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Vietnam – Overview of Pharmaceutical Licensing.

9 May, 2014

 

Legal News & Analysis – Asia Pacific – Vietnam – Corporate/M&A

 

 

  Operating License for foreign pharmaceutical company (OL)  Drug registration  
Purpose   The holder of the OL may:

  • Supply drugs directly to local importers;
  • Be the holder of the Marketing Authorization (MA) for circulation of drugs in Vietnam;
  • Organize scientific seminars to exchange professional experience and information; and
  • Engage in certain types of marketing activities such as advertising non-prescription drugs or conducting drug introduction activities.
To allow the circulation of the registered drug within Vietnam. 
Licensing authority   Ministry of Health (MOH)  Drug Administration of Vietnam (DAV) under the MOH 
Government filing fees   VND 15m (approx. USD 750) VND 4.5-6m(approximately USD 220-300)(depending on whether the medicinal products have data confidentiality requirements or bioequivalent dossier and/or clinical dossier requirements) 
Key documents required in dossiers 1. Application;

2. Company profile;
 3. Legalized copy of Certificate of Incorporation and/or Business Registration Certificate; 

4. Legalized copy of the License for Manufacturing and/or

Trading in Pharmaceuticals/ Vaccines;

 

5. Legalized copy of the GMP Certificate and/or GDP

Certificate;

 

6. Legalized Taxation Certificate.

 

The application dossier must be made in English and Vietnamese, in one original set. Any language other than English or Vietnamese must be translated into Vietnamese and certified by a competent agency.

 

An application dossier for a new chemical entity (NCE) registration should include the following parts:

  • Part I. Administrative data and product information;
  • Part II. Quality;
  • Part III. Preclinical/Safety; and
  • Part IV. Clinical/Efficacy.

 

An application dossier for generic drug registration only needs to include Part I and Part II.

Timeframe   4-6 months from the date of submission of the complete application documents  For new registration: 

  • Vaccines, biological medicines and chemical medicines (NCEs): 18-24 months from the date of submission of the dossier
  • Generics: 14-22 months from the date of submission of the dossier

 

Renewal: 12-14 months from the date of submission of the dossier;

 

Variation: 4-6 months from the date of submission of the dossier

Comments   The OL is a key license that a foreign pharmaceutical company should obtain from the beginning because it allows it to conduct further actions such as holding MAs, directly supplying drugs to a local importer, advertising drugs, etc. To successfully obtain an OL, a foreign pharmaceutical company must satisfy certain primary criteria, such as having valid licenses for manufacture or trading in the country of origin and having at least 3 years of experience in manufacture or trading of medicines. 

This is a time-consuming procedure. It may take up to 8 months or so to obtain this license.

The MA holder must hold appropriate licenses, such as Certificate of satisfaction of eligibility of drug business conditions (for domestic applicants), or OL (for foreign applicants). 

 

  Drug advertisement registration Registration for provision of drug information documents to medical professionals  Registration for holding a drug introduction seminar for medical professionals
Purpose To advertise non-prescription drugs to the general public  To provide information on drugs (prescription and non-prescription drugs) to medical professionals. To introduce information on drugs (prescription and non-prescription drugs) to medical professionals.
Licensing authority DAV DAV Provincial Department of Health (DOH)
Government filing fees VND 1.8m (approx. USD 90) VND 1.8m (approx. USD 90) VND 1.8m (approx. USD 90)
Key documents required in dossiers 1. Application;2. Maquette for advertisements; 

3. Package inserts

 

4. Copy of the Incorporation License and Certificate of satisfaction of eligibility of drug business conditions (for domestic companies):

 

5. Copy of Rep. Office License and OL (for foreign companies); and

 

6. Copy of MA or Decision of issuance of MA numbers issued by the DAV.

 

1. Application;2. Maquette for drug information documents; 

3. Package inserts;

 

4. Copy of the Incorporation License and Certificate of satisfaction of eligibility of drug business conditions (for domestic companies):

 

5. Copy of Rep. Office License and OL (for foreign companies); and

 

6. Copy of MA or Decision of issuance of MA numbers issued by the DAV.

 

1. Application;2. Proposed seminar schedule; 

3. Copy of MA or Decision of issuance of MA numbers issued by the DAV; or CPP issued by the authority in the country of origin (if any);

 

4. Copy of the Incorporation License and Certificate of satisfaction of eligibility of drug business conditions (for domestic companies):

 

5. Copy of Rep. Office License and OL (for foreign companies);

 

6. Package inserts; and

 

7. CV and speech of each speaker.

Timeframe   1-2 months from the date of submission of the complete documents 1-2 months from the date of submission of the complete documents 10-15 days from the date of submission of the complete documents
Comments   All drug advertisement must be approved by the DAV in advance. All advertisement of (non-prescription) drugs must comply with the DAV approval in all aspects (advertising content, form, etc.). 

It is prohibited to advertise prescription drugs to the public.

All drug informative documents for medical professionals must be approved by the DAV in advance. The drug informative documents may only be provided to medical professionals. 

These documents must not be provided to the public.

All drug introduction seminars must be approved by the provincial DOH in advance.

Unregistered drugs may only be introduced to medical professionals at seminars for introduction of drugs to medical professionals.

 

Tilleke & Gibbins T&G - Stylized

 

For further information, please contact:

 

Michael K. Lee, Partner, Tilleke & Gibbins

michael.l@tilleke.com

 

Tilleke & Gibbins Corporate/M&A Practice Profile in Vietnam


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