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Before any product can be sold within the European market, it needs a market authorization (MA) from European Medicines Agency (EMA). Once a medicinal product gets MA from the European Medicines Agency (EMA), it is ready to be sold in EU. However, the Marketing Authorization Holder (MAH) must follow some mandates:

  • The medicinal product must be placed on the market within three years of the authorisation being granted  
  • Marketing status of the product will have to be monitored and reported to the agency in a periodical way

If the MAH fails to comply with above requirements, the Sunset Clause comes into effect. Sunset Clause is a provision introduced by the EMA in accordance with Regulation (EC) No 726/2004, Article 14(4-6). The aim of Sunset Clause is to monitor the marketing status of centrally authorized medicinal products within the European Union and European Economic Area (EEA).

Applicability and Validity

The Sunset Clause came into force on December 20, 2005. It applies to all centrally authorized medicinal products even if a product acquired its MA before December 20, 2005. In such cases, the product began counting its three-year period from 20th November 2005. This rule applies to any product that was discontinued from the market at the time Sunset Clause came into act.

As per the articles 14(4) and 14(5) of the Regulation, the Sunset Clause is applicable if after procuring MA, the product is not placed immediately on the market. The sunset timer starts from the date on which MA was granted by the Commission. It is also applicable in case the product has been taken off from the market for over three years from the last date of distribution. The concerned agency will need to be informed.

The Sunset Clause timer stops running when even a single member state places a medicinal product on the market. It also stops when after temporary cessation of the product, the product is placed on the market once again. Thirdly, the Sunset Clause timer stops whenever the Commission permits an exclusion and allows a medicinal product to be exempted from the Sunset Clause.

Sunset Clause Exemptions

In Europe, the European Commission grants exemption from the Sunset Clause on public health grounds or under exceptional circumstances. Exemptions from the Sunset Clause can be permitted at any stage of the marketing authorization life cycle (at the time of marketing application, during the market application life or at the time of Sunset Clause expiry time).

The MAH may be aware at the marketing application stage that an exemption maybe applicable. Medicinal products which are exempted include:

  • Medicinal products that are utilized in emergency situations and recognised either by the World Health Organization or by the Community
  • Medicinal products that can also be used in countering bio-terrorism; and therefore, antimicrobial medicinal products such as antibiotics, antivirals, and immunologicals (for active and passive immunization) which can be used in the prevention and/or treatment of disease caused by bio-terror agents

 

In such cases, it is the responsibility of the MAH to make a case for the exemptions. Exemptions need to be well-documented and must be notified to the commission. The typical procedure while applying for an exemption is to first apply either on public health or exceptional circumstances, then notifying the Commission. The commission will consider it on a case-by-case basis. The MAH must also address a copy of these requests to the EMEA.

It is important to note that the application of Sunset Clause completely depends on the reports submitted by the MAH. It is the responsibility of the MAH to ensure that the EMA is updated with the marketing status of their products. Regular detailed reporting and appraising EMA of any changes requires time and resources. Don’t run the risk of being taken off the market, talk to our experts at sales@freyrsolutions.com.