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Guideline on the "sunset clause" - notification about initiation or cessation of marketing of medicinal products

17 January 2008, Updated 14 September 2017

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Background

Under section 22(1) of the Danish Medicines Act, the holder of a marketing authorisation for a medicinal product is required to notify the Danish Health and Medicines Authority of the date of actual marketing of the medicinal product and to notify the Danish Health and Medicines Authority if the product ceases to be placed on the market, either temporarily or permanently.

The provision implements article 23a of the directive on medicinal products for human use (2001/83/EC) and article 27a of the directive on veterinary medicinal products (2001/82/EC).

Such notification is required for the Danish Health and Medicines Authority's to administer section 28(1) of the Danish Medicines Act, which stipulates that a marketing authorisation ceases to be valid if the product is not, marketed for three consecutive years – hence the name "sunset clause".

What medicinal products are comprised by the "sunset clause"?

The Danish Medicines Act's rules on the "sunset clause" apply to all medicinal products for which the Danish Health and Medicines Authority has issued a marketing authorisation. Parallel imported medicinal products are not comprised.

For medicinal products authorised according to the centralised procedure, the holder of the marketing authorisation must notify EMA of the date of actual marketing of the medicinal product in the Community with reference to the different pack sizes authorised.

EMA must also be notified if the medicinal product ceases to be placed on the market, either temporarily or permanently. Unless exceptional circumstances apply, such notification must be made no less than 2 months before the product ceases to be on the market. See also: http://www.ema.europa.eu

How is a notification made?

Section 22(2) of the Danish Medicines Act stipulates that notification s to Medicine Prices1 (Medicinpriser) are deemed to constitute notification pursuant to section 22(1).

Instead of making a notification, cf. section 22(2) of the Danish Medicines Act, it is also possible to use the form "Notification about initiation or cessation of marketing of medicinal products", which is now available at the Danish Health and Medicines Authority's website (see box to the right).

Please note that the form is to be used in relation to the "sunset clause" only. In other words, it cannot be used for notification of changes in prices, authorisation and withdrawal, etc .

If the medicinal product in question has been authorised with Denmark as Reference Member State, but is not marketed in Denmark, the form can be used to notify initiation of marketing if:

  • the medicinal product is marketed in one or several Concerned Member States, or
  • the holder of the marketing authorisation is in possession of at least one pack of the medicinal product which is in compliance with the Executive Order on Labelling, etc. of Medicinal Products.

If the medicinal product concerned has been authorised according to the national procedure, the form can be used for notification of initiation of marketing if:

  • the holder of the marketing authorisation is in possession of at least one pack of the medicinal product prepared in compliance with the Executive Order on Labelling, etc. of Medicinal Products.

Furthermore, if the basis for notification ceases to exist, the Danish Health and Medicines Authority should be informed thereof by means of the form.

If the product concerned is a pharmacy only medicinal product, it is still assumed that neither delivery of nor advertising for the product take place without notification (including price) having been made to Medicine Prices (Medicinpriser) 14 days in advance.

Global marketing authorisations

When several marketing authorisations constitute a global marketing authorisation (a family of medicinal products), and a notification is made about initiation of marketing for one of the products in the family, all of the products in the family are regarded as marketed under the "sunset clause".

If notification has only taken place for one product in a product family, and the marketing of the product concerned subsequently ceases , a notification must be made for initiation of marketing for one of the other products in the family for them to be considered as marketed under the "sunset clause".

Entry into force

It appears from section 107(3) of the Danish Medicines Act that with regard to medicinal products comprised by a marketing authorisation at the time of entry into force of the Act, the 3-year time limit stated in section 28 commences at the time of entry. The Danish Medicines Act entered into force on 17 December 2005, and hence the earliest date when a marketing authorisation can cease to be valid under the "sunset clause" is 17 December 2008.

Note 1: Global marketing authorisation is a designation for an initial marketing authorisation with all subsequent strengths, pharmaceutical forms, administration routes , presentations , variations and extensions with the same name and active substance. See also Notice to Applicants, Volume 2A, chapter 1, section 2.3.

The Danish Medicines Agency, 17 January 2008. 


Note 1. Medicine Prices (Medicinpriser) – previously referred to as the Price List

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