Guidelines on import procedures for medical products


Guidelines on import procedures for medical products - Annex 5


This document is a revision of the 1996 publication:

• Guidelines on import procedures for pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations, thirty-fourth report. Geneva: World Health Organization; 1996: Annex 12 (WHO Technical Report Series, No. 863;

Click on the titles below for complete guidelines


1. Introduction 

2. Scope

3. Glossary 

4. Legal responsibilities 

5. Legal basis of control 

6. Required documentation 

7. Implementation of controls 

8. Procedures applicable to pharmaceutical starting materials 

9. Storage facilities 

10. Training requirements 


1. Introduction

1.1 Public health considerations demand that medical products should not be treated in the same way as ordinary commodities. Their manufacture and subsequent handling within the distribution chain, both nationally and internationally, must conform to prescribed standards and be rigorously controlled. These precautions serve to assure that patients receive quality assured medical products, and to prevent the infiltration of substandard and suspected falsified medical products into the supply system.

Guidelines on import procedures for medical products - Annex 5:

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