The Selection and Use of Essential Medicines - WHO Technical Report Series, No. 914: 3. The new procedures for updating and disseminating the Model List: 3.3 Review of the new procedures: 3.3.1 Applications for additions

The Selection and Use of Essential Medicines - WHO Technical Report Series, No. 914
(2003; 132 pages)

Table of Contents

WHO Expert Committee on the Selection and Use of Essential Medicines
1. Introduction
2. Open session
3. The new procedures for updating and disseminating the Model List
	3.1 Background
	3.2 Key features of the new procedures
	3.3 Review of the new procedures
		3.3.1 Applications for additions
		3.3.2 Applications for deletions
		3.3.3 Selection criteria
	3.4 The WHO model formulary
	3.5 The WHO Essential Medicines Library
4. Other outstanding technical issues
	4.1 Change of name of the Expert Committee
	4.2 Description of essential medicines
	4.3 Role of treatment costs in relation to the Model List
	4.4 Inclusion of additional items in the Model List
5. Format and presentation of the 12th Model List
	5.1 Section headings
	5.2 The core and complementary lists
	5.3 The “square box” symbol
6. Changes made in revising the Model List
	6.1 Applications for additions
		6.1.1 Antiretroviral medicines
		6.1.2 Artemether + lumefantrine (fixed-dose combination)
		6.1.3 α/β-Arteether
		6.1.4 Artemotil (β-arteether)
		6.1.5 Amodiaquine
		6.1.6 Insecticide-treated bednets
		6.1.7 Miconazole nitrate buccal tablets
	6.2 Applications for deletions
	6.3 Other changes
		6.3.1 Meglumine antimoniate
		6.3.2 Antineoplastic and immunosuppressive medicines
		6.3.3 Reserve list medicines
7. Future reviews of sections of the Model List
	7.1 Update on the review of medicines for the treatment of hypertension
	7.2 Review of the core and complementary lists
	7.3 Review of the use of the “square box” symbol
	7.4 Review of injectable medicines
	7.5 Priorities for further systematic reviews
8. Recommendations
	8.1 Procedures for updating and disseminating the Model List of Essential Medicines¹
	8.2 Description of essential medicines
	8.3 Presentation of the 12th Model List
	8.4 Additions and changes to the Model List
	8.5 Deferred applications
	8.6 Rejected applications
	8.7 Priorities for future reviews of sections of the Model List
	8.8 Change of name of the Expert Committee
	8.9 Other recommendations
Acknowledgements
References
Annex 1 The 12th WHO Model List of Essential Medicines
Annex 2 Additional notes on the medicines recommended for inclusion in the 12th WHO Model List of Essential Medicines
Annex 3 The Anatomical Therapeutic Chemical (ATC) classification system¹
Alphabetical list of essential medicinces (with ATC classification codes)

3.3.1 Applications for additions

The new procedures state that all applications for additions to the Model List should be submitted through the appropriate WHO technical department, i.e. the department that deals with the disease or condition pertaining to the medicine in question. During the open session, concern was expressed that some WHO departments might not be able or willing to process applications, or that some diseases, such as neglected diseases, might not be covered by a WHO technical department. It was suggested that an additional procedure would be needed for filing applications in such cases.

In its discussion of the new procedures that followed the open session, the Expert Committee acknowledged that a separate mechanism was required for applications that are not submitted by an appropriate WHO technical department, or for which no relevant technical department exists within WHO. The Committee therefore recommended that the new procedures should allow any individual or organization, including technical departments within WHO, to submit an application. Applications should always be submitted directly to the Secretariat of the Expert Committee, who, after reviewing the application for completeness, should send any outside application to the relevant WHO department for detailed consideration. External authorities would be consulted in the event that the disease or condition in question was not covered by a WHO department. If the Secretariat, preferably after consultation with the relevant WHO department, concluded that the application was inappropriate for review by the Expert Committee or did not follow the standard format for applications and/or failed to provide the necessary information, a provisional decision not to proceed with the application could be taken. A provisional decision, along with the application and supporting documentation, should be reported to the Expert Committee at its next meeting for final endorsement.

The Committee also recommended that the new standard review procedure for applications for additions to the Model List should be modified as shown in Table 1.