Pharmaceutical quality of inhalation and nasal products - Scientific guideline
Table of contents
This document outlines expected quality aspects of human medicinal products intended for delivery of the active substance into the lungs, or to the nasal mucosa, with the purpose of evoking a local or systemic effect. These include pressurised metered dose inhalers, dry powder inhalers, products for nebulisation, and nonpressurised, metered dose inhalers, as well as pressurised metered dose nasal sprays, nasal powders, and nasal liquids.
Keywords: Inhalation, nasal, pharmaceutical quality, lung, pressurised metered dose inhalers, dry powder inhalers, products for nebulisation, non-pressurised metered dose inhalers, nasal sprays, nasal powders, nasal liquids
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Guideline on the pharmaceutical quality of inhalation and nasal products (PDF/237.73 KB)
Adopted
First published: 21/06/2006
Last updated: 21/06/2006
Legal effective date: 01/10/2006
EMEA/CHMP/QWP/49313/2005 -
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Concept paper on revision of the guideline on the pharmaceutical quality of inhalation and nasal products (PDF/107.96 KB)
Draft: consultation closed
First published: 22/03/2017
Last updated: 22/03/2017
Consultation dates: 22/03/2017 to 22/06/2017
EMA/CHMP/QWP/115777/2017