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COS Menu :
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CHANGE OF MANUFACTURING SITE
Change of Manufacturing Site (COS) refers to change of manufacturing site for certain part or all of the manufacturing process of a product, but it does not cover changes related to a new site, where only:
a) batch release takes place OR
b) to a new packager (secondary packaging or labelling), as these changes are covered under applications for amendments to the particulars of a registered product (variation). Please refer to Amendment to the particulars of the product
However, a change of manufacturing site for biologics shall require a new product registration if the change is extensive and will have an impact on the quality, safety and efficacy profile of the final product.
Upon receipt of complete application, the application shall be processed within sixty (60) working days.
CONDITIONS ON APPLICATION FOR COS:
Change in Manufacturing Site is only applicable for the following situations:
a) a change in manufacturing site for the same company, including rationalization in the event of mergers; or
b) a company which previously contracts out the manufacture of its product(s), transfers the manufacture of the product to its own manufacturing premises; or
c) a company appoints a contract manufacturer in Malaysia for pharmaceutical products i.e. scheduled poison, non-scheduled poison & health supplement products except natural products. This change includes a change from a contract manufacturer to a local contract manufacturer or a change from own manufacturing premise to a local contract manufacturer.
Note: The change in manufacturing site for this condition will not be considered if the change is made without acceptable justification or submitted too frequently.
A change of manufacturing site under a crisis situation may be considered for the following:
a) A change between contract manufacturers for natural products;
b) A change to a contract manufacturer outside of Malaysia for pharmaceutical products.
Validity of registration for a product which has been approved for change of manufacturing site remains unchanged.
CONDITIONS ON GOOD MANUFACTURING PRACTICE (GMP):
a) The new manufacturing site shall comply with current Good Manufacturing Practice (cGMP);
b) Local manufacturing sites are subjected to pre-licensing inspections by the NPRA inspectors;
c) For manufacturing sites outside Malaysia, certification on GMP by the competent authority is acceptable.
d) The Authority reserves the right to conduct an inspection on any manufacturing site.
e) For further information pertaining to the requirements on GMP, please refer to these circulars and directive.
i) Bil (35) dlm. BPFK/PPP/01/03
Pemeriksaan Amalan Pengilangan Baik Bagi Pengilang Di Luar Negara (03 June 2009)
ii) Bil (40) dlm. BPFK/PPP/01/03
Pekeliling Pemeriksaan Amalan Pengilangan Baik Bagi Pengilang Di Luar Negara (08 September 2009)
iii) Bil (25) dlm BPFK/PPP/01/03 Jld 1
Arahan Pengarah Kanan Perkhidmatan Farmasi Bil 1 Tahun 2012 : Syarat Pendaftaran Produk Farmaseutikal Dari Luar Negara Berkaitan Keperluan Amalan Perkilangan Baik (APB) (09 February 2012)
iv) 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)
TYPES OF MANUFACTURING SITE CHANGES (COS)
Table XVIII:
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No. |
Types of COS |
Description |
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1. |
Type I |
Change of manufacturing site within Malaysia |
Change in the location of the site of manufacture within Malaysia only. This change may be due to upgrading of facilities, and/or expansion of manufacturing activities or moving to a newly constructed plant, or appointment of a contract manufacturer for pharmaceutical products. |
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2. |
Type II |
Change of manufacturing site from foreign country to Malaysia |
Change in location of the site of manufacture from outside of Malaysia to a location in Malaysia. This change may be due to the ability of the local counterpart to manufacture the product, or appointment of a contract manufacturer for pharmaceutical products. |
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3. |
Type III |
Change of manufacturing site located outside Malaysia |
Change of location of the site of manufacture to manufacturing facilities located outside Malaysia. This may be due to a merger or rationalization of manufacturing sites in line with multinationals’ manufacturing strategies. |
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4. |
Type IV |
Change of manufacturing site for sterile products |
i) Transfer of manufacturing of an aseptically processed sterile product to a: a) newly constructed or refurbished aseptic processing facility or area; b) an existing processing facility or area that does not manufacture similar approved products. (For example, transferring the manufacture of a lyophilized product to an existing aseptic process area where there is no approved lyophilized product is manufactured). ii) Transfer of a finished product sterilized by terminal processes to a newly constructed facility at a different manufacturing site. |
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5. |
Type V |
Change of manufacturing site in crisis situation |
i) Change of location of the site of manufacture that is deemed necessary due to certain circumstances such as natural disasters, closure or suspension of premise (revocation of manufacturing license), bankruptcy and matters related to breach of product quality, safety and efficacy ONLY.
ii) Prior to submission of Type V COS, approval letter issued by the secretariat of the Authority shall be obtained.
iii) Application for Type V COS must be made within three (3) months from the date of the crisis.
iv) Type V COS applications for natural products and health supplements are only applicable for local manufacturers. |
MODE OF SUBMISSION
Applicant shall submit the application through the current online system.
OTHER INFORMATION
a) Application for COS will be rejected if applicant failed to submit required data within six (6) months from the first correspondence date;
b) All supporting documents in accordance to the specified conditions laid down for each type of COS should be submitted. For details, please refer to: Supporting Documents Required For Change Of Manufacturing Site (COS) Application
c) If deemed necessary, NPRA reserves the right to request for additional supporting documents.
d) For further information pertaining to COS, please refer these circulars.
Prosedur Permohonan Pertukaran Tapak Pengilang Produk Berdaftar: Polisi Menolak Permohonan Pertukaran Tapak Pengilang Sekiranya 'Tiada Maklumbalas / Maklumbalas Tidak Lengkap' Dikemukakan Oleh Pemohon Dalam Tempoh Enam (6) Bulan Dari Tarikh Permintaan' (20 May 2009)
ii) Bil (22) dlm. BPFK/PPP/01/03
Keperluan Kajian BioEkuivalens Bagi Produk “Generic Immediate Release Oral Solid Dosage Form” yang Bertukar Tapak Pengilangan (01 February 2009)
iii) Bil (31) dlm. BPFK/PPP/01/03
Makluman Susulan Berkaitan Kajian Bioekuivalens bagi Produk 'Generic Immediate Release Oral Solid Dosage Form' yang Bertukar Tapak Pengilangan (13 May 2009)
iv) Bil (39) dlm. BPFK/PPP/01/03
Permohonan Pertukaran Tapak Pengilang Jenis V Iaitu Pada Situasi Krisis (16 July 2009)
v) (10) dlm.BPFK/PPP/01/03 Jilid 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)
vi) Bil (7)dlm.BPFK/PPP/01/03 Jld. 3
Kebenaran Pertukaran Tapak Pengilang Ke Pengilang Kontrak Tempatan (18 February 2014)
