ims剂型缩写2018版指导.doc

NEW FORM CODE CLASSIFICATION GUIDELINES VERSION 2018 PUBLICATION DATE JANUARY 2018 New Form Code Classification Guidelines CONTENTS Page INTRODUCTION 4 GENERAL CLASSIFICATION RULES 5 - Rule 1. Level of Detail 5 - Rule 2. Long-Acting and Ordinary Forms 5 - Rule 3. Alphabetical Rule 6 - Rule 4. Oral Systemic Forms Which Require Modification 6 Before Use THE HIERARCHIES WITHIN THE SYSTEM 7 DEFINITON OF THE FIRST LETTER 8 THE VALID FIRST LETTER CODES 9 A.. Oral Solid Ordinary 10 B.. Oral Solid Long-Acting 10 D.. Oral Liquid Ordinary 10 E.. Oral Liquid Long-Acting 10 F.. Parenteral Ordinary 10 G.. Parenteral Long-Acting 11 H.. Rectal Systemic 11 I.. Nasal Systemic 11 J.. Other Systemic 11 K.. Oral Topical 11 M.. Topical, Dermatological, Haemorrhoidal, External 12 N.. Ophthalmic 12 P.. Otic 12 Q.. Nasal Topical 13 R.. Lung Administration 13 T.. Vaginal/Intra-uterine 14 V.. Non-human Use and Others 14 Z.. Unknown 14 DEFINITION OF THE SECOND LETTER 15 THE VALID SECOND LETTER CODES 15 DEFINITION OF THE THIRD LETTER 16 VERSION 2018 Page Amendment Date: ? EphMRA 2 New Form Code Classification Guidelines VALID COMBINATIONS OF SECOND AND THIRD LETTERS AND DEFINITIONS 17 .A. Tablets .B. Coated Tablets .C. Capsules .D. Solid Special Forms .E. Powders/Granules .F. Gases .G. Liquids .H. Pressurised Aerosols .J. Bath Preparations .K. Teas .L. Suppositories .M. Ampoules .N. Pre-filled Syringes .P. Vials .Q. Infusions .S. Ointments .T. Creams .V. Gels and Sols .W. Medicated Dressings .Y. Other Special Forms .Z. Medical Aids 17 19 21 23 25 27 28 31 33 35 36 37 39 42 45 47 48 49 51 54 57 VALID COMBINATIONS OF FIRST, SECOND AND THIRD LETTERS 60 LIST OF VALID NEW FORM CODES AND THEIR ABBREVIATED DESCRIPTIONS 84 VERSION 2018 Page Amendment Date: ? EphMRA 3 New Form Code Classification Guidelines INTRODUCTION The THREE LETTER CODE (TLC) was introduced as a dosage Form Code in the audits during the middle of the 1960s. A large number of new dosage forms have appeared since that time and it w