New Legislation for Pediatric Medicines

On 23 October 2006, the Council of the European Union approved all the compromise amendments to the proposal for a Regulation on Medicinal Products for Paediatric Use which were agreed at its second Parliamentary reading. The Regulation was officially published on 27 December 2006 and will enter into force on 26 January 2007.

eCTD Viewer and Validator

GECCO is a new eCTD Viewer that provides a uniform and consistent view of eCTDs in the different regions. 

New legal framework for harmonisation of the data exclusivity

The new periods of data exclusivity will only take effect for reference products applying for marketing authorisation after the new law is fully in effect (around November 2005). Therefore, the first generics applications under the 8+2+1-year data exclusivity period will not occur until late 2013.

HITH: Concept and clinical guidelines

Hospital in the Home (HITH) is the provision of hospital care in the comfort of the persons own home. In this patients are regarded as hospital inpatients and remain under the care of their treating doctor in the hospital, they receive the same treatment that they have been received in a hospital bed. Patients may be able to receive all their hospital care in HITH. Participation in HITH is voluntary - patients and their carers must agree to have their care provided at home. There are no additional charges to patients for being in HITH and it is available to public patients from the 43 participating public hospitals across the state.

Requirement for GMP audit of  API manufacturer by MAH

The implementation of EU directives 2004/27/EC and 2004/28/EC makes the requirement for marketing authorisation holder (MAH) to ensure that their Active Pharmaceutical Ingredients (API) have been manufactured to GMP.