Sweden Pharmaceutical Licensing

Pharmacies, wholesale and manufacturing/import in Sweden are regulated centrally by the MPA; licences are not issued separately by state/province. Obtain separate authorisations based on the actual retail, possession/supply, manufacturing/packaging and import activities.[1] [2] [3]

The materials reviewed do not establish a uniform company form, capital requirement or foreign-investment restriction; company, tax and local construction matters require separate verification. Certain OTC medicines sold outside pharmacies are subject to a separate notification scheme for a limited list of products, not a pharmacy licence.[4]

— Business licences, product authorisations, import/export and controlled-medicine permits, and individual qualifications are separate.

— Wholesale and manufacturing authorisations may be issued separately for human and veterinary medicines.

The Medicinal Products Trading Act governs pharmacy and wholesale authorisations; the Medicinal Products Act governs products, manufacturing and imports from outside the EEA; and the Medicinal Products Trading Ordinance sets out time limits, fees and data-reporting requirements for pharmacies and wholesalers. The MPA issues authorisations and conducts inspections under this framework. [5] [6] [7]

The Swedish eHealth Agency receives statutory sales and returns data; it is not the licensing authority for the three types of business authorisation.

— MPA: authorisations, inspections and narcotic-drug authorisations.

— E-hälsomyndigheten: receipt of statistical data.

Operating an open pharmacy requires an MPA authorisation, which applies to a specific pharmacy and remains valid. The assessment covers the suitability of the applicant and persons in control, the operating plan, premises and staff, the quality manager, and the ability to supply medicines. [5] [8]

Pharmacies have duties relating to the safe use and supply of medicines and to providing tailored information and advice. Online/distance sales are still based on a pharmacy authorisation; the MPA must be notified, and delivery quality, traceability and information must be controlled. Outside pharmacies, only certain approved OTC medicines may be sold. [4] [9]

— Each open pharmacy requires a separate authorisation.

— The MPA must be notified of distance/online sales when applying or at least 2 months before commencing.

Wholesale authorisation is required to procure, supply, hold or export medicinal products in Sweden, including where the wholesaler does not own the stock or stores products on behalf of another party. Human and veterinary medicinal products require separate authorisations. The applicability of cross-border EEA authorisations should be checked case by case. [2] [5]

Wholesalers must comply with GDP and maintain suitable premises, traceability records, self-inspections and a responsible person, and must verify that the supply chain is authorised. The MPA inspects after receiving a complete application; authorisation is granted only if the requirements are met. [2] [5] [7]

— Wholesale authorisation is not the same as authorisation to import from outside the EEA.

— The relevant authorisations of suppliers and customers must be verified.

Manufacturing finished or intermediate products on a commercial basis requires an MIA; manufacturing includes packaging and repackaging. Imports from outside the EEA also fall within the scope of an MIA or a special import authorisation. Human and veterinary medicinal-product manufacturing require separate authorisations. [3] [6]

Manufacturing must comply with GMP and have at least one QP. The MPA inspects equipment, premises and the quality system both initially and subsequently. The exception from the MIA requirement for active-substance manufacturing does not exempt finished medicinal products. [3]

— Investigational medicinal products, hospital exemptions and other cases are subject to separate specific regimes.

— An MIA does not replace marketing authorisation for a product or wholesale authorisation.

The pharmacy quality manager must be a pharmacist with sufficient competence and experience and is responsible for the pharmacy's compliance; ordinarily, one person may be responsible for no more than 3 pharmacies. [5]

The wholesale responsible person must have adequate education and experience; manufacturing must have at least one QP, who may be a consultant. The official materials do not provide a universal, generally applicable conclusion on education level, nationality, full-time working percentage or recognition of overseas qualifications. [2] [3]

— Pharmacy: pharmacist quality manager.

— Wholesale: responsible person; manufacturing: QP.

