ADVERSE REACTIONS
 

FREQUENTLY ASKED QUESTIONS
 

Q. What is the Suspected Adverse Reaction Surveillance Scheme (SARSS)?

A.This is the national voluntary scheme for monitoring suspected adverse reactions to authorised medicines in the UK.
 

Q. What is a Suspected Adverse Reaction (SAR)?

A. An animal SAR is a harmful and unintended reaction which may be due to exposure to a veterinary medicine administered to an animal at its normal dose. In other words, it is any harmful side effect to a veterinary medicine. A reaction may occur in an animal undergoing treatment or in an untreated animal in the same household as a treated animal. A human SAR may occur in a person administering a veterinary medicinal product, or a person exposed to a recently treated animal. 
 

Q. What is a serious SAR?

A. A serious SAR is an adverse reaction which is fatal, life threatening, disabling or incapacitating, or which results in permanent or prolonged signs in the treated animal.  All human reactions are considered serious SARs.
 

Q. What does the Suspected Adverse Reaction Scheme cover?

A. The scheme covers reactions in animals (all species)  to veterinary medicinal products when administered according to the label instructions. It also covers:

• Unauthorised use of authorised veterinary medicines, including misuse and off-label use, i.e. use not in accordance with the manufacturer’s instructions.

• Suspected lack of efficacy, i.e. when a product which has been used correctly fails to have the expected effect.

• Incidents in which residues of a product are found in a food animal or its produce after the withdrawal period has been correctly observed.

• Adverse environmental effects of veterinary medicines.

• Suspected adverse reactions following the use of human medicines in animals. (N.B. Reactions in humans to human medicines should be reported to the Medicines and Healthcare products Regulatory Agency)

• Suspected adverse reactions following the use of unauthorised medicines in animals.  These may be passed to the Unauthorised Products Section of the Enforcement Branch of the VMD.

The scheme also covers suspected adverse reactions to veterinary medicines in humans.

Reactions which are expected, i.e., described in the product literature, may be reported in addition to those which are unexpected, i.e. not consistent with information provided in the product literature.

Q. What are the aims of the scheme?

A. The scheme aims to record, collate and assess all reports of SARs submitted to the VMD. The objective is to monitor the quality, safety and efficacy profile of authorised veterinary medicines in the market place.  If a trend is detected in relation to a particular product, the VMD takes corrective action, such as:

• Recommending changes to the labelling to incorporate new warnings or modifying instructions for use.
   

• Recalling the product.
   

• Suspending the marketing authorisation.
   

• Revoking a marketing authorisation.
   

Q. Who can report a suspected adverse reaction to the VMD?

A. Anyone can send in a report on an adverse reaction to a veterinary medicine, which they have experienced or observed.  Members of the public, veterinary surgeons, farmers, doctors and pharmacists are all encouraged to report to the scheme.

The company which holds a marketing authorisation (the MA holder) is legally required to report serious adverse reactions within 15 days of receiving a report and non-serious adverse reactions in Periodic Safety Update Reports (PSURs) submitted at intervals specified in the marketing authorisation. Guidance for MA holders in the UK is provided in Veterinary Medicines Guidance Note 13 and via the VMD publication entitled MAVIS which is published quarterly.  Further guidance for MA holders is available from the EMEA (see the European Medicines Evaluation Agency (EMEA) website.
 

Q. I want to report a suspected adverse reaction to the VMD. How do I do this?

A. You need to complete a Yellow Form (Form MLA 252A). Yellow Forms are also available from the NOAH Compendium, or you can request a copy from the following address: Veterinary Medicines Directorate, FREEPOST KT4503, Woodham Lane, New Haw, Addlestone, Surrey KT15 3BR. Alternately contact Denise Burge at the VMD on 01932 338427 or d.burge@vmd.defra.gsi.gov.uk.

 The details of what you should report are in the form. It is important that you ensure that the product is correctly identified, and you should also include the Marketing Authorisation number (which will be prefixed MA, Vm or EU and will be printed on the label), the product batch number and any relevant post mortem reports and laboratory reports.
 

Q. Is my report confidential?

A. Yes. The VMD will pass the details of the case to the Marketing Authorisation holder, but if you wish to remain anonymous tick the appropriate box in the form and your contact details will be deleted.
 

Q. What happens to my report?

A. All information in every report to the scheme is recorded on a database.  The details of each report are assessed and all suspected adverse reactions are reviewed bimonthly by a group of veterinarians, immunologists, pharmacists, toxicologists and ecotoxicologists from the VMD.  In addition, all serious adverse reactions are considered on a bimonthly basis by the Veterinary Products Committee (VPC), a group of independent experts.  Adverse reactions in humans are reviewed by the Appraisal Panel for Human Suspected Adverse Reactions to Veterinary Medicines, which is a sub-committee of the VPC.  The Panel meets three times per year.  SARSS representatives participate in the activities of the European Pharmacovigilance Working Party which meets regularly to monitor and harmonise adverse reaction reporting in the EU.
 

Q. How can I get further information on the scheme?

A. Further information on the scheme and on adverse reaction reporting can be found in the document Guidance for Veterinary Surgeons, Reporting Environmental Incidents Leaflet or in the SARSS Brochure. Alternatively, contact Denise Burge  on 01932 338427.

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