The Legislation in respect of veterinary medicines is broadly similar to that for human medicines. It has now been consolidated at the EU level pursuant to the Directive. Principles of mutual recognition of animal remedies apply within the EU. The Irish regulation is the EU (Animal Remedies) Regulations. The Department of Agriculture administers the regulations.
The Animal Remedies Act is domestic legislation. The Irish Medicines Board (now the Healthcare Products Regulatory Authority) licenses veterinary medicinal products. It maintains the pharmacovigilance system. It grants licences for the manufacture of animal remedies and importation from outside the EU.
Veterinary medical products are substances having properties for treating or preventing disease in animals or substances or combinations which may be used or administered to animals with a view to restoring, correcting, modifying physiological functions or exerting a pharmacological, immunological or metabolic action or to making a medical diagnosis.
Veterinary medicinal products must be authorised before being placed on the market. An animals remedies authorisation includes licences and authorisations under the regulations as well as marketing authorisation under EU law granted under centralised procedure or other documents, registration or licence deemed to be so.
It is an offence to import, possess, sell or supply an animal remedy unless there is an authorisation for that remedy in force.
There are exemptions in respect of
- homeopathic animal remedies which are registered before 1993 under prior regulations.
- if the Irish Medicines Board (now the Healthcare Products Regulatory Authority) determines that the substance is not within the Directive or
- in the case of veterinary products intended for fish, caged birds, homing pigeons, small rodents, parrots and rabbits, kept exclusively as pets; they must not contain substances which require veterinary control.
There are a number of different mechanisms by which authorisations may be granted for veterinary medicine. An application may be made to the Irish Medicines Board (now the Healthcare Products Regulatory Authority) for a national authorisation.
Details of the characteristics of the product must be given together with data in relation to its efficiency, safety and quality. The Irish Medicines Board (now the Healthcare Products Regulatory Authority) grants or refuses a licence in accordance with the requirements in the Directive.
There are special procedures where an applicant wishes to obtain authorisation in two or more states. Following the grant of authorisation by one state, the holder may apply to one or more states to issue equivalent authorisations
There is a further procedure where there is no existing authorisation. In this case, one state from a number may be chosen as a reference state. A coordinated assessment takes place.
The EU legislation provides for the central authorisation of human and veterinary products. A single application may be made and the authorisation is valid to the EU. The procedure must be followed in respect of certain types of medicine, such as
- high-tech medicinal products, particularly those which emanate from bio-technical processes and for veterinary medical processes which are primarily as performance enhancers to promote the growth of treated animals or increase yields in the treated animal. In other cases it is discretionary.
- qnew product, which contains a new active substance for products with significant therapeutic, scientific and technical innovation or for immunological products for the treatment of animals’ diseases.
Regulations allow for veterinary practitioners in other states providing cross-border services to supply and administer small quantities of animal remedies, notwithstanding that it is not authorised in Ireland. This is subject to certain conditions. It must be authorised in the state in which the veterinary practitioner is established.
It must be brought into the state in its original packaging and used in a food-producing animal. It must be similar in qualitative and quantitative composition to a remedy authorised in Ireland.
In this case, the vet must inform the owner of the animal of the withdrawal procedure. The quantity must be such as may be expected to be in the possession of a practitioner in terms of daily needs and good practice. It must not exceed five days’ supply. Records are required, which must be retained for five years including particulars of animals treated, date and number of animal, address of persons in charge, details and dosage, duration of treatment.
The Department of Agriculture may issue licences to import, possess, sell or administer an animal remedy which is not otherwise authorised. This may be permissible if the animal’s health status requires this and it is authorised in another state.
It may be permitted in other situations where authorisation is pending in Ireland or before the European Medicines Agency. It may be permitted where immunological remedies are required to deal with a serious disease, in exceptional circumstances where an animal is to be exported outside the EU and there is requirement to use an immunisation remedy authorised in that country.
A licence may be issued to allow an animal remedy to be imported, manufactured, possessed or sold in circumstances where it is not authorised, authorised in certain limited situations. This includes use for a trial in research, supply for education and research and exportation from Ireland, supplied for the purpose of an application to the medical IMV.
The application for authorisation requires the veterinary medicinal product to be tested against criteria of safety, quality, efficiency when used in accordance with the recommended usage, takes accounts of risks to animals, person administering the medicine and others who may consume the medicine from produce of the animals concerned and from the environment.
The Board and other authorities undertake a risk-benefit analysis.
A vet must not prescribe animal remedies to a food producing animal other than in accordance with animal remedies authorisation rules in respect of the relevant type of animal. If there is no treatment available and it is necessary to avoid unacceptable suffering, an unauthorised medicine may be administered. However the medicine to be administered must be available, be one licensed for another condition in the same species, for human use or authorised abroad.
Only if the foregoing cannot be met may be veterinary practitioner prepare or prescribe another remedy. Other conditions apply.
A withdrawal period must be prescribed to ensure that food from the animal does not contain residues. Minimum periods are prescribed. Records must be made and retained setting out details of the animal and the substance administered together with reasons and the particulars of withdrawal period.
