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1 October 2019, Rev.4 1 EMA/469917/2018 Human Medicines Research and Development SupportPostorphan medicinal product designation procedures Guidance for sponsors submitting an application via the

How to fill out post-orphan medicinal product designation

How to fill out post-orphan medicinal product designation

1. Gather all the necessary information about the medicinal product, including its name, indication, active substance, and pharmaceutical form.
2. Prepare a dossier containing the required documents, such as a summary of product characteristics, proposed labeling, and information on the orphan indication.
3. Fill out the application form for post-orphan medicinal product designation, providing all the requested details and attachments.
4. Submit the completed application form and dossier to the appropriate regulatory authority.
5. Pay the necessary fees as specified by the regulatory authority.
6. Await the regulatory authority's decision on the post-orphan medicinal product designation. If approved, the product will benefit from the post-orphan status.

Who needs post-orphan medicinal product designation?

1. Companies developing medicinal products for rare diseases or conditions may need post-orphan medicinal product designation.
2. This designation provides certain benefits, such as market exclusivity, reduced regulatory requirements, and access to incentives for further clinical development.
3. It is also advantageous for patients with rare diseases as it encourages the development of treatments for their conditions.

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What is post-orphan medicinal product designation?

Post-orphan medicinal product designation is a status granted to a product that has previously been designated as an orphan medicinal product. It allows the product to benefit from certain incentives and market exclusivity.

Who is required to file post-orphan medicinal product designation?

The marketing authorization holder of the orphan medicinal product is required to file for post-orphan medicinal product designation.

How to fill out post-orphan medicinal product designation?

The marketing authorization holder must submit an application to the regulatory agency providing information on the product, its intended use, and any additional data required for post-orphan designation.

What is the purpose of post-orphan medicinal product designation?

The purpose of post-orphan medicinal product designation is to provide continued support for products that have received orphan designation, ensuring they maintain their incentives and market exclusivity.

What information must be reported on post-orphan medicinal product designation?

The application for post-orphan medicinal product designation must include updated information on the product, its intended use, and any additional data required by the regulatory agency.