| General
Information
1. Name
and address of the applicant (agent in Pakistan) alongwith a brief
about his distribution
network.
2. Name,
address and the status of the manufacturer abroad (Private Ownership,
private
limited, public limited).
3. Name
and address of various working branches,
a. Inside
country of origin.
b. Outside
country of origin.
4. Name
and address of branch supplying the Pakistan market.
5. Year
of Foundation.
6. Ranking
amongst other manufacturer, factory lay-out and facilities for manufacturer.
7. Working
Capital.
8. Annual
sales value.
9. Total
number of employees.
10. List
of drugs with composition being manufactured.
a. Are
these preparations totally or partially manufactured
by
the firm itself.
b. If
partially manufactured what are these products, where
manufactured and why.
c. Research
products produced by the firm itself during the last ten years.
d. Other
activities beside pharmaceutical manufacturing.
e. Name
of countries where products are marketed.
11. Do you
have research laboratories.
a. Number
of specialized personnel working in these research
laboratories
(excluding administratives).
b. Physicians.
c. Pharmacists.
d. Chemists.
e. Others.
f. What
research activities and trials carried by these laboratories.
g. Do
you own or have at your disposal hospitals or medical centers
for
carrying out test and experiments on your products.
h. Do
you collaborate with universities or scientific centers in research
centers
in research fields; give details.
i. What
is the annual budget reserved for research and development.
j. Number
of square meters assigned for these laboratories.
12. Origin
of principal raw materials.
a. Self
Manufacturing.
b. Under
licence.
c. Other
sources.
d. Number
and qualification of personnel working in this division.
e. Number
of square meters assigned for production area.
13. Do you
have control laboratories.
a. For
testing raw materials.
b. For
in-process control.
c. For
testing final products.
d. What
type of laboratory tests you perform.
e. Physico-chemical
tests.
f.
Microbiological tests.
g. Pharmacological
tests.
h. Other
tests.
i. Number
and qualification of personnel working in these laboratories.
j. Give
in details the activities performed by the competent
authorities
for controlling your establishment and its production.
14. Name
of the products, if any, being exported to Pakistan which are no
more allowed for sale
or withdrawn in the country of origin.
15. Qualification
of the inspector conducting the inspection.
16. 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 both for GMP and conduct of inspection.
17. Plant
automatic or not.
18. Photograph
of company and of each section.
19. Brochure.
20. 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 manufacturing that the information
given
above
are correct.
Legalization
of the Pakistani Consulate.
N.B:
Please sign and stamp each page of this form.
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