Safety and residues: Pharmaceuticals

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This page lists the European Medicines Agency's guidelines on safety and residues of veterinary medicines.

If you have comments on a document that is open for consultation, use the form for submission of comments on scientific guidelines.

Table of contents

Toxicology

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Studies to evaluate the safety of residues of  veterinary drugs in human food: General approach to establish an acute reference dose (ARfD)Draft guidelineVICH/699251/2010Released for consultation 20 March 2015 Deadline for comments 15 August 2015
Limits for genotoxic impuritiesDraft concept paperCVMP/SWP/398880/2012Released for consultation January 2013 Deadline for comments 30 April 2013
Replacement of animal studies by in-vitro models (CPMP/SWP/728/95)Revised Concept PaperEMA/CHMP/CVMP/JEG-3Rs/169839/2011-Rev.1Released for consultation July 2012 Deadline for comments 28 September 2012
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) GL22: Safety studies for veterinary drug residues in human food: Reproduction studiesAdopted guidelineCVMP/VICH/525/2000July 2002June 2004 
VICH GL23(R): Studies to evaluate the safety of residues of veterinary drugs in human food: Genotoxicity testing

Adopted guideline

Draft guideline

CVMP/VICH/526/2000November 2014 October 2015 
VICH GL23: Safety studies for veterinary drug residues in human food: Genotoxicity studiesAdopted guidelineCVMP/VICH/526/2000July 2002June 2004 
VICH GL28: Studies to evaluate the safety of veterinary drugs in human: Carcinogenicity testingAdopted guidelineCVMP/VICH/645/2001 Rev.1May 2005March 2006 
VICH GL31: Safety studies for veterinary drug residues in human food: Repeat-dose (90) toxicity testingAdopted guidelineCVMP/VICH/484/2002October 2003June 2004 
VICH GL32: Studies to evaluate the safety of residues of veterinary drugs in human food: Developmental toxicity testingAdopted guidelineCVMP/VICH/485/2002June 2004  
VICH GL33: Safety studies for veterinary drug residues in human food: General approach to testingAdopted guidelineCMVP/VICH/486/2002April 2009February 2010 
VICH GL37: Safety of veterinary drugs in human food repeat-dose (chronic) toxicity testingAdopted guidelineCVMP/VICH/468/2003June 2004May 2005 

Antimicrobials

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Use of extended-spectrum penicillins in animals in the European Union: development of resistance and impact on human and animal healthDraft concept paper

EMA/CVMP/AWP/37203/2015

Released for consultation 17 July 2015 Deadline for comments 31 October 2015
Assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animalsDraft guideline

EMA/CVMP/AWP/706442/2013

Released for consultation 4 March 2015 Deadline for comments 31 August 2015
Antimicrobial resistance risk assessmentDraft concept paperCVMP/680258/2012Released for consultation January 2013 Deadline for comments 30 April 2013
Use of aminoglycosides in animals in the European Union: Development of resistance and impact on human and animal healthConcept paperEMA/CVMP/AWP/158821/2014Released for consultation 23 July 2014 Deadline for comments 31 October 2014
Risk of antimicrobial resistance transfer from companion animals

Overview of comments

Reflection paper

Draft reflection paper

EMA/CVMP/AWP/401740/2013January 2015  
Use of pleuromutilins in food-producing animals in the European Union: development of resistance and impact on human and animal health

Overview of comments

Adopted reflection paper (Rev.1)

Adopted reflection paper

Draft reflection paper

Concept paper

EMA/CVMP/AWP/119489/2012February 2014  
Meticillin-resistant Staphylococcus pseudintermedius

Overview of comments
Adopted reflection paper
Draft reflection paper
Concept paper

EMEA/CVMP/SAGAM/736964/2009February 2011  
Use of macrolides, lincosamides and streptogramins in food-producing animals in the European Union (EU): Development of resistance and impact on human and animal healthOverview of comments
Adopted reflection paper
Draft reflection paper
Concept paper
EMEA/CVMP/SAGAM/741087/2009November 2011 

 

 

Joint scientific report of the European Centre for Disease Prevention and Control (ECDC), the European Food Safety Authority (EFSA) and the European Medicines Agency on meticillin-resistant Staphylococcus aureus (MRSA) in livestock, companion animals and foodScientific report June 2009June 2009 
MRSA in food-producing and companion animals in the EU: Epidemiology and control options for human and animal healthAdopted reflection paperEMEA/CVMP/SAGAM/68290/2009March 2009  
Use of third- and fourth-generation cephalosporins in food-producing animals in the EU: Development of resistance and impact on human and animal health

