Change Of Product Registration Holder (COH)

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16.3       :   Change Of Product Registration Holder
16.3.1     :   Introduction
16.3.2     :   Conditions
16.3.3     :   Application
16.3.4     :   Processing Fee
16.3.5     :   Supporting Documents
16.3.6     :   Supporting Document Format Example
16.3.7     :   Flowchart For The Change Of Product Registration Holder

 

 

 

 

16.3    CHANGE OF PRODUCT REGISTRATION HOLDER

[Reference: Directive (3)dlm.BPFK/PPP/07/25]

Arahan Pengarah Kanan Perkhidmatan Farmasi Bil 4 Tahun 2013 : Direktif Untuk Meminda Prosedur Permohonan Pertukaran Pemegang Pendaftaran Produk (03 June 2013)

 

16.3.1        INTRODUCTION

 

A transfer procedure for the purpose of changing the existing product registration holder (PRH) that is authorized to market a registered product in Malaysia to another holder.  This procedure allows the registered product to maintain the same registration number.

Upon receipt of complete online application via QUEST system and hardcopy of original documents, the change of PRH application shall be processed within forty-five (45) working days.

 

 

 

 

16.3.2        CONDITIONS

 

The application is subjected to the following conditions:

1)    An application to transfer the marketing authorization of a registered product shall be submitted by the existing PRH.

2)    The new PRH shall be a registered company/ business with Companies Commissioner of Malaysia and a registered QUEST user with National Pharmaceutical Regulatory Division (NPRA).

3)    The registered product intended to be transferred to a new PRH shall have a remaining registration validity period of at least six (6) months. If the registration validity is less than six (6) months, the existing PRH shall first apply for the renewal of this registered product.

4)    No change/s can be made to the technical data or approved pharmaceutical / pharmacological information, including the texts of the product label and leaflet, except the name and address of the approved PRH.

5)    In the interim, the existing PRH shall still bear the marketing authorization responsibility of the said registered product.

6)    The transfer shall come into effect on the day the DCA makes a decision on the outcome of the Change of PRH application. Upon the transfer of product registration to the new PRH, the authorization issued to the previous PRH will be cancelled as the product cannot be marketed simultaneously by two different PRHs. The new PRH shall then bear responsibility for the said product.

7)    However, the existing PRH is allowed to deplete the stocks and will still be held liable should any pharmacovigilance issues or quality defects associated with the product arise during the interim of the transfer.

8)    The existing PRH or newly approved PRH shall submit a written request to deplete the existing stocks after DCA approval has been obtained for the transfer. The PRH that submits the request shall be held responsible for the batches and quantity requested in the event any pharmacovigilance issues or quality defects associated with those product batches arise.

9)    Application shall be rejected if the applicant fails to provide satisfactory required documents within 30 working days starting from the first date of correspondence by the evaluator.

 

 

 

 

 

16.3.3        APPLICATION

 

            The existing PRH shall submit the following documents and payment to NPRA:

1.      Fill and submit application online via the current QUEST system

2.      Processing Fee (refer 16.3.4)

3.      Original Supporting Documents (refer 16.3.5)

 

 

 

 

 

16.3.4        PROCESSING FEE

 

1.            NON-REFUNDABLE processing fee:

-       For a Traditional Product                                  : RM    500.00

-       For a Pharmaceutical Product (including      : RM 1,000.00

Health Supplement)

 

2.            The processing fee shall be paid online via QUEST immediately after the change of PRH application has been submitted.

 

3.            Foreign currency is not accepted.

 

 

 

 

 

16.3.5        SUPPORTING DOCUMENTS 

 

1.      List of required supporting documents:

 

i)     Letter of Authorization (LOA) issued by the Product Owner. If the Product Owner is an entity registered outside of Malaysia then the LOA must be certified by the Notary Public from the country of origin of said Product Owner. However, if the Product Owner is a Malaysian registered entity then the LOA must be certified by a local Commissioner for Oaths The LOA shall consist of the following information:

a.    The registered name and registration number of the product(s) concerned.

b.    Company name, business registration number and address of the proposed new PRH as registered in QUEST.

c.    Company name, business registration number and address of the existing PRH as registered in QUEST.

d.    Effective date of the appointment and termination given by the product owner. If the effective date is not mentioned, the date of the LOA issued will be considered as the effective date.

e.    Signature of the Managing Director/ Director/ President/ Chief Executive Officer/ General Manager who has overall responsibility for the company or organization.

f.     Full and complete name, address, email address (if available), telephone and fax number (if available) of the Product Owner as registered in QUEST.

g.    The Product Owner name and address in the letterhead of the LOA must be identical to the information of the Product Owner registered in QUEST for the product(s) concerned.

 

*Note: LOA format example (Please refer 16.3.6 Supporting Document Format Example)

 

ii)    Resolution by the Company Board of Directors of local Product Owner verifying that ALL the Board of Directors/ Partners have given their consent to the Change of PRH. This resolution must be signed by ALL the Board of Directors/ Partners. If the Product Owner is not a local entity, please omit.

iii)   Latest document indicating details of director/s and shareholder/s of local Product Owner (e.g. Corporate Information, Summary of Share Capital, Directors/Officers, Shareholders/Members from the MyData SSM website).  These documents must be certified by the Commissioner for Oaths (i.e. Statutory Declaration).  If the Product Owner is not a local entity, please omit.

iv)   Resolution by the Company Board of Directors of existing PRH verifying that ALL the Board of Directors/ Partners have given their consent to the Change of PRH.  This resolution must be signed by ALL the Board of Directors/ Partners.

v)    Latest document indicating details of director/s and shareholder/s of existing PRH (e.g. Corporate Information, Summary of Share Capital, Directors/Officers, Shareholders/Members from the MyData SSM website).  These documents must be certified by the Commissioner for Oaths (i.e. Statutory Declaration).

vi)   The Company/ Business Registration Certificate of the proposed new PRH certified true copy by a MAICSA accredited company secretary or by the Companies Commission of Malaysia (e.g. Form 9 and/ or Form 13).

vii) Statement of Acceptance as Product Registration Holder, NPRA-430.5(3) to be filled by the proposed new PRH.

2.    The ORIGINAL documents listed above shall be submitted to the Centre of Product Registration, NPRA once payment for the application has been made.  Photocopies of documents will not be accepted.

3.    Date of the documents including date of stamps/signatures of certifying bodies must be recent, i.e. not exceeding six (6) months from the date of application.

4.    Each page of attachment (if any) i.e. product list must be endorsed by the signatory.

5.    The Secretariat, if necessary, has the right to request further supplementary information or documentation.  Failure to provide these additional information or documentation(s) will result in the rejection of the transfer application.

 

 

 

 

 

 

16.3.6        SUPPORTING DOCUMENT FORMAT EXAMPLE

 

Download :  pdf Letter Of Authorization For Transfer Of Product Registration Holder (89 KB)

 

 

 

 

 

16.3.7 FLOWCHART FOR THE CHANGE OF PRODUCT REGISTRATION HOLDER

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
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