Decision
On 20 September 2002, the Environmental Protection Agency (EPA) granted consent, subject to specified conditions, to Schering Healthcare Limited to carry out a clinical trial on patients suffering from angina pectoris, using a genetically modified organism, at the following four sites, from September 2002 to February 2006.
Relevant Documentation
Inspector’s Report
Consent Conditions
GMO Register G0134-01
GMO Register
The trial was assigned GMO Register No G0134-01. The Register provides significant details about the trial.
Legislation
Any person or organisation proposing to carry out a deliberate release of a genetically modified organism (GMO) for purposes other than placing on the market (performance of field trials) must comply with the legislative requirements set out under Part II of the GMO (Deliberate Release) Regulations S.I. No 500 of 2003.