Pharmaceutical Wholesale License

Pharmaceutical wholesale covers all handling of medicines from manufacturer release to retail, including procurement, storage, export, delivery, and sale. Even companies that own medicines without physically handling them are considered wholesalers and need a license.

You must obtain a license from the Medical Products Agency (Läkemedelsverket) and follow Good Distribution Practice (GDP). Your operation must have a qualified person (sakkunnig person) with sufficient pharmaceutical competence and experience. Separate licenses are required for human and veterinary medicines. Läkemedelsverket inspects wholesale operations regularly to verify compliance with GDP standards and license conditions.

Requirements

  • Good Distribution Practice (GDP): Operations must comply with good distribution practice for medicines.
  • Qualified person: A qualified person with sufficient competence and experience must be appointed.
  • Separate licenses: Separate licenses are required for human medicines and veterinary medicines.
  • Fees: Application fee and annual license fee.

Procedure

  • Application: Submit application to the Medical Products Agency with information about the operation and proposed qualified person.
  • Pre-license inspection: The Agency inspects operations before issuing a license.
  • Ongoing inspections: Regular inspections are conducted by the Agency for license holders.