4.1 Maintenance of Registration

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a) The 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).

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

c) After the expiry date, the status of product registration shall be automatically changed to “expired”, following which the applicant will not be able to submit an application for product re-registration. Any form of appeal shall not be considered if the re-registration application is not submitted before the expiry date of a product registration since the reminder letter is issued three (3) months prior to the expiry date. A new registration application is required if the applicant wishes to continue to market the product.

d) After the expiry date of the product registration, the product is deemed unregistered. For products with their re-registration on hold due to unmet requirements past their registration expiry date, the new registration date shall be updated according to the DCA meeting date when the re-registration application is approved by the DCA.

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

f) The application for product re-registration shall be submitted with proof of payment via the online QUEST system.

g) The non-refundable processing fees for product re-registration are:

(i) Traditional product : RM 500.00 per product

(ii) Pharmaceutical product (including Health Supplement) : RM1,000.00 per product

h) The following are requirements for product re-registration of different product categories, where applicable:

 (i) Exemption of bioequivalence study report for all registered generic products in immediate release, oral, solid dosage form (starting 15 March 2020).

Reference:

Bil. (2) dlm. BPFK/PPP/07/25 Jld. 4

Arahan Pengarah Kanan Perkhidmatan Farmasi Bil. 2 Tahun 2020: Direktif Pertimbangan Pengecualian Keperluan Data Bioekuivalens (BE) Bagi Produk Generik Dalam Bentuk Oral Solid, Immediate Release Yang Mengemukakan Permohonan Pendaftaran Semula (10 March 2020)

(ii) Products previously registered as “Pendaftaran Hak” or “Not Commercially Viable Medicine (NCVM)”

Reference:

Bil. (20) dlm. BPFK/PPP/07/25 Jld. 2

Arahan Pengarah Kanan Perkhidmatan Farmasi Bil. 20 Tahun 2018: Direktif Permohonan Pendaftaran Semula Produk Yang Pernah Didaftarkan secara “Pendaftaran Hak” dan Produk “Not Commercially Viable Medicine (NCVM)” (26 June 2018) 

(iii) 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. Refer to Appendix 23: Patient Dispensing Pack for Pharmaceutical Products

(iv) Bioequivalence study report for all registered generic products containing scheduled poison with immediate release, oral, solid dosage form (starting 1January 2013)

Reference:

Bil. (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)

(v) Bioequivalence study report for all registered generic products containing scheduled poison with effervescent, dispersible, orodispersible, sublingual, buccal and chewable dosage form (For expiring product registrations starting 1 January 2019)

References:

Bil. (27) dlm. BPFK/PPP/07/25

Arahan Pengarah Kanan Perkhidmatan Farmasi Bil. 3 Tahun 2015: Direktif Penguatkuasaan Keperluan Kajian Bioekuivalens (BE) Bagi Produk Generik Dalam Bentuk Dos Oral Tablet/Kapsul Yang Bersifat Effervercent, Dispersible, Orodispersible, Sublingual, Buccal Dan Chewable Yang Mengandungi Bahan Aktif Racun Berjadual (23 February 2015)

Bil. (45) dlm.BPFK/PPP/01/03 Jld.3

Lanjutan Tarikh Penguatkuasaan Untuk Memenuhi Keperluan Kajian Bioekuivalens (BE) Bagi Produk Generik Dalam Bentuk Dos Oral Tablet/Kapsul Yang Bersifat Effervescent, Dispersible, Orodispersible, Sublingual, Buccal dan Chewable Yang Mengandungi Bahan Aktif Racun Berjadual (31 May 2016)

(vi) Regulatory control of active pharmaceutical ingredient (API) for all dosage form of registered pharmaceutical products containing scheduled poison (For expiring product registrations starting from 1 January 2020)

• API information shall be submitted at least one year prior to the product registration expiry date.

• Refer to Appendix 11: Regulatory Control of Active Pharmaceutical Ingredients

References:

Bil. (7) dlm.BPFK/PPP/07/25

Arahan Pengarah Kanan Perkhidmatan Farmasi Bil. 8 Tahun 2013: Direktif Pelaksanaan Pengawalan Bahan Aktif Farmaseutikal Bagi Produk Generik (Fasa II) (16 January 2014)

Bil. (11) dlm.BPFK/PPP/01/03 Jld.3

Lanjutan Tarikh Pelaksanaan Pengawalan Bahan Aktif Farmaseutikal (API) Bagi Produk Farmaseutikal Berdaftar Yang Mengandungi Racun Berjadual (27 June 2014)

(vii) For pharmaceutical products submitted for registration before 2009, applicants shall ensure that the Zone IVB stability study for the products have been conducted and granted variation approval before submission of re-registration application.

