SB Law provides the legal service for Pharmaceutical Product Registration in Vietnam, we would like to list required documents and legal procedure for client’s reference:

PART A:              ADMINISTRATIVE DOCUMENTS AND PRODUCT INFORMATION

 

No

DESCRIPTION

FORMALITY REQUIREMENT

COPY/01 DOSSIER

IN-CHARGE

Cover page To be made in accordance with the format

01 original

Service Provider draft
Index To be made in accordance with the format

01 original

Service Provider draft
Application To be made in accordance with the format

01 original

Service Provider draft
Power of Attorney (if any) To be made in accordance with the format

01 original

Service Provider draft
Trading License of Applicant

01 Vietnam notarized copy

Manufacturer to provide
CPP –          Should be in effective at the time of submission and assessment.

–          Legalized copy

01 Legalized copy

Manufacturer to provide
GMP and FSC –          Should be in effective at the time of submission and assessment.

–          Legalized copy

01 Legalized copy

Manufacturer to provide
Labelling samples –          02 A4 colour printing copy with stamp of the mannufacturer to be affixed on;

–          01 original labeling sample that are being circulated in the origin country (A4 priting copy with stamp of the mannufacturer to be affixed on)

03 copy as instructed in the Formality requirement. Manufacturer to provide
Packing insert To be made in accordance with the format

01 original

Service Provider draft
Summary of Product characteristic To be made in accordance with the format

01 original

Service Provider draft
Notification of filing acceptance (if product name is not identical to generic name) –          Notarized copy

01 Vietnam notarized copy

Manufacturer to provide
Product sample

01 unit (Blisters in carton box, vial in carton box)

Manufacturer to provide

 

PART B:               QUALITY DOCUMENTS

To be made in accordance with Part II of ACTD(ASEAN COMMEN TECHNICAL DOCUMENTS)

 

No

DESCRIPTION

FORMALITY REQUIREMENT

COPY/01 DOSSIER

IN-CHARGE

Index To be made in accordance with the format –

Part II ACTD

01 original copy

Service Provider draft
Overview on product quality To be made in accordance with the format

Part II ACTD

01 original copy

Manufacturer to provide

Service Provider revise and make modification (if any)

Content and data To be made in accordance with the format

Part II ACTD

01 original copy

Manufacturer to provide

Service Provider revise and make modification (if any)

Reference documents To be made in accordance with the format

Part II ACTD

01 original copy

Manufacturer to provide

Service Provider revise and make modification (if any)

General Profile of the Manufacturer To be made in accordance with the format

Part II ACTD

01 original copy

Manufacturer to provide

Service Provider revise and make modification (if any)

2.         TIMING SCHEDULE

2.1. Dossier preparation:

  • To complete checklist of application dossier(s): 05-10 working day from the date of receipt of dossier from client.
  • To review and draft forms for manufacturer to complete: 15 – 30 working days from the date of receipt of dossier from client.

Note:

  • The above timing schedule may be longer depending on the quantity of application dossier to be dispatched to Service Provider;
  • Only when receiving all required documents (sufficient dossier) as mentioned in the above list, do we submit application dossier to DAV and following up examination process.

2.2. Following up the appraisal process:

Within 14 working days from the date that clients provide SERVICE PROVIDER with sufficient required documents, SERVICE PROVIDER commit to submit the dossier to DAV.

Except other than clientshave any different, timing schedule to follow up the appraisal process shall be 06 months – 08 months from the date of lodging sufficient dossier to DAV.

3.         SERVICE FEE AND MODE OF PAYMENT

3-A      SERVICE FEE

No. Type of product Relevant service fee
1
  • Product having less than 03 generic and such generic is not new substance in Vietnam.
Please contact us for more information
2
  • Products having more than 03 generics; or
  • Product having generic that is new substance in Vietnam;
  • Products having insufficient dossier.
  • Products in the manner of KIT
Please contact us for more information

3-B      SERVICE FEE STRUCTURE

Service fee as mentioned above is inclusive of the following:

  • Translation fee;
  • Communication fee;
  • Photocopy fee.

Service fee as mentioned aboveis exclusive of the following:

  • Official fee of VND1,500,000 (One million and five hundred thousand Vietnam dong) per each dossier to be submitted;
  • 10% value added tax on the total service fee;
If you would like further information on Pharmaceutical Product Registration in Vietnam, please either email to our Partners at: info@sblaw.vn or call to our Office:
Ha Noi Office: +84 (4) 62 62 0246
HCM Office: +84 (8) 35 208 101.
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Hotline: +84.904.340.664 | Email: info@sblaw.vn

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