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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 | Name | Number | Effective from | Note | | 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 | Name | Number | Effective from | Note | | 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 | Name | Number | Effective from | Note | | VICH GL6 Environmental impact assessment (EIAS) for veterinary medicinal products - Phase I | CVMP/VICH/592/1998 | 20/07/2000 | Guideline
| | VICH GL38 Environmental impact assessments for veterinary medicinal products - Phase II | CVMP/VICH/790/2003 | 01/10/2005 | Guideline | | 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 | Guideline | | 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 | 30/03/2011 | Guideline | | Higher tier testing to investigate the effects of parasiticidal veterinary medicinal products on dung fauna | EMA/CVMP/ERA/87473/2021 | - | Reflection paper | Plant testing strategy for veterinary medicinal products
| EMA/CVMP/ERA/689041/2015 | 01/10/2017 | Guideline | | Assessing the environmental and human health risks of veterinary medicinal products in groundwater | EMA/CVMP/ERA/103555/2015 | 01/11/2018 | Guideline | | Poorly extractable and/or 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 implementation of CVMP Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH Guidelines GL6 (Phase I) and GL38 (Phase II) | EMEA/CVMP/ERA/172074/2008 Rev.7 | - | QaA Rev. 7 | Antimicrobial resistance in the environment
| EMEA/CVMP/ERA/632109/2014 | -
| Reflection paper | | ERA-QaA document in support of the guideline on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products (EMA/CVMP/ERA/52740/2012) | EMA/593989/2019 | - | QaA | | Interpretation of Article 18(7) of Regulation (EU) 2019/6 | EMA/CVMP/ERA/622045/2020 | - | Reflection paper | | Interpretation of Article 72 of Regulation (EU) 2019/6 | EMA/CVMP/ERA/245311/2021 | - | Reflection paper | | Criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation 2019/6 | EMA/CVMP/116512/2021 | - | Reflection paper
| Environmental risk assessment of ectoparasiticidal veterinary medicinal products used in cats and dogs
| EMA/CVMP/ERA/31905/2021
| -
| Draft Reflection paper
| Â List of scientific guidelines on the safety - part III.B : RESIDUES/WITHDRAWAL PERIODS | Name | Number | Effective from | Note | | Approach towards harmonisation of withdrawal periods | EMEA/CVMP/036/1995 | 01/01/1997 | Under revision | | Updated application software: withdrawal time calculation for tissues | - | - | web page EMA | | Determination of withdrawal periods for milk | EMEA/CVMP/473/1998 | 08/09/2000 | Under revision | | Updated application software: withdrawal time calculation for milk | - | - | web page EMA | | Injection-site residues | EMEA/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 facilities | EMA/CHMP/CVMP/SWP/169430/2012 | 01/06/2015 | Under 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 studies | EMEA/CVMP/VICH/463104/2009 | 01/02/2012 | - | | 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 periods | EMEA/CVMP/VICH/463199/2009 | 01/01/2016 | - | | 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 studies | EMEA/CVMP/VICH/463202/2009 | 01/01/2016 | - | | 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 periods | EMA/CVMP/VICH/176637/2014 | 24/02/2017 | Draft | | 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 species | EMA/CVMP/VICH/517152/2013 | 26/01/2018 | Draft | | Injection-site residues: considerations for risk assessment and residue surveillance | EMA/CVMP/520190/2007-Rev.1 | 18/10/2013 | 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 49 | EMA/CVMP/SWP/878228/2011 | 15/02/2012 | Concept papers |
 MAXIMUM RESIDUE LIMITS (MRL´S) | Name | Number | Effective from | Note | | 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) | Name | Number | Effective from | Note | | 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 | Name | Number | Effective from | Note | | Guideline on pharmaceutical fixed combination products | EMEA/CVMP/83804/05 | 18/12/2006 | - | | Investigation of chiral active substances | III/3501/91 | 01/10/1993 | - | Â
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Authorisation & Approval 
