Notification, changes and denotification

Invoice for the annual fee

Once your notification has been registered, you can commence sales of non-prescription medicinal products.

You will receive a communication from the Swedish MPA once your outlet has been registered. The Swedish MPA charges a supervision fee for each outlet.

The fee is SEK 1 600 per calendar year (January to December). It is always the same amount, regardless of when during the year the notification/denotification was made and regardless of how many medicinal products are sold.

Municipality's fee for checks

The Swedish MPA will inform your municipality when you have registered, so that it can check your outlet. The municipality may charge a fee for their checks.

Contact your municipality to find out about the amount of the fee. If the municipality finds serious errors or deficiencies which are not remedied, it will report them to the Swedish MPA.

New notification

If you wish to sell non‍-‍prescription medicinal products you must give notification thereof to the Swedish MPA. If you have several outlets, notification must be given of all the outlets concerned and this applies to both physical shops and online sales.

Notification form (Swedish only)

Changed information

If there are any changes in your operations, you must submit a notification of changes to the Swedish MPA. This applies, inter alia, to changed information on the company or the outlet, such as the contact information or a change of address or name. Changed information about e-trading or distance trading must also be notified.

Notification form (Swedish only)

Denotification

When you plan to cease selling non-prescription medicinal products, a denotification must be sent to the Swedish MPA. After the closing date you may not have non‍-‍prescription medicinal products left over in the shop for sale. Medicinal product waste can harm the environment and may not be disposed of among waste or effluent. Your remaining medicinal products must therefore be destroyed by a waste management company which does so safely.

Notification form (Swedish only)

Change of owner

If the outlet is to have a new owner, the current owner must be denotified and complete information on the new owner must be provided.

Denotification of the current owner

New notification of the new owner

Notification of e-trading

If you plan to sell non-prescription medicinal products online, you need to give notification thereof to the Swedish MPA and state your outlet and web address.

If you have already given notification of your outlet and plan to expand your operations with e‍-‍trading, please use the e‍-‍form for changed information.

EU common symbol

When selling non-prescription medicinal products online, you must have a symbol which shows that you have notified your outlet to the Swedish MPA and thus have the right to sell non‍-‍prescription medicinal products.

You must sign a licensing agreement with the Swedish MPA to have the right to use the EU common symbol.

Once you have given notification of e‍-‍trading, you will receive an agreement in duplicate for signature. You will sign both copies and send them to the Swedish MPA. We will sign both and send one back to you.

Once we have received your licensing agreement, we will send you the electronic version of the EU symbol and a document setting out how you are to use it. The document is known as a ‘visual identity'.

Your online store must provide a link to the list of e‍-‍traders

The EU symbol on your website must include a hyperlink to the Swedish Medical Product Agency's list of e-traders. The link will lead to your specific line in the list. Each operator is therefore given a unique hyperlink to the list of e‍-‍traders.

Personal data

Personal data submitted to the Swedish MPA in connection with the notification of trade in certain non-prescription medicinal products will be processed by the Swedish MPA for the purpose of carrying out supervision, municipal checks and annual invoicing.

The treatment forms part of the Swedish Medical Product Agency's exercise of official authority. The personal data requested is a legal requirement for engaging in retail sales of non-prescription medicinal products. The data will be stored indefinitely. Your personal data will be shared with the municipalities when supervision is to be carried out and with the eHealth Authority for information on sales statistics relating to medicinal products.

The Swedish MPA must be able to inform consumers and wholesalers about which outlets have been notified and which have de‍-‍notified their activity.

The Swedish MPA is responsible for the treatment of personal data. You have the right to request access to the information and in certain cases also the right to demand restriction of your personal data.

If you wish to complain about the Swedish MPA's treatment of your personal data, you should contact the Data Surveillance Authority.