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.