IMB publishes Guide on GDP (wholesale distribution)

On 29 September 2011, the Irish Medicines Board (IMB) published the Guide on wholesaling of medicinal products for human use in Ireland. This guidance document covers the wholesale distribution of medicinal products for human use and includes:

• A summary of the applicable legislation
• An overview of the EU Guideline on Good Distribution Practice, with which a wholesaler must comply in order to become authorised and to retain the authorisation
• Discussion of policy and IMB requirements relating to wholesale distribution of medicinal products for human use

According to the Guide section 13, the IMB will inspect authorised wholesaler's premises on a regular basis. Routine inspections are carried out once every three years. A greater frequency may be applied to large wholesalers or to any wholesaler which exhibits a poor record of GDP compliance.

Non-routine inspections may be carried out as a result of a variation application; a for-cause inspection may be carried out due to non-compliance with the conditions of an authorisation. New wholesalers may also be subject to an inspection approximately 12 to 18 months following the granting of their authorisation.

According to section 15.1 of the Guide, the IMB also expects that the wholesaler has implemented a risk management system. It is stated in the Guide that "companies using risk management should have a procedure in place and training should be performed on its use. All documentation for risk assessments performed should be available to an inspector during the course of an inspection."

For further details please see the Guide on wholesaling of medicinal products for human use in Ireland.