Guidance

Glossary

Updated 8 June 2022

Applies to England, Scotland and Wales

1. Adverse event

Any observation in animals, whether or not considered to be product-related, that is unfavourable and unintended and that occurs after any use of a veterinary medicine (off-label and on-label uses). Included are events related to a suspected lack of expected efficacy according to approved labelling or noxious reactions in humans after being exposed to a veterinary medicine(s). Ref. VICH GL 24 (Pharmacovigilance: AERs).

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. Ref. The Veterinary Medicines Regulations 2013, Part 1, Part 8. This guidance will not include the word ”suspected” when making full text reference to adverse reactions, serious adverse reactions or human adverse reactions.

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 medicines 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, Schedule 4.

5. Centrally Authorised Product (CAP)

A product for which the marketing authorisation is granted, in accordance with Regulation (EC) No 726/2004, by the European Commission, and once granted is valid in all European Union and EFTA States (Iceland, Liechtenstein and Norway) and Northern Ireland.

6. 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 product under investigation.

7. Competent Authority (CA)

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.

8. Data Lock Point (DLP)

A cut-off date for data to be included in a PSUR. It may be set according to the European birth date or International birth date of the medicinal product. The MAH should in any case submit the PSUR no later than 60 days after the DLP.

9. Detailed Description of a Pharmacovigilance System (DDPS)

Document by which the applicant describes the pharmacovigilance system he/she intends to put in place. It is to be included in the Marketing Authorisation Application.

10. EU Birth Date (EBD)

The date of the first marketing authorisation within the European Union.

11. 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. Ref. The Veterinary Medicines Regulations 2013, Part 1.

12. Expedited report

A report of a serious adverse reaction, human adverse reaction or unintended transmission of an infectious agent through a veterinary medicine following administration of the product in the UK submitted within 15 days following receipt of the information in accordance with the Veterinary Medicines Regulations 2013, Schedule 1, Part 8, paragraph 57. In addition, a serious unexpected adverse reaction, human adverse reaction or unintended transmission of an infectious agent through a veterinary medicine following administration of the product in a country outside the UK must also be expedited and reported within 15 days Ref. The Veterinary Medicines Regulations 2013, Schedule 1, Part 8, paragraph 58.

13. Harmonised Birth Date (HBD)

A Birth Date agreed amongst MS and industry for one specific product participating in the MS work share initiative on PSUR assessments.

14. Human adverse reaction

A reaction that is noxious and unintended and that occurs in a human being following exposure to a veterinary medicine. Ref. The Veterinary Medicines Regulations 2013, Schedule 1, Part 8, paragraph 57(5). This guidance will not include the word “suspected” when making full text reference to human adverse reactions.

15. International Birth Date (IBD)

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

16. 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.

17. Lack of expected efficacy

The apparent inability of an authorised product to have the expected efficacy in an animal, according to the claims of the SPC and following use of the product in accordance with the SPC. This guidance will not include the word ‘suspected’ when making full text reference to lack of expected efficacy.

18. Marketing Authorisation (MA)

A decision given either by the European Commission, under centralised procedure, or by national competent authorities under national procedures, including decentralised and mutual recognition procedures, authorising the placing on the market of the veterinary medicine, in accordance with The Veterinary Medicines Regulations 2013 Part 2, Regulation 4).

19. Marketing Authorisation Holder (MAH)

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

20. National Competent Authority (NCA)

The Competent Authority of a country having the responsibility for the evaluation and authorisation of MAs. In the UK this is the Veterinary Medicines Directorate (VMD) for veterinary medicines.

21. Off-label use

The use of a veterinary medicine that is not in accordance with the SPC, including the misuse and serious abuse of the product.

22. 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 safety hazard relating to an authorised veterinary medicine. Ref. The Veterinary Medicines Regulations 2013, Schedule 1, Part 8, paragraph 56.

23. Primary data

Data transmitted from the original reporter to a MAH or the VMD.

24. 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.

25. 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. Ref. The Veterinary Medicines Regulations 2013, Schedule 1, Part 8, paragraph 59.

26. PSUR, abridged

A PSUR that contains less information than a full PSUR and that contains only administrative data, and which has been prepared for a non-marketed product for which no reports have been received during the period.

27. 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 (Pharmacovigilance: AERs). See also definition for “Animals managed and treated as a group”.

28. Serious adverse reaction

An adverse reaction which results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly/birth defect, or which results in permanent or prolonged signs in the animals treated. Ref. The Veterinary Medicines Regulations 2013, Schedule 1, Part 8, paragraph 57. Life-threatening in this context refers to a reaction in which the animal was at risk of death at the time of the reaction. See also definition for “animals managed and treated as a group”.

29. 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.

30. Unexpected adverse event

An unexpected adverse event is an adverse event of which the nature, severity or outcome is not consistent with approved labelling or approved documents describing expected adverse events for a veterinary medicine. Ref. VICH GL 24 (Pharmacovigilance: AERs).

31. Unexpected adverse reaction

An adverse reaction is unexpected if its nature, severity or outcome is not consistent with the summary of product characteristics. Ref. The Veterinary Medicines Regulations 2013, Schedule 1, Part 8, paragraph 58.

32. 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.

33. Veterinary Medicine

Any substance or combination of substances, in accordance with The Veterinary Medicines Regulations 2013, Part 1, presented as having properties for treating or preventing disease in animals; or 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.