NEW VETERINARY MEDICINES LEGISLATION

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NEW VETERINARY MEDICINES LEGISLATION

• John FitzGerald
• Director of Policy VMD
• AHDA Conference
• January 2006

2

• Background why we are, where we are
• The new legislation
• What does this mean for SQPs
• Informal consultation
• Legal classification review
• The future

3
Background

• Supply of veterinary medicines based on EC
  legislation
• Changes proposed
• Key UK aim retain main elements of current
  distribution system

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Background

• All food producing animal medicines POM

• - plan A get proposal deleted
• - plan B use Marsh and Competition Commission
  recommendation for tiered POM system

• Tiered POM major change to UK thinking on POMs

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New Legislation

• EU Directive requirements
• All food producing animal medicines POM
• Veterinary prescription any prescription for a
  veterinary medicinal product issued by a
  professional person qualified to do so in
  accordance with applicable national law

• - prescribing not restricted to veterinary
  surgeons
• - no prior diagnosis required

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New Legislation

• Distribution categories
• Allowed UK to maintain distribution system by
  implementing Marsh and CC recommended tiered POM
  system
• POM POM-V
• P deleted products become POM-V, POM-VPS or
  NFA-VPS
• PML POM-VPS or NFA-VPS
• GSL AVM-GSL

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New Legislation

• Distribution
• Internet/Postal supply allowed provided permitted
  supplier applies statutory controls i.e.

- if a prescription is necessary (e.g. POM-V
products) you must have it - you provide advice
on safe administration - you advise as necessary
on warnings or contra-indications - you are
satisfied that the buyer is competent to use the
product safely and intends to use it for which it
is authorised add to basket not acceptable
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New Legislation
Other key changes

• SQPs permitted to break bulk to facilitate supply
  only for outer packaging and if instructions on
  use are readily available
• SQP training enhanced because of requirement to
  meet definition of veterinary prescription
• SQP competencies agreed with stakeholder groups
• Horse medicines for non-food producing animals
  preserved.

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What does this mean for SQPs

• Distribution
• SQPs
• Must pass exam
• Must register with recognised body
• May sell POM-VPS and NFA-VPS products for which
  trained, from registered premises
• May receive advertisements about POM-VPS and
  NFA-VPS products

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What does this mean for SQPs

• SQP - Prescriptions

• May be oral or written (unlikely)
• If written must include following information

• (a) the name and address of the person
  prescribing the product
• (b) the qualifications enabling the person to
  prescribe the product
• (c) the name and address of the owner or keeper
• (d) the species of animal, identification and
  number of the animals

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What does this mean for SQPs

• SQP Prescriptions (contd)

• (e) the premises at which the animals are kept if
  this is different from the address of the owner
  or keeper
• (f) the date of the prescription
• (g) the signature or other authentication of the
  person prescribing the product
• (h) the name and amount of the product
  prescribed
• (i) the dosage and administration instructions
• (j) any necessary warnings
• (k) the withdrawal period if relevant.

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What does this mean for SQPs

• SQP Registration Bodies

• SoS approval that the body

- has an adequate training programme - has
adequate standards in deciding whether or not to
register someone as an SQP - maintains a
programme of CPD for persons registered with
it - operates an appeal system against
non-registration or removal
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What does this mean for SQPs
Informal consultation

• Asked many questions on how to implement new
  regulations
• Informal consultation on fundamental point of
  SQPs responsibility

• SQP is responsible in law for supplying POM-VPS
  and NFAQ-VPS medicines
• If SQP takes an order on farm should he remain
  responsible for the whole supply process or
  should another SQP be responsible for the picking
  and supply/despatch

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Informal consultation

• If an SQP prescribes a product away from the
  registered premises, should the person
  responsible for picking and despatching/supplying
  the product also be an SQP?
• or
• If an SQP prescribes a product away from the
  registered premises, should a non-SQP working
  within the registered premises be permitted to
  pick and despatch/supply the product under the
  supervision of the SQP who remains legally
  responsible for all aspects of the supply?

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Informal consultation

• Where a farmer gives an order on farm to an SQP
  who does not supply the product himself, must a
  written prescription be provided to an SQP in the
  registered premises in all cases for the supply
  of a POM-VPS medicine to the farmer?
• or
• Where a farmer gives an order on farm to an SQP
  who does not supply the product himself, the
  instructions to the person picking and
  dispatching the order should be the legal
  responsibility of the prescribing SQP who is
  responsible for all aspects of the supply and may
  decide whether a written prescription is required
  in each case?

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Informal consultation

• The SQP must personally communicate with the
  customer for example face-to-face, e-mail, fax or
  phone etc. during every transaction in which a
  POM-VPS or NFA-VPS product is supplied
• or
• The SQP can supervise a member of staff who
  communicates with the customer but the SQP
  remains responsible legally for all aspects of
  the supply

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Informal consultation

• The SQP must personally pick for despatch/supply
  every POM-VPS or NFA-VPS product to be supplied
• or
• The SQP can supervise a member of staff to pick
  for despatch/supply the product but the SQP
  remains responsible legally for all aspects of
  the supply

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Informal consultation

• The SQP must personally despatch/hand over the
  product to the customer every POM-VPS or NFA-VPS
  product that is supplied
• or
• The SQP can supervise a member of staff to
  despatch/hand over the product to the customer
  but the SQP remains responsible legally for all
  aspects of the supply

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Informal consultation

• The SQP must provide customers with written
  advice on the safe administration, warnings and
  contra-indications for every product he supplies
• or
• The SQP should be able to decide whether the
  advice on the safe administration, warnings and
  contra-indications for each product he supplies
  should be written or verbal

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Legal Classification Review

• Marsh and Competition Commission recommendation
• 1st phase views from stakeholders completed
• Pet ectoparasiticides to NFA-VPS
• Anthelmintics to POM-V
• VMD VPC will consider and advise Ministers
• Further consultation on proposed changes

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The Future

• Comments on informal consultation will feed into
• 3 month consultation on changes to Veterinary
  Medicines Regulations
• 2006 Regulations will come into force on 1
  October