A pharmacy requires premises suitable for their intended use and sufficient staff, but no uniform floor-area requirement or fixed staffing-schedule figures have been identified. Wholesale requires suitable premises, GDP, traceability and self-inspections; manufacturing inspections cover equipment, premises and the quality system. [2] [3] [5]

Retail sale of OTC medicines outside pharmacies also requires premises suitable for storage; private homes and garages cannot be used under this separate retail regime. This rule should not be treated as the complete premises standard for the three core authorisations. [4]

— Pharmacy: suitable premises and staff.

— Wholesale: GDP; manufacturing: GMP and a quality system.

Pharmacies must use the designated forms; the MPA assesses suitability, premises, staff, the quality manager and the ability to supply medicines. A complete, current, item-by-item English document checklist has not been verified; refer to the MPA forms and any requests for additional information. [8]

Wholesale applications are submitted through the MPA e-service, followed by an inspection once the application is complete; manufacturing applications are submitted to the MPA and an inspection takes place before the initial authorisation. Marketing authorisation for products, parallel import authorisation and narcotic-drug authorisation are separate application routes. [2] [3] [10] [11]

— First determine the product, whether it is for human or veterinary use, and the actual activities.

— Allow time for requests for further information and inspection preparation.

Under the current regulations: the application fee and annual fee are each SEK 20,000 for a pharmacy, and SEK 45,000 each for a wholesaler. The decision period for pharmacy and wholesale applications is 90 days after a complete application is submitted. [7]

Manufacturing fees vary by site and activity: SEK 86,000 for non-sterile finished products, SEK 146,000 for terminal sterilisation, SEK 172,000 for aseptic processing, SEK 215,000 for biotechnology, SEK 60,000 for packaging, etc., and SEK 26,000 for import/batch release. The application fee and annual fee are the same amount. Significant manufacturing changes usually take 30 days, or 90 days in special cases. [3]

— The usual initial MIA decision period and general validity/renewal cycle have not been uniformly verified.

— Fees and regulations may change; check them again before submission.

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Pharmacies must maintain a responsible person, supply responsibilities and duties relating to the safe use of medicines; distance sales also require controls over delivery, traceability and subcontractors. Wholesalers must maintain GDP, traceability, self-inspections, authorisation verification and data reporting. [2] [5] [7] [9]

Manufacturers must maintain GMP and QP responsibilities, and the MPA conducts periodic inspections. Marketing authorisation holders for products have separate responsibilities for pharmacovigilance, records and updating product information. [3] [12]

— Maintain business authorisations and product authorisations separately.

— Non-compliance or failure to report significant changes may trigger regulatory action.

Significant changes to a pharmacy must usually be reported at least two months in advance. These include changes to directors, sale to another legal entity, distance sales, closure, relocation, refurbishment and a change of responsible person. If only the owner of the company holding the authorisation changes, a notification is sufficient; if a new legal entity takes over, the original authorisation is revoked and the new entity must apply. [13]

Significant changes to wholesale operations must usually be notified two months in advance. Significant manufacturing changes require an application in advance; manufacturing authorisations are issued by organisation number, and if the organisation number changes, the old authorisation must be revoked and the new entity must apply. Changes to product authorisations are handled separately. [2] [3]

— A change in shareholding does not necessarily mean there is a new marketing authorisation holder.

— Assess changes to the address, responsible person, scope and organisation in advance.

Medicinal products require the relevant approval/registration before they can be sold in Sweden; approval in another EU country does not automatically apply in Sweden. A marketing authorisation for an approved product is usually initially valid for five years, and is renewed at least once thereafter; check the specific route according to product category and EU procedure. [12] [14]

Importation from outside the EEA cannot rely solely on a wholesale authorisation; parallel importation also requires a product sales authorisation and a wholesale authorisation, while repackaging/re-labelling additionally requires an MIA. Import, export, transit, manufacture or trade in narcotic drugs requires a separate authorisation; imports and exports of Classes I–IV are also subject to consignment-specific permits. [2] [6] [10] [11]

— Product approval is not a business, import or controlled-drug authorisation.

— Manage classification, labelling and authorisations separately for each SKU.