Farmalex

Guidance for Industry

Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal Flora

ftp://ftp.fao.org/es/esn/jecfa/2004-10-15_fnp41-16final_4.pdf 

 

Veterinary International Conference on Harmonization (VICH)

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000172.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac058002dea9#

 

Residues of some veterinary drugs in animals and foods

ftp://ftp.fao.org/es/esn/jecfa/2004-10-15_fnp41-16final_4.pdf 

 

Joint FAO/WHO Expert Committee on Food Additives Sixty-Second Meeting Rome, 4-12 February 2004: Summary and Conclusions

ftp://ftp.fao.org/es/esn/jecfa/jecfa62_summary.pdf 

 

ORDONANTA nr. 47 din 11 august 2005

privind reglementari de neutralizare a deseurilor de origine animala

http://ec.europa.eu/agriculture/stateaid/newms/ro/og_47_2005_ro.pdf

 

Joint FAO/WHO Technical Workshop on Residues of Veterinary Drugs without ADI/MRL

ftp://ftp.fao.org/es/esn/food/meetings/bangkok2004_report.pdf

 

Toxicological evaluation of certain veterinary drug residues in food

http://whqlibdoc.who.int/publications/2004/9241660538.pdf

 

Guidance for Industry: Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern

http://whqlibdoc.who.int/publications/2004/9241660538.pdf

 

Veterinary Drugs Health Canada
www.hc-sc.gc.ca

http://www.hc-sc.gc.ca/dhp-mps/vet/index-eng.php  

 

Food Animal Residue Avoidance & Depletion Program

http://www.farad.org/

 

Veterinary Medicines Manufacturers & Suppliers India

http://health-beauty.exportersindia.com/medicines/veterinary_medicines.htm 

 

European Medicines Agency

 

EMEA

Maximum Residue Limits (MRL) applications

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000165.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac058002d89b

 

EMEA

Product information requirements

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000204.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac058002d4ee

 

EU Legislation - Eudralex

http://ec.europa.eu/health/documents/eudralex/index_en.htm

Volume 1 - EU pharmaceutical legislation for medicinal products for human use

Volume 2 - Notice to applicants and regulatory guidelines for medicinal products for human use 
Volume 3 - Scientific guidelines for medicinal products for human use
Volume 4 - Guidelines for good manufacturing practices for medicinal products for human and veterinary use

Volume 5 - EU pharmaceutical legislation for medicinal products for veterinary use

Volume 6 - Notice to applicants and regulatory guidelines for medicinal products for veterinary use
Volume 7 - Scientific guidelines for medicinal products for veterinary use
Volume 8 - Maximum residue limits
Volume 9 - Guidelines for pharmacovigilance for medicinal products for human and veterinary use
Volume 10 - Guidelines for clinical trial

 

EMEA

Revised Procedure for the Submission of all types of Applications and Enquiries to the Agency relating to the Authorisation and Maintenance of Veterinary Medicinal Products

http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/01/WC500069900.pdf

 

EMEA

Eudravigilance

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000173.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac058002dea6#

 

ANSVSA

Farmacovigilenta & Furaje

http://www.ansvsa.ro/?pag=33

 

ANSVSA

Legislatie autorizare sanitara veterinara

http://www.ansvsa.ro/index.php?pag=745&pg=1

Legislatie Specifica

http://www.ansvsa.ro/index.php?pag=37

 

 

 

 

 

 

 

 

 

 

 

 

 

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