Upon the establishment of The
BSO Benin, 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 Benin. 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 Benin 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 BSO Benin 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 BSO Benin, 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 Benin. 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 Benin 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 BSO Benin 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