THE CODE OF PRACTICE

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THE CODE OF PRACTICE ENFORCEMENT OF THE
REGULATIONS AND CODE

• John Millward
• Head of Animal Medicines Inspectorate
• AHDA Conference
• January 2006

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• Introduction whats new
• Background to the Code
• An SQPs main responsibilities
• Other important points in the new legislation
  Code
• Enforcement of the Regulations and Code of
  Practice

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Introduction whats new

• The AMI has transferred to VMD from the RPSGB
• Review of the AMIs role and procedures during
  2006

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Background to the Code

• The Secretary of State shall recognise bodies
  that are suitable to provide training for SQPs to
  prescribe and supply POM-VPS NFA-VPS medicines.
• The Secretary of State may issue a Code of
  Practice for SQPs, and the registration body must
  ensure that its SQPs comply with it.

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Background to the Code

• The Code provides further guidance on-
• The requirements for registration bodies
• The three types of Registered Qualified Persons
  (RQPs)
• The duties and responsibilities of SQPs
• Registration of premises
• Storage and supply of veterinary medicines

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An SQPs main responsibilities

• To prescribe POM-VPS medicines
• To advise on POM-VPS NFA-VPS medicines
• To correctly store supply those products

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1. Prescribing

• The Code of Practice defines the act of
  prescribing to be-
• the decision made by the SQP as to which product
  should be supplied taking account of-
• The circumstances of the holding and the animals
  being treated
• The available authorised veterinary medicinal
  products
• The need for responsible use of medicines and the
  requirement to prescribe the minimum amount of
  product necessary for the treatment
• The requirement for the person receiving the
  product to use it for an authorised use according
  to the MA
• Any available animal health plan

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Prescribing

• Or more simply
• Prescribing refers to the action of assessing the
  customers requirements, deciding on the most
  appropriate medicine and giving critical
  advice.
• A prescription, which can be either oral or
  written, is the means by which the action of
  prescribing is relayed to the customer.

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2. Advising

• Any person who supplies a POM-V, POM-VPS or
  NFA-VPS medicine-
• Must always advise on the safe administration of
  the veterinary medicinal product
• Must advise as necessary on any warnings or
  contra-indications on the label or package
  leaflet
• Must be satisfied that the person who will use
  the product is competent to use it safely, and
  intends to use it for a use for which it is
  authorised.

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2. Advising

• the advice can be either oral or written.
• a) and b) specify the critical advice that must
  be given by the SQP on each occasion.
• The SQP must also be satisfied that the person
  who will use the medicine is competent to do so.
• If the customer is not the user consider giving
  written advice.

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3. Supply

• The supply of products permitted to be sold by
  SQPs must take place from premises approved by
  the Secretary of State and the SQP must be
  present at each supply of such product.

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3. Supply

• Most frequently asked question.
• Subject of an informal consultation
• Opportunity for SQPs to comment
• Need to consider-
• - will the system adopted ensure that VMPs are
  appropriately supplied so that they are used
  safely and effectively
• - is the system defensible if challenged by the
  European Commission

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Other important points for SQPs

• reclassification of medicines to POM-VPS or
  NFA-VPS
• Saddlers SQPs permitted to supply VPS
  medicines for the
  treatment of horses and companion animals
• supply is by SQP type not premise type
• SQPs can open packs but not break the immediate
  packaging of a POM-VPS/NFA-VPS medicine

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Other important points for SQPs

• regulation 7(2) makes it an offence to supply a
  veterinary medicine that has passed its expiry
  date and this applies to all medicines, including
  AVM-GSLs.
• regulation 7(4) makes it an offence for a person
  to possess a veterinary medicine that was not
  supplied in accordance with Schedule 3.
• regulations 26 and 27 make it an offence to
  possess and supply unauthorised veterinary
  medicinal products.
• regulation 42(2)(a) extends offences to SQPs who
  have been party to an offence being committed by
  way of consent, connivance or neglect.

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Other important points for SQPs

• The Code provides further guidance on
  record-keeping e.g.
• Horse wormers are POM-VPS and sales must be
  recorded
• Batches of medicines must be traceable
• Expiry dates must be recorded

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Other important points for SQPs

• The Code sets out the requirements for approved
  premises e.g.
• the premise must be a permanent building and be
  capable of being made secure
• it must be designed and constructed to allow
  storage requirements to be met
• it must be regularly maintained and cleaned
• Each registered premise must have a registered
  SQP

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Other important points for SQPs

• The Code also sets out the requirements for
  storage of POM-VPS NFA-VPS medicines e.g.
• Temperature sensitive products must be stored in
  a controlled environment and temperature records
  kept
• Medicines must not be stored in areas used to
  store food or drink for human consumption
• Not available by self-service

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Other important points for SQPs

• Schedule 5 Products
• SQPs are no longer allowed to supply the former
  MFS classified in-feed medicinal premixes.
• SQPs can supply the former MFSX products (in-feed
  wormers), subject to the relevant controls being
  observed.
• Agricultural merchants are no longer authorised
  to supply medicated feedingstuffs additional
  approval as a Distributor is required.

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Enforcement of the Regulations and Code

• New regulations will require a bedding-in
  period.
• Enforcement only where a business/SQP is
  deliberately evading the regulations.
• Range of sanctions including warnings,
  improvement Notices and ultimately prosecution

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Enforcement of the Regulations and Code

• Improvement Notices
• Issued where advice/warnings are ignored or major
  deficiencies noted
• Seizure Notices
• Products seized can be destroyed at owners cost
• Right of Appeal against Notices
• Notices published

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Enforcement of the Regulations and Code

• Registration body responsible for ensuring SQPs
  comply with the Code
• MoU with VMD
• SQPs reported to registration body

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Summary

• Similar to the former PML Order
• Supply of POM-VPS/NFA-VPS products the subject of
  an informal consultation
• Comments considered for 2006 Regulations and Code
  of Practice
• Clear guidance issued as FAQs
• Light touch enforcement