Overview of comments

Adopted reflection paper

Draft reflection paper

EMEA/CVMP/SAGAM/81730/2006 Rev.1March 2009March 2009 
Antimicrobial-resistance surveillance as post-marketing authorisation commitment

Overview of comments

Adopted reflection paper

EMEA/CVMP/SAGAM/428938/2007October 2008  
 Use of (fluoro)quinolones in food-producing animals in the EU: Development of resistance and impact on human and animal health

Overview of comments

Public statement
 

EMEA/CVMP/SAGAM/184651/2005February 2007  
VICH GL27: Guidance on the pre-approval information for registration of new veterinary medicinal products for food-producing animals with respect to antimicrobial resistanceAdopted guidelineCVMP/VICH/644/2001January 2004December 2004 
Further guidance on interpretation of the data from VICH GL27Concept paperCVMP/1034/2004Released for consultation Mar 2005 End of consultation June 2005

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User safety

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TopicDocumentsReference numberPublication dateEffective dateRemarks
User safety of topically administered productsDraft concept paperEMA/CVMP/SWP/92311/2014Released for consultation March 2014 Deadline for comments 30 June 2014
User safety for pharmaceutical veterinary medicinal products

Overview of comments

Adopted guideline

Draft guideline

Concept paper

EMEA/CVMP/543/2003 Rev. 1March 2010October 2010Report on focus group on user safety guideline
User safety for pharmaceutical veterinary medicinal products

Overview of comments

Adopted guideline

EMEA/CVMP/543/2003January 2005July 2005Superseded

Environmental risk assessment

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Plant testing strategy for veterinary medicinal productsDraft guidelineEMA/CVMP/ERA/689041/2015Released for consultation May 2016 Deadline for comments 30 November 2016
Testing strategy and risk assessment for plants in the Phase II of the environmental risk assessment for veterinary medicinal productsConcept paperEMA/CVMP/ERA/698394/2014Released for consultation June 2015 Deadline for comments 30 September 2015
Reflection paper on poorly extractable and/or non- radiolabelled substances

Overview of comments

Adopted reflection paper

Reflection paper

EMA/CVMP/ERA/349254/2014March 2016  
Assessing the toxicological risk to humans and the environment of veterinary pharmaceuticals in groundwaterConcept paperEMA/CVMP/ERA/718229/2012Released for consultation 19 Apr 2013 Deadline for comments 30 June 2013
Risk-mitigation measures related to the environmental risk assessment of veterinary medicinal products

Overview of comments

Adopted reflection paper

Draft reflection paper

EMA/CVMP/ERAWP/409328/2010March 2012  
Testing strategy and risk assessment for plants

Overview of comments

Adopted reflection paper

Draft reflection paper

EMA/CVMP/ERA/147844/2011December 2011 June 2012 
Authorisation of veterinary  medicinal products containing (potential) persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substancesDraft reflection paperEMA/CVMP/448211/2015Released for consultation 26 February 2016 Emd of consultaion 31 May 2016
Assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products

Overview of comments (second public consultation)

Adopted guideline

Overview of comments

Draft guideline

Concept paper

EMA/CVMP/ERA/52740/2012Sep 20151 Apr 2016 
Determining the fate of veterinary medicinal products in manure

Overview of comments

Adopted guideline

Draft guideline

Concept paper

EMA/CVMP/ERA/430327/2009March 2011  
Higher-tier testing of antiparasitics to dung organismsConcept paperCVMP/ERA/12254/2009Released for consultation September 2009 Deadline for comments 30 November 2009
VICH GL6: Environmental impact assessment (EIAS) for veterinary medicinal products - Phase IAdopted guidelineCVMP/VICH/592/1998July 2000July 2000 
VICH GL38: Environmental impact assessments for veterinary medicinal products (VMPs) - Phase IIAdopted guidelineCVMP/VICH/790/2003January 2005July 2005 
Environmental impact assessment for VMPs in support of the VICH guidelines GL6 and GL38

Overview of comments

Adopted guideline

Draft guideline

EMEA/CVMP/ERA/418282/2005-Rev.1November 2008March 2008

Summary of meeting held on 23/01/2008

Questions and answers (revision 4)

Residues and withdrawal periods

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Adopted guideline

Draft guideline

EMA/CHMP/CVMP/SWP/169430/2012September 2015June 2015 
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 49Concept paperEMA/CVMP/SWP/878228/2011Released for consultation February 2012 Deadline for comments 31 May 2012
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 studies

Adopted guideline

Draft guideline

EMEA/CVMP/VICH/463202/2009February 2015January 2016 
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 periods

