6. Sunset Clause

6.1 What is meant by “be available on the Swedish market”?

In order for a medicinal product to be considered as available on the Swedish market, at least one package of a strength, pharmaceutical form or taste must be marketed.

“Available on the Swedish market” means that the product must be available for the user it is intended for. In most cases the product should be available through a wholesaler. For products intended for hospital use only, the product may be considered marketed if bids for tenders are made on regular basis.
Please refer to question 6.3 for information on how to notify the MPA when marketing begins or ends.

6.2 When do we need to inform when marketing begins or ends? 

You are obliged to continuously inform the MPA when marketing begins, and no less than two months before actual marketing ends (but please note the answer to question 6.6 below). 

6.3 Do we have to notify on a special form? 

Please use the form below. It can be sent to the MPA by mail or e-mail. If the form is sent by e-mail it does not require a handwritten signature.

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6.4 Why does not the MPA use the marketing information which can be found in NPL? 

According to Chapter 4 Section 18 of the Medicinal Products Act the holder of the authorisation must inform the MPA when marketing begins or ends.

6.5 How is duplicates treated? 

Each separate marketing authorisation granted by a National Competent Authority must be applied individually, also when those authorisations are duplicates. It is not enough to have the product with the “original” marketing authorisation placed on the market if the duplicate has not been marketed during the latest three years. The same principle is applicable if the duplicate is marketed but not the “original” medicinal product.

6.6 If a product is out of stock, will it be considered as not marketed? 

If the product is anticipated to be out of stock during a long time (more than a year) you must contact the MPA for a discussion. In case of a shorter interruption of delivery, it is not necessary to notify the MPA.

6.7 How do we apply for exemption from the application of Sunset clause? 

The Medical Products Agency has decided to consider payment of the annual fee to be a notification of the intention to market the product in Sweden. As a consequence, the marketing authorisation does not cease to be valid due to Sunset Clause, provided the annual fee is paid on time. No application for exemption from invalidation of a marketing authorisation due to Sunset Clause needs to be submitted.

6.8 How is Sunset clause applied if Sweden is RMS and the product is not placed on the Swedish market? 

The Sunset clause is generally not applied on these products. Providing the annual fee is paid on time, the marketing authorisation stays valid.

 
 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information