Evaluation & Registration Department

EVALUATION AND REGISTRATION DEPARTMENT
Upon the establishment of the LMHRA, the Products Evaluation & Registration Department embarked on listing of Pharmaceutical products for human use in 2011. In 2012, with support from a consultant (Mr. Ben Botwe) from Ghana, the department began registration of medicinal products in Liberia. 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 medicinal Products in circulation in the pharmaceutical sector in Liberia, the department has moved to conduct:

Full assessment for the registration of allopathic medicines
Assessment for the registration of Herbal medicines and supplements
Assessment for medical devices listing gearing to registration
Listing of Health Products (Cosmetics)

The Department is yet to 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 LMHRA 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, Mrs. Patricia Quaye-Freeman as Director, assisted by Pharmacist Mary Jalloh-Tozo 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 nonrefundable fees;


• processing of the application;


• Attach IP/Processing form, Bill Request, Invoice & Payment Receipt;


• Submits application to Research Team.

MEDICINE REGISTRATION UNIT

• Receives all applications for Registration of all Pharmaceuticals from the Reception Unit;


• Conducts check lists for all medicines;


• Conducts screening and preliminary evaluation;


• Communicates preliminary evaluation findings to Applicant;


• Receives feedback;


• Codes all Pharmaceutical products;


• Conducts assessment for evaluation of dossiers.

COSMETIC UNIT

• Prepares matrix for submission to Research, Record & data Unit.


• Codes all Medical Devices application;


• Conducts screening for all Medical Devices;


• Performs checklist for the listing of Medical Devices;


• Receives all applications for listing of Medical Devices;


• MEDICAL DEVICE UNIT


• Prepares matrix for submission to Research, Record & data Unit.


• Codes all cosmetics application;


• Conducts screening for all Cosmetic applications;


• Performs checklist for the listing;


• Receives all application for listing of Cosmetics;

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.