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Part III Safety and Residues Tests PDF Print E-mail
Written by Leona Nepejchalová   

This is a list of guidelines for the safety of veterinary medicines as issued by the European Medicines Agency (EMA) and the International Veterinary Conference on Harmonization (VICH).

 

The page is structured and contains instructions from the field of toxicology, user safety, environmental safety, and guidance on residue safety assessment (lead times, MRLs). Please click here: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000384.jsp&mid=WC0b01ac058002dd37

 

In addition to the guidelines mentioned below, the EMA also publishes and updates a list of frequently asked questions and answers concerning MRL determination, please click here: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000039.jsp&mid=WC0b01ac058002d89b

 

List of scientific guidelines on the safety - part III.A :

 

TOXICOLOGY

NameNumber Effective fromNote
VICH GL22 Safety studies for veterinary drug residues in human food: reproduction studies CVMP/VICH/525/2000 01/07/2002 Final
VICH GL23 Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing CVMP/VICH/526/2000 01/10/2015 Rev. 1
VICH GL28 Studies to evaluate the safety of veterinary drugs in human: carcinogenicity testing CVMP/VICH/645/2001 Rev.1 01/03/2006 Rev. 1
VICH GL31 Safety studies for veterinary drug residues in human food: repeat-dose (90) toxicity testing CVMP/VICH/484/2002 01/06/2004 Final
VICH GL32 Studies to evaluate the safety of residues of veterinary drugs in human food: developmental toxicity testing CVMP/VICH/485/2002 - Final Adopted by CVMP 16/5/2004
VICH GL33 Safety studies for veterinary drug residues in human food: general approach to testing EMEA/CVMP/VICH/486/02-Rev.2 01/02/2010 Rev. 2
VICH GL37 Safety of veterinary drugs in human food repeat-dose (chronic) toxicity testing CVMP/VICH/468/2003 30/05/2005 Final
VICH GL54 Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish an acute reference dose (ARfD) EMA/CVMP/VICH/699251/2010 01/11/2017 -
Assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products EMA/CVMP/SWP/377245/2016 - Draft guideline
Regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches EMA/CHMP/CVMP/JEG-3Rs/450091/2012 01/07/2017 -

 

USER SAFETY

NameNumber Effective fromNote
User safety for pharmaceutical veterinary medicinal products EMEA/CVMP/543/2003 Rev. 1 01/10/2010 Rev. 1
User safety of topically administered products EMA/CVMP/SWP/721059/2014 - Draft guideline

 

ENVIRONMENTAL RISK ASSESSMENT

NameNumber Effective fromNote
VICH GL6 Environmental impact assessment (EIAS) for veterinary medicinal products - Phase I CVMP/VICH/592/1998 20/07/2000 Final
VICH GL38 Environmental impact assessments for veterinary medicinal products - Phase II CVMP/VICH/790/2003 01/10/2005 Final
Environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 EMEA/CVMP/ERA/418282/2005 Rev. 1 Corr. 01/03/2009 Rev. 1 Corr (2016)
Assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products EMA/CVMP/ERA/52740/2012 01/04/2016 -
Authorisation of veterinary medicinal products containing (potential) persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances EMA/CVMP/448211/2015 - Reflection paper
Determining the fate of veterinary medicinal products in manure EMA/CVMP/ERA/430327/2009 01/10/2011 -
Higher-tier testing of veterinary medicinal products to dung fauna EMA/CVMP/ERA/409350/2010 - Draft guideline
Plant testing strategy in the risk assessment for veterinary medicinal products EMA/CVMP/ERA/689041/201 01/10/2017 Under revision
Assessing the toxicological risk to human health and groundwater communities from veterinary pharmaceuticals in groundwater EMA/CVMP/ERA/103555/2015 - Draft guideline
Poorly extractable and/r non- radiolabelled substances EMA/CVMP/ERA/349254/2014 - Reflection paper
Risk-mitigation measures related to the environmental risk assessment of veterinary medicinal products EMA/CVMP/ERAWP/409328/2010 - Reflection paper
ERA - QaA document EMEA/CVMP/ERA/172074/2008 Rev.6 - Rev. 6

 

List of scientific guidelines on the safety - part III.B :

 

