Criteria for medicinal drug promotion (WHO, 1988, 8 p.): Information for patients: package inserts, leaflets and booklets

Criteria for medicinal drug promotion (WHO, 1988, 8 p.)

		(introductory text...)
		Resolution WHA41.17 adopted by the Forty-first World Health Assembly, 13 May 1988
		Introduction
		Objective
		Ethical criteria
		Applicability and implementation of criteria
		Promotion
		Advertising
		Medical representatives
		Free samples of prescription drugs for promotional purposes
		Free samples of non-prescription drugs to the general public for promotional purposes
		Symposia and other scientific meetings
		Post-marketing scientific studies, surveillance and dissemination of information
		Packaging and labelling
		Information for patients: package inserts, leaflets and booklets
		Promotion of exported drugs
		Appendix: Sample drug information sheet1
		Back cover

Information for patients: package inserts, leaflets and booklets

29. Adequate information on the use of medicinal drugs should be made available to patients. Such information should be provided by physicians or pharmacists whenever possible. When package inserts or leaflets are required by governments, manufacturers or distributors should ensure that they reflect only the information that has been approved by the country's drug regulatory authority. If package inserts or leaflets are used for promotional purposes, they should comply with the ethical criteria enunciated in this document. The wording of the package inserts or leaflets, if prepared specifically for patients, should be in lay language on condition that the medical and scientific content is properly reflected.

30. In addition to approved package inserts and leaflets wherever available, the preparation and distribution of booklets and other informational material for patients and consumers should be encouraged as appropriate. Such material should also comply with the ethical criteria enunciated in this document.