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ASSESSMENT OF STRUCTURES FOR ACCREDITATION
OF VETERINARY DRUGS IN THE ECOWAS MEMBER
STATES (CAPE VERDE, THE GAMBIA, GHANA, GUINEA,
NIGERIA, LIBERIA, SIERRA LEONE).
Dr AssiongbonTEKO-AGBO,
Dr Junaidu MAINA
Dr Serge DIAGBOUGA
Workshop of the ECOWAS Animal Health Networks (RESEP-AO, RESOLAB-AO and
CVOs) and the Establishment of Animal Production Networks
21 to 25 September
2015, Abuja, Nigeria
Plan
INTRODUCTION
I. REGIONAL CONTEXT
II. OBJECTIVES
III. METHODOLOGY
IV. PRINCIPAL FINDINGS
V. PRINCIPAL RECOMMENDATIONS
Agricultural policy of ECOWAS
Challenges in veterinary drugs associated with
manufacturing, importation, distribution in regional
markets, unethical handling/administration, quality control
and pharmaco-vigilance are of great concern in the context
of the implementation of ECOWAS agricultural policy.
National and regional studies in Africa have
highlighted:
Circulation of poor quality veterinary drugs/biologicals in
national markets.
Lack of laws, regulations, inefficient registration
procedures and poor quality control of veterinary
drugs/biologicals.
INTRODUCTION
To address these challenges, the ECOWAS
Commission with the political support of the
member states:
is intervening to meet international standards in
these areas in order to enhance food security and
safety, protect the health of the people, animals
as well as promote environmentally friendly
veterinary practices.
Introduction-cont’d
The recommendations of the OIE
Conference on Veterinary Medicinal
Products in Africa held in Dakar from 25 to
27 March 2008, has further affirmed that:
the harmonization of veterinary
pharmaceutical legislations is the most
appropriate and feasible way forward .
Introduction-cont’d
Monetary and Economic Union of West Africa
(WAEMU): Benin, Burkina Faso, Cote d’Ivoire,
Guinee Bissau, Mali, Niger, Senegal, Togo
Harmonized veterinary pharmaceutical legislation:
A Permanent Secretariat for Veterinary drugs
A Regional Committee for Veterinary Medicinal
Products
A Regional Veterinary Committee.
REGIONAL CONTEXT
ECOWAS
Harmonized veterinary pharmaceutical legislation:
In eight ECOWAS member states, both Committees are
already operational in the following member states: Benin,
Burkina Faso, Côte d'Ivoire, Guinea Bissau, Mali, Niger,
Senegal and Togo.
What is the situation in the following countries: Cape Verde,
Gambia, Ghana, Guinea, Nigeria, Liberia and Sierra Leone.?
This is the role of this consultancy
REGIONAL CONTEXT
ECOWAS
ECOWAS, the 65th
regular session of the Council of
Ministers of the Member States held in Abuja Nigeria
25 - 26 November 2010 adopted the following 3
regulations and a directive as follows
1.The Regulation C/REG.21/11/10 on the harmonization of the
structural framework and operational rules of safety of
plants, animals and food in the ECOWAS region
REGIONAL CONTEXT
ECOWAS
2.The Regulation C/REG.22/11/10 establishing community
procedures for management of veterinary drugs or biologics
3.The Regulation C/REG.23/11/10 / establishing and operating
procedures for a Regional Veterinary Committee (RVC) within
the ECOWAS
The Directive C/DIR.1/11/10 on veterinary pharmacy within
the ECOWAS
REGIONAL CONTEXT
OBJECTIVES
General Objective
Evaluate the structure and management system for
registration of veterinary medicinal products in
these Member States:
• Cape Verde,
• The Gambia,
• Ghana,
• Guinea,
• Nigeria,
• Liberia and
• Sierra Leone
OBJECTIVES
Specific Objectives
Review the current structure of application procedures,
management and registration of veterinary medicinal
products in each country;
Identify gaps (technical and organizational) and make
proposals to simplify and / or improve the implementation of
rules and procedures for the management and registration of
veterinary medicinal products;
Analyze the needs of technical and institutional support,
capacity building;
Propose a plan to upgrade the systems in these countries.
