CREDENTIAL OF THE MANUFACTURER ABROAD GENERAL INFORMATION

1. 2. 3. Name and address of the applicant (agent in Pakistan) alongwith a brief about his distribution network. Name, address and the status of the manufacturer abroad (private ownership, private limited, public limited). Names and addresses of various working branches, a. b. 4. 5. 6. 7. 8. 9. 10. Inside country of origin. Outside country of origin.

Name and address of branch supplying the Pakistan market. Year of Foundation. Ranking amongst other manufacturers, factory layout and facilities for manufacture. Working capital. Annual sales value. Total number of employees. List of drugs / medical device with composition being manufactured. a. b. c. d. e. Are these preparations totally or partially manufactured by the firm itself. If partially manufactured what are these products, where manufactured and why. Research products produced by the firm itself during the last then years. Other activities beside pharmaceutical manufacturing. Name of countries where products are marketed. Numbers of specialized personnel working in these research laboratories (excluding administratives). b. Physicians.
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Do you have research laboratories. a.

c. d. e. f. g. h. i. j. 12. a. b. c. d. e. 13. a. b. c. d. e. f. g. h. i. j. 14. 15.

Pharmacists. Chemists. Others. What research activities and trials carried by these laboratories. Do you own or have at your disposal hospitals or medical centers carrying out test and experiments on your products. Do you collaborate with universities or scientific centers in research fields; give details. What is the annual budget reserved for research and development. Number of square meters assigned for these laboratories. Self manufacturing. Under licence. Other sources. Number and qualification of personnel working in this division. Number of square meters assigned for production area. For testing raw materials. For in-process control. For testing final products. What type of laboratory tests you perform. Physico-chemical tests. Microbiological tests. Pharmacological tests. Others tests. Number and qualification of personnel working in these laboratories. Give in details the activities performed by the competent authorities for controlling your establishment and its production.

Origin of principal raw materials.

Do you have control laboratories.

Name of the products, if any being exported to Pakistan, which are no more allowed sale or withdrawn in the country of origin. Qualification of the inspector conducting the inspection.
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Provide a copy of the most recent inspection report in original or its copy attested by the Drug Registration Authority (DRA) or their Ministry of Health, which should be based on the WHO guidelines for both GMP and conduct of inspection.

17. 18. 19. 20.

Plant automatic or not. Photograph of company and of each section. Brochure. I the undersigned (full name of the person responsible for the establishment, hereby declare that all the information, given above is true, and I assume full responsibility for this Declaration with the consequences which might arise from false or erroneous information. Date. Name of establishment. Signature and stamp. Legalization of the Ministry of Health or the official organization in charge of the control and inspection of pharmaceutical manufactures that the information given above are correct. Legalization of the Pakistani Consulate. N.B. Please sign and stamp each page of this form.