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EMEA: Guideline on The replacement of rabbit pyrogen testing by an alternative test for plasma derived medicinal products

06.05.2009
This guideline lays down the requirements to be addressed in any justification for use of a test for bacterial endotoxins as an alternative to a test for pyrogens for plasma derived medicinal ...

EMEA: Updated inventory of herbal substances for assessment

06.05.2009
Updated inventory of herbal substances for assessment in Alphabetical order (New EU Legislation) ...

Polish Ministry of Health: Regulation project relating to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

28.04.2009
The regulation project introduce the new rights and obligations of the President of the Office for Registration. ...

European Commision: Maximum Residue Limits - Key documents

28.04.2009
Substances considered as not falling within the scope of Council Regulation (EEC) No 2377/90. Updated version (revision 14 April 2009) from the Committee for Veterinary Medicinal Products. The ...

FDA: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document

28.04.2009
This guidance is intended to clarify for industry where to include the integrated summary of effectiveness (ISE) and integrated summary of safety (ISS) when submitting applications in the common ...

EMEA: Application Procedures - Quality Review of Documents (QRD)

28.04.2009
http://www.emea.europa.eu/htms/human/qrd/docs/listnonstandard.pdf ...

EMEA: Regulatory and Procedural Guidance - Article 58 Applications

28.04.2009
Administrative information application form for a Scientific Opinion according to Article 58 of Regulation (EC) 726/2004 ...

EMEA: Guideline on the Development of Medicinal Products for the Treatment of Post-Traumatic Stress Disorder (PTSD)

28.04.2009
The aim of this guideline is to provide guidance for the planning of clinical studies concerning the treatment of posttraumatic stress disorder (PTSD), the only psychiatric disorder with a causal ...

HMA: Variation Procedure

10.04.2009
HMA: Variation Procedure: BPG CMD(h) recommendations on unforeseen variations; Flow Chart for Recommendations on unforeseen variations - Request to CMD(h); Timetables for resquest ...

HMA: Paediatric Regulation

10.04.2009
HMA: Paediatric Regulation: Paediatric Regulation:Article 29 Recommendations for implementing Commission Decisions following an Art. 29 Application under the Paediatric Regulation ...