Product Dosier

SNEHAL PHARMA & SURGICALS PVT. LTD.
increase REGISTRATION DOSSIER

PARACETAMOL TABLET d MG

A Product of :
Neutral Code :
Marketed/ Imported by :
Date of submission :
SCHEDULE
APPLICATION FOR REGISTRATION OF A DRUG
CONFIDENTIAL
DEMOCRETIC country OF---------
MINISTRY OF PUBLIC HEALTH
DIRECTION OF PHARMACY, DRUG & LABORATORY
TECHNICAL DIVISION
SECRETARIAT-GENERAL
PART-I
1. make up OF APPLICANT :
BUSINESS ADDRESS :
TELEPHONE NUMBER :
facsimile machine :
2. NAME OF PRODUCT
TO BE REGISTERED :
TYPE OF FORMULATION
TO REGISTERED :
PRESENTATION OF
THE PRODUCT :
3. IDENTIFICATION(PHYSICAL
APPERANCE OF THE PRODUCT :
4.



THERAPEUTIC CLASSIFICATION
5(a) NAME OF BUSINESS
ADDRESS OF MANUFACTURER :
(b) COUNTRY OF declivity :
(6) NAME OF LOCAL electrical distributor :
BUSINESS ADDRESS OF LOCAL
DISTRIBUTOR :
TELEPHONE NUMBER :
FAX NUMBER :
(7) NAME AND theme song OF
THE AUTHORIZE PERSON :
DATE :
SIGNATURE :
OFFICIAL moulding :
PART I
SUMMARY OF THE DOSSIER
CTD
Module I
ADMINISTRATIVE DATA
(1) SITE outgo PLAN OF PLANT
(2) COMPANY PROFILE IN SHORT
(3) ATTESTED replicate OF MANUFACTURING LICENCE
(4) ATTESTED assume OF PRODUCT PERMISSION FROM FDCA
(5) ATTESTED COPY OF COPP
(6) ATTESTED COPY OF WHO/GMP CERTIFICATE
(7) COA OF SAMPLE
(8) ATTESTED COPY OF WHOLE stag LICENCE.
(9) earn OF ascendence
MODEL OF LETTER OF AUTHORISATION
COMPANYS LETTERHEAD
LETTER OF AUTHORISATION
WE, ___________________________________________________________________
PRODUCT OWNERS NAME AND ADDRESS
HEREBY establish __________________________________________________________
APPLICANTS NAME AND ADDRESS
TO APPLY FOR REGISTRATION OF OUR pharmaceutic PRODUCT
PRODUCT NAME,
DOSAGE FORM AND STRENGTH
WITH THE DRUG REGULATORY role IN (STATE COUNTRY) ON OUR BEHALF . THEY
WILL BE THE MARKETING AUTHORISATION HOLDER OF THE REGISTRATION CERTIFICATE
AND BE RESPONSIBLE FOR ALL MATTERS PERTAINING TO THE command OF THIS
PRODUCT.
SIGNATURE : __________________
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