Non-prescription (over-the-counter) medicines
Conducting retail sales of certain non-prescription (over-the-counter or OTC) medicines at points of sale other than pharmacies.
How to notify
Notify by the e-service for this purpose at the Swedish Medical Products Agency. Once the notification has been registered, the point of sale can be found in the search service "search point of sale" on the Swedish Medicines Agency's website. Then you can start to sell non-prescription (over-the-counter) medicines.
The annual fee charged by the Swedish Medical Products Agency for conducting retail sales of non-prescription medicines is SEK 2,700 per point of sale (outlet). The amount is always the same, regardless of what time of the year the registration is made. The annual fee is the same regardless of whether you choose to sell a large or small range of over-the-counter medicines. Your municipality also has the right to charge a fee for checks.
Läkemedelsverket
Information about the notification
To conduct retail sales of certain non-prescription medicines, you must first notify the Swedish Medical Products Agency. Similarly, changes in your operations must be notified, or if you want to stop selling such medicines altogether. There is a search service on the Swedish Medicines Agency's website, in which you can search for medicines that are approved for sale in places other than pharmacies. If you use the default filter, you will get search results for all medicines that can be sold in places other than pharmacies.
Requirements
Before you can begin sales, you must set up a quality system (self-monitoring programme) of written procedures for how your staff are to handle medicinal products and you need to train your staff so that they understand which rules apply.
The medicines are to be purchased from a supplier that has a wholesale authorisation for medicines. It is not permitted to purchase medicines at a pharmacy or another retail shop and then resell them. The medicines must have Swedish labels and be approved for sale in shops other than pharmacies. It is important that the medicines are handled correctly to guarantee their quality to the customer. For example, damaged packages must be removed from sale, and you must ensure that the medicines have sufficient serviceable life left when they are sold.
Non-prescription medicines may only be sold to those customers who are 18 or older. Your shop must therefore have procedures for checking age. There must also be signs stating the age limit in your shop.
Medicines must be stored either under lock and key, or under the direct surveillance of personnel and separated from products that are not medicines, and it must be clearly apparent which products are medicines.
Every month/quarter, you must report how much of the medicines have been sold in your shop to the Swedish eHealth Agency.
Notification and supervision
Send your notification to the Swedish Medical Products Agency. Your municipality will carry out checks in your shop and report non-compliances with the requirements to the Swedish Medical Products Agency.
If you are rejected
How to appealLänk till annan webbplatsPublisher: Tillväxtverket