4.1	:	Introduction : Maintenance of Registration
4.1.1	:	Re-Registration Process
4.1.2	:	Re-Registration Fees
4.1.3	:	Rejection of Application

 

 

 

Registration of a product shall be valid for five (5) years or such period as specified in the Authority database (unless the registration is suspended or cancelled by the Authority).

Application for re-registration (renewal of product registration) of a product shall be submitted within six (6) months prior to the expiry of the validity period of a product registration. A letter of reminder for product re-registration will be issued to the product registration holder 3 months prior to the expiry date of a product registration.

After the expiry date, the status of product registration shall be automatically changed to ‘expired’, and applicant will not be able to submit the application for product re-registration. Any form of appeal shall not be considered if re-registration application is not submitted before the expiry date of a product registration since reminder letter is issued 3 months prior to the expiry date. A new registration application shall be submitted if applicant wishes to continue to market the product.

After the expiry of product registration date, the product is deemed unregistered. Products of which their re-registration is on hold due to unmet requirements but has passed its registration expiry date, the new registration date shall be updated according to the DCA Meeting date where the re-registration application is approved by the DCA.

The application for product re-registration shall only be submitted when all of the registration requirements have been complied with. Failure to do so shall result in the re-registration application being rejected by the Authority.

 

 

 

4.1.1 RE-REGISTRATION PROCESS

REQUIREMENT

The requirements for product re-registration as aforementioned are as follows:

a)    Patient dispensing pack size for pharmaceutical product containing scheduled poison or non-scheduled poison with tablet/capsule dosage form, including oral liquid preparation and dermatological preparation.

Note: Please refer Appendix 10: Guideline on Patient Dispensing Pack for Pharmaceutical. 

b)    Bioequivalance study report for all registered generic products containing scheduled poison with immediate release, oral, solid dosage form (came into force starting from 1st January 2013)

Reference: 

1. (10) dlm.BPFK/PPP/01/03 Jld.1 - Arahan Pengarah Kanan Perkhidmatan Farmasi Bil 1 Tahun 2011 : Direktif Penguatkuasaan Keperluan Kajian Bioekuivalens Bagi Semua Produk Generik “Immediate Release, Oral, Solid Dosage Form” Yang Mengandungi Bahan Aktif Racun Berjadual Serta Akreditasi Pusat Kajian BioEkuivalens (2 March 2011)

2. Bioequivalence study report for all registered generic products containing scheduled poison with effervescent, dispersible, orodispersible, sublingual, buccal and chewable dosage form (comes into force for product registration which is expiring starting from 1st January 2019)

3. Direktif Permohonan Pendaftaran Semula Produk Yang Pernah Didaftarkan Secara Pendaftaran Hak Dan Produk Not Commercially Viable Medicine (NCVM). 

4. Direktif Mengenai Penerimaan Pengesahan Pematuhan Amalan Perkilangan Baik (APB) Bagi Pegilang Farmaseutikal Bagi Tujuan Pendaftran Baru/ Pendaftaran Semula Produk Farmaseutiakl Berdaftar Dengan Pihak Berkuasa Kawalan Dadah (PBKD) 

5. Direktif Kaji Semula Pendaftaran Produk untuk Tujuan Eksport sahaja/ For Export Only (FEO)

6. Direktif untuk pendaftaran semula bersyarat bagi produk farmaseutikal berdaftar yang masih belum memenuhi keperluan data kajian stabiliti dalam zon IV B.

7. Pekeliling Pendaftaran Semula Bersyarat Bagi Produk Generik Berdaftar Yang Masih Belum Memenuhi Keperluan Kajian Bioekuivalens (BE) Semasa Proses Pendaftaran Semula Dan Produk Generik Yang Telah Digantung Pendaftaran Kerana Penilaian Laporan Kajian BE Didapati Tidak Memuaskan

8. Arahan Pengarah Kanan Perkhidmatan Farmasi Bil. 11 Tahun 2016 - Penerimaan Pengesahan Pematuhan APB Bagi Tujuan Pendaftaran Semula Produk Farmaseutikal Berdaftar

9. Pendaftaran Semula Bersyarat bagi Produk Generik Berdaftar yang Mengandungi Bahan Aktif Racun Berjadual dalam Bentuk Immediate Release, Oral, Solid Dosage Form yang belum Memenuhi Keperluan Kajian Bioekuivalens (BE) Semasa Pendaftaran Semula Produk dan Produk Generik di mana Penilaian Laporan Kajian BE didapati Memuaskan

10. Arahan Pengarah Kanan Perkhidmatan Farmasi Bilangan 1 Tahun 2016 - Direktif Mengenai Keperluan Pemeriksaan Amalan Perkilangan Baik (APB) Luar Negara bagi Tujuan Pendaftaran / Pendaftaran Semula Produk Farmaseutikal Berdaftar dengan Pihak Berkuasa Kawalan Dadah (PBKD)

11. Pekeliling Kawalan Produk Persediaan Parenteral Sebagai Racun di bawah Akta Racun 1952

12. Direktif Untuk Menguatkuasakan Penggunaan Guideline For Registration Of Drug-Medical Device And Medical Device-Drug Combination Products

13. Pekeliling Penggunaan Nama Generik Pada Nama Produk Bagi Produk Farmaseutikal

 

 

 

 

4.1.2 RE-REGISTRATION FEES

The application for product re-registration shall be submitted and herein paid via the current online system.

a)    The non-refundable processing fees for product re-registration are as follow:

1.	Traditional Product	RM 500.00 per product
2.	Pharmaceutical Product (including Health Supplement)	RM1,000.00 per product

 

 

 

 

4.1.3 REJECTION OF APPLICATION 

As stipulated in Regulation 18, CDCR 1984:

a)    Any person aggrieved by the decision of the Authority or the Director of Pharmaceutical Services, a written appeal may be made to the Minister of Health Malaysia;

b)    All notice of appeals shall be made within fourteen (14) days from the date of notification from the Authority;

A period of 60 days from the date of appeal confirmation is given for submission of any additional information/ supplementary data/ documents for all categories of product.

The appeal shall not be considered if all the required information is not submitted within the specified timeframe given. Any request for extension of this period shall not be considered too.

c)    Any decision of the Minister made on an appeal shall be final.

Re-submission for product registration of a rejected application due to reason of safety and efficacy shall not be accepted within two (2) years after the rejection. However, if the product is registered in the reference countries, submission of application can be made earlier.