CRED 8 Presentations

01/07/2024

Module 1.7 Information relating to Orphan Market Exclusivity (CP)

• Required for orphan drugs (OD) and ’all new applications and type II variations for new indications, where the indication applied for is the same as the indication of an authorised Orphan Medicinal Product • Report is required to address similarity of your drug to all other drugs which are approved for the same orphan drug ‘condition ’ • List of orphan designations approved for the same drug condition is available on the European Commission register (Union Register of medicinal products - Public health - European Commission (europa.eu)) Search under ‘indication’.

The Organisation for Professionals in Regulatory Affairs

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Module 1.7 Information relating to Orphan Market Exclusivity (CP)

What is meant by similarity? • Similar active substance or substances as contained in a currently authorised orphan medicinal product which has: • Same therapeutic indication • Same mechanism of action

• If similar according to EMA guidance then a derogation is required under one of the criteria. This may include demonstration of clinical superiority over an existing therapy, which may require clinical data to support.

Ref: European Commission Guideline on Assessing Similarity of Medicinal Products versus authorised orphan medicinal products benefiting from market exclusivity and applying derogations from that market exclusivity Microsoft Word - Gudeline as adopted on 19 September 09 - copy from e Greffe.doc (europa.eu)

The Organisation for Professionals in Regulatory Affairs

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