I.3. Etude des contaminants des aliments
The methodology used for the mission included:
Literature & Documentary search and exchange of electronic
messages (E-mail)
Visits to 7 countries (Cape Verde, The Gambia, Ghana,
Guinea, Nigeria, Liberia and Sierra Leone):
• Visits to Departments of Veterinary Services,
• Food and Drugs Regulatory Authorities,
• Laboratories,
• Private veterinary pharmacies (wholesalers and retailers)
• Veterinary clinics and
• Livestock farmers.
METHODOLOGY
Les bactéries
Collection of data and administration of Questionnaire on:
• System of quality assurance of veterinary drugs,
• Local production of veterinary drugs
• Imports of drugs and veterinary raw materials
• Distribution of veterinary medicines
• Pharmacovigilance system
• Awareness of ECOWAS regulations on veterinary drugs.
METHODOLOGY
Country Period Responsible
Consultant
NIGERIA 19-22 August 2013 Dr Teko-Agbo
Dr Maina
Dr Diagbouga
SIERRA LEONE 12-14 February 2014 Dr Maina
GUINEA 27 February-1 March
2014
Dr Teko-Agbo
METHODOLOGY
Work Programme
Visit the Sierra Leone Animal Welfare Society
(veterinary clinic)
Visit to Lagos: Office of the TURNER WRIGHT LIMITED (Private
veterinary)
Meeting at the National Agency for Food and Drug Administration and Control
at Lagos
Presentation of the objectives of the mission at Department of
Livestock Services at Conakry
Visit of the Public Veterinary Clinic at Abuko
(Gambia)
Visit of Ghana FDA laboratory of control drugsPresentation of the objectives of the mission at Department
of Livestock Services at Praia
Country Period Responsible
Consultant
THE GAMBIA 26 - 28 March
2014
Dr Teko-Agbo
CAPE VERDE 12-14 March 2014 Dr Diagbouga
GHANA 14-16 April 2014 Dr Teko-Agbo
Dr Maina
Dr Diagbouga
LIBERIA 16-18 April 2014 Dr Maina
METHODOLOGY
Work Programme
PRINCIPAL FINDINGS
Guarantee system on quality of veterinary drugs
All countries have legislations on veterinary
drugs or draft under review in the case of Cape
Verde.
The drafting of these legislations was by the
Ministry of Agriculture in partnership with the
Ministry of Health (Guinea, Ghana, Sierra
Leone) or solely drafted by the Ministry of
Health (Nigeria, Liberia).
PRINCIPAL FINDINGS
Local production of veterinary drugs
Ghana and Nigeria have the structures for local
production of veterinary drugs and vaccines, while
other countries (Gambia, Sierra Leone, Liberia, Cape
Verde, Guinea) do not.
PRINCIPAL FINDINGS
Importations of veterinary drugs and raw materials
The structures, for regulation of veterinary products in most
countries are managed by pharmacists (Nigeria, Ghana,
Gambia, Liberia) or through a joint committee composed of
pharmacists and veterinarians (Guinea). Note recent creation of
Directorate for Veterinary Drugs.
Generally, to obtain an authorization for marketing of a
veterinary medicinal product, the applicant must provide a full
registration dossier. In Ghana, Guinea and Nigeria the dossier
takes into account the quality, safety and efficacy of the drug.
Ghana, Nigeria and Guinea have a list of veterinary products
imported. In Ghana the management of importation of the
veterinary products is under the responsibility of the veterinary
service that issue permits.
PRINCIPAL FINDINGS
Veterinary drug distribution
On distribution, despite the existence of laws governing the
possession and administration of drugs, there seems to be
confusion in the powers and roles of different operators
(importers, wholesalers / distributors, veterinary offices,
professional associations of farmers, etc.). For example,
there are no specific veterinary pharmacy inspection units in
all states visited. Except in Cape Verde, many veterinary
products are sold in parallel markets.
There was almost total absence of an organized quality
control of veterinary drugs in visited countries except in
Ghana and Nigeria that have quality control laboratories of
international standards.
PRINCIPAL FINDINGS
Pharmacovigilance system for veterinary
products
There were no pharmacovigilance and risk
assessment of the effects of or abuse of
veterinary medicinal products in all the
Countries visited.
PRINCIPAL FINDINGS
Awareness and knowledge of ECOWAS legislation on the
management of veterinary drugs
The ECOWAS Community regulation on the
management of veterinary drugs were found to be poorly
distributed and poorly understood in the countries
visited.
