Ref. No.

:
Dated:
G O V E R N M E N T O F P A K I S TA N
OFFICE OF THE DRUGS CONTROL ADMINISTRATION
M INISTRY O F H EALTH (H EALTH D IVISION )
2nd Floor, N.I.M.R. & T. Building, 6 - Bird Wood Road, Lahore-Pakistan.

FREE SALE AND G.M.P CERTIFICATE

1.

NAME & DOSAGE FORM OF THE PRODUCT

Crepe Bandage
()

2. PACK SIZE
Pack
3.
4.

01Crepe Bandage Shrink

015801; 10th May 2000

REG. NO; DATE

POTENCY

Each Crepe Bandage contains:

Thread Count warp= 17/cm(Cotton)
Determine by containing the total no of thread
in the wrap and dividing by the width,
in cm, of un stretched Bandage
Weft=78/cm(Cotton)Determine on fully stretched
Bandage.

5.

MANUFACTURING LICENSE NO

6.
NAME OF MANUFACTURER &
Industries.,
ADDRESS
Sargodha Road,

000354
Faisal Pharmaceutical
602-C P.S.I.E
Faisalabad Pakistan.

It is certified that the product is sold in Pakistan subject to statutory requirement.

The manufacturer plant in which the product is manufactured is subject to
inspection at suitable intervals and it is mandatory for the manufacturer to confirm
Good Manufacturing Practice as recommended by the Drugs Act 1976,
Government of Pakistan in Respect of Products to be sold or distributed within the
country of origin or to be exported.

Assistant Drugs Controller

For Director General Health
Government of Pakistan
Lahore Pakistan.

Certificate of a Pharmaceutical Product

No. of Certificate:_____________________________________________________________________
Exporting (certifying) country:

Pakistan

Importing (requesting) country:

Sudan

1.

Name and dosage form of product:

Crepe Bandage
1.1 Active ingredient(s) and amounts per unit dose
7.5 cm 4.5 m , 10.0 cm 4.5 m , 15.0 cm 4.5 m
1.2 Is this product licensed to be placed on the market for use in the exporting country?
Yes / No
1.3 Is this product actually on the market in the exporting country ?
Yes / No / unknown.
If the answer to 1.2 is yes, continue with section 2A and omit section 2B
If the answer to 1.2 is no, omit section 2A and continue with section 2B
2A.1 Number of product licence and date of issue:
Registration No. 015801dated 10th May 2000
2A.2 Product-licence holder (name and address):
Faisal Pharmaceutical Industries, 602-C Punjab Small Industrial Estate Sargodha
Road Faisalabad.
2A.3 Status of product-licence holder.
A

C.

2A.3.1 For categories B and C the name and address of the manufacture
producing the dosage form are:
N. A.
2A.4

Is Summary Basis of Approval appended ?

Yes / No

2A.5

Is the attached officially approved product information complete and

consonant with the licence ?
Yes / No

2A.6

Application for certificate, if difference from licence holder (name and

address):
N. A.

2B.1

2B.2

Applicant for certificate (name and address):

N. A.

N. A.

Status of applicant: a/b/c.

2B.2.1 For categories b and c the name and address of the manufacturer
form are:
N. A.
2B.3

2B.4

Why is marketing authorization lacking ?

Not reqiured/not requested/under consideration/refused
N. A.

3.

producing the dosage

_

Remarks:
N. A.

Does the certifying authority arrange for periodic inspection of the manufacturing plant
in which the dosage form is produced?
Yes / No / Not applicable.
If no or not applicable proceed to question4

3.1

Periodicity of routine inspection (years):

4 times a year

3.2

Has the manufacture of this type of dosage form been inspected ?

Yes / No

3.3

Do the facility and operations conform to GMP has recommended by the World Health
Organization ?
Yes / No / Not applicable

4.

