The IMB has published a list of frequently asked questions concerning the regulation of veterinary medicines in Ireland. The full document of questions and answers is available here.

The following are the questions that are answered in the document: 

• How can I recognise that a veterinary medicine has been authorised by the IMB?
• How can I recognise that a veterinary medicine has been authorised by the European Medicines Agency?
• Where can I obtain information on the authorisation status of a veterinary medicinal product in Ireland?
• Where can I find more detailed information about an authorised veterinary medicinal product?
• Where can I find information in relation to the assessment of a veterinary medicinal product?
• Where will I find information in relation to the rules governing the prescription and dispensing of veterinary medicines?
• What is the IMB policy regarding the disclosure of information in respect of the authorisation of veterinary medicinal products?

• Can veterinary medicines be advertised to farmers and the public?
• Can a veterinary medicine be promoted for indications not specifically claimed on the product literature?
• Does the IMB monitor and/or regulate the advertising of veterinary medicines?
• Does the IMB monitor the on-line advertising of veterinary medicines?

• Can I purchase a veterinary medicine over the internet?
• Can I import a veterinary medicine from another country?
• As a veterinary practitioner, how do I apply for a licence to import veterinary medicines under the ‘cascade’?
• Can a company import a veterinary medicine which is already authorised in Ireland but is available more cheaply in another EU member state?
• Are there veterinary medicines other than those authorised by the IMB which may be legally supplied in Ireland?
• Can wholesalers of human medicines supply veterinary practitioners with product?

• Can companies or members of the public contact the IMB with queries relating to problems with veterinary medicinal products i.e. - broken tablets in pack/incorrect tablets in pack etc.?

• What procedure is followed by the IMB in relation to evaluation and eventual authorisation of veterinary medicinal products?
• What is the procedure and how long does it take to get a marketing authorisation application for a new veterinary medicinal product approved by the IMB?
• As an applicant, what is the procedure to enquire regarding the status of a pending application from my company?
• What are the procedures for contacting the IMB to discuss an issue regarding the authorisation of a veterinary medicine?
• Where an applicant does not agree to the evaluation conducted by the IMB, what procedures are there to appeal the decision?

Monitoring of veterinary medicines

• Can a marketing authorisation holder communicate information relating to pharmacovigilance concerns to the general public?
• What is a Qualified Person for Pharmacovigilance?
• No suspected adverse reactions or safety issues occurred during the PSUR reporting period. Does a PSUR need to be submitted to the IMB?
• If a veterinary medicinal product is not marketed does a PSUR have to be submitted to the IMB?
• Is it an obligation for the MAH to indicate in the PSUR the changes to the SPC and product literature made in other EU Member States and in third countries during the PSUR period covered?