View Procedure

Procedure Name

Granting permission to import finished combined drugs containing addictive ingredients, psychotropic substances and precursor substances without registration numbers for circulation Drug Administration of Vietnam - Ministry of Health

Description

Category	License/Permit
Responsible Agency	Drug Administration of Vietnam - Ministry of Health Address: Phone: Email:
Legal base of the Procedure	Law on Pharmacy No. 105/2016/QH13 Decree 102/2016/NĐ-CP on Drug business requirements Decision 151/2007/QD-TTg dated September 12, 2007, promulgating the Regulation on the Import of Drugs without Registration Numbers in Vietnam Circular 19/2014/TT-BYT management of addictive drugs, psychotropic drugs, and drug precursors Circular 47/2010/TT-BYT guiding the export, import of drugs/medicines and packaging in direct contact with drugs/medicines
Processing time	Within 20 working days from the date of reception of adequate and valid dossier
Fee	VND 0

Required documents:

No	Type of documents	Note
1	Import order (Form 5a)	01 original copy
2	Certificate of Pharmaceutical Product (CPP) or domestically-granted Certificate of Free Sale (FSC) and GMP certification	01 original copy
3	Standards and testing methods	01 original copy
4	Original labels enclosed with the user guides in actual circulation in the country of origin	01 original copy
5	Set of labels intended to be put in circulation in Vietnam enclosed with user guides already translated into Vietnamese.	02 original copy
6	Inventory report of addictive ingredients, psychotropic substances and precursor substances (Form 3)	01 original copy
7	Pre-clinical and clinical records for drugs containing new pharmaceutical substances, drugs with new combinations of circulating pharmaceutical substances.	01 original copy

Conditions:

The Ministry of Health shall grant the import permit if one of the following conditions are met:

a) Drugs composed of pharmaceutical ingredients of groups with pharmacological effects or preparation forms with few registration numbers for circulation in Vietnam according

to the list of drugs with registration number for circulation in Vietnam in each period;

b) Drugs composed of pharmaceutical ingredients without registration number in Vietnam:

- Drugs composed of pharmaceutical ingredients with registration number for circulation in Vietnam but at the time of submission of import dossiers, these registration numbers have expired without registration renewal;

- Drugs composed of pharmaceutical ingredients which have been permitted for circulation in other countries but are not yet been granted a registration number in Vietnam, except new pharmaceutical ingredients;

Rare drugs, drugs imported for the needs of treatment

in special cases or the drugs with special formula for the needs of treatment.

(Clause 2 Article 7 of Decision No.151/2007/QD-TTg dated September 12, 2007 of the Prime Minister stipulating on the import of drugs/medicines without registration numbers in Vietnam.

Enterprises having certificates of eligibility for drug/medicine trading and drug/medicine warehouses obtaining standard "Good Storage Practice" (GSP) are imported directly and received entrusting to import finished drugs, addictive ingredients, psychotropic substances and precursor substances with registration numbers for circulation in accordance with the business scope stated in the certificate of eligibility for drug/medicine trading and GSP certificate;

(Clause 1 Article 3 - Circular No. 47/2010/TT-BYT dated December 29, 2010 of the Ministry of Health guiding the export, import of drugs/medicines and packaging in direct contact with drugs/medicines)

Process Steps

Step 1	The applicant shall submit a dossier of Application to the Drug Administration of Vietnam - Ministry of Health
Step 2	The Drug Administration of Vietnam shall receive and examine the dossier.
Step 3	The Administration shall inform the applicant of the results. In case of refusal, the Administration shall reply in writing and clearly state relevant reasons.

Process Map:

Title	Description	Created Date	Updated Date	Issued By
Form 4 - Addictive inventory report	Form 4 - Addictive inventory report	28-05-2016	09-06-2016	Ministry of Health
Form 5b - List of import drugs containing addictive haven't registered	List of import drugs containing addictive haven't registered in the list of the combination	31-05-2016	01-06-2016	Ministry of Health