51茶馆

1.听础诲惫别谤蝉别 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.

2.听础诲惫别谤蝉别 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.听础苍颈尘补濒蝉 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 鈥榥ormal鈥� or 鈥榚xpected鈥�. 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.听颁补蝉肠补诲别 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鈥檚聽Product Information Database聽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聽cascade. 搁别蹿.听

5.听颁濒颈苍颈肠补濒 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.听顿补迟补 Lock Point (DLP)

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

7.听罢丑别 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.听贰虫辫别诲颈迟别诲 adverse event report

Any adverse events occurring worldwide for a marketing authorisation holder鈥檚 (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.

搁别蹿.听

9.听贬耻尘补苍 adverse event

A reaction that is noxious and unintended and that occurs in a human being following exposure to a veterinary medicinal product. 搁别蹿.听

10.听滨苍迟别谤苍补迟颈辞苍补濒 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.听滨苍迟别谤苍补迟颈辞苍补濒 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. .

12.听尝补肠办 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.

13.听惭补谤办别迟颈苍驳 Authorisation (MA)

A decision by a regulatory authority authorising the placing on the market of the veterinary medicine. 搁别蹿.听

14.听惭补谤办别迟颈苍驳 Authorisation Holder (MAH)

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

15.听翱蹿蹿-濒补产别濒 use

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

16.听笔辞蝉迟-尘补谤办别迟颈苍驳 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.听笔丑补谤尘补肠辞惫颈驳颈濒补苍肠别 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.听笔别谤颈辞诲颈肠 Safety Update Report (PSUR)

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

19.听搁别驳耻濒补迟辞谤测 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.听厂别谤颈辞耻蝉 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. 搁别蹿.听. See also definition for 鈥淎nimals managed and treated as a group鈥�.

21.听厂别谤颈辞耻蝉 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 鈥淎nimals managed and treated as a group鈥�.

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.听厂耻尘尘补谤测 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. 搁别蹿.听

24.听痴别迟别谤颈苍补谤测 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. .

25.听痴别迟别谤颈苍补谤测 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.