EN · The contracting authority for the project - except for expected result 1.2, activities 1.2.2...
Transcript of EN · The contracting authority for the project - except for expected result 1.2, activities 1.2.2...
1
EN
THIS ACTION IS FUNDED BY THE EUROPEAN UNION
ANNEX
of the Commission Decision amending Commission Decision C(2013)4641 of 23.7.2013 on
the financing of the Annual Action Programme 2013 in favour of the Republic of Zambia
Action Document for Health Systems Strengthening Programme
1. Title/basic act/
CRIS number
Health Systems Strengthening Programme (HSSP)
CRIS number: ZM/FED/023-203
financed under the European Development Fund (EDF)
2. Zone benefiting
from the
action/location
Republic of Zambia
The action shall be carried out at the following location: Zambia
3. Programming
document
National Indicative Programme (NIP) 2008-2013 for Zambia
NIP 2014-2020 for Zambia
4. Sustainable
Development
Goals (SDGs)
Main: SDG 3 (Health)
5. Sector of
intervention/
thematic area
Health DEV. Assistance: YES1
6. Amounts
concerned
Total estimated cost: EUR 22 273 008.59
Total amount of EDF contribution: EUR 20 300 000.00
Of which:
11th
EDF: EUR 2 300 000.00
10th
EDF: EUR 18 000 000.00
This action is co-financed in parallel co-financing by:
- Government of Zambia for an amount of EUR 1 973 008.59
7. Aid modality
and
implementation
modalities
Project Modality
Direct management through:
- Grants
1 Official Development Assistance is administered with the promotion of the economic development and
welfare of developing countries as its main objective.
2
- Procurement
Indirect management with the Republic of Zambia
8 a) DAC code Health policy – 12110
8 b) Main Delivery
Channel
12000 – Recipient Government
9. Markers
(from CRIS DAC
form)
General policy objective Not
targeted
Significant
objective
Principal
objective
Participation development/good
governance ☐ X ☐
Aid to environment X ☐ ☐
Gender equality and Women’s and
Girl’s Empowerment X ☐ ☐
Trade Development X ☐ ☐
Reproductive, Maternal, New born
and child health ☐ X ☐
Disaster Risk Reduction X ☐ ☐ Inclusion of persons with disabilities
X ☐ ☐
Nutrition X ☐ ☐
RIO Convention markers Not
targeted
Significant
objective
Principal
objective
Biological diversity X ☐ ☐
Combat desertification X ☐ ☐
Climate change mitigation X ☐ ☐
Climate change adaptation X ☐ ☐
10. Internal markers Policy objectives Not
targeted
Significant
objective
Principal
objective
Digitalisation X ☐
Migration X ☐
COVID response ☐ ☐ X
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1 BACKGROUND AND CONTEXT DESCRIPTION
Context and problem description 1.1
In line with the National Indicative Programme (NIP) 2014-20202, the EU’s response in
Zambia to the COVID-19 pandemic calls for an adaptation of the Health Systems
Strengthening Programme (HSSP) adopted under the NIP 2008-2013 3
.
Zambia is still facing significant challenges with regard to health outcomes and health service
provision. The country ranks 143rd
out of 189 countries according to the 2019 Human
Development Index. In 2017, maternal mortality stood at 224 per 100 000 live births (DHS
2017) and child mortality still remained high and standing at 63.4 per 1 000 live births.
The Seventh National Development Plan includes an important focus on health related
interventions. However, decreasing budget allocations (from 16.1% in 2018 to 8.8% in 2020)
and inefficient health spending remain a concern.
Improving Zambians’ access to quality health services and essential medicines remains
critical, especially in light of the COVID-19 pandemic, as is ensuring that Zambia has the
capacity to ensure that all medicines provided are of suitable quality.
To improve access to essential medicines the government has adopted the National Supply
Chain Strategy and has transferred responsibility for the procurement of medicines and
medical supplies from the Ministry of Health to Medical Stores Limited (MSL).
In addition, the Zambia Medicines Regulatory Authority (ZAMRA) has been mandated to
ensure quality assurance of medicines as laid down in the Pharmaceutical Act of 2004 and
reconfirmed in the National Health Strategic Plan 2017-21. Both organisations, as well as the
Ministry of Health, are undergoing institutional and administrative changes. Moreover,
shortages and the efficient use of human resources in the health sector are persistent problems.
