p. 63 -

Question 1

Withdrawal period for FPA

Answer 1

Vet specifies appropriate WP – unless the medicinal product indicates a WP for the concerned species, then the WP is;
o Eggs & milk – 7 days
o Poultry, mammal meat including offal and fat – 28 days
o Fish meat – 500 degree days

Question 2

Packaging of medicial products

Answer 2

• Name of product: strength and pharmaceutical form (eye drop, tablet, oral)
• Common name appears if the medicinal product contains only 1 active substance and its name is
invented
• Statement of active substances expressed qualitatively & quantitatively per unit or according to the
form of administration for volume/weight using common names
• Manufacturers batch and authorisation number
• Name/corporation and permanent address/place of business of marketing authorisation holder and
of the representative designated by the marketing authorisation holder
• The species of animal that the product is intended, the method and if necessary, the route of
administration
• Space provided for prescribed dose
• Expiration date: plain language
• Special storage precautions
• Specific precautions for disposal of unused medicinal products/waste from the products – as well as
reference to appropriate collection system in place
• Words “For animal treatment only”, “For animal treatment – to be supplied only on vet prescriptions”
• FPA: WP for vet medical products – meat, offal, eggs, milk, honey – even if the WP is 0!!!!
• Pharmaceutical form and contents by weight, volume or number of dose-units need only be shown on
the outer package

Question 3

Leaflets should contain at least

Answer 3

of the representative designated by the marketing authorisation holder
• Name of vet medicinal product, strength, pharmaceutical form. Common name IF the product
contains only 1 active substance and its name is invented
• Therapeutic indications
• Contra-indications and adverse reactions – still necessary for the use of the medicinal product
• The species of animal that the product is intended, , the dosage for each species, the method and if
necessary, the route of administration and advice on correct administration if necessary
• WP: for FPA even if 0
• Special storage conditions, special precautions of disposal/waste

Question 4

Operational phases of vet public health actions in zoonoses control

Answer 4

o Surveillance
o Control in animals
o Control in infective media
o Prevention in man
o Strategy selection

Question 5

Name some examples where the slaughter of animals is prohibited!

Answer 5

Anthrax, Glanders, Rift Valley Fever

Question 6

List the 5 different veterinary laboratories

Answer 6

a. a) veterinary institutes functioning with national or regional competence perform the
diagnostic and examinations for the prevention of epidemics prevention connected
with reduction in production, infections, diseases, death of animals;
b. b) the institute performing tasks of food examination (food safety) adopts the
international methods of food examination and makes them general, operates
residuum, radiological and toxicological monitoring systems (system of food control)
adequate to the international and national regulations, carries out international and
national reference laboratory activities, also, performs institutional expert tasks
concerning similar activities of the laboratories of the veterinary offices;
c. c) the institute performing tasks of vaccine-, medicine-and fodder examination:
contributes to procedures of permission concerning products of veterinary
therapeutics (vaccines, diagnostics, medicines) as well as to fodder containing
medicine as an expert institute;
d. d) laboratories operated by the regional veterinary authority: the task of the
laboratories is making a microbiological examination of food and fodder;
e. e) the laboratory of reproduction biology of the authority of animal breeding, in
the competence provided in the law;

Question 7

How can we perform examinations in laboratories in connection with notifiable animal diseases

Answer 7

Examinations connected with notifiable animal diseases shall be performed, until the official
confirmation, only by laboratories named in points a) and c) of point 1
• Should a suspicion of a notifiable animal disease arise in the examination material of a public
laboratory as stated in points 2 or 3, the laboratory is obliged to inform immediately the
veterinary authority competent in the region and to act as ordered by it, and to send
simultaneously the examined material to the competent diagnostic institute.

Question 8

What if the transport of notifiable material was not appropriate?

Answer 8

IF risk of notifiable/zoonotic disease; The examinations with the aim of diagnosing notifiable
diseases and diseases presenting risk to human health must always be tried to carry out by using the
material sent into the laboratory – (can deny if it’s not sent in suitable way but if zoon/notif then
they HAVE to try)