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INVESTMENT INVESTMENT SYSTEM LIVESTOCK AGRICULTURE INFRASTRUCTURE
INDUSTRIAL SECTOR OIL INDUSTRY OIL SECTOR MINING SECTOR ENERGY SECTOR
INVESTMENT OPPORTUNITIES IN THE KHARTOUM STATE
REQUIREMENTS FOR REGISTRATION OF
FOREIGN DRUG MANUFACTURING COMPANY
GENERAL REQUIREMENTS FOR THE REGISTRATION OF PHARMACEUTICAL PRODUCTS


THE REPUBLIC OF THE SUDAN
MINISTRY OF HEALTH
THE BOARD OF PHARMACY
KHARTOUM


REQUIREMENTS FOR REGISTRATION OF FOREIGN DRUG MANUFACTURING COMPANY


Name, address and type of the foreign company.

Name and address of local licensed local agent.

Copy of agency agreement certified by the Registrar of Companies

The manufacturing license ( photocopy ) for the company to manufacture pharmaceutical products for use in the country of origin issued by the health authority in the same country.

Valid Statement of Licensing Status of Pharmaceutical Products (SLSPP) conforming to the format recommended by the World Health Organization, issued by competent certifying authority in the country of origin authenticated, certified and stamped by Sudan Embassy in country of origin.

Valid GMP certificate issued by competent certifying authority in the country of origin authenticated, certified and stamped by Sudan Embassy in country of origin.

List of other divisions, subsidiaries….etc. of the Mother Company and their full addresses.

Other countries where the company is registered confirmed by photocopies of the certificates of registration in those countries.

Full information and details about the pharmaceutical plant including at least the following information :

Name and address of the drug manufacturing plant(s).

Date of establishment.

Name and address of both Chairman of Board of Directors and the Managing Director of the company.

Value in US $ of local sales of products manufactured in the plant during previous 12 months.

Value in US $ of exported products manufactured in the plant and names of importing countries during previous 12 months.

Products other than pharmaceuticals manufactured in that factory.

Layout plan of the factory, indicating location and floor area of all buildings and facilities.

List of all technical full-time staff of the factory, their posts and qualifications (name : post : qualifications ).

List of lines and types of production.

List of major equipment.

Evidence of any internationally recognized awards or certifications of

Excellence or compliance with international standards, e.g. ISO 9000, 9001.

List of main research studies performed by the company during the last 5 to 10 years.

Pharmaceutical products released to the market based on that research.

Any other useful information about the company, its manufacturing plants and there products.

Fill in official forms if any are required.

Company Master file is required.

Dr. Salah edelin Abd Elrahman
Chairman, Committee
For registration of Pharmaceutical
Products for Human Use


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