RESIDUES/WITHDRAWAL PERIODS 

NameNumberEffective fromNote
Approach towards harmonisation of withdrawal periodsEMEA/CVMP/036/1995 01/01/1997Under revision
Updated application software: withdrawal time calculation for tissues-- web page EMA
Determination of withdrawal periods for milkEMEA/CVMP/473/199808/09/2000 Under revision
Updated application software: withdrawal time calculation for milk-web page EMA
Injection-site residuesEMEA/CVMP/542/2003 13/04/2005-
Setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilitiesEMA/CHMP/CVMP/SWP/169430/2012 01/06/2015Under revision
VICH GL46 studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: metabolism study to determine the quantity and identify the nature of residues EMEA/CVMP/VICH/463072/2009 01/02/2012-
VICH GL47 studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: laboratory animal comparative metabolism studiesEMEA/CVMP/VICH/463104/200901/02/2012 -
VICH GL48 studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker-residue- depletion studies to establish product withdrawal periodsEMEA/CVMP/VICH/463199/200901/01/2016 -
VICH GL49 studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: validation of analytical methods used in residue depletion studiesEMEA/CVMP/VICH/463202/200901/01/2016 -
VICH GL56 studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing MRLs and withdrawal periodsEMA/CVMP/VICH/176637/2014 24/02/2017Draft
VICH GL57 on studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: marker residue depletion studies to establish product withdrawal periods in aquatic speciesEMA/CVMP/VICH/517152/201326/01/2018Draft
Injection-site residues: considerations for risk assessment and residue surveillanceEMA/CVMP/520190/2007-Rev.118/10/2013 Reflection papers
Introducing a review and update of existing EU guidelines on residues studies to bring these into line with the VICH metabolism and residues guidelines GL46 to 49EMA/CVMP/SWP/878228/201115/02/2012 Concept papers

 

 MAXIMUM RESIDUE LIMITS (MRL´S)

NameNumber Effective fromNote
Approach to establish a pharmacological acceptable daily intake (ADI) CVMP/SWP/355689/2006 01/06/2013 -
Data to be provided in support of a request to include a substance in the list of substances considered as not falling within the scope of regulation (EC) No 470/2009 EMEA/CVMP/516817/2009 01/06/2011 -
Risk-analysis approach for residues of VMPs in food of animal origin EMEA/CVMP/187/00 10/04/2001 -
VICH GL36 Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI EMA/CVMP/VICH/467/2003 01/05/2012 -
Assessment of bioavailability of bound residues in food commodities of animal origin in the context of Council Regulation (EEC) No 2377/90 EMEA/CVMP/SWP/95682/2007 22/09/2008 Reflection papers
Consideration of adjuvants and preservatives under Council Regulation (EEC) No 2377/90 laying down a community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin CVMP/339116/2007 17/12/2007 Reflection papers
New approach developed by the Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives for exposure and maximum residue limit assessment of residues of VMPs CVMP/SWP/138366/2008 22/09/2008 Reflection papers
Approaches on how to consider excipients in the context of Regulation 2377/90 EMEA/CVMP/223005/2005 22/11/2005 Concept paper
Definition of substances capable of pharmacological action in the context of Council Directive 2001/82/EC as amended, with particular reference to excipients and manufacturing materials CVMP/072/1997 Rev.1 30/04/2010 Position Paper
Establishment of maximum residue limits for milk considering the daily intake by children EMEA/CVMP/391/2002 01/11/2002 Position Paper

 

AVAILABILITY (MINOR USES / MINOR SPECIES)

NameNumber Effective fromNote
Guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market EMA/CVMP/SWP/66781/2005-Rev.1 08/12/2016 -
Note regarding CVMP guidelines on data requirements for veterinary medicinal products intended for minor uses or minor species EMEA/CVMP/133672/2005-Rev.1 01/07/2006 -
Establishment of MRLs for Salmonidae and other fin fish EMEA/CVMP/153b/97 01/01/1998 -
Position paper regarding availability of veterinary medicinal products - extrapolation of maximum residue limits EMEA/CVMP/457/03 10/12/2003 -

 

MULTIDISCIPLINARY

NameNumber Effective fromNote
Guideline on pharmaceutical fixed combination products EMEA/CVMP/83804/05 18/12/2006 -
Investigation of chiral active substances III/3501/91 01/10/1993 -

 

Last Updated on Wednesday, 24 October 2018 10:00