Selling OTC medicines

Before you start selling medicinal products:

• you must notify the Swedish MPA
• you must have a self-monitoring programme for your outlet
• you should be aware that the municipality and the Swedish MPA will check that you are complying with the rules
• you should be aware that the annual fee to the Swedish MPA is SEK 2 700 per calendar year (January to December) and outlet, which is always the same amount, regardless of when during the year you give notification and how many medicinal products you sell
• you should be aware that the municipalities can charge a fee for their checks (contact your municipality for further information).

Annual fee

The Swedish MPA charges a supervisory fee for each outlet. The fee is SEK 2 700 per calendar year (January to December).

You will receive an invoice from the Swedish MPA when you register and each year for as long as you are registered to sell non‍-‍prescription medicinal products.

Tasks of the authorities

The municipality will check your outlet and report non-compliances with the requirements to the Swedish MPA.

The Swedish MPA is the supervisory authority and responsible for:

• taking measures on non‍-‍compliances reported by the municipality which have not been remedied by the retailer
• maintaining an up‍-‍to‍-‍date register of all outlets registered for trade in non‍-‍prescription medicinal products.
• providing guidance and inspecting outlets

What happens if a retailer does not comply with the rules?

The Swedish MPA can order a trader to comply with the rules and in severe cases prohibit sales of medicinal products. Orders and prohibitions can be combined with a conditional fine and if the trader fails to comply with a decision the Swedish MPA can ask a court to impose the fine.

Important rules and procedures

Written procedures

Before you start selling medicinal products, you must have a self-monitoring programme for your outlet with written procedures on how medicinal products are to be handled and sold.

This should serve as support for your staff and lead to safe handling of the non-prescription medicinal products.

Purchase of non-prescription medicinal products for your shop

The medicinal products which you are to sell at the outlet must be purchased from a supplier which has a wholesale authorisation for medicinal products. It is not permitted to purchase medicinal products in a pharmacy or other shop and resell them. You need to check with your supplier that they have a valid wholesale authorisation. The medicinal products which you sell must have Swedish labelling and be approved for sale in Sweden by the Swedish MPA.

Age limit

Non-prescription medicinal products may only be sold to customers who have reached the age of 18. There must be a sign about the age limit at the outlet.

Nicotine medicinal products

Medicinal products containing nicotine may not be sold if it may be suspected that they will be passed on (peddled) to someone who has not reached the age of 18. If you sell nicotine containing medicinal products, there must also be a sign about the prohibition on sales if peddling of nicotine containing medicinal products is suspected.

Display and storage

• Medicinal products must be stored either under lock and key or under the direct supervision of staff.
• Medicinal products must be stored separately from non‍-‍medicinal products.
• It must be clear to the customer which products are medicinal products.

Report your sales

You must report how many medicinal products are sold at each outlet.

This is done every month/quarter to the eHealth Authority.

Regulations

• Lag (2009:730) om handel med vissa receptfria läkemedel.

• Förordning (2009:929) om handel med vissa receptfria läkemedel.

• Läkemedelsverkets föreskrifter (LVFS 2009:20) om handel med vissa receptfria läkemedel.

• Vägledning - Att sälja receptfria läkemedel i butik eller via e-handel.