The outbreak of the COVID-19 pandemic in March 2020 has already had a significant impact
on Zambia, which is likely to increase in the months ahead. The World Health Organiaation
(WHO) considers Zambia to have one of the lowest preparedness and response capacities to
the COVID-19 pandemic in the world. This results from several challenges that the Zambian
health system is facing, including a shortage of essential medicines, inadequate equipment
and infrastructure combined with a very weak government fiscal situation and unsustainable
debt levels.
The Government of the Republic of Zambia has prepared a COVID-19 Multi-sectoral
National Contingency and Response Plan which it has asked cooperating partners to support,
2 Comission Decision C(2007)6057 of 6 December 2007 on the adoption of the 10
th EDF National Indicative
Programme between the European Union and Zambia, as amended by Commission Decision C(2012)1799 of
21.2.2013 3 Commission Decision C(2014)3607 of 12.6.2014 on the adoption of the 11
th EDF National Indicative
Programme between the European Union and Zambia, as amended by Commission Decision C(2018)3723 of
14.6.2018
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in particular pillar 2 ‘Transmission and Case Management’ in order to help address the most
immediate needs for the prevention and control of the virus.
The proposed budget increase of EUR 2 300 000 includes EUR 1 800 000 for the
procurement of essential medicines to ensure the continuity of health service provision, as
well as life-saving medical supplies in response to the COVID-19 pandemic in Zambia. In
addition, an amount of EUR 500 000 is provided to help finalise the completion of the
National Quality Medicines Testing Laboratory (NQMCL) and ZAMRA offices.
2 RISKS AND ASSUMPTIONS
Risks Risk level
(H/M/L)
Mitigating measures
For the pharmaceutical Act of 2004
to be implemented effectively,
ZAMRA needs a secure financial
basis, which assures a certain level of
independence.
H
The programme supports ZAMRA to
develop and adopt a comprehensive
and sustainable business plan. Income
from drug licencing is expected to
increase once the laboratory is fully
operational.
To sustainably improve the
availability of essential medicines
and supplies, the National Supply
Chain Strategy needs to be
efficiently implemented and MSL
needs to have the adequate capacity
for the procurement of drugs.
H
Substantial support is provided under
the programme to improve the
logistics and supply chain of
ZAMRA. Additionally, the EU
foresees continuation of technical
assistance after the end of this project
through a separate contract funded by
the Technical Cooperation Facility
VI4.
Essential medicines and life-saving
medical supplies procured in
response to the COVID-19 pandemic
will not reach the final beneficiaries.
M
MSL is in charge of the distribution of
the procured medicines and supplies.
Technical Assistance (TA) will be
provided to MSL through a separate
contract to support and oversee the
distribution of the supplies to the
provincial and district health centres.
Assumptions
- The Government will maintain the legal provisions and policies required for MSL and
ZAMRA to carry out their mandates.
- The Government is committed to ensuring the access to quality health services for the
Zambian population and mitigate the impact of the COVID-19 pandemic.
4 C(2020) 3076 final of 6.5.2020 on the financing of the Annual Action Programme 2020 in favour of the
Republic of Zambia.
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3 COMPLEMENTARITY, SYNERGY AND DONOR COORDINATION
In the EU response to the COVID-19 pandemic, synergies are sought between this
programme and the following operations:
EU supported Millennium Development Goals initiative (MDGi): This programme has
strengthened maternal, child and nutrition services in ten districts in Zambia constituting
about one third of the population. HSSP supported this programme by improving the
access to essential medicines and strengthening information systems.
Pharmaceutical logistics systems: Support has been provided by several donors and
programmes, including Sweden, the United Kingdom, the United States of America, the
World Bank and the Global Fund. The EU support complements the support from other
cooperating partners by increasing the funds for investments in infrastructure and
equipment and by offering resources for technical assistance.
Procurement of essential medicines and life-saving supplies in response to the COVID-
19 pandemic: This action complements the support provided by Germany, Ireland,
Sweden, through the UN system as well as by USAID. All supplies to be procured
under this programme have been coordinated with these partners, the Ministry of Health
and MSL. Most of the supplies have been identified as vital and are either already out of
stock or in very limited supply and expected to run out shortly, especially at the district
and community health facilities.