PRINCIPAL RECOMMENDATIONS
• All Countries visited have in principle accepted the
harmonization of pharmaceutical legislations within the
ECOWAS Community. To this effect, the following
recommendations are made:
1. ECOWAS Commission should establish a plan to allow the
appropriation of Community texts by member states of
ECOWAS. These member states of ECOWAS must undertake to
accept the principle of subsidiary should it apply in such
situations.
2. ECOWAS Commission should review all existing legislations of
these 7 Member States with a view to harmonizing them.
PRINCIPAL RECOMMENDATIONS
3. ECOWAS Commission should assist Member States with no
parliamentary act establishing the Veterinary Medicines and
Products Regulatory Framework and Regulatory Authority to
immediately pass one.
4. ECOWAS Commission should encourage the strengthening of
veterinary competencies within the Regulatory Authorities in
the following Member States, Ghana, The Gambia, Sierra
Leone, Liberia, Cape Verde and Guinea. This should be through
employment of veterinarians and capacity building of those
within.
5. Implement urgently within the ECOWAS Commission a
Permanent Secretariat in accordance with Article 4 of
Regulation C/REG.22/11/10 with a view to pursuing the
harmonization process.
PRINCIPAL RECOMMENDATIONS
6. Establish the Regional Committee for Veterinary Medicinal
Products in accordance with Article 3 of Regulation
C/REG.22/11/10 taking into account the existence of a Regional
Committee in the WAEMU Commission.
7. Collaborate with the WAEMU Commission with a view to
gradually pooling of regulations and the establishment of a
regional office for veterinary medicinal products and SPS risk
assessment.
CONCLUSION
• Sales of veterinary drugs in the regional market
must be strictly controlled because of their impacts
on:
– human public health,
– animal health and
– the environment.
• Structure for registration and management of
veterinary medicinal products must be put in
place without further delay in all member states.
• Similar structures already exist in eight member
states of ECOWAS under the auspices of the West
African Economic and Monetary Union (WAEMU).
• We need to go together for the development of the
Whole ECOWAS region.
ACKNOWLEDGMENTS
• The three consultants express their deep and
heartfelt gratitude to the ECOWAS Commission;
specifically :
– it’s President and the
– Commissioner for Agriculture, Environment and his team
for the trust placed on us and for their cooperation during
the mission.
• The consultants are also grateful to all the officials
of the countries visited, particularly the authorities
responsible for supervising veterinary services for
their availability, and cooperation.
THANKS YOU
FOR YOUR KIND ATTENTION

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Ecowas meeting presentation

  • 1. ASSESSMENT OF STRUCTURES FOR ACCREDITATION OF VETERINARY DRUGS IN THE ECOWAS MEMBER STATES (CAPE VERDE, THE GAMBIA, GHANA, GUINEA, NIGERIA, LIBERIA, SIERRA LEONE). Dr AssiongbonTEKO-AGBO, Dr Junaidu MAINA Dr Serge DIAGBOUGA Workshop of the ECOWAS Animal Health Networks (RESEP-AO, RESOLAB-AO and CVOs) and the Establishment of Animal Production Networks 21 to 25 September 2015, Abuja, Nigeria
  • 2. Plan INTRODUCTION I. REGIONAL CONTEXT II. OBJECTIVES III. METHODOLOGY IV. PRINCIPAL FINDINGS V. PRINCIPAL RECOMMENDATIONS
  • 3. Agricultural policy of ECOWAS Challenges in veterinary drugs associated with manufacturing, importation, distribution in regional markets, unethical handling/administration, quality control and pharmaco-vigilance are of great concern in the context of the implementation of ECOWAS agricultural policy. National and regional studies in Africa have highlighted: Circulation of poor quality veterinary drugs/biologicals in national markets. Lack of laws, regulations, inefficient registration procedures and poor quality control of veterinary drugs/biologicals. INTRODUCTION
  • 4. To address these challenges, the ECOWAS Commission with the political support of the member states: is intervening to meet international standards in these areas in order to enhance food security and safety, protect the health of the people, animals as well as promote environmentally friendly veterinary practices. Introduction-cont’d
  • 5. The recommendations of the OIE Conference on Veterinary Medicinal Products in Africa held in Dakar from 25 to 27 March 2008, has further affirmed that: the harmonization of veterinary pharmaceutical legislations is the most appropriate and feasible way forward . Introduction-cont’d
