Pharmalex

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
http://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
http://www.ema.europa.eu/ema/index.jsp?curl=pages/audience/alp_audiencetype_000003.jsp&murl=&mid=

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

ANSVSA

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

 

 

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