Active Pharmaceutical Ingredients, Operation (Notification)

If you manufacture, import, or distribute active pharmaceutical ingredients (APIs) for medicines, you must notify the Swedish Medical Products Agency (Läkemedelsverket) before starting operations. APIs are the active substances that give medicines their therapeutic effect.

Your facility must comply with Good Manufacturing Practice (GMP) and is subject to inspection by Läkemedelsverket. After the initial notification, you must submit an annual update confirming your current operations and contact information. The notification requirement applies regardless of whether the APIs are intended for human or veterinary medicines.

Requirements and Scope

  • Notification requirement: Applies to manufacture, import and distribution of active pharmaceutical ingredients
  • Annual update: The information in the notification must be updated every year
  • Active pharmaceutical ingredients: The active substances in medicines (API)
  • Authority: The Swedish Medical Products Agency is the recipient of the notification

Notification Procedure

  • Initial notification: Must be made before the operation begins
  • Annual reporting: Update of information must be submitted every year
  • Responsible authority: The Swedish Medical Products Agency receives and processes notifications
  • Information: Detailed instructions are available on the Swedish Medical Products Agency's website