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

Steg 1 av 2. Notification of sales of certain non-prescription 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 mandatory and must be filled in.

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Notification

The notification is for sales of

Operator (company/sole trader)
Enter the corporate identity number if the operator is a corporation (e.g. limited liability company (AB), trading partnership (HB), or limited partnership (KB)) and the personal identity number if it is a sole trader.
Enter the company’s, firm’s or economic association’s name. The name of your selling outlet/shop will be provided further down in the form.
Is the operator part of a retail chain?
Sales outlet/shop
Enter the sales outlet’s/shop’s name. If sales are only conducted online, then provide the web address’ URL.
A GLN (Global Location Number, GS1 location number) is used, e.g., when reporting sales statistics to the Swedish e-Health Agency. If you do not have a GLN code, the Swedish e-Health Agency will give you a code to use on reports.
Enter the shop’s visiting address (i.e. not a box number). If this is for online sales, enter the address of the location where the medicine is stored/handled. Note that sales, storage and handling of medicine must not occur in a residence as such locations are unsuitable for such activities.
Select the municipality where the visiting address is located.
Main operations of sales outlet

Select an alternative

Liquor licenseaccording to Chap. 8 Para.1 of the Swedish Alcohol Act (2010:1622)No medicine other than nicotine-containing medicine may be sold in serving areas where a liquor license applies.

Online sales

Will the sales outlet sell medicines online?Answer Yes if your customers will be able to order medicines on your website. Answer No if you will not be selling medicines on your website.

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
Invoicing
The annual fee (currently SEK 2700) 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.
Electronic invoicing
The Medical Products Agency sends invoices in PEPPOL or as PDF.
Please enter PEPPOL-ID, or an e-mailaddress for PDF-invoice.
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.
Enter your own name.
Enter your e-mail address. A copy of your notification will be sent to this 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).