  • 6. Monetary and Economic Union of West Africa (WAEMU): Benin, Burkina Faso, Cote d’Ivoire, Guinee Bissau, Mali, Niger, Senegal, Togo Harmonized veterinary pharmaceutical legislation: A Permanent Secretariat for Veterinary drugs A Regional Committee for Veterinary Medicinal Products A Regional Veterinary Committee. REGIONAL CONTEXT
  • 7. ECOWAS Harmonized veterinary pharmaceutical legislation: In eight ECOWAS member states, both Committees are already operational in the following member states: Benin, Burkina Faso, Côte d'Ivoire, Guinea Bissau, Mali, Niger, Senegal and Togo. What is the situation in the following countries: Cape Verde, Gambia, Ghana, Guinea, Nigeria, Liberia and Sierra Leone.? This is the role of this consultancy REGIONAL CONTEXT
  • 8. ECOWAS ECOWAS, the 65th regular session of the Council of Ministers of the Member States held in Abuja Nigeria 25 - 26 November 2010 adopted the following 3 regulations and a directive as follows 1.The Regulation C/REG.21/11/10 on the harmonization of the structural framework and operational rules of safety of plants, animals and food in the ECOWAS region REGIONAL CONTEXT
  • 9. ECOWAS 2.The Regulation C/REG.22/11/10 establishing community procedures for management of veterinary drugs or biologics 3.The Regulation C/REG.23/11/10 / establishing and operating procedures for a Regional Veterinary Committee (RVC) within the ECOWAS The Directive C/DIR.1/11/10 on veterinary pharmacy within the ECOWAS REGIONAL CONTEXT
  • 10. OBJECTIVES General Objective Evaluate the structure and management system for registration of veterinary medicinal products in these Member States: • Cape Verde, • The Gambia, • Ghana, • Guinea, • Nigeria, • Liberia and • Sierra Leone
  • 11. OBJECTIVES Specific Objectives Review the current structure of application procedures, management and registration of veterinary medicinal products in each country; Identify gaps (technical and organizational) and make proposals to simplify and / or improve the implementation of rules and procedures for the management and registration of veterinary medicinal products; Analyze the needs of technical and institutional support, capacity building; Propose a plan to upgrade the systems in these countries.
  • 12. I.3. Etude des contaminants des aliments The methodology used for the mission included: Literature & Documentary search and exchange of electronic messages (E-mail) Visits to 7 countries (Cape Verde, The Gambia, Ghana, Guinea, Nigeria, Liberia and Sierra Leone): • Visits to Departments of Veterinary Services, • Food and Drugs Regulatory Authorities, • Laboratories, • Private veterinary pharmacies (wholesalers and retailers) • Veterinary clinics and • Livestock farmers. METHODOLOGY
  • 13. Les bactéries Collection of data and administration of Questionnaire on: • System of quality assurance of veterinary drugs, • Local production of veterinary drugs • Imports of drugs and veterinary raw materials • Distribution of veterinary medicines • Pharmacovigilance system • Awareness of ECOWAS regulations on veterinary drugs. METHODOLOGY
  • 14. Country Period Responsible Consultant NIGERIA 19-22 August 2013 Dr Teko-Agbo Dr Maina Dr Diagbouga SIERRA LEONE 12-14 February 2014 Dr Maina GUINEA 27 February-1 March 2014 Dr Teko-Agbo METHODOLOGY Work Programme
  • 15. Visit the Sierra Leone Animal Welfare Society (veterinary clinic) Visit to Lagos: Office of the TURNER WRIGHT LIMITED (Private veterinary) Meeting at the National Agency for Food and Drug Administration and Control at Lagos
  • 16. Presentation of the objectives of the mission at Department of Livestock Services at Conakry Visit of the Public Veterinary Clinic at Abuko (Gambia) Visit of Ghana FDA laboratory of control drugsPresentation of the objectives of the mission at Department of Livestock Services at Praia
  • 17. Country Period Responsible Consultant THE GAMBIA 26 - 28 March 2014 Dr Teko-Agbo CAPE VERDE 12-14 March 2014 Dr Diagbouga GHANA 14-16 April 2014 Dr Teko-Agbo Dr Maina Dr Diagbouga LIBERIA 16-18 April 2014 Dr Maina METHODOLOGY Work Programme
  • 18. PRINCIPAL FINDINGS Guarantee system on quality of veterinary drugs All countries have legislations on veterinary drugs or draft under review in the case of Cape Verde. The drafting of these legislations was by the Ministry of Agriculture in partnership with the Ministry of Health (Guinea, Ghana, Sierra Leone) or solely drafted by the Ministry of Health (Nigeria, Liberia).
