The sunset clause for marketing authorisations

Under the ‘sunset clause’ of Article 24(4) to (6) of Directive 2001/83/EC, any marketing authorisation (MA) granted under the national, mutual recognition or decentralised procedure for a medicinal product, which has not been marketed for three years, will cease to be valid.

This also applies if the product was initially marketed, upon the MA being granted, but later ceased to be on the market. To be considered as being ‘on the market’, the product should be within the distribution chain, which means it should have left the control of the MA holder’s company.

The sunset clause provisions came into force on 20 November 2005. The three-year period for any product not on the market, which was granted an MA prior to this date, would begin to run on 20 November 2005. More generally, the period is effective from when the MA holder enters the last batch of product into the supply chain. If, on the other hand, the product did not enter the market at all, the date at which the MA was granted will be taken as the starting date of the three-year period. In respect of generic products, the three-year period starts on the later of: the date of grant of the MA; the end of the period of market exclusivity; or the end of the period of patent protection…

If you are registered and logged in to the site, click on the link below to read the rest of the Taylor Wessing briefing. If not, please register or sign in with your details below.

Briefings from Taylor Wessing

View more briefings from Taylor Wessing

Analysis from The Lawyer

  • singapore orchid

    Singapore: Cash course

    The city-state is working hard to become a global wealth management hub, and law firms are gearing up for a prosperous new world

  • Money 317

    Crunch boom

    Financial disputes are starting to dominate the English courts as the long-awaited fallout from the downturn finally comes to town

View more analysis from The Lawyer

Overview

5 New Street Square
London
EC4A 3TW
UK
http://www.taylorwessing.com

Turnover (£m): 228.00
No. of Lawyers: 860
No. of Lawyers (Asia Pacific): 79
Offices (Asia Pacific): 3

Jobs