Concept paper on revision of the guideline on the pharmaceutical quality of inhalation and nasal products

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Document details

Download document Concept paper on revision of the guideline on the pharmaceutical quality of inhalation and nasal products
Reference number EMA/CHMP/QWP/115777/2017
Status draft: consultation open
First published 2017-03-22
Last updated 2017-03-22
Consultation start date 2017-03-22
Consultation end date 2017-06-22
Email address for submissions qwp@ema.europa.eu

Summary

This concept paper concerns the guidance document on quality aspects of human medicinal products intended for delivery of drug substance into the lungs or to the nasal mucosa with the purpose of evoking local or systemic effect. These include pressurised metered dose inhalers, dry powder inhalers, products for nebulisation and non-pressurised metered dose inhalers as well as pressurised metered dose nasal sprays, nasal powders and nasal liquids.