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PF3011 > Veterinary Medicines > Flashcards

Veterinary Medicines Flashcards

1
Q

VMP means any substance/ combination of substances which fulfils at least one of the following 4 criteria:

A
  • it is presented as having properties for treating/ preventing disease in animals
  • its purpose is to restore, correct or modify physiological function by exerting a pharmacological, immunological or metabolic action
  • its purpose is to be used in animals with a view of making a medical diagnosis
  • used for euthanasia of animals
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2
Q

Name the 2 authorities in ireland responsible for VMPs

A
  • HPRA
  • department of agriculture, food and the marine
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3
Q

Products are not regarded as VMPs when:

A
  • no medicinal claims are made on the product literature
  • the product does not contain pharmacologically active substances
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4
Q

What are disinfectants/ antiseptics referred to as when there are no medicinal claims made?

A

Biocides

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5
Q

How long is an MA for a VMP valid for?

A

Unlimited period of time
(only granted to an applicant established in the EU)

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6
Q

Where are MA applications submitted to when they concern a centralised MA?

A

EMA
analysed by CVMP

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7
Q

Where are centralised MAs valid?

A

Throughout the EU

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8
Q

When are centralised MAs required? (5 conditions)

A
  • contain an API not authorised as a VMP in the EU
  • intended primarily as performance enhancers to promote the growth of treated animals or to increase yields from treated animals
  • contain engineered allogeneic tissues or cells (biological VMPs)
  • novel therapy VMPs
  • developed by biotechnological processes
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9
Q

How long does centralised procedure take?

A

210 days, unless they are VMPs of major interest - time may be decreased to 150 days

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10
Q

Where are national MAs valid?

A

Single member state only

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11
Q

Where are applications for national MAs directed?

A

Competent authority in that member state - HPRA

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12
Q

What 2 conditions will national MAs not be granted for:

A

those who already have a:
- centralised MA
- national MA or a pending application in another member state

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13
Q

How long does national MA take

A

max. 210 days

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14
Q

Where are decentralised MAs valid?

A

several member states

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15
Q

Who are decentralised MAs granted from?

A

Competent authorities in the member states in which the applicant seeks to obtain an MA

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16
Q

What 2 conditions will decentralised MAs not be granted for:

A

those who already have a:
- centralised MA
- national MA or a pending application in another member state

17
Q

What is the procedure for a decentralised MA application?

A
  • dossier is sent to one selected national authority (RMS)
  • RMs carries out scientific assessment and produces a draft assessment report
  • this is sent to authorities in CMS within 120 days
  • authorities in CMS have 90 days to review and feed back
  • if report is favourable: MA granted in all member states
  • if report is not favourable: MA not granted
  • IF no consensus: report goes back to EC and procedure followed in accordance with article 54
18
Q

What is the minimum wait between national MA and MRP

A

6 Months

19
Q

What is the procedure for applying for an MRP?

A
  • If a VMP has already been granted an MA in one or more member states, then the company can use the MRP to have this “mutually recognised” in other member states of its choice.
  • Application for mutual recognition submitted to both the RMS and authorities in the member states where seeking MA.
  • Within 90 days, the RMS shall provide an updated assessment report to authorities in the other member states, who can then choose to mutually recognise the MA or not.
20
Q

What is the wait period for a subsequent recognition?

A

60 days

21
Q

What is the procedure for a subsequent recognition procedure?

A
  • After completion of a decentralised procedure or a mutual recognition procedure, the MA holder may submit an application for the VMP to authorities in additional Member States.
  • Within 60 days: report from RMS sent to additional Member States with any variations and pharmacovigilance data.
  • Additional Member States can either agree and approve MA or provide objections if applicable
22
Q

What is the union product database?

A

single information source on all authorised VMPs and their availability in the EU/EEA

23
Q

List the 8 VMP classes which are subject to veterinary prescription?

A

➢ those which contain narcotic drugs or psychotropic substances,
➢ those for food-producing animals;
➢ those which are antimicrobials;
➢ those intended for treatments of pathological processes which require a precise prior diagnosis or the use of which impede or interfere with subsequent diagnostic or therapeutic measures;
➢ those used for euthanasia of animals;
➢ those containing an API authorised < 5 years in the EU;
➢ immunological VMPs;
➢ those with an API having a hormonal/thyrostatic action or β-agonists.

24
Q

Who is the only person allowed to prescribe VMPs in Ireland?

A

A registered vet

25
Q

Which elements should a veterinary prescription contain?

A

i. identification of the animal/animals groups to be treated;
ii. full name and contact details of the animal owner/keeper;
iii. issue date;
iv. full name and contact details of the vet (and professional number);
v. signature or an equivalent electronic ID of the vet;
vi. name of the VMP, including its active substances;
vii. pharmaceutical form and strength;
viii. quantity, or the number of packs, including pack size;
ix. dosage regimen;
x. for food-producing animals, withdrawal period (even if zero);

26
Q

How long are VMP Rx valid?

A

12 months

27
Q

How long are antimicrobial Rx valid?

A

5 days from date of issue - must be filled within this timeframe
Animals can be treated for as long as is specified by the vet on the Rx

28
Q

List the steps in the NVPS process

A
  • Vet undertakes proper assessment or clinical exam and diagnosis.
  • Vet logs onto NVPS and creates Rx → saves → transmits
  • Farmer receives SMS/email/printed copy of Rx
  • Animal keeper free to present Rx at dispensing agent.
    ➢ Mobile number is mandatory but keeper’s email is optional.
  • The prescription will generate a unique prescription ID and a unique ID for each item on a prescription (a ‘line item ID’).
  • The keeper can present the:
    ➢ prescription ID to enable the dispenser to see the full Rx,
    ➢ line item ID – in which case only that line item (VMP) will be available to the dispenser to view.
  • This functionality will allow each medicine to be dispensed at different times or by different dispensers.
  • Dispenser marks Rx as dispensed/part dispensed
29
Q

If there is no VMP in a member state for an indication a vet may:

A
  • use a VMP in the relevant MS or in another MS for use in the same species or other animal species for the same indication or different indication
  • a medicinal product for human use
  • a VMP prepared extemperaneously
30
Q

What does VPO-VPO-1 mean

A

can only be sold by a vet
can only be sold via wholesaler to a vet

31
Q

POM(E)

A

prescription only exempt
can only be sold by:
- pharmacist in a pharmacy
- vet when animal is under their care

32
Q

PS

A

Pharmacy only
can only be sold:
- in a pharmacy under personal supervision of pharmacist
- by a vet when animal is under their care

33
Q

LM

A

Licensed medicine
can only be sold:
- in a pharmacy under personal supervision of pharmacist
- by a vet when animal is under their care
- from a premises to which an animal remedies merchant’s license relates

34
Q

CAM

A

companion animal medicine
can only be sold:
- in a pharmacy under personal supervision of pharmacist
- by a vet when animal is under their care
- from a premises to which an animal remedies merchant’s license relates
- from a premises to which a companion animal medicine seller’s registration relates

35
Q

Requirements for a responsible person to sell VMPs:

A

responsible person is:
- not a VP, pharmacist, nurse
- must undergo adequate training in the proper and safe handling and storage of animal remedies
- Must complete the Retail Sale and Supply of Animal Remedies Course.
- Must be employed by a Licensed Merchant

36
Q

How do you sell non-rx medicines over the internet in ireland?

A
  • register with DAFM
  • have their name listed on approved internet supply list
  • display the EU common logo on every web page that sells non-rx medicines

PF3011 (8 decks)

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