CONSUMER COMPLAINTS RELATING TO MEDICINES

This is a new program that has just been started by the National Pharmaceutical Control Bureau (NPCB),
Ministry of Health Malaysia. The REPORTING FORM FOR MEDICINES COMPLAINTS BY CONSUMERS
provides an avenue for consumers to report to NPCB if there are questions regarding the safety or
quality of medicines used, such as

Ineffective medicines
Product quality problems
If side effects or adverse drug reactions are experienced
If there is any suspicion that an unregistered product has been supplied

If you think you or someone in your family has experienced any of the situations stated above, you are
encouraged to take the REPORTING FORM to your health care provider (such as a doctor or pharmacist).
Your health care provider can provide clinical information based on your medical record that can help us
evaluate your report.
However, we understand that for a variety of reasons, you may not wish to have the form filled out by
your health care provider. You may download and print the form, then complete the REPORTING FORM
yourself before submit it to us by email, fax or post at the address stated below.
You will receive an acknowledgement from NPCB after we receive your report. You will be personally
contacted only if we need additional information. Details of the reporter will remain confidential and
will not be passed on to any person outside NPCB without his/her permission.
For enquiries about consumer complaints related to medicines please contact : -
Pusat PASCA Pendaftaran Produk
Biro Pengawalan Farmaseutikal Kebangsaan
Jalan Universiti, P.O. Box 319,
46730 Petaling Jaya, Selangor.

Tel: 03-78835550
Fax: 03-79567151
Email: fv@bpfk.gov.my

BPFK 419

REPORTING FORM FOR MEDICINES COMPLAINTS BY CONSUMERS

The information that you provide in this report will be kept safe, secure and confidential and will be used
for the sole purpose of investigating the quality and safety of the product in question. The reporter is
required to provide his/her contact details so that in the event that more information is required
he/she can be contacted. Details of the reporter will not be passed on to any person outside the drug
regulatory agency without his/her permission.

REPORTER DETAILS
Title: Dr/Mr/Mrs/Ms Name:
Address:

Town:
State:
Postcode:
Email address:
Tel:(Res)
(Off)
(Mobile)
PATIENT DETAILS
Age:
Sex: M / F
Ethnic Group:
Relationship to reporter:
MEDICINE DESCRIPTION
Name of medicine:
**(please use brand name and include sample if available)
Dosage form: Tablet Capsule
Syrup Others
What was the medicine used for:

Name of manufacturer:
(please refer to product label)

Batch No. :
Manufacturing Date :
Expiry Date :
COMPLAINT DESCRIPTION
Quality defect
Experienced side effect
Unregistered Product
Not effective
Please give details on the nature of the problem

Date when problem occurred:

Name & Address where medicine was
bought:

Date when medicine was used:

Any other information which you think
may be useful in our investigations:

Do you agree to us contacting you if we require further information: Yes

Thank you for reporting.

** Minimum 10 capsules/tablet required for laboratory test.

No

BPFK 419

BORANG LAPORAN ADUAN UBAT - UBATAN

Segala maklumat yang diberikan dalam laporan ini adalah sulit dan hanya akan diguna untuk tujuan
memantau kualiti dan keselamaan produk yang diguna.
Kerjasama pelapor diminta memberikan maklumat yang lengkap berserta alamat dan nombor telefon
yang boleh dihubungi. Ini bagi memudahkan pihak kami menghubungi anda sekiranya maklumat
lanjut diperlukan.

MAKLUMAT PELAPOR :
Nama : Tuan/Puan/Encik/Cik
Alamat:

Bandar :
Negeri :
Poskod:
Alamat e-mail:
Tel:(R)
(O)
(HP)
MAKLUMAT PESAKIT
Umur:
Jantina: L / P
Bangsa:
Hubungan dengan pelapor :
DISKRIPSI UBAT
Nama ubat :
**(Sila gunakan nama produk dan sertakan sampel sekiranya ada)
Lain - lain
Bentuk dos : Tablet Kapsul
Sirap
Kegunaan ubat :

Nama pengilang / pengedar :

(Sila rujuk pada label produk)

No. Kelompok :
Tarikh Dikilangkan :
DISKRIPSI ADUAN
Tidak berkualiti
Tidak berdaftar
Mengalami kesan sampingan
Tidak berkesan
Penerangan lanjut mengenai aduan (sekiranya ada)

Tarikh menghadapi masalah :

Nama dan alamat tempat ubat dibeli :

Tarikh Luput :

Tarikh ubat mula digunakan :

Maklumat tambahan untuk membantu
siasatan (sekiranya ada) :

Adakah anda bersetuju untuk dihubungi sekiranya maklumat lanjut diperlukan : Ya

Tidak

Terima kasih di atas laporan yang dikemukakan

** Minima 10 kapsul/tablet diperlukan untuk ujian makmal