4 DESCRIPTION OF THE ACTION
Results chain Indicator Source of data
IMP
AC
T
Impact
(overall
objective)
To improve the health status of
the people in Zambia in order to
contribute to socio-economic
development and to mitigate the
impact of the COVID-19 crisis
- Maternal mortality ratio
- Infant mortality rate
- Life expectancy at birth
- COVID-19 cases / deaths
per 100 000
- Regular health
status surveys, data
from the health
information system
and other reports
- 7th National
Development Plan
monitoring
OU
TC
OM
E(S
)
Outcome 1
(specific
objective)
Improved availability and
rational and correct use of
quality assured essential
medicines in public and private
health care and support to
rational and correct use of
essential medicines in Zambia
- Increase in availability:
Proportion of health
facilities with stock-out of
essential medicines
- Increase in quality:
Number of licensed
premises
- Improvement in rational
use of medicines: Tracking
of rational drug use (RDU)
established and used
regularly
- 7th
NDP indicators
and targets
- Survey reports
- Procurement
Supply Chain
Management
(PSCM) reports
- RDU reports
Outcome 2
(specific
Improved development and
implementation of national
- Number of national
policies and strategies under - Published or
approved policies,
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Results chain Indicator Source of data
objective) health policies and strategies implementation, supported
by the programme
- Annual budgetary
allocations for the drug
supply
- Number of pharmacists
specialised personnel in the
public health sector
strategies, plans,
Joint Annual
Review (JAR)
report, mid- and end
evaluation reports
- Approved job
descriptions
- Annual budget
documents
OU
TP
UT
(S)
Output(s)
related to
Outcome 1
1.1. The Zambian Medicines
Regulatory Authority (ZAMRA)
is effectively executing its
quality control and regulatory
functions
- Status of improved
organisational capacity
- Status of the new National
Quality Control Laboratory
(NMQCL) and ZAMRA's
headquarters
- Improvement of quality
management: Number of
internal audits performed per
year, number of annual
quality management review
meetings, status of
improving quality
procedures (QP)
- Status of increased
capacity in licensing,
surveillance and
enforcement: status of
improving transport capacity
for inspectors, number of
annual inspections, status of
upgrading the expertise of
staff
- Status of improving the
Market Authorisation (MA)
capacity: number of
personnel with expertise in
Biosimilars, no of MAs
assessed annually
- Status of improving
regulations: number of
regulations updated
-Inspection reports
-MoH, ZAMRA and
MSL reports
- Programme
Estimates reports
-Technical
Assistance reports
-Tender documents
and implementation
reports
-Site meeting
minutes
- Quality reports
-Laboratory audit
reports
-ZAMRA QPs
developed and
Implemented
-Approved staff
training plan
-Training reports
-Approved
guidelines, laws and
regulations
1.2. Improved effectiveness and
cost-efficiency of the
pharmaceutical procurement and
supply management system
- Status of the Memorandum
of Understanding (MoU) for
the gradual transfer of
procurement to Medical
Stores Limited (MSL)
- The existence of and
progress on the action plan
towards certification as
procurement agent
- Status of MSL's capacity
strengthening plan (CSP)
and overall strategic plan
(SP)
- Status of MSL's central
warehouse in Lusaka
- PSCM reports
- MoU, Standard
Operating
Procedures,
Monitoring
&Evaluation, CSP,
SP and procurement
action plan
-MSL performance
reports
- Tender evaluation
reports, contract,
implementation
reports, handover
progress reports,
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Results chain Indicator Source of data
- Number of pallets of
medicines and medical
supply handled by MSL
annually
- Availability of life-saving
commodities in response to
COVID-19 and of selected
essential medicines at health
facilities
performance report
of the new store
1.3. Progress towards rational
drug use (RDU)
- % of health facilities with
functioning Pharma-
Therapeutic Committees
(PTC)
- % of health facilities with
access to up-to-date standard
treatment guidelines
- Number of people in
PSCM whose skills and
knowledge on RDU have
improved through successful
completion of on-line
masters in a relevant field
- Evidences on rational use
improved in Zambia:
Institutional drug use study
conducted
- Students
diplomas/certificates
- Study and report
on PTCs, reports on
implementation of
RDU and PE reports
Output(s)
related to
Outcome 2
2.1. The Ministry of Health and
the Ministry of Community
Development Mother and Child
Health5 have developed the
required capacities and policies
in the areas of Health
Information System6, Financing
and other strategic areas
- Status of the Procurement
Supply Chain Management
(PSCM)
technical working group
(TWG)
- Number of health-related
policies/strategies
developed/updated with
support from HSSP
- Existence/use of a M&E
framework on PSCM
- PSCM reports
- Approved
strategies,
implementation
plans, minutes of
meetings and report
on implementation
- Joint Annual
Review reports
5 IMPLEMENTATION
Financing agreement 5.1
In order to implement this action, it is foreseen to conclude a financing agreement with the
partner country.
