Guideline on quality of transdermal patches – Free PDF Download




This guideline considers the general requirements concerning the development and quality of a transdermal patch for all new marketing authorisation applications and variations. In addition, specific guidance is provided concerning the data requirements to support generic or abridged applications.

Cutaneous patches (where the active substance is not intended to be systemically absorbed) are out of
the scope of this guideline. However, some of the quality aspects of transdermal patches may  be relevant and applicable, e.g., Sections 4.2 Pharmaceutical Development, 4.3 Manufacture and 4.5 Drug Product Specifications.

Annex 1 provides supplementary information with respect to in vitro skin permeation studies.


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