GUIDELINES ON IMPORT PROCEDURES FOR ... - who.int

1 Working document May 2018 Draft document for comment GUIDELINES ON IMPORT PROCEDURES FOR 1 PHARMACEUTICAL PRODUCTS 2 3 (May 2018) 4 DRAFT FOR COMMENT 5 6 7 8 9 10 World Health Organization 2018 11 All rights reserved. 12 This draft is intended for a restricted audience only, the individuals and organizations having received this draft. The 13 draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, 14 in any form or by any means outside these individuals and organizations (including the organizations' concerned staff and 15 member organizations) without the permission of the World Health Organization.

2 The draft should not be displayed on any 16 website. 17 Please send any request for permission to: 18 Dr Sabine Kopp, Group Lead, Medicines Quality Assurance, Technologies Standards and Norms, Department of Essential 19 Medicines and Health Products, World Health Organization, CH-1211 Geneva 27, Switzerland. Fax: (41-22) 791 4730; 20 email: 21 22 The designations employed and the presentation of the material in this draft do not imply the expression of any opinion 23 whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or 24 of its authorities, or concerning the delimitation of its frontiers or boundaries.

3 Dotted lines on maps represent approximate 25 border lines for which there may not yet be full agreement. 26 The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or 27 recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors 28 and omissions excepted, the names of proprietary products are distinguished by initial capital letters. 29 All reasonable precautions have been taken by the World Health Organization to verify the information contained in this 30 draft. However, the printed material is being distributed without warranty of any kind, either expressed or implied.

4 The 31 responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health 32 Organization be liable for damages arising from its use. 33 This draft does not necessarily represent the decisions or the stated policy of the World Health Organization. 34 35 Should you have any comments on the attached text, please send these to Dr S. Kopp, Group Lead, Medicines Quality Assurance, Technologies Standards and Norms with a copy to Mrs Xenia Finnerty by 30 June 2018. Medicines Quality Assurance working documents will be sent out electronically only and will also be placed on the Medicines website for comment under Current projects.

5 If you do not already receive our draft working documents please let us have your email address (to and we will add it to our electronic mailing list. Working document page 2 36 SCHEDULE FOR THE PROPOSED ADOPTION PROCESS OF DOCUMENT : 37 GUIDELINES ON IMPORT PROCEDURES FOR PHARMACEUTICAL PRODUCTS 38 39 Proposal for revision of W O GUIDELINES on IMPORT PROCEDURES for pharmaceutical products during the consultation on Good practices for health products manufacture and inspection 25 28 April 2017 Presentation of a proposal for update to the 52nd WHO Expert Committee on Specifications for Pharmaceutical Preparations 16 22 October 2017 Preparation of draft for revision by Dr V.)

6 Gigante, WHO Medicines Quality Assurance Group February 2018 Review of draft by Dr van Zyl, member of the Expert Advisory Panel for the International Pharmacopoeia and Pharmaceutical Preparations April 2018 Finalization of draft for mailing and public consultation May June 2018 Consolidation of comments received beginning of July 2018 Discussion of working document and feedback received during the informal consultation on Good practices for health products manufacture and inspection 10 12 July 2018 (tbc) Revision based on feedback received during the informal consultation on Good practices for health products manufacture and inspection and mailing for public consultation August September 2018 Consolidation of comments received during public consultation September 2018 Presentation to the 53rd meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations 22 26 October 2018 Any other follow-up action as required Working document page 3 [Note from Secretariat.]

7 The new text of this document is presented in track-change mode, including 40 editorial revision, except for the Introduction, and Objective and Scope paragraphs.] 41 42 GUIDELINES ON IMPORT PROCEDURES FOR PHARMACEUTICAL 43 PRODUCTS1 44 45 46 1. INTRODUCTORY NOTE 47 48 Public health considerations demand that medicines should not be treated in the same way as 49 ordinary commodities. Their manufacturing and subsequent handling within the distribution 50 chain, both nationally and internationally, must conform to prescribed standards and be 51 rigorously controlled. These precautions serve to assure that patients receive high standard 52 quality medicines, and to prevent the infiltration of substandard and suspected falsified 53 medicine into the supply system.

8 54 55 The availability of pharmaceutical products is sometimes limited due to economic constraints, 56 difficulty in meeting norms and standards in their production, and lack of resources in their 57 supply chain. The market penetration by substandard and suspected falsified medicines poses 58 hazards for public health and forces the diversion of public health resources from other uses. 59 In light of this, investments towards strengthening strategies at the customs level are deemed 60 crucial to ensure high-quality medicines to patients (1, 2). 61 62 The global economy of scale and scope that characterize modern trade require continuous 63 improvement in border control.

9 This includes a departure from the traditional reactive control 64 system to a risk-based and pro-active approach. The risk-based surveillance scheme should 65 identify risks and define the controls that will protect patients from substandard, falsified and 66 unregulated medicines. A risk-based approach can improve the cost-benefit ratio with existing 67 or reduced resources through more effective and efficient controls. 68 69 Within the context of its revised medicines strategy adopted in 1986 by the Thirty-ninth 70 World Health Assembly (WHA) in resolution , the World Health Organization 71 (WHO) developed Guiding principles for small national drug regulatory authorities (3) 72 which established a regulatory approach in line with the resources available within a small 73 national regulatory authority, and were intended to assure not only the quality, but also the 74 safety and efficacy of pharmaceutical products distributed under its aegis.

10 75 76 The principles emphasize the need for the effective use of the WHO Certification Scheme on 77 the Quality of Pharmaceutical Products Moving in International Commerce (4, 5). This 78 constitutes a formal agreement between participating Member States to provide information 79 on any product under consideration for export, notably on its marketing authorization in the 80 country of origin and whether or not the manufacturer complies with WHO GUIDELINES on 81 good manufacturing practices for pharmaceutical products (6). 82 83 1 This was first published in 1996 in the WHO Technical Report Series, No.