in Tag: Safety And Performance  (clear all)


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Guideline on Preclinical Safety Studies for Veterinary Medicines (MCC: 3.05, Jan 2004)

Guideline on Preclinical Safety Studies for Veterinary Medicines. Secular 3.05

Related Tags (New Search): Safety and performance,   GCP,   Veterinary medicine

Safety of Veterinary Biologicals (MCC: 3.08, Jan 2004)

This guideline provides information on the safety aspects of veterinary biological medicines. Circular 3.0 H

Related Tags (New Search): Biological medicines,   Safety and performance,   Safety,   Veterinary medicine

Medical Devices and IVDs - Essential Principles of Safety and Performance (MCC: 8.02, Jul 2016)

Medical Devices and IVDs - Essential Principles of Safety and Performance

Related Tags (New Search): Medical devices,   IVDs,   Safety and performance,   Application

Guideline on Veterinary Drug Adverse Events (MCC: 3.09, Jan 2004)

This guideline provides information on the reporting and management of adverse events with veterinary medicines. Circular 3.09

Related Tags (New Search): Safety and performance,   Recalls,   Veterinary medicine

Conformity assessment procedures – medical devices and IVDs (MCC: 8.03, Sept 2016)

Conformity assessment procedures – medical devices and IVDs

Related Tags (New Search): Medical devices,   IVDs,   Safety and performance,   Application,   Quality

Complementary Medicines – Health Supplements Safety and Efficacy (MCC: 7.04, Jun 2016)

This guideline provides information required for the application for registration of health supplements. The guideline provides details on compliance with GMP, GLP and good agricultural and collection practices. It also provides the format for the presentation of administrative information, common…

Related Tags (New Search): Health supplements,   Vitamins & Minerals,   Safety and performance,   Application,   Efficacy,   CTD

Complementary Medicine – Discipline-Specific Safety and Efficacy (MCC: 7.01, Jun 2016)

This guideline provides information for applicants wishing to submit applications for the registration of complimentary medicines. It includes information on the format of submission, technical details on the types of substances and preparations, naming of substances and ingredients, multicomponent formulations…

Related Tags (New Search): Complementary medicines,   Health supplements,   Ayuvedic,   Unani Tibb,   Chinese traditional,   Safety and performance,   Efficacy

Guidelines for a Licence to Manufacture, Import Export or Distribute Medical Devices and IVDs (MCC: 16.03, July 2016)

Recommendations or licensing requirements for the manufacture, importation, distribution and exportation of Class B, Class C and Class D medical devices. Please note that this is a third-party website. Juta has no control over the nature, content or availability of third-party…

Related Tags (New Search): GMP,   IVDs,   Licencing,   Medical devices,   Classification,   Conformity assessment,   Safety and performance,   Fees,   Classification,   Importers,   Distributor