definiens: means all applicable principles, guidelines and guidance for current good clinical practice as found in : 3 ( a ) the Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, adopted by the World Medical Assembly in June 1964, as amended by the General Assembly of theAssociation in October 1975, October 1983, September 1989, and October 1996 . The Partiesacknowledge that later amendments have not been accepted under applicable law and are excludedfrom this Agreement until such time as they are accepted under applicable law ; ( b ) the International Conference on Harmonization of Technical Requirements for Registration ofPharmaceuticals for Human Use ICH Tripartite Guideline for Good Clinical Practice E6(R1 ) ( alsopublished as CMP/135/95, 1 July 1996 ) ; ( c ) the applicable provisions of the Medicines for Human Use ( Clinical Trials ) Regulations 2004 and furtherguidance as published by the UK Medicines and Healthcare products Regulatory Agency ; ( d ) the applicable provisions of Directives 2001/20 / EC and 2005/28 / EC, and further guidance as publishedby the European Commission in Volume 10 of The rules governing medicinal products in the EuropeanUnion ; and ; ( e ) all other legal provisions, regulations, decisions or guidance of competent authorities which areapplicable to the conduct of the Clinical Trial