Sunset-clause monitoring: questions and answers

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This page lists questions that marketing-authorisation holders (MAHs) may have on sunset-clause monitoring. It provides an overview of the European Medicines Agency's position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. Revised topics are marked 'New' or 'Rev.' upon publication.

A PDF version of the entire post-authorisation guidance is available:

These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants.

MAHs must in all cases comply with the requirements of Community legislation. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text.

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1. What is the sunset clause?

The so-called "sunset clause" is a provision leading to the cessation of the validity of the marketing authorisation if:

  • the medicinal product is not placed on the market within three years of the authorisation being granted or,
  • where a medicinal product previously placed on the market is no longer actually present on the market for three consecutive years.

The European Commission may grant exemptions on public health grounds and in exceptional circumstances if duly justified.

References:

2. Does the sunset clause apply to existing medicinal products?

This new provision applies prospectively to all centrally authorised medicinal products from the date of entry into force of the Regulation i.e. 20 November 2005.

Therefore, for medicinal products for which a MA has been granted before 20 November 2005 and for which no presentation are marketed in the Community at this date, the three-year period which leads to cessation of the MA will start as of 20 November 2005.

References:

3. What are the requirements to maintain a marketing authorisation for a centrally authorised medicinal product?

The marketing authorisation of a medicinal product will remain valid if at least one presentation/pack-size of the existing product presentations is placed on the market in the Community (in at least one Member State) including Iceland, Norway and Liechtenstein.

The marketing authorisation of a centrally authorised medicinal product includes the initial marketing authorisation and all variations (e.g. additional presentations,…) and extensions (e.g. new strengths, new pharmaceutical forms,…) authorised for this specific medicinal product. This notion has been applied since the beginning of the centralised procedure and is reflected in the way the EU numbers are allocated to a specific centrally authorised medicinal product and all its presentations.

References:

  • Chapter 1 (section 2.4.2), The Rules governing Medicinal Products in the European Union, Notice to Applicants, Volume 2A
4. What are the principles for the monitoring of the sunset clause?

A three-year period without marketing of a medicinal product in the EEA can be encountered further to the granting of the marketing authorisation: when a medicinal product has never been marketed or, after marketing of a medicinal product has been completely stopped.

The term “no longer actually present on the market” should be understood in the same way as “ceases to be placed on the market”. Therefore, the sunset clause period in case of a complete marketing cessation of the product shall start from the last date of release into the distribution chain of the medicinal product. For definition and modalities of reporting of cessation, details are given in question 1 of the Marketing and Cessation notification Q&A listing.

The European Medicines Agency has set up a system to monitor the marketing status of centrally authorised medicinal product. This is done in view to notify the Commission when a three consecutive year period without marketing has elapsed and that the sunset clause provision should take effect.

The MAH should be aware of the overall timing with regard to the sunset clause period for their product and for taking any actions, should they wish to retain the marketing authorisation.

References:

5. In case of a protection period to be respected before placing the medicinal product on the market, when will the sunset clause period start?

The determination of the start of the 3-year period from granting of the marketing authorisation should be the date when the medicinal product can be marketed by the marketing authorisation holder, taking into account, e.g. the market exclusivity and other protection rules which have to be respected.

For a medicinal product for which a MA will be granted after 20 November 2005, The Commission Decision will, in most cases, trigger the 3-year period.

However, following new data protection rules in the revised legislation, the 3-year period for generic and similar biological medicinal products will start as of the end of the 10 or 11-year protection period of the reference medicinal product.

Furthermore, other protection rules might need to be respected. Such information are not known by the Agency. MAHs are therefore advised to inform the European Medicines Agency of the existence and if known, the expiry date of the other protection period(s) to be respected as appropriate. This should be notified within 60 days from the date of the granting of the MA.

References:

6. When is the sunset timer ON/OFF?

The following situations can lead to the start of the sunset clause period (“ON”):

  • Granting of the Marketing authorisation

At the time of the granting of the marketing authorisation, the medicinal product may not be immediately placed on the Community market. As a consequence, the sunset timer will start running from the granting of the marketing authorisation by the Commission or when the MAH can legally place the medicinal product on the market. (see also question 5 of this Q&A listing: "In case of a protection period to be respected before placing the medicinal product on the market, when will the sunset clause period start counting?")

  • A temporary or permanent cessation of placing on the market the medicinal product

The MAH is obliged to inform the Agency of any product cessation (see question 1 of the Marketing and cessation notification Q&A listing). When there is no longer any presentation of the medicinal product placed on the Community market, the sunset timer will start running from the last date of release into the distribution chain of the medicinal product.

The following situations lead to the stop of the sunset clause period (“OFF”):

  • Initial placing on the Community market

The sunset timer will stop running at the time of the first placing on the market of one presentation in one Member State.

  • At the re-placing on the market after a temporary cessation of the whole medicinal product

As soon as a medicinal product is again placed on the Community market after a temporary cessation, the sunset timer will stop running at this date.

  • Exemption

As soon as an exemption is granted by the Commission for a medicinal product, the sunset timer will be stopped.

7. What about exemptions?

The Commission may grant exemptions from the application of the sunset clause on public health grounds and in exceptional circumstances.

Exemptions can apply at any time of the marketing authorisation life cycle (i.e. at the time of the marketing authorisation, during the marketing authorisation life, or approaching the expiry of the sunset clause period) depending on the type of exemptions.

At submission stage the following exemptions might be applicable:

- Medicinal products to be used in emergency situations, in response to public health threats duly recognised either by the WHO or by the Community (Decision No 2119/98/EC).

- Antimicrobial medicinal products such as antibiotics, antivirals and immunologicals (for active and passive immunisation) aimed at the prevention and/or treatment of disease caused by bio-terror agents in response to an emergency public health need.

It will be up to the MAH to justify why an exemption should apply based on public health grounds and in exceptional circumstances. A request for an exemption including a justification should be notified to the Commission and each justification will be considered on a case-by-case basis. A copy of such request should also be addressed to the European Medicines Agency.

References:

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