Notification of sales of certain non-prescription (“over the counter” – OTC) medicines

Instructions

Fill in all fields and then click “Next”, which is found in the bottom right. This will take you to a review page. Check that all information is correctly filled in and then click on “Send”. An acknowledgement that the notification has been sent to the Swedish Medical Products Agency will be sent to the e-mail addresses that are provided in the form.
Fields marked with a red asterisk * are obligatory and must be filled in.

Rättningsanvisningar

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Notification

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The notification is for sales of

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Date when sales are to start

Operator (company/sole trader)

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Is the operator part of a retail chain?

Sales outlet/shop

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Main operations of sales outlet

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Select an alternative

Liquor licenseaccording to Chap. 8 Para.1 of the Swedish Alcohol Act (2010:1622)

Online sales

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Will the sales outlet sell medicines online?

Note that the website(s) that are listed here must have their handling of medicines at the same address as that previously listed on this form as the sales outlet’s visiting address.

If the medicine is stored/handled at an address other than that provided as the visiting address, then a separate notification is required.

If the medicine is stored/handled at several physical addresses, then a notification must be submitted for each individual address.

Address of website

Website 1

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Invoicing

The annual fee (currently SEK 1600) is invoiced each calendar year. This fee is the same regardless of when during the year a notification or deregistration is made. Note that your municipality may also impose a monitoring fee.

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Contact information

We need your contact information in case we have any questions in connection with the registration of the sales outlet. In addition, a copy of your notification will be sent to your e-mail address.

As a retailer of non-prescription medicine you must follow the regulations that describe how medicines are to be handled and sold. The purpose of these regulations is to ensure continued quality of the medicines and that the medicines do not cause damage to people or the environment.

Before you can begin to sell medicines, the sales outlet must have a written self-regulation programme. All employees who work with the medicines must be familiar with the existing regulations and follow the routines laid out in the self-regulation programme.

Information and question
The Swedish Medical Products Agency’s website (www.lv.se/receptfrittibutik) contains regulations, guidelines and other important information for sales of certain non-prescription medicines. Should you have any questions, contact the Swedish Medical Products Agency by e-mail (registrator@lakemedelsverket.se) or phone (+46 (0)18 17 46 00).

Version: 1.0.0.3