References:

Bil. (1) dlm. BPFK/PPP/01/03 Jld.3

Keperluan Data Kajian Stabiliti Dalam Zon IVb Bagi Produk Farmaseutikal Berdaftar (5 April 2013)

Bil. (5) dlm. BPFK/PPP/01/03 Jilid 3

Lanjutan Tarikh Kuatkuasa Untuk Memenuhi Keperluan Data Kajian Stabiliti Dalam Zon IVb Bagi Produk Farmaseutikal Berdaftar (14 August 2013)

For pharmaceutical products requiring exemption from Zone IVb requirements, applicants shall submit the exemption request via variation application (MiV-PA) through the online QUEST system. 

(viii) Valid GMP document/ certificate for imported product (starting 1 January 2014)

To maintain the registration of an imported product, the PRH shall comply with GMP requirements as stated in the directive issued by the Director of Pharmaceutical Services under Regulation 29, CDCR 1984.

Refer to Guidance Document for Foreign GMP Inspection

References:

Bil. (25) dlm BPFK/PPP/01/03 Jld.1 Arahan Pengarah Kanan Perkhidmatan Farmasi Bil. 1 Tahun 2012: Direktif Mengenai Syarat Pendaftaran Produk Farmaseutikal Dari Luar Negara Berkaitan Keperluan Amalan Perkilangan Baik (APB) (9 February 2012)

Bil. (96) dlm.BPFK/PPP/01/03 Jld.2 Surat Pekeliling Bagi Direktif Mengenai Syarat Pendaftaran Produk Farmaseutikal Dari Luar Negara Berkaitan Keperluan Amalan Perkilangan Baik (APB) (28 December 2012)

Bil. (32) dlm. BPFK/PPP/07/25 Arahan Pengarah Kanan Perkhidmatan Farmasi Bil. 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) (22 January 2016)

Bil. (42) dlm.BPFK/PPP/07/25 Arahan Pengarah Kanan Perkhidmatan Farmasi Bil. 11 Tahun 2016: Direktif Mengenai Penerimaan Pengesahan Pematuhan Amalan Perkilangan Baik (APB) Bagi Tujuan Pendaftaran Semula Produk Farmaseutikal Berdaftar dengan Pihak Berkuasa Kawalan Dadah (PBKD) (30 June 2016)

Bil. (15) dlm. BPFK/PPP/06/06 Jld.47 Pendaftaran Bersyarat Bagi Produk-Produk Dengan Sijil Amalan Perkilangan Baik (APB) dari Ministry of Economic Affairs, Taiwan (1 February 2017)

KKM/NPRA.PKP/600-2/11(7) Arahan Pengarah Kanan Perkhidmatan Farmasi Bil. 4 Tahun 2018: Direktif Mengenai Penerimaan Pengesahan Pematuhan Amalan Perkilangan Baik (APB) Bagi Pengilang Farmaseutikal Bagi Tujuan Pendaftaran Baru/ Pendaftaran Semula Produk Farmaseutikal Berdaftar Dengan Pihak Berkuasa Kawalan Dadah (PBKD) (16 May 2018)

(ix) Amendment of product name consisting of only generic name for registered pharmaceutical product containing scheduled poison and non-scheduled poison (starting 1 January 2017)

Reference:

Bil. (39) dlm. BPFK/PPP/01/03 Jld.3

Pekeliling Penggunaan Nama Generik Pada Nama Produk Bagi Produk Farmaseutikal (21 December 2015) 

(x) Endorsement letter of ancillary medical device component (from Medical Device Authority, Malaysia) for re-registration of drug-medical device combination product (For expiring product registrations starting from 1 July 2019)

Note: Also refer to Guideline for Registration of Drug-Medical Device and MedicalDevice-Drug Combination Products.

Reference: Bil. (9) dlm. BPFK/PPP/07/25 Jld.1

Arahan Pengarah Kanan Perkhidmatan Farmasi Bil. 4 Tahun 2017: Direktif Kuatkuasa Pemakaian Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products (10 March 2017)

 

WITHDRAWAL OF PRODUCT REGISTRATION

a) The PRH shall submit an official written request to the DCA Secretary if they decide to withdraw the registration of a product before the end of the validity of such registration. The PRH is required to state the reasons for the withdrawal decision in their request. The PRH is also required to inform their manufacturer/ contract manufacturer of their withdrawal decision.

b) The registration of a product, once withdrawn, shall not be reinstated. A new application for product registration is required if the PRH wishes to have the product registered again at a later date.

 

 

 

 

 

  

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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