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A registered homeopathic product has been evaluated for whether:

  • the quality and safety of the final product follow applicable regulations
  • manufacturing has been carried out in a qualitatively acceptable manner following GMP (Good Manufacturing Practice)
  • the manufacturing has complied with established homeopathic methods
  • the raw material has been previously used in homeopathy.

This guideline describes the following points;

  • Registration of homeopathic medicinal products
  • Labelling
  • Variation application for homeopathic medicinal products
  • Renewal application for registration of homeopathic medicinal products

 

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The purpose of the guideline is to clarify the criteria for qualification of software and apps as medical devices and to highlight the legislative requirements that medical device manufacturers must fulfil.

The purpose of a device is determined by the manufacturer and not by virtue of how it is applied by the users. For example, an app intended to monitor the heart rate during exercise does not qualify as a medical device, not even if the user chooses to use the app for a medical purpose. In other words, it is the manufacturer who describes what the software/app is intended to be used for.

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