Does the information submitted by the applicant satisfy the certifying authority on all
aspects of the manufacture of the product ?
Yes / No
If no, explain:
Address of certifying authority:
Office of the Drugs Controller Administration,
Government of Pakistan,
Ministry of Health (Health Division)
National Institute of Malaria Research And Training Building,
6-Bird Wood Road,
Lahore.
Tel. No.
Name of authorized person:
Signature:
Stamp and date :

Fax No.

Explanatory Notes
1.

This certificate, which is in the format recommended by WHO, establishes the status of the
pharmaceutical product and of the applicant for the certificate in exporting country. It is for a
single product only since manufacturing arrangements and approved information for different
dosage form sand different strengths can vary.

2.

Use, whenever possible, international Nonproprietary Names (INNs) or national nonproprietary

names.

3.

The formula (complete composition) of the dosage form should be given on the certificate or be
appended.

4.

Details of quantitative composition are preferred, but their provision is subject the agreement of
the product-lience holder.

5.

When applicable, append details of any restriction applied to the safe, distribution or
administration of the product that is specified in the product licence.

6.

Section 2A and 2B are mutually exclusive.

7.

Indicate, when applicable, if the license is provisional, or the product has not yet been approved.

8.

Specify whether the person responsible for placing the product on the market:
a.
b.
c.

Manufacturers the dosage from;

Package and/or labels a dosage from manufactured by and independent company; or
Is involved in none of the above.

9.

This information can be provided only with the consent of the product-licence holder or, in the
case of non-registered products, the applicant. Non-completion of this section indicates that the
party concerned has not agreed to inclusion of this information.
It should be noted that information concerning the site of production is part of the product
licence. If the production site is changed, the licence must be updated or it will cease to be valid.

10.

This refers to the document, prepared by some national regularity authorities that summarize the
technical basis on which the product has been licensed.

11.

This refers to product information approved by the competent national regulatory authority, such
as a Summary of Product Characteristics (SPC).

12.

In this circumstance, permission for issuing the certificate is required form the product-licence
holder, this permission must be provided to the authority by the applicant.

13.

Please indicate the reason that the applicant has provided for not requesting registration:
a)

the product has been developed exclusively for the treatment of condition particularly
tropical diseases not endemic in the country of export;

b)

the product has been reformulated with a view to improving its stability under tropical
conditions;

NO. F.8-3/98 ADC (K)

GOVERNMENT OF PAKISTAN
OFFICE OF THE DRUGS CONTROLLER ADMINISTRATION,
MINISTRY OF HEALTH (HEALTH DIVISION)
NATIONAL INSTITUTE OF MALARIA RESEARCH
AND TRAINING BUILDING
6-BIRD WOOD ROAD, LAHORE.
CERTIFICATE REGARDING FREE SALE AND GMP
IN THE COUNTRY OF ORIGIN.
NAME OF PRODUCT

ACTIVE INGREDIENT

DOSAGE FORM

REGISTRATION NO.

PACK SIZE

12s/s

GROUP BELONGS

Bandages

MANUFACTURER

Faisal Pharmaceuticals Industries.

MANUFACTURING LICENCE NO.

Crepe Bandage

Supportive Bandage

000

IT IS CERTIFIED THAT THIS PRODUCT IS SOLD IN PAKISTAN SUBJECT TO THE STATUTORY

REQUIREMENTS.
IT IS ALSO CERTIFIED THAT THE MANUFACTURING PLANT WHERE THE PRODUCTS ARE
MANUFACTURED IS SUBJECT TO INSPECTION AT SUITABLE INTERVALS. THE GOOD
MANUFACTURING PRACTICE REQUIREMENTS ARE MANDATORY UNDER THE DRUG ACT
1976. INSPECTION OF PRODUCT TO BE SOLD OR DISTRIBUTED WITHIN THE COUNTRY OF
ORIGIN OR TO BE EXPORTED AS LAID DOWN IN THE DRUG ACT 1976.

PLACE:
DATE :

LAHORE

OFFICER INCHARGE
DRUG CONTROLLER ADMINISTRATION
FOR DIRECTOR GENERAL HEALTH.