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EMEA
European Medicines Agency (EMEA) Guidelines
This page provides access to regulatory guidance and other resources that are generally available from web sites operated and maintained by other organizations.
Documents which have been considered by the Committee for Human Medicinal Products or the Committee for Veterinary Medicinal Products, in consultation with the European commission and the competent authorities of the Member States, to assist applicants for a marketing authorisation.
New regulatory guidance and other resources for toxicology are now available.
Note: these links take you directly to the documents on the EMEA web site. Please click here to contact us and let us know if you have problems accessing them.
| Title | Type | Posted | |
|---|---|---|---|
| Concept Paper on the Development of a CHMP Guideline on Non-Clinical Testing for | Concept Paper | June 2005 | |
|
EMEA/CPMP/SWP/110180/04 |
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| Guideline on Requirements for Vaccine Antigen Master File (VAMF) Certification | Guideline (Revised) | June 2005 | |
|
EMEA/CPMP/4548/03/Final/Rev 1 |
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| Reflection paper on the Assessment of the Genotoxic Potential of Antisense Oligodeoxynucleotides | Reflection Paper | February 2005 | |
|
CHMP/SWP/199726/2004 |
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| Guideline on Active Substance Master File Procedure | Guideline | June 2002 | |
|
EMEA/CVMP/134/02 Rev 1 The European Medicines Agency (EMEA) Committee for Human Medicinal Products (CHMP), EU published (21 April 2005) QWP Guideline on Active Substance Master File procedure revision 1. The updated guidance was adopted at the April 2005 meeting of CHMP. |
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The links on this page are provided for the sole purpose of assisting visitors to locate the relevant web sites and BioReliance does not make any warranty with respect to the accuracy of the documents available from these sites. All documents are the copyright of the respective site owners and may be subject to certain conditions of use. Although care has been taken in the preparation of this web site BioReliance cannot be held responsible for the accuracy of the information contained within the web site, nor for any consequence arising from such information. You are advised to seek additional advice when making decisions based on information you have obtained from this web site.
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