«Pharma package I» was implemented in the Norwegian Regulation in January 2010. One of the provisions in this Regulation is the implementation of the so-called Sunset Clause, cf. “Forskrift om legemidler § 8-4”.
According to these provisions, any marketing authorisation which within three years of its granting is not followed by the actual placing on the market of the authorised product shall cease to be valid. When an authorised product previously placed on the market is no longer actually present on the market for a period of three consecutive years, the authorisation for that product shall cease to be valid.
In Norway Sunset Clause applies to products authorised via the mutual recognition procedure, decentralised procedure and national procedure incl. parallel imported products. Regarding products authorised via the centralised procedure the provisions of Sunset Clause are managed by The European Medicines Agency and the NoMA will follow the decisions made by the European Commission.
List of expiring MAs
From January 1, 2018 the Norwegian Medicines Agency will change the routine for publishing a list of expiring MA’s due to sunset clause on our website for advanced notice to all Marketing Authorisation Holder (MAHs) . This list will for the future be published once a year, in January/February. The deadline to apply for exemption will be December 31 the same year.
MA’s which already have an exemption with deadline the current year, will automatically have a prolonged exemption until December 31, the same year to apply for a new exemption.
If the information on the marketing status in the list is inaccurate; the appropriate information must be provided to the Norwegian Medicines Agency no later than the deadline in the accompanying list.
If neither written objections to the notice nor exemption application(s) are submitted by the deadline in the accompanying list, the decision of cessation of the marketing authorization will come in to force by immediate effect and without any further confirmation to the MAH.
What does "placed on the market in Norway" mean?
A medicinal product is considered as placed on the market when at least one pack size of a strength or pharmaceutical form is available on the Norwegian market. Duplicates are considered as individual products. The MAH is obliged to inform the NoMA when a medicinal product is placed on the Norwegian market. Medicinal products which are registered in the Nordic Article Number Registry (Farmalogg) or else reported to the NoMA with a marketing date are considered placed on the market in Norway.
At what time does the 3-year period start?
The 3-year period starts at the date when the marketing authorisation is granted and the product can be marketed; or if the medicinal product, previously on the market, is no longer present on the market for a period of three consecutive years.
Temporary or permanent interruption of the supply
The MAH is obliged to inform the NoMA if a medicinal product, permanently or temporarily, ceases to be placed on the Norwegian market.
Read more about notification of marketing interruption of a medicinal product in Norway, including withdrawal
The NoMA may grant exemptions from the application of Sunset Clause. Exemptions require that two conditions are fulfilled; exceptional circumstances and public health grounds. The MAH can apply for exemption from the Sunset Clause. In the application form the MAH should justify the need for exemption.
The exemption application form should preferably be submitted by e-mail, to firstname.lastname@example.org or by regular mail to The Norwegian Medicines Agency sufficient in time prior to the deadline in the published list.