Sunset clause
The Sunset Clause provision is regulated not only in Poland but mainly results from the Directive 2001/83/WE.
What is Sunset Clause?
Sunset Clause is the provision that will lead to the expiry of a marketing authorization for a medicinal product if:
- the medicinal product has not been placed on the market within three years from the date of granting the marketing authorization, or
- when a medicinal product previously placed on the market is no longer actually present on the market for a period of three consecutive years.
This provision applies to products authorized under national procedures, DCP, MRP and centrally authorized medicinal products. In Poland, the Sunset Clause provision is regulated by the Art. 33a of the Pharmaceutical Law Act of 6 September 2001.
Additionally, in case of Poland, pursuant to the Art. 33a par. 2 of the Pharmaceutical Law Act of 6 September 2001, the Marketing Authorization Holder may apply to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB) for a withdrawal from the effects of Sunset Clause and for issuing a decision stating that the authorization of the marketing authorisation for the medicinal product does not expire.
The application should contain a detailed justification:
- relating to the importance of the medicinal product in terms of protecting public health, and
- indicating the existence of exceptional circumstances that constituted the reason for not placing the product on the market.
The deadline for submitting such application is at least 30 days before the expected expiry of the marketing authorisation, and the procedure should be completed within a maximum of 30 days from the date of complete application submission.
It is worth to take into consideration that each country considers Sunset Clause issues nationally, so the above-mentioned application type should be addressed nationally to each Agency. The exception are products registered in the central procedure, as in their case the application is considered by the European Commission.
Why SciencePharma?
Our Experts have many years of experience in the field of drug registration and preparation of post-registration variations as well as exemptions from the Sunset Clause. Pharmaceutical companies from all over the world have used our support many times and often come back to us, which undoubtedly proves the high quality of services provided by SciencePharma.
Benefits for your company
Keeping abreast of the latest Competent Authorities requirements is much easier with the support of an experienced and well-informed team. At SciencePharma we offer both: preparation and submission of an application for withdrawal from the effects of Sunset Clause in Poland and other European Union countries, as well as comprehensive registration / post-registration services for medicinal products – depending on the individual needs of the Marketing Authorization Holder.
If you are interested in working with us, please do not hesitate to contact us. Our Experts will answer all your questions and doubts.