Manufacture & Import Licensing
A person may not manufacture, import an animal remedy without being licensed by the Irish Medicines Board (now the Healthcare Products Regulatory Authority). There are a number of limited exceptions including
- manufacture in a laboratory engaged in education, research or analysis, manufacture of medicated feed stuff or products in accordance with licence,
- importation from a third country for transhipment to another EU state
- dividing packaging or presenting an animal remedy not pre-prepared by
- a pharmacist to be sold from the pharmacy,
- a veterinary practitioner to be supplied by him for treatment for treatment of an animal under his care
- certain sales from an animal remedies merchant licence premises
An applicant for a manufacture’s licence must show that they have sufficient premises, technical equipments, human resources to manufacture, control and store the remedies and substances. They must show that manufacturing will take place in accordance with the relevant guidelines and principles. The services of at least one qualified person fulfilling requirements applicable must be available. The HPRA must determine the application within 90 days.
The manufacturer licence must keep records of incoming and outgoing remedies manufactured, sold or supplied. They must include details of the date, type of remedy, batch number and expiry date, quantities, names of recipients.
Records must be maintained and available for inspection by an authorised officer for at least five years or one year after the expiry date whichever is longer.
The licence remains in force for three years or shorter if specified. They must be renewed. Once renewed the validity is for an unlimited period. It may however be revoked, suspended or varied if the remedy is not being manufactured, appropriately.
Animal remedies may only be sold through a number of outlets or channels. The permitted channels are relative to the medicine concerned.
Veterinary practitioner only, medicines are those which must only be sold or supplied by a vet or by a practitioner to an animal under his care, VPO-1.
A second category VPO-2 are remedies which may be sold only by a veterinary practitioner and administered by the practitioner or by a person in his presence or under his direct supervision to an animal in his care.
Prescription only, are those which may be sold
- by a pharmacist in accordance with a prescription from a vet
- a registered veterinary practitioner for an animal under his care and he has issued a veterinary prescription.
- A responsible person from a premise in which animal remedy merchant licence relates in accordance with a veterinary prescription in the case of certain animal remedies.
There are a number of other categories of animal remedies. Prescription only exempt, are remedies which may be sold by a pharmacist from a pharmacy or a registered practitioner where the animal is under his care. Pharmacy only remedies are those which may only be supplied from a pharmacy under the personal supervision of a pharmacist or registered veterinary practitioner for an animal under his care.
A licensed merchant remedy is animal remedy which may be sold only for a pharmacy or from a premises for which an animal remedy’s licence relates.
Companion Animal Medicine
A companion animal medicine is an animal remedy which can be provided from a pharmacy, registered veterinary practitioner or from premises in which an animal remedies merchant licence is held or premises to which a companion animal medicine seller’s registration is enforced.
A person may not sell a companion animal medicines unless registered in the companion animal medicine sellers register maintained by the Department of Agriculture. The requirements do not apply to pharmacists, veterinary practitioners, licensed merchants or holders of animal remedies wholesaler’s licence.
Sellers of companion animal medicines must comply with storage requirements. They must have arrangements to receive in return unused and expired remedies. A sale other than accordance with the above conditions is unlawful.
A person may not sell or supply a remedy unless he has an animal remedies wholesaler’s licence, merchant’s licence or is registered in the companion animal medicine seller’s register. The sale or supply of animal remedies by or under the supervision of a pharmacist from a pharmacy, by a veterinary surgeon in respect of animal under his care or by wholesale by a person who has manufactured them under a manufacture’s licence is permitted.
A premises may not be used for the sale or supply of animal remedies or for storage unless it is either a pharmacy registered for a manufacture’s licence, a wholesale licence or merchant’s licence registered in the companion animal medicine seller’s register used by a veterinary surgeon for veterinary practice.
Generally, animal remedies may not be sold remotely or by mail order, travelling shops, vending machines etc. Licences may be granted to permit merchants and pharmacist to sell certain medicines by e-mail or internet.
Licence holders must have suitable premises, equipment and staff arrangements to preserve and prevent the deterioration of remedies. Changes in the premises must be notified to the Minister. There must be suitable procedures and facilities for storage, maintenance of records, handling of stocks. There must be appropriate withdrawal and recall procedures.
Records must be kept of all incoming and outgoing transactions including transaction dates, details of the remedy, manufacturer’s batch number, particulars of supplier or consignee, quantity. The records must be maintained for five years and may be inspected by authorised officer.
An animal remedies merchant’s licence is granted by the Department of Agriculture. It permits the sale or supply of certain animal remedies generally and others in accordance with a designated route of supply or prescription. The licence is valid for three years.
The same provisions as apply both in respect of an animal remedies wholesaler’s licence, apply. Requirements in respect of premises, stock handling records and sales apply. Licence holders must have sessions to receive back unused and expired products. Customers must be notified of the facility.
Remedies may only be sold by a responsible person. The Minister may approve training requirements for responsible persons and certification of training for proper handling and storage of medicine.