Adopted guideline

Draft guideline

EMEA/CVMP/VICH/463199/2009February 2015January 2016 
VICH GL47: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Laboratory animal comparative metabolism studies

Adopted guideline

Draft guideline

EMEA/CVMP/VICH/463104/2009March 2011February 2012 
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

Adopted guideline

Draft guideline

EMEA/CVMP/VICH/463072/2009March 2011 February 2012 
Injection-site residues: Considerations for risk assessment and residue surveillanceConcept paperEMEA/CVMP/520190/2007Release for consultation June 2008 Deadline for comments 30 Sep 2008
Injection-site residues: considerations for risk assessment and residue surveillanceDraft reflection paperEMA/CVMP/520190/2007 Rev.1Release for consultation Oct 2013 Deadline for comments 30 Apr 2014
Injection-site residues

Overview of comments

Adopted guideline

EMEA/CVMP/542/2003October 2004April 2005 
Revision of the note for guidance on the approach towards harmonisation of withdrawal periodsConcept paperEMA/CVMP/SWP/285070/2013Release for consultation Oct 2013 Deadline for comments 31 Jan 2014
Approach towards harmonisation of withdrawal periodsAdopted guidelineEMEA/CVMP/036/1995April 1996January 1997Note for guidance
Updated application software - Withdrawal time calculation for tissues  May 2002May 2002This is a zipped file (1.84 MB) containing an executable and other related files. Save the application to your desktop first and then proceed with extraction.
Explanatory note on updated application software - Withdrawal time calculation for tissuesNote for guidanceEMEA/CVMP/563/2002May 2002  
Revision of note for guidance for the determination of withdrawal periods for milkConcept paperEMA/CVMP/SWP/736014/2010Released for consultation December 2010 Deadline for comments 31 March 2011
Determination of withdrawal periods for milkAdopted guidelineEMEA/CVMP/473/1998Mar 2000September 2000Note for guidance
Updated application software - Withdrawal time calculation for milk   May 2002 This is a zipped file (2.74 MB) containing an executable and other related files. Save the application to your desktop first and then proceed with extraction.
Explanatory note on updated application software - Withdrawal time calculation for milkNote for guidanceEMEA/CVMP/231/2000/Rev.1May 2002May 2002 

Establishment of maximum residue limits (MRLs)

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TopicDocumentsReference numberPublication dateEffective dateRemarks
New approach developed by the Joint Food and Agriculture Organization / World Health Organization Expert Committee on Food Additives for exposure and MRL assessment of residues of VMPsReflection paperCVMP/SWP/138366/2008 Rev. 1September 2008  
Consideration of adjuvants and preservatives under Council Regulation (EEC) No 2377/90 laying down a community procedure for the establishment of MRLs of VMPs in foodstuffs of animal originReflection paperCVMP/339116/2007Released for consultation December 2007 End of consultation March 2008
Assessment of bioavailability of bound residues in food commodities of animal origin in the context of Council Regulation (EEC) No 2377/90

Overview of comments

Adopted guideline

Draft guideline

EMEA/CVMP/SWP/95682/2007September 2008September 2008Reflection paper
Approaches on how to consider excipients in the context of Regulation 2377/90Concept paperEMEA/CVMP/223005/2005   
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

Overview of comments

Adopted guideline

Draft guideline

Concept paper

EMEA/CVMP/516817/2009November 2010 June 2011 
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 materialsConcept paperCVMP/072/1997 Rev.1July 2004August 2004CVMP position paper
Approach to establish a pharmacological acceptable daily intake (ADI)

Overview of comments

Adopted guideline

Concept paper

CVMP/SWP/355689/2006November 2012 June 2013 
VICH GL36: Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI

Adopted guideline

Draft revised guideline

EMA/CVMP/VICH/467/2003July 2012May 2012End of consultation 14 September 2011
VICH Topic GL36: Safety of veterinary drugs in human food: General approach to establish a microbiological ADIAdopted guidelineCVMP/VICH/467/2003June 2004May 2005Superseded
Assessment of the effect of antimicrobial substances on dairy starter culturesAdopted guidelineEMEA/CVMP/276/1999March 2000September 2000 
Establishment of MRLs for residues of VMPs in foodstuffs of animal origin Volume 8October 2005October 2005See footnote
Risk-analysis approach for residues of VMPs in food of animal originAdopted guidelineEMEA/CVMP/187/00January 2001April 2001Explanatory note on implementation
Establishment of MRLs for milk considering the daily intake by childrenConcept paperEMEA/CVMP/391/2002November 2002November 2002CVMP position paper

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