5 The responsibility for primary health care was in 2015 transferred from the Ministry of Community Development,
Mother and Child Health to the Ministry of Health. 6 Support for improvement of the Health Information Systems is addressed by other EU interventions than the HSS
Programme.
8
Indicative implementation period 5.2
The indicative operational implementation period of this action, during which the activities
will be carried out and the corresponding contracts and agreements implemented, is 90
months from the date of entry into force of the financing agreement.
Extensions of the implementation period may be agreed by the Commission’s responsible
authorising officer by amending this Decision and the relevant contracts and agreements.
Implementation modalities 5.3
The Commission will ensure that the EU appropriate rules and procedures for providing
financing to third parties are respected, including review procedures, where appropriate, and
compliance of the action with EU restrictive measures7.
Grants: (direct management) 5.3.1
(a) Purpose of the grant(s)
The grant will contribute to achieve part of output 1.2. It will support the expansion of MSL's
storage facilities (warehouse construction), in order to contribute to the improved
effectiveness and cost-efficiency of the pharmaceutical procurement and supply management
system in Zambia. The specific purpose of this direct grant is to support the
construction/upgrading of the MSL central warehouse in Lusaka, in accordance with the
planned phase 2 of the MSL Master Plan for Extension of the Storage and Distribution
Capacity approved in September 2015.
(b) Type of applicants targeted
Potential eligible applicants must be a legal person, non-profit making and be directly
responsible for the preparation and management of the action.
(c) Justification of a direct grant
Under the responsibility of the Commission’s authorising officer responsible, the grant may
be awarded without a call for proposals to MSL.
Under the responsibility of the Commission’s authorising officer responsible, the recourse to
an award of a grant without a call for proposals is justified in line with Article 195 (c) based
on the fact that MSL – a state owned private company limited by shares – executes storage and
distribution functions in the health sector in a de-facto monopoly situation. MSL is fully owned
by two Ministries of the Government of Zambia (Ministry of Finance and Ministry of Health).
7 www.sanctionsmap.eu Please note that the sanctions map is an IT tool for identifying the sanctions regimes. The
source of the sanctions stems from legal acts published in the Official Journal (OJ). In case of discrepancy between
the published legal acts and the updates on the website it is the OJ version that prevails.
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Procurement (direct management) 5.3.2
The activities under output 1.2 relating to the procurement of essential medicines and life-
saving medical supplies in response to the COVID-19 outbreak in Zambia will be
implemented in direct management (EUR 1 800 000).
Subject Indicative type
(works, supplies,
services)
Indicative trimester of
launch of the procedure
Essential medicines and life-saving
medical supplies in response to the
COVID-19 outbreak
Services and
supplies
Q2 2020 onwards
Indirect management with the partner country 5.3.3
A part of this action with the objective of improving availability and rational and correct use
of quality assured essential medicines in public and private health care in Zambia ( outputs
1.1, 1.3 and the activities related to the TA under output 1.2); and improving the development
and implementation of national health policies and strategies (output 2.1) may be
implemented in indirect management with the Republic of Zambia according to the following
modalities:
The partner country will act as the contracting authority for the procurement and grant
procedures. The Commission will control ex-ante all the procurement procedures except in
cases where programme estimates are applied, under which the Commission applies ex-ante
control for procurement contracts above EUR 50 000 (or lower, based on a risk assessment)
and may apply ex-post control for procurement contracts up to that threshold. The
Commission will control ex-ante the grant procedures for all grant contracts.
