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.
When do we need to inform when marketing begins or ends?
You are obliged to continuously inform the Medical Products Agency when marketing begins, and no less than two months before actual marketing ends.
Do we have to notify on a special form?
Yes, the form on the MPA web site is preferable, since the information is structured in such a way that it will simplify entering the correct information into the MPA data base for each medicinal product. The form can be sent to the MPA by mail, fax or by e-mail.
Why does not the MPA use the marketing information which can be found in NPL?
According to the Medicinal Products Act the holder of the authorisation must inform the MPA when marketing begins or ends.
How will duplicates be 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 “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.
If a product is out of stock, will it be considered as not marketed?
If the product is estimated 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 delivery stop, it is not necessary to notify the MPA.
How will we know if an authorisation of a medicinal product will be withdrawn because it has not been placed on the Swedish market in the last three years?
The MPA will send information approx. half a year before an authorisation of a medicinal product will be withdrawn. The first possible date for withdrawal due to Sunset clause is May 1, 2009. The MAH will be notified by the end of 2008, which medicinal products are concerned. No medicinal product authorisations will be withdrawn without the MPA contacting the MAH.
Are there possibilities for exemptions from the application of Sunset clause?
The Medical Products Agency may grant exemptions from the application of Sunset clause. The Marketing Authorisation Holder has to justify why an exemption should apply, based on public or animal health grounds and in exceptional circumstances. The justification will be considered by the MPA on a case by case basis. For medicinal products approved by the MR procedure, a copy of the application must be sent to the RMS.
How do we apply for exemption from the application of Sunset clause?
Preferably you can use the form on the MPA web site in which you can tick a box for the most common particular reasons. The form can be sent to the MPA by mail, fax or by e-mail.
When can we apply for exemption from the application of Sunset clause?
Application for exemption from “sunset clause” should be made at least three months before the actual time for invalidation of the marketing authorisation.
Are there any examples for what can be a particular reason for exemption from the application of Sunset clause?
Particular reasons can for example be if there is lack of suitable alternative suppliers or alternative treatments to the medicinal product, which means there is the potential for adverse impact on public or animal health. Or, the medicinal product is a medicine held as part of emergency preparedness arrangements, for example vaccines.
If Sweden is RMS and the product is not placed on the Swedish market, how will Sunset clause be applied?
Sunset clause will generally not be applied on these products. The Marketing Authorisation Holder still has to apply for exemption from Sunset clause and give a motive. The MPA will assess and decide in case by case.