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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 registration is made to facilitate the Swedish Medicines Agency’s control of the medical technology products that have been CE-marked and placed on the market by the manufacturer. It is the manufacturer of a medical device that ensures that the products covered by the notification meet the applicable requirements in the Medical Devices Act and the Swedish Medicines Agency’s regulations.

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