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SPC Proposal NumberAPPLICATION FOR RESEARCH STUDY I.Study InformationTitle of research: Date of submission: Proposed research starting date: Proposed research ending date:II.Primary Investigator,
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How to fill out supplementary protection certificates and

01
Check the expiration date of the patent of the medicinal product.
02
Fill out the application form for supplementary protection certificates with accurate information.
03
Submit the application form along with any supporting documents to the relevant authority.
04
Wait for the decision on the application from the authority.

Who needs supplementary protection certificates and?

01
Pharmaceutical companies who have developed a new medicinal product that has been granted a patent.
02
Manufacturers who wish to extend the period of exclusivity for their medicinal products in the marketplace.
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Supplementary Protection Certificates (SPCs) are legal instruments in the European Union and certain other jurisdictions that extend the protection of patented pharmaceuticals and plant protection products for a maximum of five years after the expiry of the base patent. This extension compensates for the time taken to obtain regulatory approval for these products.
The holder of the valid patent for the pharmaceutical or plant protection product is required to file for a Supplementary Protection Certificate.
To fill out a Supplementary Protection Certificate application, the applicant must provide information such as the details of the patent, the authorisation for placing the product on the market, and certain administrative details, following specific forms provided by the relevant regulatory authority.
The purpose of Supplementary Protection Certificates is to provide additional patent protection for innovative medicines and plant protection products, ensuring that companies can recoup their investment in research and development after an initial patent term has expired.
The information that must be reported on Supplementary Protection Certificates includes the patent number, the product name, the regulatory approval details, and the identity of the applicant, among other related information.
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