New Applications

Applications for new Authorisation/Licence for the following should be submitted to the Licensing Section of Compliance Department of the IMB.

Upon receipt of an application for a new Authorisation / Licence, an inspector will contact the company to ensure that the company is ready for an inspection. An inspection will then be scheduled to take place at the facility. On successful completion of an inspection, a recommendation for approval or rejection of the Authorisation / Licence application is referred to the Management Committee of the IMB. If approved, the appropriate Authorisation / Licence is drawn up and issued to the company. Where possible, this process has a 90 day turnaround time.

If rejected, the company is informed and given the right to appeal the decision of the Board. Such appeals are dealt with in accordance with defined procedures.

For details on how to apply and for details in relations to the fees for an Authorisation / Licence please refer to the application form which can be found in Publications section of this website.

If you wish to contact the IMB with further questions on this topic please address your query to compliance@imb.ie

The Irish Medicines Board - www.imb.ie

New Applications