Payments are executed by the Commission except in cases where programmes estimates are
applied, under which payments are executed by the partner country for direct labour and
contracts below EUR 300 000 for procurement and EUR 100 000 for grants.
The financial contribution does not cover the ordinary operating costs incurred under the
programme estimates.
The partner country shall apply the Commission’s rules on procurement and grants. These
rules will be laid down in the financing agreement to be concluded with the partner country.
Scope of geographical eligibility for procurement and grants 5.4
The geographical eligibility in terms of place of establishment for participating in
procurement and grant award procedures and in terms of origin of supplies purchased as
established in the basic act and set out in the relevant contractual documents shall apply,
subject to the following provisions.
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The Commission’s authorising officer responsible may extend the geographical eligibility on
the basis of urgency or of unavailability of products and services in the markets of the
countries concerned, or in other duly substantiated cases where the eligibility rules would
make the realisation of this action impossible or exceedingly difficult.
Indicative budget 5.5
Interventions/Expected Results/Activities/and Indicative
Implementation Methods
EU
contribution
amount in
EUR
Beneficiary’s
contribution
in EUR
SPECIFC OBJECTIVE/OUTCOME 1 17 043 640 1 973 008.59
EXPECTED RESULT/OUTPUT 1.1
ZAMRA is effectively executing its quality control and regulatory
functions
8 661 000
1 973 008.59
Activity 1.1.1. Provide TA for ZAMRA support (Procurement – indirect
management with Zambia – services) 1 296 000
Activity 1.1.2. Construction of National Quality Control Laboratory (NQCL) and
ZAMRA premises (Procurement – indirect management with Zambia – works and
supervision)
5 000 000 1 973 008.59
Activity 1.1.3. Short Term TA, equipment and training (Procurement - indirect
management with Zambia - supplies and programme estimates) 2 365 000
EXPECTED RESULT/OUTPUT 1.2.
Improved effectiveness and cost-efficiency of the pharmaceutical
procurement and supply management system
7 582 000
Activity 1.2.1. Provide TA to Medical Stores Limited (MSL) for strengthening
pharmaceutical logistics ( Procurement - indirect management with Zambia –
services)
960 000
Activity 1.2.2. Extend storage facilities, provide short-term TA and training ( Direct
Award Grant under direct management)
4 822 000
Activity 1.2.3. Procure essential medicines and life-saving medical supplies in
response to the COVID-19 outbreak in Zambia (Procurement of supplies - direct
management).
1 800 000
EXPECTED RESULT/OUTPUT 1.3
Progress towards rational drug use (indirect management with Zambia
– programme estimates)
800 640
Activity 1.3.1. Conduct surveys on drug use (Year 1 and year 3) and the functioning
of Pharmacy Therapeutics Committees (effectively working, outputs, challenges)
Activity 1.3.2. Carry out refresher trainings on rational drug use for 500 district staff
for two days (Unit = training day);
Activity 1.3.3. Strengthen monitoring of prescription practices by setting up a
monitoring module within the Health Management Information System (HMIS)
Activity 1.3.4. Organise further education (phMPH) through distance learning for
Ministry of Health Pharmacists
Activity 1.3.5. Strengthen quality assurance mechanisms through the setting up of
quality circles at district level involving prescribers and pharmacists and monitoring
trends with regard to rational drug use at national level.
SPECIFIC OBJECTIVE/OUTCOME 2 1 100 000
11
EXPECTED RESULT/OUTPUT 2.1.
Strengthened capacities and policies in the areas of Health Information
System, financing and other strategic areas
Activity 2.1.1. TA Implementation and TA in the areas of Health Information System,
financing and other strategic areas (Procurement - indirect management
with Zambia – services)
1 100 000
Monitoring 100 000
Communication and Visibility 120 000
Evaluation and Audit 300 000
Contingencies* 1 636 360
Total 20 300 000
1 973 008.59
*The European Union's contribution to the "Contingencies" heading may be used only with prior agreement of the
Commission.”
