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
 

8.6 Responsible government agency for regulation

The responsible government agency could be the Drug Regulatory Authority or other government agencies with similar responsibilities. It is recommended that a special unit for herbal medicines should be created under the responsible agency for the regulation of medicines.

The responsible agency should review and evaluate all the data received from manufacturers or wholesalers. The applicants should be informed on time whether or not their products have been accepted for notification (listing) or registration.

The responsible agency should keep all the records for registration or notification of herbal medicines.

A registration or notification number should be given when an herbal medicine has been accepted with the drug regulatory authority. A certificate of registration or notification will be issued to each herbal medicine accepted by the relevant authority.

The regulatory authority should provide information to medical practitioners, pharmacists, owners of herbal drug stores and the public on the regulatory process and should have available a list of accepted medicinal herbal products.

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