  • 19. PRINCIPAL FINDINGS Local production of veterinary drugs Ghana and Nigeria have the structures for local production of veterinary drugs and vaccines, while other countries (Gambia, Sierra Leone, Liberia, Cape Verde, Guinea) do not.
  • 20. PRINCIPAL FINDINGS Importations of veterinary drugs and raw materials The structures, for regulation of veterinary products in most countries are managed by pharmacists (Nigeria, Ghana, Gambia, Liberia) or through a joint committee composed of pharmacists and veterinarians (Guinea). Note recent creation of Directorate for Veterinary Drugs. Generally, to obtain an authorization for marketing of a veterinary medicinal product, the applicant must provide a full registration dossier. In Ghana, Guinea and Nigeria the dossier takes into account the quality, safety and efficacy of the drug. Ghana, Nigeria and Guinea have a list of veterinary products imported. In Ghana the management of importation of the veterinary products is under the responsibility of the veterinary service that issue permits.
  • 21. PRINCIPAL FINDINGS Veterinary drug distribution On distribution, despite the existence of laws governing the possession and administration of drugs, there seems to be confusion in the powers and roles of different operators (importers, wholesalers / distributors, veterinary offices, professional associations of farmers, etc.). For example, there are no specific veterinary pharmacy inspection units in all states visited. Except in Cape Verde, many veterinary products are sold in parallel markets. There was almost total absence of an organized quality control of veterinary drugs in visited countries except in Ghana and Nigeria that have quality control laboratories of international standards.
  • 22. PRINCIPAL FINDINGS Pharmacovigilance system for veterinary products There were no pharmacovigilance and risk assessment of the effects of or abuse of veterinary medicinal products in all the Countries visited.
  • 23. PRINCIPAL FINDINGS Awareness and knowledge of ECOWAS legislation on the management of veterinary drugs The ECOWAS Community regulation on the management of veterinary drugs were found to be poorly distributed and poorly understood in the countries visited.
  • 24. PRINCIPAL RECOMMENDATIONS • All Countries visited have in principle accepted the harmonization of pharmaceutical legislations within the ECOWAS Community. To this effect, the following recommendations are made: 1. ECOWAS Commission should establish a plan to allow the appropriation of Community texts by member states of ECOWAS. These member states of ECOWAS must undertake to accept the principle of subsidiary should it apply in such situations. 2. ECOWAS Commission should review all existing legislations of these 7 Member States with a view to harmonizing them.
  • 25. PRINCIPAL RECOMMENDATIONS 3. ECOWAS Commission should assist Member States with no parliamentary act establishing the Veterinary Medicines and Products Regulatory Framework and Regulatory Authority to immediately pass one. 4. ECOWAS Commission should encourage the strengthening of veterinary competencies within the Regulatory Authorities in the following Member States, Ghana, The Gambia, Sierra Leone, Liberia, Cape Verde and Guinea. This should be through employment of veterinarians and capacity building of those within. 5. Implement urgently within the ECOWAS Commission a Permanent Secretariat in accordance with Article 4 of Regulation C/REG.22/11/10 with a view to pursuing the harmonization process.
  • 26. PRINCIPAL RECOMMENDATIONS 6. Establish the Regional Committee for Veterinary Medicinal Products in accordance with Article 3 of Regulation C/REG.22/11/10 taking into account the existence of a Regional Committee in the WAEMU Commission. 7. Collaborate with the WAEMU Commission with a view to gradually pooling of regulations and the establishment of a regional office for veterinary medicinal products and SPS risk assessment.
  • 27. CONCLUSION • Sales of veterinary drugs in the regional market must be strictly controlled because of their impacts on: – human public health, – animal health and – the environment. • Structure for registration and management of veterinary medicinal products must be put in place without further delay in all member states. • Similar structures already exist in eight member states of ECOWAS under the auspices of the West African Economic and Monetary Union (WAEMU). • We need to go together for the development of the Whole ECOWAS region.
  • 28. ACKNOWLEDGMENTS • The three consultants express their deep and heartfelt gratitude to the ECOWAS Commission; specifically : – it’s President and the – Commissioner for Agriculture, Environment and his team for the trust placed on us and for their cooperation during the mission. • The consultants are also grateful to all the officials of the countries visited, particularly the authorities responsible for supervising veterinary services for their availability, and cooperation.
  • 29. THANKS YOU FOR YOUR KIND ATTENTION