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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| Impurities in New Drug Products (CPMP/ICH/282/95) |
| Short Title: | Q3B |
| Internet: | http://www.ema.europa.eu/index/indexh1.htm |
| Origin/Publisher: | Sector for Document Management and Publishing, European Agency for the Evaluation of Medicinal Products, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK, http://www.ema.europa.eu/ |
| Content: | This ICH guideline gives recommendations for the limits and qualification of impurities in medicinal products with new active substances which have to be taken into account in marketing authorizations. Still valid, but a revised guideline, Q3B(R) is currently in preparation. |
| Document Type: | ICH Guidelines |
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