The "Sunset Clause": One-off exercise to establish the marketing status of all medicinal products on the UK market

Under Article 24 (4-6) of Directive 2001/83/EC (as amended), which came into force in the UK on 30 October 2005, any marketing authorisation (MA) which, within three years of granting, is not followed by the placing on the market of the authorised product will cease to be valid. If a product is placed on the market after authorisation, but subsequently ceases to be placed on the market in a Member State for a period of three consecutive years, its authorisation will also cease to be valid.

The provision that invalidates marketing authorisations (MAs) of products not on the market for three consecutive years has no retrospective effect, and so will not impact on the validity of any MA before 30 October 2008. However, the MAs for products not marketed since 30 October 2005 will become invalid on 30 October 2008 unless the MA holder applies for, and is granted, an exemption from invalidation on public health grounds. Going forward, the MAs of medicinal products that were last placed on the market on a date later than 30 October 2005 will become invalid on dates that are three years after that date, if they remain off the market for three consecutive years, and if they are not granted an exemption on public health grounds. Please note that you must formally apply for a public health exemption to avoid the MA for a product becoming invalid after the expiry of three years in which the product has not been marketed.

The MHRA will be conducting a one-off exercise to establish the marketing status of all medicinal products on the UK market, whether they have purely national authorisations, or were authorised under the decentralised or mutual recognition procedures. Herbal medicinal products with a full MA are included, but other categories of herbal medicines, homeopathic products and parallel imported/distributed products are outside the scope of this exercise. Products authorised under the centralised procedure are the responsibility of the EMEA/European Commission and their marketing status does not have to be notified to the MHRA under this exercise.

We are planning to issue instructions on how to comply with this exercise from 12 May 2008, with responses required from MAHs by 12 July 2008. We propose to issue a CD to each MA holder with details of each MA they hold on an Excel spreadsheets for completion and return by e-mail or return of the CD. A detailed explanation of how to comply with this exercise will be sent to each MA holder.

If you intend to apply for an exemption on public health grounds in respect of a product that has not been on the market in the UK since 30 October 2005, you may do so at the same time as you complete and return the spreadsheet. You do not need to send any data supporting your application for a public health exemption, but you will need to have any such information available to submit should we ask you to do so. An electronic version of the proforma we have developed for you to use when applying for a public health exemption will be included in the CD we send you. It can be completed and returned electronically with the spreadsheet. A copy is available to download below for information. Proposals for conducting this exercise have been discussed and agreed with the trade associations (ABPI, BIA, BGMA, PAGB and the Herbal Forum).

We would be grateful for prompt responses to this exercise which will enable us to:

• update MHRA records
• avoid the possibility that products with invalidated MAs are unwittingly placed back on the market by MA holders
• reduce confusion and unnecessary future correspondence about the status of individual MAs.

Until we launch this exercise, you should continue to notify (first placing on the market and temporary interruptions in supply) by e-mail to: info@mhra.gsi.gov.uk.

For your information our updated “Q&A” document that now provides additional information about the sunset clause and this one-off exercise is available to download below.  Our policy statement on the sunset clause is also available to download below.