Upon the
establishment of The
ECOWAS PHC, the Products Evaluation & Registration
Department
embarked on listing of
Pharmaceutical products for human use in 2011. In 2012, the
department began
registration of foreign and local products in ECOWAS.
Currently, the department
uses the ECOWAS agreed CTD protocol for dossier submission
as ECOWAS member
state for the harmonized registration procedure established
through the efforts
of the West African Health Organization (WAHO) in the ECOWAS
region..
In adherence to
the ACT of
2010 which provides the provision for the Registration of
all consumable
Products in circulation in the in the ECOWAS markets, the
department has moved to
conduct::
*
Full assessment for the registration of medicines, veterinary
medicines,
vaccines, biological products, tobacco & tobacco products,
herbal medicines,
homoeopathic medicines, food supplements, medical devices,
cosmetics and
household chemicals.
The Department has begin registration of
Biosimilar medicines
(Biological and Blood related substances and Psychotropic
substances).
OVERVIEW
The Product
Evaluation & Registration Department is one of
the four technical departments of The ECOWAS PHC with the
responsibility to receive
applications for (medicines and health product) registration
and provides
feedback to applicants on the registration process; conduct
evaluation of
product dossiers; generate information for billing (i.e.
payment for products
registration, listing of medical devices, cosmetics, health
products and
pre-market analysis); prepare Market Authorization
(Import/Clearance); list
medical devices, health products, and cosmetics; publish
registered products;
conduct regular workshops for clients – i.e. Importers,
Pharmacists, etc. for
information sharing; and generate and update registration
guidelines and related
documents.
STRUCTURE
The
Evaluation and
Registration Department is headed by an astute Pharmacist, Mr
James Akakpo as Director, assisted by
Pharmacist Mary Ganyon- Dekpe as Deputy Director and seven unit
managers. The
Department comprises of the following Units: Reception,
Medicines Registration,
Cosmetics Registration, Medical Devices Registration, Research
& Development,
Records Management and Narcotics & Psychotropic Registration
Units.
RECEPTION UNIT
Receives all
application for Registration of all
Pharmaceuticals and processes them, including:
* raising of
bills for payment of non
refundable fees;
* processing of
the application;
* Attach
IP/Processing form, Bill
Request, Invoice & Payment Receipt;
* Submits
application to Research
Team
FOOD PRODUCT REGISTRATION UNIT:
*
Receives all applications for Registration from the
Reception Unit;
* Conducts check lists for
products;
* Conducts screening and
preliminary evaluation;
* Communicates preliminary
evaluation findings to
Applicant;
* Receives feedback;
* Codes all
products;
* Conducts assessment for
evaluation of dossiers.
COSMETIC UNIT
* Receives all
application for listing of Cosmetics;
* Performs checklist for the
listing;
* Conducts screening for all
Cosmetic
applications;
* Codes all cosmetics
application;
* Prepares matrix for submission to
Research, Record &
data Unit.
MEDICAL DEVICE UNIT
* Receives all applications for listing of Medical
Devices;
* Performs checklist for the listing of
Medical Devices;
* Conducts screening for all Medical
Devices;
* Codes all Medical Devices
application;
* Prepares matrix for submission to
Research, Record & data
Unit.
VETERINARY UNIT
*
Receives all applications for listing of Vet. Products;
* Performs checklist for the listing of
Vet Products;
* Conducts screening for all Vet
Products;
* Codes all Vet Product application;
* Prepares matrix for submission to
Research, Record & data
Unit
HERBAL UNIT
* Receives all
applications for listing of Herbs
* Performs checklist for the listing of
Herbs
* Conducts screening for all Herbal
Products;
* Codes all Herbal Product
application;
* Prepares matrix for submission to
Research, Record & data
Unit
RESEARCH AND DATA UNIT
.*
Conducts research on all Pharmaceutical manufacturing
Companies;
* Provides information on the
manufacturing
details of each company (Tablets, Capsules, small volume
parenteral ( Injectable,
Infusion ,Syrups, Suspensions etc.) ointments and
Creams; *
Prepares Import Permit & Clearances;
* Conducts full research on
the products
characteristics (Product’s Name, Registration Number,
Strength, Pack Size,
Volume, Color of Packaging and Manufacturer;
* Designs matrixes for all
pharmaceuticals.
RECORD AND DEVELOPMENT UNIT
*
Records all pharmaceuticals into the various Matrixes
designed by the Research &
Data Unit;
* Prepares the certificate
for marketing
authorization;
* Prepares products
registration list;
* Updates website periodically for
all pharmaceuticals.
