For many Marketing Authorisation Holders (MAHs), the MHRA Sunset Clause is one of those regulatory obligations that receives attention only when an expiry warning arrives. Unfortunately, by that point the timelines can be tight and the regulatory options limited. Effective monitoring of marketing status is therefore essential to avoid the unintentional loss of a UK marketing authorisation (MA).
This article provides a practical overview of the MHRA Sunset Clause, when regulatory teams should act, how to maintain compliance, available exemption routes, and the consequences of allowing an MA to lapse.
What is the Sunset Clause?
The Sunset Clause is laid out in regulation 67 of the Human Medicines Regulations 2012. In simple terms, a marketing authorisation becomes invalid if:
- The product is not placed on the UK market within three years of the MA being granted; or
- A product that was previously marketed ceases to be on the UK market for three consecutive years.
The purpose of the provision is to ensure that regulatory authorities are not maintaining licences for products that are no longer available to patients.
Importantly, the Sunset Clause applies at MA level, not necessarily individual pack level. Once at least one authorised presentation has been placed on the market, the initial three-year countdown is stopped. However, a new three-year period begins if the product subsequently disappears from the market.
What counts as “Placed on the Market”?
The MHRA considers a product to have been placed on the market when it enters the distribution chain and leaves the control of the MAH. Simply manufacturing stock or holding inventory in a warehouse is unlikely to be sufficient. MAHs should also notify the MHRA when a newly authorised product is first marketed and when products are temporarily or permanently discontinued.
When should Regulatory teams act?
The best time to think about the Sunset Clause is long before the three-year deadline.
A robust regulatory process should include:
1. Maintain a Sunset Clause tracker
Track:
- MA grant dates
- First marketing dates
- Temporary supply interruptions
- Permanent discontinuations
- Ownership transfers
- Existing exemption expiry dates
Many companies review their trackers quarterly and escalate products approaching the three-year threshold.
2. Monitor Commercial and Supply Chain decisions
Regulatory departments often learn of discontinuations late in the process. Establish communication channels with commercial, manufacturing and supply teams so that any interruption in supply is recorded promptly.
3. Notify MHRA of changes in marketing status
The MHRA expects MAHs to notify the Agency when products are first marketed and when marketing ceases temporarily or permanently. Notification should be made as close as possible to the actual change in status.
Can a product be exempted?
Yes. The MHRA may grant an exemption where invalidation of the MA would not be in the interests of public health. Applications are made using the MHRA Sunset Clause exemption form.
Examples of recognised exemption grounds include:
- Lack of suitable alternative suppliers or treatments
- Emergency preparedness requirements
- Products used in critical care settings
- Certified export-only products
- Ongoing regulatory procedures preventing market entry
- Manufacturing site transfer or process changes
- Company mergers and acquisitions
- Maintaining future supplier choice for the NHS
- Intellectual property restrictions
- Products supporting parallel imports
- Products used as reference medicines in clinical trials.
Depending on the justification, exemption periods may range from one year to three years. Some exemption categories may also be renewed, and it is important to keep track of when these renewals may be required.
When should an exemption be requested?
The key message is: before the MA expires. The MHRA is clear that retrospective exemption requests are not accepted once a licence has lapsed under the Sunset Clause.
A practical approach is to begin assessing exemption needs well in advance of expiry, allowing sufficient time to gather supporting evidence and obtain internal approval.
For exemptions that have already been granted, the MHRA has indicated that applications for extension should generally be submitted no earlier than three months before the exemption expiry date.
What happens if the licence Is lost?
Once the Sunset Clause takes effect, the MA is no longer valid.
The consequences are significant:
- The product must not be marketed.
- A public health exemption cannot be requested after invalidation.
- The licence cannot simply be reactivated.
Where a company later wishes to return the product to the market, the MHRA requires the submission of a new marketing authorisation application, with all associated regulatory, administrative and commercial implications.
For older products with complex manufacturing histories or legacy regulatory data, obtaining a new MA can be substantially more burdensome than maintaining the original licence through timely monitoring and exemption management.
Key learnings
The Sunset Clause should not be viewed merely as a licensing technicality. It is an active regulatory requirement that can lead to permanent loss of valuable marketing authorisations.
Regulatory Affairs teams should therefore:
- Maintain an up-to-date Sunset Clause tracker.
- Record first marketing dates accurately.
- Monitor supply interruptions and discontinuations.
- Ensure timely notifications to the MHRA.
- Assess exemption eligibility well before the three-year deadline.
- Never assume a licence can be recovered once invalidated.
With proactive monitoring and good cross-functional communication, the Sunset Clause can be managed effectively, protecting valuable licences and ensuring continued patient access to medicines in the UK.
Key MHRA reminder: the responsibility for monitoring Sunset Clause status remains with the MA holder. If a product has been off the market for more than three consecutive years, or an exemption has expired, the MA is considered cancelled and the product must not be marketed.
If you would like to discuss how we can support you with Sunset Clause guidance, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.
