Annex 1. Application form for inclusion in the Model List of Essential Drugs1

¹ A summary (maximum 3 pages) of relevant background information should be attached, together with relevant literature to support the therapeutic use.

Submitted by:

Name of responsible officer:

Address:

Contact person (if submitted by an organization):

Telephone No.:

Fax No.:

We hereby request the World Health Organization to consider the following pharmaceutical product for inclusion in the WHO Model List of Essential Drugs

Signature _________________________ Date________________________

Name of drug (INN and trade name):

Dosage form and strength:

Why is this drug being proposed for inclusion in the list?

Please state how it conforms to the criteria for inclusion as an essential drug:

Please provide evidence of efficacy (with references):

If a therapeutic class for this drug already exists in the list, please summarize the advantages of this product:

Describe the drug’s pharmacokinetics:

List any contraindications, precautions and toxic effects:

Is this drug available as a generic product?

Please state any restrictions on the use of this drug. Should a note be included in the list regarding its use?