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Pharmaceutical Product Registration in Vietnam

Pharmaceutical Product Registration

Pharmaceutical Product Registration

Pharmaceutical Product Registration in Vietnam. S&B 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

1
Cover page To be made in accordance with the format 01 original Service Provider draft
2 Index To be made in accordance with the format 01 original Service Provider draft
3 Application To be made in accordance with the format 01 original Service Provider draft
4 Power of Attorney (if any) To be made in accordance with the format 01 original Service Provider draft
5 Trading License of Applicant   01 Vietnam notarized copy Manufacturer to provide
6 CPP
  • Should be in effective at the time of submission and assessment.
  • Legalized copy
01 Legalized copy Manufacturer to provide
7 GMP and FSC
  • Should be in effective at the time of submission and assessment.
  • Legalized copy
01 Legalized copy Manufacturer to provide
8 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
9 Packing insert To be made in accordance with the format 01 original Service Provider draft
10 Summary of Product characteristic To be made in accordance with the format 01 original Service Provider draft
11 Notification of filing acceptance (if product name is not identical to generic name)
  • Notarized copy
01 Vietnam notarized copy Manufacturer to provide
12 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

1 Index To be made in accordance with the format –
Part II ACTD
01 original copy Service Provider draft
2 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)
3 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)
4 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)
5 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 clients have 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 above is 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;

» Guideline for declaration of product quality regarding imported funtional food

License Services:
Contact: Law Firm - SB Law in Vietnam
Complete contact request: Contact Form
Or Tel: 0983367068 / Send request email: dongtaylaw@gmail.com
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