In 1996, the NDA embarked on a drug registration exercise. Before then, all drugs imported into the country had not been subjected to a drug registration process. This exercise has been a control measure to ensure that only drugs of proven quality, safety and efficacy are licensed to for importation into Uganda. To date, NDA has registered approximately 4500 human drugs, and 450 veterinary drugs.
The main function is to assess pharmaceutical products by evaluating documentary evidence in order to ensure that the product meets its intended purpose. After a pharmaceutical product has been assessed and found to meet its intended purpose, it is included on a list of authorized drugs for use in Uganda.
A list of authorized drugs is often referred to as the National Drug Register (or the National Formulary) and the drugs are said to be registered (sometimes it is said that marketing authorization has been granted).
The prime purpose for registration is to ensure that all pharmaceutical products intended for use in Uganda meet their intended purpose and the requirements laid down by NDA.
Main activities that are carried out in this process include:
- Collaboration with relevant national institutions on registration matters.
- Collaboration with relevant international bodies in drug registration matters.
- Organize and coordinate GMP audit of foreign manufacturing facilities of applicants.
- Participate in cGMP audits/ Quality Assurance inspections for both local and foreign manufacturing facilities.
NDA’s objective is to ensure effective control over the quality, safety and efficacy of all human and veterinary medicines in the country so as to protect the end-user.
NDA has laid down strategies to achieve this by:
- Strengthening registration of human and veterinary medicines.
- Establishing a system of regulating and controlling the commercial manufacture and distribution of traditional medicines.
The parties involved in the registration process include:
- National Drug Authority, the competent Drug Regulatory agency in Uganda.
- The manufacturer, who generates the information and therefore owns the information submitted to NDA.
- The importer in Uganda or the exporter in a country of manufacture.
According to NDA guidelines, any of the following can apply for registration of a product:
- Legally authorized agent/distributor acting on behalf of the manufacturer and/or patent holder (discoverer).
For any pharmaceutical product to be assessed, NDA requires specific information.
A stipulated application form should be completely and accurately filled in. This form is divided into sections:
- Administrative information (i.e. particulars of applicant, particulars of the manufacturer etc).
- Particulars of the product being applied (e.g. brand name, INN name, pack size, strength etc).
- Authorized local technical representative in Uganda, which should be a body corporate duly licensed to handle drugs in Uganda.
- Specifications of packaging materials and the composition of the product.
- Chemistry and Pharmaceutical information of the product.
- Registration status of the product in other countries.
- Pharmacology and toxicology of the product.
- General information on the product (information on the product published in recognized international books, journal etc)
Application forms are available from NDA headquarters. An applicant may take as many applications as required at a nominal fee of US$ 10.00 per application. A copy of guidelines as to how the application form should be filled accompanies the application forms
The application is received at NDA with all its addenda:
- Appropriate Application fee:
Product manufactured outside Uganda .......................... US$ 500
Product manufactured in Uganda .................................. US$ 200
Product manufactured outside Uganda but packaged in Uganda .... US$ 300.
- Samples (Minimum two<2>) of each formulation pack intended for use in Uganda
- Dossier (completed as laid out in the application form)
Summary of the processes of registration
- Entering of data on Siamed Program
- Storing/ Retrieval of applications and samples
- Presentation of applications to the Committee on the National Formulary (CNF) and The Authority
- Communication to applicants
The following are notified
Future notifications
- Notifications are completed on the stipulated forms. A notification fee of US $ 20 per product is levied.
Other activities involved in the registration process include:
- Deletion of products from the National Drug Register
Resources
- Technical Staff - Pharmacists, drug analysts.
- Standard Literature - Pharmacopoeias, National Formularies etc.
Guidelines used in drug registration
|
