Presentation to AHDA Conference

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Presentation to AHDA Conference

• Wednesday, 18th January 2006
• Brendan Barnes, Director, APHA

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Animal Remedies Regulations (Ireland)

• EU Directive 2004/28/EC
• In Law 1st January 2007
• However, Regulations 44 and 45 in operation from
  1st January 2006

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Regulation 44 and 45

• Regulation 44. Under the care of a Veterinary
  Practitioner
• Relationship is real not merely nominal
• Detail cost of remedy and service separately
• Regulation 45. Prescribing and Dispensing
• Animal must be under his/her care
• Specify at least two alternative remedies
• Maximum of six month supply
• Issued in triplicate (retain five years)
• Dispensed written on both copies of prescription

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Veterinary PrescriptionIssued by a Veterinary
Practitioner

• Requirements
• Serial Number
• Authorised name and number of Veterinary Product
  Authorisation
• Plus alternative
• Date of issue
• Manner and site of administration
• Dose rate and withdrawal period
• Description of animal/animals to which
  prescription related
• Name and address of farmer
• Period for which prescription is valid
• Special instructions, risks, etc.
• Name, address and signature

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Categories

• Veterinary Practitioner Only. VPO,VPO-1.
• POM Prescription Only Medicine
• POM(E) Prescription Only Medicine (Exempt)
• PS Pharmacy Only
• LM Licensed Merchant
• CAM Companion Animal Medicine

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Prescription Only (POM) from 1st January 2007

• Intramammaries open to LM license holders from
  1st January 2007
• Antifungal Animal Remedy
• Endo/Ecto Parasiticide
• Immunological Animal Remedy
• Injectable Digestive Stimulant
• Injectable Vitamin Mineral

Application for Exempt Status
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Minister Press Release

• Her Department would review this issue and in
  particular, the qualifications needed by
  non-veterinarians and the categories of products,
  which may be prescribed by them, in light of the
  outcome of the EU decision on the exempt
  criteria, with a view to ensuring competition in
  the market place while at the same time
  protecting public and animal health

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Article 95 (a)

• Member States shall ensure that appropriate
  collection systems are in place for veterinary
  medicinal products that are unused or expired.
• Ireland
• Obligation of Marketing Authorisation Holder
• Shall maintain a system designed to ensure
  compliance with 95 (a)
• Obligation of Wholesaler
• Have in place the necessary systems to return
  unused or expired product
• Obligation of Retailer
• Have in place the necessary systems to return
  unused or expired product plus additionally
  ensure customers are aware of arrangements

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Advertising

• Not publish or cause to be published an
  advertisement
• Promotional material/literature??
• Display price list of all animal remedies held in
  stock

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Labelling of Certain Animal Remedies (POM)

• At time of sale
• Affix a label to the Animal Remedy
• Dispensers name and address
• Serial number of prescription
• Name of prescribing practitioner
• Date of sale or supply

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Retail Sale of Animal Remedy (Records)

• (i)
• Date of transaction
• Name, pharmaceutical form and pack size
• Manufacturers batch number and expiry date
• Quantity received or supplied
• Name and address of supplier or .
• Quantities received or returned
• (ii)
• Arrangements to receive and return unused and
  expired products
• (iii)
• Ensure Animal Remedy is not sold other than by
  responsible person

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Responsible Person

• 54. Saver for qualified persons
• 32. 3(b) Potential for additional training
• (i) Intramammaries
• Exempt list (success/failure)
• 31. Retail ensure AR is not sold other than by
  responsible person.

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Summary

• Directive Objective To safeguard animal health
  and welfare as well as human health.
• Achieved by means that do not hinder the
  development .or trade of Veterinary medicinal
  products within the community
• Uncertainty for all agribusiness.
• Least flexible interpretation of directive.
• What extra quantifiable added benefits to public
  or animal health or animal welfare WILL BE
  ACHIEVED?