Guidelines for the Appropriate use of Herbal Medicines
(1998; 88 pages)
Table of Contents
View the documentForeword
Open this folder and view contents1. Introduction
Open this folder and view contents2. Goals and objectives of the guidelines
View the document3. Definitions
Open this folder and view contents4. National policy development
Open this folder and view contents5. Development of a national programme on herbal medicines
Open this folder and view contents6. Regulation of practitioners
Open this folder and view contents7. Regulation of the manufacture and distribution of medicinal herbal products
Close this folder8. Regulation of herbal medicines
View the document8.1 General considerations
View the document8.2 Requirements for raw plant materials
View the document8.3 Requirements for processed plant materials
View the document8.4 Requirements for medicinal herbal products
View the document8.5 Label requirements
View the document8.6 Responsible government agency for regulation
View the document8.7 Promotion and advertisement of herbal medicines
View the document8.8 Monitoring of adverse reactions to herbal medicines
View the document9. Use of the guidelines
View the documentAnnex 1: Report of the meeting of the working group on herbal medicines
View the documentAnnex 2: List of temporary advisers, consultants, observers and secretariat
View the documentAnnex 3: Agenda
View the documentAnnex 4: Opening Speech of Dr S.T. Han, WHO Regional Director for the Western Pacific Region Working Group on Herbal Medicines, 8 December 1997, Manila, Philippines
View the documentAnnex 5: Closing Remarks of Dr S.T. Han, WHO Regional Director for the Western Pacific Working Group on Herbal Medicines, 12 December 1997, Manila, Philippines
View the documentReferences
 

8.5 Label requirements

It is recommended that the following is printed on the product label in the official language(s) used by the countries or areas:

(a) name of product;

(b) name and quantity (in dry weight when relevant) of active ingredient(s);

(c) dosage form;

(d) directions for use including indications, dosage, mode of administration, duration of use, age group limitations, and use during pregnancy and lactation;

(e) warning statements and relevant contraindications, adverse effects, if any, and overdose information when relevant;

(f) batch number;

(g) expiry date;

(h) storage conditions;

(i) name and address of manufacturers and/or importers; and

(j) registration or notification (listing) number.

The scientific name of active ingredient(s), in addition to the common name in the language of preference of the national regulatory authority, should be used.

The label and package insert should be “user-friendly”. Easy and understandable information should be provided.

The drug regulatory authority may provide to industry directions on labelling and on allowable indications and claims.

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