Update on 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 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 has undertaken 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 were included, but other categories of herbal medicines, homeopathic products and parallel imported/distributed products were outside the scope of this exercise. Products authorised under the centralised procedure are the responsibility of the EMEA/European Commission and their marketing status did not have to be notified to the MHRA under this exercise.

The MHRA issued instructions on how to comply with this exercise which should have been completed by marketing authorisation holders (MAHs) by 12 July 2008. We issued 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 was sent to each MA holder.

MAHs intending 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 could do so at the same time as they completed and returned the spreadsheet, but may also do so at a later date, as long as this is at least two months before the date on which the MA will become invalid. 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. You may use the proforma we developed for you to use with the CD we send you for the one-off exercise. A copy is available to download below for information:
› Request for public health exemption from invalidation of a marketing authorisation (63Kb)

Our policy statement, and detailed Q&A on the sunset clause is available on our website. MA holders notifying us by email of issues relevant to the “sunset clause” provisions in Directive 2001/83/EC must now use the following email address: sunsetclause@mhra.gsi.gov.uk

If you have not yet completed the spreadsheet and returned the required information to the MHRA we would be grateful if you would do so forthwith.

As was explained in the letter sent to MAHs in May, if we do not receive information about the marketing status of the products for which you hold marketing authorisations that will enable us to amend our records, we will assume that these products are not marketed. The effect of this will be that after three years has elapsed the Marketing Authorisations for those products will be deemed invalid, and will be cancelled.

If you are experiencing difficulties in completing the spreadsheet we sent to you or in returning it to us in the required format, please contact the Regulatory Information Service at the MHRA immediately on 020 7084 3400.

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.