Sunset Clause Implementation in the EU

When a Marketing authorization (MA) is granted in the European Union/United Kingdom via any procedure (centralized, national, mutual recognition, or decentralized procedure), it is the responsibility of the marketing authorization holder (MAH) to keep the MA valid in the particular member state. Many aspects are accounted for in the MA validity, including renewing the marketing authorization, maintaining the product’s life cycle, and keeping the marketing authorization compliant with health authority requirements so that the medicinal product’s safety, efficacy, and quality are not compromised.

What is the Sunset Clause

After the grant of the MA, the ultimate goal of the MAH is to commercialize the product in the market. However, according to Article 14(4-6) of Regulation (EC), No 726/2004 and Article 24(4-6) of Directive 2001/83/EC as amended, a sunset clause comes into the picture if due to specific reasons, the MAH failed to:

• Commercialize the product within three years after the MA grant (the date is calculated from the MA grant date).
• Or maintain the continuity of the supply of the product into the market for three consecutive years.

For generic hybrids and similar biological medicinal products, if any protection rules are applicable, such as market exclusivity or patents after the MA grant, the sunset clause timer will start after the relevant protection rule expires, as appropriate.

So, concisely, with the Sunset Clause, the health authority (HA) wants to monitor the marketing status of the MAs so that the supply of the product in the market to meet unexpected patient demands can be taken care of.

Applicability

The Sunset Clause (SC) provisions came into force on 20 November 2005. So, this SC provision is now applicable to all authorized products. However, if one of the pack sizes of the particular strength of the MA is marketed in individual member states, then it will not come under the provision of Sunset Clause expiry. On the other hand, for centralized procedures, the MA will continue to be valid so long as there is at least one product presentation on the market in at least one member state of the Community.

Exemption

The Sunset Clause provision is handled at the national level by individual member states for nationally authorized products, and it is possible to apply the exemption at the national level. Every EU member state has its requirements while applying for exemption under the Sunset Clause expiry. Still, it is the responsibility of the MAH to make their case for the exemption. National competent authority will evaluate the application on a case-by-case basis. If duly justified, it can grant the exemption based on public health grounds or the availability of alternate medicines in exceptional circumstances. The deadline to submit the exemption application varies between health authorities. However, the request should usually be made 30-90 days before the upcoming Sunset Clause expiry date, and MAH can expect the HA decision within 30 days after applying.

On the contrary, for centralized procedures, depending on the type of exemptions, the application can be submitted at any time of the marketing authorization life cycle (i.e., at the time of the MA, during the MA life, or approaching the expiry of the sunset clause period).

There are exceptions for some member states, such as if the annual fee has been duly paid and other conditions of MA are complied then the medicinal product is not entitled to the Sunset Clause.

Given that, MAHs are obligated to justify the reason for exemption and keep the HAs informed regarding the marketing status of the product.

ProductLife Group’s Sunset Clause Exemption Application Support

At ProductLife Group, we understand the importance of filing the exemption application on time and understand local HA requirements in filing the applications. Our presence in most EU countries supports presenting the case before HA to increase the chances of getting the exemption to keep MA valid.

Contact us to learn more about our services and how we can help you prepare your applications.