BPFK 501
National Pharmaceutical Control Bureau
Ministry of Health Malaysia
Foreign GMP Inspection Application Form
(August 2015)
PART A – APPLICANT INFORMATION
Name of Applicant
Name of Product
Registration Holder
Address
Company/Business
Registration No.
Tel. No
Fax No
Email Address
PART B – FOREIGN MANUFACTURER INFORMATION
Manufacturer Name
Address
Country
Purpose of
Application
(Please tick the
appropriate box)
Product Registration (New)
Change of Site to Existing Manufacturer
Product Registration (Renewal)
Others (Please specify) : ___________
PART C – SCOPE OF INSPECTION
Category of
products to be
inspected
(Only 1 category to
be chosen)
Pharmaceutical
dosage form of
products
Sterile
Large Volume Parenterals
Tablet
Small Volume Parenterals
Capsule
Liquid (External)
Powder
Liquid (Internal)
Granule
Cream / Ointment
Lotion
Products
included in the
scope of
inspection
Non Sterile

Others (please specify) ___________
____________
Penicillins or Cephalosporins
Hormone
s
Cytotoxics or Anti-Cancer
preparations
Steroid
Biologicals (eg: vaccines, blood
products, biotechnology products)
None of above
BPFK 501
PART D – LIST OF SUPPORTING DOCUMENTS
Tick (√) if
provided
Please ensure that the following documents are attached together with this application.
1.
2.
3.
4.
5.
6.
7.
8.
9.
For office
purpose
only
Payment of Processing Fee RM5,000
A copy of Company/Business Registration Certificate (for Product Registration Holder)
Details of new products to be registered in Malaysia (Annex I)
Details of existing registered products of renewal of product registration (Annex II)
Details of existing registered products for change of manufacturing site (Annex III)
Site Master File
Validation Master File
Proposed flight route and hotel rate per night
Hotel quotation [Name of hotel, distance between hotel and manufacturing facility,
accommodation during transits (if any)]
PART E - APPLICANT DECLARATION
1. I am hereby authorised by the company to make this application. I undertake to pay the non-refundable
processing fee of RM5,000 upon application and inspection fee of RM20,000 at least one month before the
foreign inspection is conducted using a banker’s cheque payable to BIRO PENGAWALAN FARMASEUTIKAL
KEBANGSAAN. [Note: Only completed application form with confirmed payment will be processed by NPCB]
2. I have read and understood the contents of the Drug Registration Guidance Document and Guidance Document
on Foreign GMP Inspection.
3. I declare that the particulars given in this application and the supporting documents are true, authentic or true
copies and undertake to notify NPCB within one week of any change in the particulars submitted in this
application.
4. I undertake to pay all required inspection expenses which include flight ticket, accommodation, and other
associated expenses (such as allowances, insurance, etc.). I shall make the payment in the form of contribution
into a trust fund established under the Malaysian Ministry of Health (MOH) namely Akaun Amanah Penilaian,
Pengiktirafan Akreditasi dan Pemeriksaan APB (Main Code: 886341, Sub Code: 4001) through a banker’s
cheque made payable to:
Name
: KETUA SETIAUSAHA KEMENTERIAN
KESIHATAN MALAYSIA
Account No
: 21401360003459
5. I understand that the remainder of the contribution will be retained in the trust fund for future purposes as
outlined in the Arahan Amanah Penilaian, Pengiktirafan Akreditasi dan Pemeriksaan APB. I undertake to add
more contribution to the trust fund if the expenses for the inspection are more than expected. I also understand
that in the event where the foreign inspection cannot be conducted, the contribution will be refunded.
6. I hereby confirm that the manufacturer had agreed to be inspected by NPCB, Malaysia.
7. I undertake to ensure that the medicinal products are manufactured in accordance with current PIC/S Guide to
Good Manufacturing Practice for Medicinal Products.
8. I hereby confirm that I agree with any decision from NPCB regarding this application.
____________________
_____________
(Signature)
(
__________________
(Date)
(Company Stamp)
)
(Name & Designation )
FOR OFFICIAL USE ONLY
Application No
Name and signature of
officer processing this
application
:
:
……………………….
Initial Evaluation:
Products to be inspected
are of necessity and
essential to Malaysia
Requirement for
inspection
Yes
No
:


:


BPFK 501
No.
No.
No.
Annex I
(Details of new products to be registered in Malaysia)
Product (Reference No. - If any)
Active Ingredient
Annex II
(Details of existing registered products for renewal of product registration)
Product
Registration Number
Registration Period
Annex III
(Details of existing registered products for change of manufacturing site)
Product
Registration Number
Registration Period
Current Manufacturer
& Address