Frequently Asked Questions
The World Health Organization (WHO) has updated its frequently asked questions (FAQ) on the “PC Joint Application Package” (JAP) in response to global stakeholder participation in a survey of outstanding questions from users about the JAP. The FAQ consolidate the new questions from neglected tropical disease (NTD) programme managers, pharmacists, monitoring and evaluation (M&E) officers, implementing partners, and pharmaceutical and financial donors, to provide a comprehensive list of responses.
The FAQ complement the Standard operating procedures for supply chain management of health products for neglected tropical diseases amenable to preventive chemotherapy (1), the accompanying OpenWHO training course (2) and the JAP guidance (3). Further resources including the latest JAP (version 4) forms are downloadable from the WHO/NTD website (4). At this point, the JAP is used to request medicine and treatments for lymphatic filariasis (LF), onchocerciasis (ONCHO), schistosomiasis (SCH) and soil-transmitted helminthiases (STH) only.
The goals of the survey and the expanded FAQ are to increase user understanding of the JAP, including how it is used, who reviews it, and the process and timing for WHO approval and delivery of medicines donated by pharmaceutical companies. Accurate and timely submission is crucial to ensure that donated treatments are available in the correct quantities for targeted populations and arrive on time for implementation of PC campaigns in countries where these diseases are endemic.
The FAQ are divided into five sections: general questions on the JAP; and specific questions on each of the four forms within the JAP, namely the Joint Request for Selected PC Medicines (JRSM), the PC Joint Reporting Form (JRF), the PC Epidemiological Data Reporting Form (EPIRF) and the Annual Work Plan (AWP).
Answers to each question raised were considered by members of the JAP Working Group, a subgroup of the NTD Supply Chain Forum, with participants from WHO, the United States Agency for International Development, The Task Force for Global Health and Merck KGaA.
Any questions not listed in this document can be submitted by email to pctdata@who.int. Answers should be provided within 1-2 working days. The team will update the FAQ periodically as the JAP is updated and more questions are submitted.
All FAQs on the joint application package
Frequently asked questions on the joint application package for preventive chemotherapy...
1. The PC Joint Application Package: general questions
Is there a deadline for the JAP submission, and what is the lead time for medicines to arrive?
There is no fixed deadline for submission of the JAP forms (JRSM, JRF, EPIRF and AWP). Please refer to the Q&A sections for each form for additional guidance on submission processes and timing.
To ensure the medicines are delivered on time, the final request must be submitted at least 9 months before the first date of MDA planned in the calendar year of the request.
For example, if a country plans to conduct two MDA rounds in May and October 2024, the request should be submitted by August 2023. This lead time is required for reviewing and approval of the request, placing orders, manufacturing PC medicines and shipment to the country.
Some countries that have specific procedures requiring more time should apply earlier, taking into consideration the required additional time, for example, pre-shipment inspection.
See SOPs on green lighting and customs clearance (1) for more details.
What steps are involved in completing the JAP?
The steps for completing the JAP are outlined in the WHO SOPs (1), the accompanying training course in OpenWHO website (2) and the JAP guidance (3). Additional resources including the JAP forms are available on the WHO/NTD website (4).
The first step is for countries to hold a planning meeting at least 2 months before submitting the JAP to gather all the necessary data and identify and gather additional data for the application so that a complete JAP is submitted.
he NTDP, M&E officers, pharmacists, logisticians and implementing partners should also attend this meeting to support the JAP preparation effort. The next steps are to complete the JAP forms and determine the amount of medicine and, finally, to verify completion of the checklist indicated in each form. The forms should be signed by the correct authority within the MoH and submitted to WHO.
How does one ask WHO questions on the JAP process?
You can contact your NTD Regional Adviser or, if within the African Region, contact ESPEN (the Expanded Special Project for Elimination of NTDs). You can also email your question to: pctdata@who.int
However, it is very important first to check the SOPs (1), the training course (2) and the JAP guidance (3).
How long does it take from submission to review and approval of a country’s JAP?
The process of JAP approval takes a minimum of 2–3 weeks if the forms and data are complete and of good quality.
A complete and accurate JAP (with supporting forms such as the JRSM and JRF) will be reviewed and approved by the WHO RO (in consultation with WHO/HQ and the RPRG). However, if missing or inaccurate information is noted by WHO or the RPRG, the approval will take as long as needed until all satisfactory clarifications from the requesting country are received. It is important for the country to submit timely responses to WHO enquiries to avoid delays in the approval of medicines.
Even if requests are submitted on time, can delays occur in delivering the medicines?
Timely submission is only one step of the supply chain management cycle; delays can happen at any time.
Delays are not only related to timely submission but also to submitting good-quality, complete information on the JAP and responding promptly when clarification or additional information is requested during the review process.
What are the top 3‒5 reasons for delays in JAP approval, and how can countries preempt these issues?
The main reasons for delayed JAP approval are:
- late submission;
- incomplete or poor-quality JAP submission, particularly related to remaining balances available in the country;
- delay in providing feedback when WHO reviewers send questions; and
- not indicating the availability of operational funds for distribution.
If a country has no funding for MDA, what should they do?
It is essential that countries secure funding for MDA either internally or externally before submitting the JAP for medicine requests to WHO. WHO will not approve requests where funding for implementation is not secured.
Who is the responsible party for bearing transportation/ customs clearance costs pertaining to the delivery of medicines at the consignee address?
Each pharmaceutical donor handles this slightly differently.
For albendazole, praziquantel and mebendazole, the relevant pharmaceutical companies provide funds to DHL to support relevant customs clearance costs, with WHO typically being the consignee.
