Safety and residues: pharmaceuticals
The European Medicines Agency's scientific guidelines on the safety and resideus of veterinary medicinal products help medicine developers prepare marketing authorisation applications.
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- Toxicology
- User safety
- Environmental risk assessment
- Residues and withdrawal periods
- Establishment of maximum residue limits
Toxicology
- Assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products
- Regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches
- VICH GL22 Safety studies for veterinary drug residues in human food: reproduction studies
- VICH GL23 Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing
- VICH GL28 Studies to evaluate the safety of veterinary drugs in human: carcinogenicity testing
- VICH GL31 Safety studies for veterinary drug residues in human food: repeat-dose (90) toxicity testing
- VICH GL32 Studies to evaluate the safety of residues of veterinary drugs in human food: developmental toxicity testing
- VICH GL33 Safety studies for veterinary drug residues in human food: general approach to testing
- VICH GL37 Safety of veterinary drugs in human food repeat-dose (chronic) toxicity testing
- VICH GL54 Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish an acute reference dose (ARfD)
User safety
- User safety for pharmaceutical veterinary medicinal products
- User safety of topically administered products
Environmental risk assessment
- Assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products
- Assessing the toxicological risk to human health and groundwater communities from veterinary pharmaceuticals in groundwater
- Determining the fate of veterinary medicinal products in manure
- Environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38
- Higher-tier testing of veterinary medicinal products to dung fauna
- Plant testing strategy in the risk assessment for veterinary medicinal products
- VICH GL6 Environmental impact assessment (EIAS) for veterinary medicinal products - Phase I
- VICH GL38 Environmental impact assessments for veterinary medicinal products - Phase II
- Antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products
- Authorisation of veterinary medicinal products containing (potential) persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances
- Poorly extractable and/r non- radiolabelled substances
- Risk-mitigation measures related to the environmental risk assessment of veterinary medicinal products
Residues and withdrawal periods
- Approach towards harmonisation of withdrawal periods
- Determination of withdrawal periods for milk
- Injection-site residues
- Setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
- 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
- VICH GL47 studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: laboratory animal comparative metabolism studies
- 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
- 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
- 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
- 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
Establishment of maximum residue limits
- Approach to establish a pharmacological acceptable daily intake (ADI)
- 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
- Risk-analysis approach for residues of VMPs in food of animal origin
- VICH GL36 Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI
- Assessment of bioavailability of bound residues in food commodities of animal origin in the context of Council Regulation (EEC) No 2377/90
- 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
- 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
Position papers