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This Guide applies to the manufacture of APIs for medicinal products for both human and veterinary use. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not covered but should be performed in accordance with the principles and guidelines of GMP as laid down in national legislations and interpreted in the GMP Guide including its Annex 1.

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This guideline is applicable to the manufacture of the finished dosage form of chemical and herbal medicinal products for human use intended for marketing authorisation. It also applies to variations for authorised products in cases where changes to the manufacturing process affecting the MA are proposed.

The principles described are in general also applicable to biological medicinal products. Where relevant, the principles of this guideline may also be applied to radiopharmaceuticals and to chemical investigational medicinal products.

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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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Within the European Union (EU) all herbal substances for oral consumption come under the control of either food
legislation or medicines legislation.

Herbal substances for topical application can fall into either cosmetics legislation or medicines legislation.

Herbals are products that may be used for human consumption as:

• Food Supplements/Novel Foods
• Medicines
• Cosmetics

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The guide elaborates on the provisions of the Executive Order on herbal medicines. In addition, the requirements for manufacture, quality, harmlessness, documentation of impact, labelling etc. are elaborated.

This guideline describes the following points;

  • Application for Marketing Authorization
  • Requirements for Natural Medicines
  • Summary of Product
  • Label and Package Leaflet (Labeling)
  • Advertising
  • Charges

 

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