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  • Patient-reported therapeutic benefits of herbal medicinal products in . . .
    Herbal Medicinal Products (HMPs) are used traditionally for the treatment of menstrual and menopausal ailments as well as uncomplicated urinary tract infections (uUTIs) for centuries and constitute a suitable addition to current treatment options
  • Microbiological Contamination of Medicinal Products —Is It a . . .
    These are monitored by relevant agencies, which may order the recall of defective product batches from the market However, in recent years, numerous cases of microbiological contamination in drugs and drug-related infections have been reported
  • Article 5 (3) opinions on any scientific matter: human medicines
    This page lists the opinions drawn up by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) under Article 5 (3) of the Regulation establishing the EMA, concerning any scientific matter related to the evaluation of medicines for use in humans
  • Guidance documents related to data submission for authorised medicines
    This page lists documents related to data submission for authorised medicines, including the legal notice, detailed guidance documents and controlled vocabularies for the Extended EudraVigilance Product Report Message (XEVPRM) schema
  • Auxiliary Medicinal Products in Clinical Trials
    Directive 2001 83 EC Article 1(2) defines a medicinal product as: “(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting
  • Clinical Benefits and Safety of Medical Cannabis Products: A . . . - Springer
    In this narrative review, we evaluate the published evidence for the clinical benefits of CBMPs and overall benefits in well-being We also review the overall safety profile and discuss the potential for dependence with CBMPs
  • Nanotechnology-based medicinal products for human use – EMA Report
    In the context of medical science, it is expected that nanotechnology will contribute to unlock a broad range of applications for innovative medicinal products such as controlled drug release, targeted cancer therapies, medical imaging including theranostics, tissue engineering, etc and will most likely be disruptive for the diagnosis and
  • 의약품등 안전성 정보관리 규정 - 식품의약품안전처
    (2) In accordance with Article 68-8 of [Pharmaceutical Affairs Act], a manufacturer etc of Medicinal products etc, a drug wholesaler, a pharmacy founder, and a medical institute founder shall promptly report a serious ADR to the Chairman of KIDS within 15 days from the recognition date




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