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EML Application Form

The 20th Expert Committee on the Selection and Use of Essential Medicines will convene in April 2015 at WHO Headquarters to update the WHO Model List of Essential Medicines. Applications for the inclusion, change, or deletion of medicines must be submitted electronically between June 15 and December 1, 2014, with specific information required for each application. Detailed guidelines for the application process and necessary information are provided for interested organizations and individuals.

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19 views1 page

EML Application Form

The 20th Expert Committee on the Selection and Use of Essential Medicines will convene in April 2015 at WHO Headquarters to update the WHO Model List of Essential Medicines. Applications for the inclusion, change, or deletion of medicines must be submitted electronically between June 15 and December 1, 2014, with specific information required for each application. Detailed guidelines for the application process and necessary information are provided for interested organizations and individuals.

Uploaded by

Rehab werida
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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20th Expert Committee on the Selection and Use of Essential Medicines

April 2015
The 20th Expert Committee meeting will take place at WHO Headquarters, Geneva, in April 2015 in order to
revise and update the WHO Model List of Essential Medicines for both adults and children.

Applications for inclusion, change (addition or modification of an indication) or deletion of a medicine in the
next WHO Model List of Essential Medicines 2015 should be sent in the recommended electronic format
th
(both a pdf file and a Word document) to the WHO Essential Medicines List Secretariat between 15 June
st
and 1 December 2014 (email: [email protected]).

The information to be included with an application is provided below.

For further information, please refer to:


Essential Medicines List Secretariat
Medicines Policy, Access and Use Team (PAU)
Department of Essential Medicines and Health Products (EMP)
World Health Organization
20 Avenue Appia
CH-1211 Geneva 27
Switzerland
email: [email protected]

Information to be included with an application for inclusion or deletion of


a medicine in the WHO Model List of Essential Medicines
1. Summary statement of the proposal for inclusion, change or deletion
2. Name of the focal point in WHO submitting or supporting the application (where relevant)
3. Name of the organization(s) consulted and/or supporting the application
4. International Nonproprietary Name (INN, generic name) of the medicine
5. Formulation proposed for inclusion; including adult and paediatric (if appropriate)
6. International availability - sources, of possible manufacturers and trade names
7. Whether listing is requested as an individual medicine or as an example of a therapeutic group
8. Information supporting the public health relevance (epidemiological information on disease burden, assessment of
current use, target population)
9. Treatment details (dosage regimen, duration; reference to existing WHO and other clinical guidelines; need for special
diagnostics, treatment or monitoring facilities and skills)
10. Summary of comparative effectiveness in a variety of clinical settings:
• Identification of clinical evidence (search strategy, systematic reviews identified, reasons for selection/exclusion of particular data)
• Summary of available data (appraisal of quality, outcome measures, summary of results)
• Summary of available estimates of comparative effectiveness
11. Summary of comparative evidence on safety:
• Estimate of total patient exposure to date
• Description of the adverse effects/reactions and estimates of their frequency
• Identification of variation in safety that may relate to health systems and patient factors
• Summary of comparative safety against comparators
12. Summary of available data on comparative cost and cost-effectiveness within the pharmacological class or
therapeutic group:
• range of costs of the proposed medicine
• resource use and comparative cost-effectiveness presented as range of cost per routine outcome
13. Summary of regulatory status of the medicine (in various countries)
14. Availability of pharmacopoeial standards (British Pharmacopoeia, International Pharmacopoeia, United States
Pharmacopoeia, European Pharmacopeia)
15. Proposed (new/adapted) text that could be included in a revised WHO Model Formulary

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