Within the European Union Drug Master Files are not normally used for non-active components. However a Data File for ZEPHEX®134a, prepared in conjunction with GlaxoSmithKline was the subject of a co-ordinated review by the European Union's Committee for Proprietary Medicinal Products (CPMP) held during October 1994.
The CPMP also undertook co-ordinated reviews of Data Files for HFA 134a and HFA 227ea presented by the IPACT I and IPACT II consortia respectively.
To request more information on CPMP Review for HFA 134a click here
As a result of these reviews Regulatory Authorities within the European Union do not require submission of further toxicology and pharmacokinetic data on HFA propellants (eg ZEPHEX®134a) provided they are of a purity equivalent to or higher than the approved specification.
To view 'Toxicology Data for HFA 134a and HFA 227ea: The Concise Story' click here
To meet the requirements of Section 3.2 P.4 of the EU CTD for the authorisation of medicinal products, relevant 'Chemistry and Pharmacy' data concerning ZEPHEX® propellants can be supplied to the applicant for the Marketing Authorisation.