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) /
Sterile Non Sterile 
Pharmaceutical dosage form of products / Large Volume Parenterals / Tablet
Small Volume Parenterals / Capsule
Liquid (External) / Powder
Liquid (Internal) / Granule
Cream / Ointment / Others (please specify) ______
______
Lotion
Penicillins or Cephalosporins
Cytotoxics or Anti-Cancer preparations /
Biologicals (eg: vaccines, blood products, biotechnology products) /
PART D – LIST OF SUPPORTING DOCUMENTS
Please ensure that the following documents are attached together with this application. / Tick (√) if provided / For office purpose only
1. / Payment of Processing Fee RM5,000
2. / A copy of Company/Business Registration Certificate (for Product Registration Holder)
3. / Details of new products to be registered in Malaysia (Annex I)
4. / Details of existing registered products of renewal of product registration (Annex II)
5. / Details of existing registered products for change of manufacturing site (Annex III)
6. / Site Master File
7. / Validation Master File
8. / Proposed flight route and hotel rate per night
9. / 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 AkaunAmanahPenilaian, PengiktirafanAkreditasidanPemeriksaan APB (Main Code: 886341, Sub Code: 4001) through a banker’s cheque made payable to:
Name: / KETUA SETIAUSAHA KEMENTERIAN KESIHATAN MALAYSIA
Account No: / 21401360003459
  1. I understand that the remainder of the contribution will be retained in the trust fund for future purposes as outlined in the ArahanAmanahPenilaian, PengiktirafanAkreditasidanPemeriksaan 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.
  2. I hereby confirm that the manufacturer had agreed to be inspected by NPCB, Malaysia.
  3. I undertake to ensure that the medicinal products are manufactured in accordance with current PIC/S Guide to Good Manufacturing Practice for Medicinal Products.
  4. 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 / : /
/ Initial Evaluation: / Yes / No
Products to be inspected are of necessity and essential to Malaysia / : /  / 
Name and signature of officer processing this application / : / ……………………….
Requirement for inspection / : /  / 
Annex I
(Details of new products to be registered in Malaysia)
No. / Product (Reference No. - If any) / Active Ingredient
Annex II
(Details of existing registered products for renewal of product registration)
No. / Product / Registration Number / Registration Period
Annex III
(Details of existing registered products for change of manufacturing site)
No. / Product / Registration Number / Registration Period / Current Manufacturer & Address