Wholesale trade of medical products

Wholesale trade is defined in the Medicinal Products (Trading) Act  as activity including the procurement, holding, export, supply or any sale of medicinal products which cannot be regarded as retail trade.

Who may wholesalers purchase from and sell to

When a medicinal product leaves the manufacturing factory it must be handled and owned by wholesalers until it is sold to a pharmacy. A wholesaler may procure medicinal products from the person who manufactured them or from other wholesalers. It may sell medicinal products to other wholesalers or pharmacies. Any person who has wholesale distribution authorisation in any country of the EU or EEA may trade in any country of the EU or EEA.

Persons who engage in wholesale trade of medicinal products must check that their suppliers and customers have the right to supply and procure medicinal products respectively. There is a common database of manufacturers and wholesalers where the check may be carried out.

A wholesaler with authorisation issued by Swedish Medical Products Agency (Swedish MPA) may also engage in some retail trade in medicinal products. They may sell medicinal product to hospitals and sell serums and vaccines to doctors, veterinarians and other healthcare providers.

Good distribution practice in the EU

Wholesale traders must follow good distribution practice (GDP). The GDP rules are common throughout the EU and EEA and are set out in the GDP guidelines.

Application for wholesale distribution authorisation

Anyone who wishes to become a wholesaler in Sweden must submit an application to the Swedish MPA.

The form sets out what information is required.

Once the application is complete, the Swedish Medical Product Agency will inspect the person who has applied. If the undertaking concerned complies with the existing rules, the Swedish MPA will issue an authorisation.

A wholesaler that deals with both medicinal products for human use and veterinary medicinal products need separate wholesale distribution authorisations but the wholesaler only pays one fee.

Authorisation is subject to a fee

An application for wholesale distribution authorisation costs SEK 45 000 and must be paid before the inspection can be carried out by the Swedish MPA. Any person who has an authorisation must also pay an annual fee of SEK 45 000.

The Swedish MPA will send an invoice to the person who applied and to the person who has authorisation.

Wholesalers must have a responsible person

The wholesaler must have a responsible person. The name of the responsible person is stated on the wholesale authorisation. The responsible person has overall responsibility for all wholesale activity and compliance with all rules. That person must have sufficient skills and qualifications to be able to perform his or her tasks. The Swedish MPA will assess the responsible person when the application is made or where a change of responsible person is notified. The skills requirements are set out in detail in the guide to the provision.

Notification of significant changes

A wholesaler is obliged to notify significant changes two months before the changes enter into force. Notify changes to the Swedish MPA using the postal or email address shown at the bottom of this page. State that the notification concerns wholesale distribution authorisation. Please note that a notification relating to variations of a marketing authorisation for a medicinal product must be submitted separately. The following constitute significant changes:

• a change in the scope of operations
• a change of the company's name and/or business identity code
• a move to premises/an address other than that specified in the authorisation
• changes in the company's organisation which concern the wholesale activity, e.g. change of qualified person
• a change of owner
• other matters which it may be important for the Swedish MPA to be aware of.

Import of medicinal products

Import of medicinal products relates to medicinal products which come from countries outside the EU/EEA. To import these medicinal products a manufacturing authorisation is required. This therefore does not constitute wholesale trade and may not be done with wholesale distribution authorisation alone. Transit, that is to say where medicinal products are purchased outside the EU/EEA and then resold outside the EU/EEC without being placed in the Union market, can be done on a wholesale distribution authorisation. Medicinal products located in a free zone or free warehouse, that is to say outside the customs area, must also be handled in accordance with the wholesale rules.

Export of medicinal products

For export of medicinal products to a country outside the EU/EEA wholesale distribution authorisation is required and the medicinal products must be handled in accordance with EU rules as long as they are located within the border. The wholesaler should contact the local authorities in the importing country to check what rules apply to on-site sales.

Obligation to supply medicinal products, no right to purchase medicinal products

Wholesalers which supply medicinal products to the Swedish market are obliged to supply them to all Swedish community pharmacies. On the other hand, a wholesaler has no obligation to sell to another wholesaler.

Retail to hospitals and healthcare establishments

Under Chapter 4, paragraph 1, second paragraph of Medical Products (Trading) Act (2009:366), a person which has Swedish wholesale distribution authorisation may engage in retail trade with hospitals.

This means that supply may take place directly from the wholesaler to a hospital's pharmacy function without going through a pharmacy. In that case, the hospital must have notified this handling in its notification concerning the hospital's supply of medicinal products. Most hospitals in Sweden use a hospital pharmacy which has pharmacy authorisation (authorisation to operate a dispensing pharmacy) for its supply of medicinal products. Supplies can be made by any wholesaler without it being notified in the hospital's notification concerning its supply of medicinal products.

Regulations

• Lag (2009:366) om handel med läkemedel.
• Läkemedelsverkets föreskrifter (HSLF-FS 2021:95) om partihandel med läkemedel.
• Läkemedelsverkets föreskrifter (LVFS 2012:8) om sjukhusens läkemedelsförsörjning.
• Regulation (EU) 2019/6 - veterinary medicinal products

Wholesalers must report to the E‍-‍health authority

Supplies of medicinal products for retail, including medication, pharmacy and returns, must be reported to the E‍-‍health authority.

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