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Drug Regulatory Authority of Pakistan: FORM-19

The document is an application form for obtaining a provisional establishment certificate to import medical devices listed in Schedule D. It requests information such as the establishment name and address, type of ownership, names and details of partners/directors, name and qualifications of technical staff, copy of drug sale license, bank deposit slip, and authorized agency agreement. The applicant must declare that the information provided is correct and undertake to comply with all relevant laws and not sell expired, substandard, or unregistered medical devices.

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Moayed Amir
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374 views2 pages

Drug Regulatory Authority of Pakistan: FORM-19

The document is an application form for obtaining a provisional establishment certificate to import medical devices listed in Schedule D. It requests information such as the establishment name and address, type of ownership, names and details of partners/directors, name and qualifications of technical staff, copy of drug sale license, bank deposit slip, and authorized agency agreement. The applicant must declare that the information provided is correct and undertake to comply with all relevant laws and not sell expired, substandard, or unregistered medical devices.

Uploaded by

Moayed Amir
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

DRUG REGULATORY AUTHORITY OF PAKISTAN

FORM-19
[see rule 52]

APPLICATION FORM FOR GRANT OF PROVISIONAL ESTABLISHMENT CERTIFICATE


TO IMPORT MEDICAL DEVICES PROVIDED IN SCHEDULE D

I/We ………………………..of M/s……………..hereby apply for grant of provisional establishment


certificate to import medical devices provided in Schedule D at the premises situated at …………….

S. Descriptions To be filled by
No. applicant
(1) (2) (3)

1. Establishment name and address including godown address:

2. Type of ownership and copy of business registration as issued


by the Registrar of Companies, Security Exchange Commission
of Pakistan or any other authorized body (Proprietorship,
partnership, private limited, public limited, etc)

3. Names and address of partners/proprietors/directors (attached 4


photographs and CNIC of each)

4. Name, qualification, registration No, CNIC No. and address of


qualified technical person(s) for supervising import, sale and
distribution
(attach 4 photographs, CNIC and copy of degree and
Registration certificate)

5. Copy of drug sale licence issued by provincial government

6. Original bank deposit slip

7. Original and valid authorized agency agreement from market


authorization holder duly notarized in the country of origin.

DECLARATION

Certified that the documents and information provided herein are genuine and correct and if found at any
stage to be misrepresenting or incorrect it shall lead to legal action under the Drug Regulatory Authority
of Pakistan Act, 2012 and the rules made there under. This certificate must be on stamp paper duly
notarized and signed and stamped by Proprietor, Chief Executive, Managing Director or an authorized
officer. In case of an authorized officer authority letter from the owner of the establishment shall be
provided.

UNDERTAKING

I/we also undertake that I/we;

(a) shall comply with the provisions of Drug Regulatory Authority of Pakistan Act, 2012 and the
rules made there under;
(b) shall not sell or stock any expired, spurious, substandard, unregistered, misbranded, counterfeit or
any medical device in violation of the Drug Regulatory Authority of Pakistan Act, 2012 and the
rules made there under.

Name(s) of partners/proprietors/directors/ authorized person………………

Designations…………..
Signature(s)……………..
Stamp…………………..
Date…………………….

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