An applications to renew an Authorisation / Licence should be submitted to the Compliance Department three months prior to the expiry date of the Authorisation/Licence.
For details on how to renew an Authorisation / Licence please refer to the application form which can be found in Publications/Medicines/Manufacturing & Distribution.
There is no fee for a Renewal of an Authorisation/Licence. All applications to renew Authorisaiton / Licence must be approved by the Management Committee of the IMB.
If approved, the appropriate Authorisation / Licence is drawn up and issued to the company. 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.
Please note that as Medicinal Products (Control of Manufacture) Regulations 2007 (S.I. No. 539 of 2007) have now been brought into effect, any renewals issued after 23rd July 2007 shall no longer carry an expiry date. Therefore there will be no further renewal.
If you wish to contact the IMB with further questions on this topic please address your query to