Suspected Adverse Reaction Surveillance Scheme

Suspected Adverse Reaction Surveillance Scheme

"This article is about Veterinary Medicines. For Human Medicines, see the Yellow Card Scheme."

The Suspect Adverse Reaction Surveillance Scheme used by the Veterinary Medicines Directorate (VMD) is similar to the Human Yellow Card Scheme. It is used in the UK to gather information on Suspected Adverse Reactions (SARs) to veterinary medicines (in animals and humans) and other aspects of veterinary pharmacovigilance, namely suspected lack of expected efficacy, environmental problems, and residues in foodstuffs which cast doubt on the validity of the withdrawal period of the medicine concerned. SARs can be reported by anyone: most are reported by marketing authorisation holders, followed by veterinary surgeons.

The following must be reported by marketing authorisation holders within 15 days:
* Serious SARs (suspected adverse reaction that results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly/birth defect, or that results in permanent or prolonged signs in the animals treated)
* Human adverse reactions (a reaction that is noxious and unintended and that occurs in a human being following exposure to a veterinary medicine)
* unintended transmission of an infectious agent through a veterinary medicinal product

All other adverse reactions must be reported in a Periodic Safety Update Report. All SARs (to animals and humans) should be reported by veterinary surgeons (this is a professional duty).

In addition to the Yellow Card (form MLA252A) for SARs in animals and humans, there is a green card (form MLA1) to report environmental incidents, and a blue card (form MLA2) to report suspected residues of antibiotics in milk.

The reports are monitored and analysed by the Suspected Adverse Reactions Surveillance Scheme of the VMD, who make reports to the Veterinary Products Committee. Where the DEFRA Secretary of State considers, as a result of the evaluation of veterinary pharmacovigilance data that there is a significant safety concern, the marketing authorisation may be suspended, revoked or varied to restrict the indications, change the distribution category, amend the dose, add a contraindication, or add a new precautionary measure.

ee also

*Pharmacovigilance

External links

* [http://www.yellowcard.gov.uk/ Yellow Card Scheme (Human)]
* [http://www.vmd.gov.uk/home.htm Veterinary Medicines Directorate]
* [http://www.vmd.gov.uk/General/Adverse/adverse.htm Suspected Adverse Reactions Surveillance Scheme]


Wikimedia Foundation. 2010.

Игры ⚽ Поможем решить контрольную работу

Look at other dictionaries:

  • Yellow Card Scheme — This article is about Human Medicines. For Veterinary Medicines, see the Suspected Adverse Reaction Surveillance Scheme .The Yellow Card Scheme is the UK system for collecting information on suspected Adverse Drug Reactions (ADRs) to medicines.… …   Wikipedia

  • List of clinical research topics — Clinical research is the aspect of biomedical research that addresses the assessment of new pharmaceutical and biological drugs, medical devices and vaccines in humans. Contents 1 General topics 2 Drug terminology 3 T …   Wikipedia

  • Veterinary Medicines Directorate — The Veterinary Medicines Directorate (VMD) is an Executive Agency of the Department for Environment, Food and Rural Affairs (Defra) seeking to protect public health, animal health, the environment and promoting animal welfare by assuring the… …   Wikipedia

  • Tuberculosis treatment — Various pharmaceutical tuberculosis treatments their actions Tuberculosis treatment refers to the medical treatment of the infectious disease tuberculosis (TB). The standard short course treatment for TB is isoniazid, rifampicin (also known as… …   Wikipedia

  • Pharmacovigilance — Contents 1 Risks of medical treatment 2 Finding the risks of drugs 3 Spontaneous reporting …   Wikipedia

  • United States — a republic in the N Western Hemisphere comprising 48 conterminous states, the District of Columbia, and Alaska in North America, and Hawaii in the N Pacific. 267,954,767; conterminous United States, 3,022,387 sq. mi. (7,827,982 sq. km); with… …   Universalium

  • china — /chuy neuh/, n. 1. a translucent ceramic material, biscuit fired at a high temperature, its glaze fired at a low temperature. 2. any porcelain ware. 3. plates, cups, saucers, etc., collectively. 4. figurines made of porcelain or ceramic material …   Universalium

  • China — /chuy neuh/, n. 1. People s Republic of, a country in E Asia. 1,221,591,778; 3,691,502 sq. mi. (9,560,990 sq. km). Cap.: Beijing. 2. Republic of. Also called Nationalist China. a republic consisting mainly of the island of Taiwan off the SE coast …   Universalium

  • Economic Affairs — ▪ 2006 Introduction In 2005 rising U.S. deficits, tight monetary policies, and higher oil prices triggered by hurricane damage in the Gulf of Mexico were moderating influences on the world economy and on U.S. stock markets, but some other… …   Universalium

  • HISTORICAL SURVEY: THE STATE AND ITS ANTECEDENTS (1880–2006) — Introduction It took the new Jewish nation about 70 years to emerge as the State of Israel. The immediate stimulus that initiated the modern return to Zion was the disappointment, in the last quarter of the 19th century, of the expectation that… …   Encyclopedia of Judaism

Share the article and excerpts

Direct link
Do a right-click on the link above
and select “Copy Link”