Glossary
Veterinary Medicines Terms: Withdrawal Period, Metaphylaxis, Prophylaxis, Antimicrobial, Pharmacovigilance
Legal definitions from Article 4 of Regulation (EU) 2019/6 on veterinary medicinal products [1], closely paraphrased with the point number of each definition, plus the off-label withdrawal rules of Article 115 [2] and India's standard withdrawal periods [3].
Veterinary medicines terms (12)
| Term | Definition | Note |
|---|---|---|
| Withdrawal period | The minimum period between the last administration of a veterinary medicinal product to an animal and the production of foodstuffs from that animal which, under normal conditions of use, is necessary to ensure that the foodstuffs do not contain residues in quantities harmful to public health [1]. | Art. 4(34). EU, Art. 115, when the product information gives no withdrawal period for the species: meat — the longest meat period × 1.5, or 28 days if the product is not authorised for food-producing animals; milk — the longest milk period for any species × 1.5, or 7 days if not authorised for animals producing milk for human consumption; eggs — the longest egg period × 1.5, or 10 days if not authorised for animals producing eggs for human consumption [2]. India, when the label gives no period: at least one week for milk and eggs and 28 days for meat [3]. |
| Antimicrobial | Any substance with a direct action on micro-organisms used for the treatment or prevention of infections or infectious diseases, including antibiotics, antivirals, antifungals and anti-protozoals [1]. | Art. 4(12) |
| Antibiotic | Any substance with a direct action on bacteria used for the treatment or prevention of infections or infectious diseases [1]. | Art. 4(14) |
| Antiparasitic | A substance that kills or interrupts the development of parasites, used to treat or prevent an infection, infestation or disease caused or transmitted by parasites, including substances with a repelling activity [1]. | Art. 4(13) |
| Antimicrobial resistance | The ability of micro-organisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to inhibit or kill micro-organisms of the same species [1]. | Art. 4(11) |
| Metaphylaxis | The administration of a medicinal product to a group of animals after a diagnosis of clinical disease in part of the group has been established, with the aim of treating the clinically sick animals and controlling the spread of the disease to animals in close contact and at risk, which may already be subclinically infected [1]. | Art. 4(15) |
| Prophylaxis | The administration of a medicinal product to an animal or group of animals before clinical signs of a disease, in order to prevent the occurrence of disease or infection [1]. | Art. 4(16) |
| Generic veterinary medicinal product | A product with the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference product, for which bioequivalence with the reference product has been demonstrated [1]. | Art. 4(9) |
| Immunological veterinary medicinal product | A veterinary medicinal product intended to be administered to an animal in order to produce active or passive immunity or to diagnose its state of immunity [1]. | Art. 4(5) |
| Benefit-risk balance | An evaluation of the positive effects of the veterinary medicinal product in relation to its risks to animal or human health relating to quality, safety and efficacy, risks of undesirable effects on the environment, and risks relating to the development of resistance [1]. | Art. 4(19) |
| Pharmacovigilance | The science and activities relating to the detection, assessment, understanding and prevention of suspected adverse events or any other problem related to a medicinal product [1]. | Art. 4(30) |
| Veterinary prescription | A document issued by a veterinarian for a veterinary medicinal product, or for a medicinal product for human use for its use in animals [1]. | Art. 4(33) |
Frequently asked questions
What is a withdrawal period?
The minimum period between the last administration of a veterinary medicinal product and the production of food from the animal that ensures the food does not contain residues in quantities harmful to public health [1].
What is the difference between metaphylaxis and prophylaxis?
Metaphylaxis is treating a group after clinical disease has been diagnosed in part of the group; prophylaxis is treating before clinical signs of disease, to prevent it [1].
Is an antibiotic the same as an antimicrobial?
No — under EU Regulation 2019/6 an antimicrobial acts directly on micro-organisms and includes antibiotics, antivirals, antifungals and anti-protozoals, while an antibiotic acts directly on bacteria [1].
Related tools and references
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Ask WeVet about thisReferences
- Regulation (EU) 2019/6 on veterinary medicinal products — Article 4: Definitions
- Regulation (EU) 2019/6 — Article 115: Withdrawal period for medicinal products used outside the terms of the marketing authorisation
- Health ministry sets timeframe for keeping animals treated with antibiotics out of food chain (Drugs and Cosmetics Rules, rule 97 amendment)
For veterinary professionals. Information supports — never replaces — clinical judgement; always check the current product label and local regulations.