Guidance

Glossary

Updated 20 May 2024

Applies to England, Scotland and Wales

1. Adverse event

Any observation in animals that occurs after any use of a veterinary medicinal product, whether or not considered to be product-related, that is unfavourable and unintended. Ref. The Veterinary Medicines Regulations 2013 (as amended), Part 1

2. Adverse reaction

A reaction to a veterinary medicinal product that is harmful and unintended and that occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or to restore, correct or modify a physiological function.

3. Animals managed and treated as a group

Animals in intensive food animal production concerning species such as poultry, fish or bees which are managed and treated as a group. In these situations, a certain level of mortality rate is considered as ‘normal’ or ‘expected’. These species are usually treated as a group/flock and only an increase of mortality rate, or severe signs, or animal production losses exceeding the rates normally expected should be considered as serious.

4. Cascade use

Veterinary medicines are authorised for specific conditions for specific target species, based on assessed data. The conditions of use for each authorised veterinary medicine are listed in its Summary of Product Characteristics (SPC). The VMD’s Product Information Database contains the SPCs of all veterinary medicinal products authorised in the UK. Where there is no clinically suitable veterinary medicine authorised in the United Kingdom for the specific condition in the animal being treated, in particular to avoid unacceptable suffering, the veterinary surgeon may use their clinical judgement to treat animals under their care in accordance with the cascade. Ref. The Veterinary Medicines Regulations 2013 (as amended), Schedule 4

5. Clinical Trial

A single scientific experiment conducted in a target species to test at least one hypothesis relevant to the proposed effectiveness claim(s) or to in-use safety in the target animal for a veterinary medicinal product under investigation.

6. Data Lock Point (DLP)

A cut-off date for data to be included in a Benefit-Risk Report.

7. The European Medicines Agency (EMA)

A decentralised scientific body of the European Union which is responsible for the protection and promotion of public and animal health, through the coordination of evaluation and supervision of centrally authorised medicinal products for human and veterinary use.

8. Expedited adverse event report

Any adverse events occurring worldwide for a marketing authorisation holder’s (MAH) veterinary medicinal products which are authorised in the UK, or the equivalent products authorised elsewhere, should be sent via expedited reporting to the VMD within 30 calendar days of the MAH being made aware of them.

Ref. The Veterinary Medicines Regulations 2013 (as amended), Schedule 1, Part 8, paragraph 57

9. Human adverse event

A reaction that is noxious and unintended and that occurs in a human being following exposure to a veterinary medicinal product. Ref. The Veterinary Medicines Regulations 2013 (as amended), Part 1

10. International Birth Date (IBD)

The date of the first marketing authorisation for a same or similar product granted anywhere in the world, including any VICH region.

11. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)

A trilateral (EU-Japan-USA) programme aimed at harmonising technical requirements for veterinary product registration. Ref. VICH.

12. Lack of efficacy

The apparent inability of an authorised veterinary medicinal product to have the expected efficacy in an animal, whether or not the product was used in accordance with the Summary of Product Characteristics (SPC). Ref. The Veterinary Medicines Regulations 2013 (as amended), Part 1

13. Marketing Authorisation (MA)

A decision by a regulatory authority authorising the placing on the market of the veterinary medicine. Ref. The Veterinary Medicines Regulations 2013 Part 2, Regulation 4)

14. Marketing Authorisation Holder (MAH)

A person or entity who/which holds the authorisation of a veterinary medicine.

15. Off-label use

Off-label use relates to situations where a veterinary medicinal product is used outside the terms of its marketing authorisation.

16. Post-marketing surveillance studies

Pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying and investigating a pharmacovigilance concern relating to an authorised veterinary medicinal product.

17. Pharmacovigilance System Master File (PSMF)

A detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to one or more authorised veterinary medicinal products.

18. Periodic Safety Update Report (PSUR)

A periodical scientific report on adverse events and other issues within the scope of pharmacovigilance that have been reported to a MAH during a specific period.

19. Regulatory authority

An authority responsible for the granting of marketing authorisations for medicinal products and the supervision of marketing of such products in accordance with the relevant laws and regulations established under applicable law.

20. Serious adverse event

Any adverse event which results in death, is life-threatening, results in persistent or significant disability/incapacity, or a congenital anomaly or birth defect. For animals managed and treated as a group, only an increased incidence of serious adverse events as defined above exceeding the rates normally expected in that particular group is considered a serious adverse event. Ref. VICH GL 24 . See also definition for “Animals managed and treated as a group”.

21. Serious adverse reaction

Any adverse reaction which results in death, is life-threatening, results in persistent or significant disability/incapacity, or a congenital anomaly or birth defect. For animals managed and treated as a group, only an increased incidence of serious adverse events as defined above exceeding the rates normally expected in that particular group is considered a serious adverse event. See also definition for “Animals managed and treated as a group”.

22. Signal

Information that arises from one or more sources which may suggest a new potentially causal association, or a new aspect of a known association, between an adverse event or set of related events and one or more veterinary medicinal products or active substances.

23. Summary of Product Characteristics (SPC)

A document that contains the information on the condition of use of a veterinary medicine as developed during the course of the assessment process. Ref. The Veterinary Medicines Regulations 2013, Schedule 1, Part 1, paragraph 3

24. Veterinary Dictionary for Drug Regulatory Activities (VeDDRA)

A list of standard clinical terms to be used in reporting suspected adverse events in animals or humans after exposure to veterinary medicinal products. Ref. Combined Veterinary Dictionary for Drug Regulatory Activities.

25. Veterinary Medicinal Product

Any substance or combination of substances presented as having properties for treating or preventing disease in animals; or any substance or combination of substances that may be used in, or administered to, animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis; or any substance or combination of substances that may be used for the purpose of euthanising an animal. Ref. The Veterinary Medicines Regulations 2013 (as amended), Part 1