This section provides information for Marketing Authorisation Holders (MAHs) and users on how the HPRA evaluates various pack sizes of veterinary drugs. It also provides information to retailers and purchasers on how to identify that a product presentation has been authorised and how to report any suspected unauthorised product to the HPRA or the Department of Agriculture, Food and the Marine.
In accordance with national legislation (Animal Remedies Act, 1993 as amended) a product which is not compliant with the terms and conditions of the marketing authorisation, or is no longer compliant with the terms and conditions of the marketing authorisation, is classified as a ‘prohibited animal remedy’.
Pack sizes and presentations of veterinary medicines are assessed during the evaluation of an application for marketing authorisation. The approved pack sizes take into account:
- The product itself – Is the in-use shelf life limited to some days after opening (sterile products) or does it last for several months? Does it need special storage (e.g. refrigerated, or away from sunlight)?
- The indications for use - Is the product intended for individual use or for use in groups of animals? Does the disease being treated occur in individual animals or in groups of animals?
- The precautions for use - Is there any limitation for the use of the product (e.g. as is the case for many antibiotics in accordance with responsible use principles)?
- The dosage and dose regiment - How many animals (or kilograms of animals) can be treated with a given pack size when the dosage indicated is followed? Is a re-treatment allowed or not? Among a target species, are there different recommended dosages or durations of treatment for different indications? Is the maximum number of treatments in the product realistic under Irish conditions?
- The intended user - Is the product to be used only by the veterinary practitioner or can it be administered by others?
- The risks and warnings – Does the product present a risk to the animal if used inappropriately (e.g. resistance, adverse effects or unintended residues) or does it present a risk to the environment? Does the product present a risk to the user, or to others who might reasonably be expected to come into contact with it?
- The intended supply route – Is the product intended to be supplied through specialist outlets (e.g. veterinary practices or pharmacies) or through retail outlets (e.g. supermarkets or general merchant outlets)?
Where a device (e.g. a dosing gun) is included for use with the product, this forms part of the product presentation and is also assessed at the time of authorisation.
It should be noted that not all product presentations that are authorised for use (as detailed in the product’s Summary of Product Characteristics) may be marketed in Ireland (some presentations may only be marketed in other EU Member States).
Veterinary medicines can be identified as having been evaluated and authorised for use by means of its authorisation number. This is usually indicated on the label of the product itself (in small ampoules and blister packs the number may instead by on the outer container and package leaflet). The authorisation number issued by the HPRA is given in the following format: VPA 11000/011/001. VPA stands for ‘veterinary product authorisation’. In the case of products authorised under the centralised procedure, following the opinion of the European Medicines Agency, the authorisation number is given in the following format: EU/2/95/001/001.
Where a product does not have a marketing authorisation number and is therefore suspected of not being authorised for use in Ireland, the purchaser should check the status on this website (in the case of nationally authorised medicines) and/or on the EMA website (in the case of centrally authorised medicines). If information on the product is not available on these websites, you should check with the HPRA or with the Department of Agriculture, Food and the Marine.