Permit to Operate a Pharmacy
A permit is required to operate a pharmacy in Sweden. The Medical Products Agency (Läkemedelsverket) examines applications and assesses the applicant's suitability, that the business description is reasonable, that the pharmacy premises are appropriate and adequately staffed, and that no circumstances exist that constitute a prohibition against granting a permit.
Pharmacy operations include retail sales of medicines to the public and to healthcare facilities. The activity must meet strict requirements for competence, premises, safety and quality assurance to ensure patient safety and correct medicine handling.
Permit requirements
- Suitability: The applicant must be suitable to operate a pharmacy regarding competence, financial position and reliability.
- Business description: The description of the pharmacy's operations must be reasonable and feasible.
- Premises: The pharmacy premises must be appropriate for safe medicine handling and sales.
- Staffing: The pharmacy must be adequately staffed with qualified personnel, including licensed pharmacists.
- No grounds for prohibition: There must be no circumstances that according to law constitute grounds for prohibition of a permit.
Application procedure
- Licensing authority: The application is sent to the Medical Products Agency (Läkemedelsverket).
- Documentation: The application must contain information about the applicant, business description, premises, staffing, procedures for quality assurance and medicine handling.
- Assessment: The Medical Products Agency reviews that all requirements are met before granting a permit.
- Supervision: The Medical Products Agency exercises supervision over pharmacy operations after a permit is granted.