Sunset Clause and European Reference Product - questions and answers
What does sunset clause mean?
Sunset clause means that marketing authorisations cease to be valid after a non-marketing period of three consecutive years.
However, exceptional circumstances and public health grounds may lead to exceptions. When interpreting the sunset clause it is important to bear in mind the meaning of:
- The term ”a market”
- Utilisation of a marketing authorisation
From when does the 3-year limit count?
The 3-year limit is counted from the point in time when it is actually possible to market the product. This means that lawsuits, injunctions, patents, etc. suspend the time limit.
What does ” exceptional circumstances and public health grounds ” mean?
Exceptional circumstances and public health grounds could be:
- Vaccines only used for pandemic outbreaks
- Exports to third countries
Does the provision include medicinal products authorised before the entering into force of the Medicinal Products Act on 17 December 2005?
Yes, the provision covers all medicinal products – whether or not they have been authorised before or after 17 December 2005. However, the 3-year period only counts from 17 December 2005.
Does payment of the annual fee have any impact on the sunset clause?
Yes. The Danish Health and Medicines Autority has decided to consider payment of the annual fee to be a notification of an intention to market a product, provided that the annual fee is paid on time for the product concerned in 2012. As a consequence, the marketing authorisation does not cease to be valid due to the sunset clause.
European Reference Product (ERP)
What is the difference between the two types of reference medicinal product?
Reference medicinal product: Is a medicinal product which is or has been authorised in Denmark in accordance with Danish provisions and where the marketing authorisation application of a generic product refers to the data of such product.
European Reference Product (ERP): Is a medicinal product that is or has been authorised in another EU/EEA member state but not in Denmark.
When can you use a European reference product?
You can use a European reference product when the medicinal product to which data you refer is not or has not been authorised in Denmark.
If the medicinal product is authorised in Denmark this product, not the ”foreign” product, must be used as the reference medicinal product.
Which data protection period will be relevant when you use a European reference product?
If you use a European reference product, the period of data protection must have expired in the member state where the medicinal product is.
Which SPC will be used when a medicinal product is to be authorised based on a European reference product?
This will depend on the individual case, but the SPC applicable in the other EU member state will probably be taken into consideration.