Quality Assurance, Regulatory Affairs (cGMP, cGLP, cGCP), Quality Control, Microbiology and Post Marketing Surveillance.


More Definitions of Post Marketing Surveillance

Post Marketing Surveillance means all post-marketing safety surveillance in the Initial Territory with respect to the Product that is required by a Regulatory Authority in the Initial Territory or any Additional Territory in which the Products are being Developed or Commercialized.
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Post Marketing Surveillance means clinical trial or other investigations usually conducted under a single protocol to gather specific information about an approved medicinal or biological product.
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Post Marketing Surveillance means surveillance activities that occur following market approval of a regulated product including maintenance of product authorisation and/or registration of variations or renewals; regular inspection of manufacturers, wholesalers, distributors and retailers; quality control testing; public reporting of poor quality products; handling of market complaints; and removal and disposal of non-compliant products
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Post Marketing Surveillance or "PMS" shall have the meaning ascribed to it in Section 7.6 of this Agreement.
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Related to Post Marketing Surveillance

  • Surveillance means monitoring and observation of the disposal site for purposes of visual detection of need for maintenance, custodial care, evidence of intrusion, and compliance with other license and regulatory requirements.

  • Direct Marketing ’ means to approach a data subject, either in person or by mail or electronic communication, for the direct or indirect purpose of—

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;

  • EMEA means the European Agency for the Evaluation of Medicinal Products, or any successor agency thereto.

  • PJM Markets means the PJM Interchange Energy and capacity markets, including the RPM auctions, together with all bilateral or other wholesale electric power and energy transactions, capacity transactions, ancillary services transactions (including black start service), transmission transactions and any other market operated under the PJM Tariff or Operating Agreement within the PJM Region, wherein Market Participants may incur Obligations to PJMSettlement.