Statutory Instruments

The Medicinal Products (Control of Placing on the Market) Regulations 2007 (Amendment) Regulations 2009

The main purpose of these Regulations is to facilitate the operation of Regulation (EC) No. 1394/2007 relating to advanced therapy medicinal products. The Regulations also provide for controls in respect of advanced therapy medicinal products which are prepared on a non-routine basis according to specific quality standards, and used within the State in a hospital under the exclusive professional responsibility of a medical practitioner, to comply with an individual medical prescription for a custom-made product for an individual patient

Provisions are also included in respect of the traceability of all advanced therapy medicinal products. The Judgment of the European Court of Justice in Case C-143/06 concerning the prohibition of the advertising of unauthorised medicinal products has also been taken into account in the making of these Regulations

Download the document here