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Reporting

  • Adverse drug reaction (CS only)

  • Suspected defect in the quality of a medicine

  • Suspected presence of a counterfeit medicine

  • Use of an unauthorized medicinal product

  • Reporting of stocks of medicinal products

  • Launch, interruption, renewal or cessation of a medicine on the market

  • Reporting by marketing authorisation holders (according to Medicinal Products Act)

  • Non-interventional post-registration studies

  • Failed verification of protective elements


  • Status and movement of stocks of addictive substances listed in Annex 1 or 5 to the Government Regulation

  • Opening/termination of pharmacies, sales of reserved medicinal products and specialised departments of medical facilities

  • Reporting the originator’s price

  • Establishment, method of operation and change of address of a publicly accessible professional information service on medicinal products

  • Supplies of distributed medicines

  • Haemovigilance reporting

  • Batch release for selected medicines

  • Mail order dispensing of medicines

  • Change of contact details

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