Organisational set-up and responsibilities 5.6
The contracting authority for the project - except for expected result 1.2, activities 1.2.2 and
1.2.3 - is the National Authorising Officer, Secretary to the Treasury, Ministry of Finance.
The overall project supervisor is the Ministry of Health.
Under this overall coordination, each involved institution supervises the implementation of
the activities in its particular area of responsibility. The involved institutions are: Zambia
Medicines Regulatory Authority (ZAMRA), Medical Stores Limited (MSL) and the Ministry
of Health.
A Steering Committee has been set up to oversee and validate the overall direction and policy
of the project and to reach agreement on the assignment of responsibilities, wherever those
responsibilities are not yet defined by applicable legal or administrative rules and regulations.
A Technical Assistance (TA) team assists the Beneficiary in the implementation of the
project. The TA team works under the terms of reference agreed by both the contracting
authority and the Commission and consists of three long-term key experts (team leader, TA
for ZAMRA/output 1.1 and TA for MSL/output 1.2) and a pool of non-key experts providing
short-term expertise as required.
As part of its prerogative of budget implementation and to safeguard the financial interests of
the Union, the Commission may participate in the above governance structures set up for
governing the implementation of the action.
Performance and Results monitoring and reporting 5.7
The day-to-day technical and financial monitoring of the implementation of this action will be
a continuous process, and part of the implementing partner’s responsibilities. To this aim, the
implementing partner shall establish a permanent internal, technical and financial monitoring
system for the action and elaborate regular progress reports (not less than annual) and final
reports. Every report shall provide an accurate account of implementation of the action,
difficulties encountered, changes introduced, as well as the degree of achievement of its
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results as measured by corresponding indicators, using as reference the simplified Logframe
matrix (for project modality) available in section 4 or the partner’s strategy.
The Commission may undertake additional project monitoring visits both through its own
staff and through independent consultants recruited directly by the Commission for
independent monitoring reviews (or recruited by the responsible agent contracted by the
Commission for implementing such reviews).
Evaluation 5.8
Having regard to the importance of the action, a final evaluation will be carried out for this
action or its components via independent consultants contracted by the Commission.
It will be carried out for accountability and learning purposes at various levels (including for
policy revision), taking into account in particular the fact that the aim is to provide an
understanding of the performance of the programme so as to inform the planning of future EU
interventions in the same or similar sectors and to measure its contribution towards the
implementation of the SDGs.
The Commission shall inform the implementing partner at least one month in advance of the
dates foreseen for the evaluation missions. The implementing partner shall collaborate
efficiently and effectively with the evaluation experts, and inter alia provide them with all
necessary information and documentation, as well as access to the project premises and
activities.
The evaluation reports shall be shared with the partner country and other key stakeholders.
The implementing partner and the Commission shall analyse the conclusions and
recommendations of the evaluations and, where appropriate, in agreement with the partner
country, jointly decide on the follow-up actions to be taken and any adjustments necessary,
including, if indicated, the reorientation of the project.
Evaluation services may be contracted under a framework contract.
Audit 5.9
Without prejudice to the obligations applicable to contracts concluded for the implementation
of this action, the Commission may, on the basis of a risk assessment, contract independent
audits or expenditure verification assignments for one or several contracts or agreements.
It is foreseen that audit services may be contracted under a framework contract.
Communication and visibility 5.10
Communication and visibility of the EU is a legal obligation for all external actions funded by
the EU.
This action shall contain communication and visibility measures which shall be based on a
specific Communication and Visibility Plan of the Action, to be elaborated at the start of
implementation.
For the purpose of enhancing the visibility of the EU and its contribution to this action, the
Commission may sign or enter into joint declarations or statements, as part of its prerogative
of budget implementation and to safeguard the financial interests of the Union.
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In terms of legal obligations on communication and visibility, the measures shall be
implemented by the Commission, the partner country, contractors, grant beneficiaries and/or
entrusted entities. Appropriate contractual obligations shall be included in, respectively, the
financing agreement, procurement and grant contracts, and delegation agreements.
The Communication and Visibility Requirements for European Union External Action (or any
succeeding document) shall be used to establish the Communication and Visibility Plan of the
Action and the appropriate contractual obligations.