Transcription of REGULATORY REQUIREMENTS ON STORAGE AND EXPORT …
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REGULATORY REQUIREMENTS ON STORAGE AND EXPORT …
PHARMACY, MEDICINES & POISONS BOARD REGULATORY REQUIREMENTS ON STORAGE AND EXPORT OF SAMPLES / SPECIMENS COLLECTED FROM PARTICIPANTS / CLINICAL TRIAL SUBJECTS DURING CLINICAL TRIALS FOR TESTING 1 Table of Contents Page 1 Introduction 4 2 Scope 6 3 Responsibilities of the Sponsor, Carrier and Receiver 6 4 Abbreviations, Definitions 7 5 Classification of infectious substances and diagnostic specimens 7 Infectious substance, Category A 7 Infectious substance, Category B 8 Cultures 9 Trial participant specimens 9 Biological products 9 Human material 9 Genetically modified micro-organisms and organisms 9 Exceptions 9 6 Labelling and Packaging for STORAGE and EXPORT 10 General preparation of shipments for transport 10 Basic triple packaging system 11 Packaging for Exempt Patient Specimens 11 Packaging, labelling and documentation REQUIREMENTS for infectious substances in Category A (UN 2814 04 UN 2900) 11 Packaging 11 Marking 12 Labelling 12 Documentation
tested immediately and remain either frozen, or at refrigerated temperatures. Delays in transit times or incorrect storage conditions may lead to the loss of a sample and will negatively ... Rail Regulations concerning the International Carriage of Dangerous Goods by Rail (RID) apply to countries in Europe, the Middle East and North Africa. RID ...
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