Revised guidance under Directive 91/414 and Council Regulation 1107/2009

The UK regulatory authority (CRD) have recently issued revised guidance on the requirements for submitting efficacy data under Directive 91/414 and under Council Regulation 1107/2009. The document includes detailed advice on the use of the draft Registration Report for submissions to the UK and how zonal efficacy assessments and mutual recognition will be handled under the Council Regulation.  JSC experts already have experience of preparing draft Registration Reports and are happy to discuss individual clients’ requirements as necessary.