Where possible, fee waivers should be sought.
For ivermectin, the Mectizan Donation Program pays its own third-party consignees and clearing agents. For azithromycin, Pfizer and the International Trachoma Initiative have Memorandums of Understanding with each NTDP specifying that the NTDP will be responsible for all clearance and transport fees once the medicines arrive at the port or airport. For diethylcarbamazine, Eisai only guarantees delivery to the port of entry. Clearance costs are the responsibility of the MoH.
What should we do with the opened bottles
According to the advice from pharmaceutical donors, for diethylcarbamazine, the opened bottle is valid within one month from the time it was opened; for mebendazole and praziquantel, it is valid for 3 months; and for albendazole, it is valid for as long as it is still within its expiry date.
This advice applies PROVIDED the opened bottles are within their expiry dates AND they are properly closed after being opened.
What happens if the medicines expire?
WHO expects countries to manage their donated medicines appropriately to prevent expiry before distribution. However, should medicines expire, the relevant Waste Management SOP (1) should be consulted. Any expired medication should be reported on the JRF and properly disposed of to reconcile stock numbers and availability.
What are the key responsibilities of implementing partners? How should stakeholders (non-ministry) participate in completing the JAP?
WHO advises the MoH to work together with all NTD stakeholders in the country in planning and preparing the JAP. Implementing partners can frequently assist with helping to identify the data to be collected, support planning meetings to gather and identify missing JAP information and assist with reviewing previous JAP processes. Implementers can also help in addressing the questions that WHO asks during follow-up. Their role may be both technical and financial in assisting with JAP preparation, depending on the needs of the NTDP, which should be leading the JAP process. Also, implementing partners can confirm whether donor funding is available for MDA implementation.
3. The PC Joint Reporting Form (JRF)
What challenges do countries face with producing the JRF form as it can take a substantial amount of time for WHO to receive it in some cases?
Countries may face several challenges in producing the JRF, including collecting treatment data from communities, schools and health facilities. Validating, collating, compiling and aggregating data at various levels of the health system take time. Data collection is also mostly paper-based, which increases delays and is prone to human errors.
Challenges can arise if an NTDP begins filling out the JAP and each individual form without planning and gathering the required information that may be needed from different locations, such as stock-on-hand or recent MDA data. Then, if an incomplete JAP is submitted, it will trigger several follow-up emails from WHO to complete the application.
It frequently takes an NTDP several weeks to months to gather the missing information, delaying JAP approval and shipment of medicines.
WHO strongly encourages countries to hold a planning meeting at least 2 months before submitting the JAP to gather all necessary data and to identify and gather additional information needed for the application so that a complete JAP is submitted the first time. This will reduce the need for WHO follow-up and expedite JAP approval.
It is also recommended that the NTDP include M&E officers, pharmacists, logisticians, the local WHO NPO and implementing partners at this meeting to support the JAP preparation effort.
If the JRF is not submitted on time, what impact will it have on MDA implementation?
If the JRF is not submitted on time (within 3 months after the last implementation round), it may delay approval of the request for medicines required for the next implementation year. As a result, the requested medicines may arrive in the country after the planned MDA date. The JRF should be submitted before or together with the request for the next implementation year.
Are there any preconditions for the approval of the JRF?
Data reported in the JRF should be in line with the latest available demographic and epidemiological data.
Treatment data should be self-validated by running VALIDATION macros to avoid any technical errors and to identify potential data paradoxes. When submitted, the review team runs several tests to validate data and, after completion, can recommend it for approval or further revision.
Can the JAP be approved without having the JRF?
The JAP, in particular the JRSM, will not be approved without submission of the final version of the JRF.
If MDA was not implemented as planned during the implementation year, the JRF should be submitted with complete data provided in COUNTRY_INFO and a written explanation of the reasons in the additional information box in the SUMMARY worksheet.
Can the JRF be submitted more than once a year (when there are multiple rounds of treatment)?
During the implementation year, the JRF can be partially completed after each MDA round, when treatment data become available.
The final Report should be ready (submitted) within 3 months after the last round was implemented.
Treatment coverage of populations sometimes exceeds 100% in certain endemic districts due to population differences from national civil society organizations. How can this be addressed in the JRF?
Such discrepancies are common in many countries.
All districts where coverage rates exceed 100% can be identified (highlighted) when running the VALIDATION macro.
Differences of less than 10% are usually accepted by the reviewing team. If discrepancies are higher, further clarification and corrections from a respective country are required.
The review team can also run a cross-check test to see demographical data reported in previous years to identify potential data errors.
How can I enter subdistrict level data for SCH only?
SCH data on population requiring and receiving PC reported at subdistrict level should be aggregated at district level and entered manually, by replacing auto-calculated values in the COUNTRY_INFO worksheet and SCH related worksheets (T1 and T2).
5. The Annual Work Plan (AWP)
Is the work plan part of the overall NTD master plan?
No, the AWP is part of the annual JAP submission to support the request for PC medicines.
What is the purpose of the annual work plan (AWP)?
The AWP allows national programmes to identify the specific objectives to be achieved in the year, to focus on the key activities that need to be implemented to achieve those objectives, and to identify the gap in financial and technical resources to achieve the objectives.
The AWP also allows WHO to closely monitor the progress of the national programmes, and to identify the obstacles and coordinate for provision of financial and technical support in time.
Who is responsible for developing the work plan?
The NTD National Programme under the MoH is responsible for developing the work plan.
Is the AWP required with the JAP submission and can you use your own format?
No, the AWP is optional to submit with the JAP using the WHO form. In fact, it will be beneficial for the country to use.