Medicinal products for human use

A medicinal product for humans can be briefly defined as one or more substances that are intended to prevent, treat, or diagnose diseases in humans. It can also restore bodily functions through pharmacological, immunological, or metabolic effect. The medicinal product concept is comprehensive, and there are several products that have medicinal-product-like effects, just as there are a number of subgroups of medicinal products.

 
  • Chemical medicinal products

    • Non-clinical testing

      • Pharmacological studies

      • Safety studies

      • Who may carry out GLP studies?

      • Guidelines, etc.

    • Production of an investigational medicinal product

    • Clinical trials of medicinal products

      • Regulations and permits for clinical trials

      • Clinical trial of medicinal product or not?

      • First-in-human clinical trials

      • Guidelines for various therapy areas

    • Commercial production

    • Approval of medicinal products

  • Biological medicinal products

    • Non-clinical testing

      • Pharmacological studies

      • Safety studies

      • Who may carry out GLP studies?

      • Guidelines, etc.

    • Production of an investigational medicinal product

    • Clinical trials of medicinal products

      • Regulations and permits for clinical trials

      • Clinical trial of medicinal product or not?

      • First-in-human clinical trials

      • Guidelines for various therapy areas

    • Commercial production

    • Approval of biological medicinal products

  • Radioactive medicinal products

  • Advanced therapy medicinal products

    • Hospital Exemption

    • Is the product an ATMP?

    • Approval of ATMPs

  • Herbal medicinal products

    • Documentation of effect and safety

      • Complete application

      • Well-established medicinal use

      • Traditional herbal medicinal products

        • Community herbal monographs

        • European Commission's register

    • Quality and manufacture of the product

      • Herbal substance/Raw material

      • Active substance

      • Finished product

      • Quality documentation

    • Approval/Registration

      • Procedures

        • National procedure

        • Decentralised and Mutual recognition procedures

      • Fees

      • Applications

  • Natural remedies

    • Documentation of effect and safety

    • Quality and manufacture of the product

      • Active substance

      • Finished product

      • Quality documentation

    • Approval procedure

      • Applications

      • Fees

      • National procedure

  • Homeopathic medicinal products

    • Safety documentation

    • Effect documentation

    • Quality and manufacture of the product

      • Raw materials and mother tincture preparations

      • Finished products

      • Quality documentation

    • Registration procedure

      • Applications

      • Fees

      • Procedures

        • National procedure

        • Decentralised and mutual recognition procedures

 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information