NARCOTIC & PSYCHOTROPIC UNIT
*
Receives applications for import authorization;
* Screens applications according to the
Narcotic Act;
* Prepares authorization in line with the
MOH guidelines for
importation of Narcotic & Psychotropic;
* Collaborates with MOH for periodic
monitoring
Evaluation and Registration Department
Upon the establishment of The ECOWAS PHC, the Products Evaluation & Registration Department embarked on listing of Pharmaceutical products for human use in 2011. In 2012, the department began registration of foreign and local products in ECOWAS. Currently, the department uses the ECOWAS agreed CTD protocol for dossier submission as ECOWAS member state for the harmonized registration procedure established through the efforts of the West African Health Organization (WAHO) in the ECOWAS region..
In adherence to the ACT of 2010 which provides the provision for the Registration of all consumable Products in circulation in the in the ECOWAS markets, the department has moved to conduct::
* Full assessment for the registration of medicines, veterinary medicines, vaccines, biological products, tobacco & tobacco products, herbal medicines, homoeopathic medicines, food supplements, medical devices, cosmetics and household chemicals.
The Department has begin registration of Biosimilar medicines (Biological and Blood related substances and Psychotropic substances).
OVERVIEW
The Product Evaluation & Registration Department is one of the four technical departments of The ECOWAS PHC with the responsibility to receive applications for (medicines and health product) registration and provides feedback to applicants on the registration process; conduct evaluation of product dossiers; generate information for billing (i.e. payment for products registration, listing of medical devices, cosmetics, health products and pre-market analysis); prepare Market Authorization (Import/Clearance); list medical devices, health products, and cosmetics; publish registered products; conduct regular workshops for clients – i.e. Importers, Pharmacists, etc. for information sharing; and generate and update registration guidelines and related documents.
STRUCTURE
The Evaluation and Registration Department is headed by an astute Pharmacist, Mr James Akakpo as Director, assisted by Pharmacist Mary Ganyon- Dekpe as Deputy Director and seven unit managers. The Department comprises of the following Units: Reception, Medicines Registration, Cosmetics Registration, Medical Devices Registration, Research & Development, Records Management and Narcotics & Psychotropic Registration Units.
RECEPTION UNIT
Receives all application for Registration of all Pharmaceuticals and processes them, including:
* raising of bills for payment of non refundable fees;
* processing of the application;
* Attach IP/Processing form, Bill Request, Invoice & Payment Receipt;
* Submits application to Research Team
FOOD PRODUCT REGISTRATION UNIT:
* Receives all applications for Registration from the Reception Unit;
* Conducts check lists for products;
* Conducts screening and preliminary evaluation;
* Communicates preliminary evaluation findings to Applicant;
* Receives feedback;
* Codes all products;
* Conducts assessment for evaluation of dossiers.
COSMETIC UNIT
* Receives all application for listing of Cosmetics;
* Performs checklist for the listing;
* Conducts screening for all Cosmetic applications;
* Codes all cosmetics application;
* Prepares matrix for submission to Research, Record & data Unit.
MEDICAL DEVICE UNIT
* Receives all applications for listing of Medical Devices;
* Performs checklist for the listing of Medical Devices;
* Conducts screening for all Medical Devices;
* Codes all Medical Devices application;
* Prepares matrix for submission to Research, Record & data Unit.
VETERINARY UNIT
* Receives all applications for listing of Vet. Products;
* Performs checklist for the listing of Vet Products;
* Conducts screening for all Vet Products;
* Codes all Vet Product application;
* Prepares matrix for submission to Research, Record & data Unit
HERBAL UNIT
* Receives all applications for listing of Herbs
* Performs checklist for the listing of Herbs
* Conducts screening for all Herbal Products;
* Codes all Herbal Product application;
* Prepares matrix for submission to Research, Record & data Unit
RESEARCH AND DATA UNIT
.* Conducts research on all Pharmaceutical manufacturing Companies;
* Provides information on the manufacturing details of each company (Tablets, Capsules, small volume parenteral ( Injectable, Infusion ,Syrups, Suspensions etc.) ointments and Creams;
* Prepares Import Permit & Clearances;
* Conducts full research on the products characteristics (Product’s Name, Registration Number, Strength, Pack Size, Volume, Color of Packaging and Manufacturer;
* Designs matrixes for all pharmaceuticals.
RECORD AND DEVELOPMENT UNIT
* Records all pharmaceuticals into the various Matrixes designed by the Research & Data Unit;
* Prepares the certificate for marketing authorization;
* Prepares products registration list;
* Updates website periodically for all pharmaceuticals.
NARCOTIC & PSYCHOTROPIC UNIT
* Receives applications for import authorization;
* Screens applications according to the Narcotic Act;
* Prepares authorization in line with the MOH guidelines for importation of Narcotic & Psychotropic;
* Collaborates with MOH for periodic monitoring