Consultation procedures : Registration of foreign medicines circulating in Vietnam

Applied to the case of traders importing medicines from abroad into Vietnam

The order of

Step 1 - registration dossier is sent Drug Administration ( QLD Department )

Step 2 - Drug Administration receives , records and appraisal review board organized medicine and drug list was issued with registration numbers ;

Step 3 - Trachodonvithongbao , Decision issued registration number at reception

  Composition , the number of records

a) Composition profiles include:

1 - Cover ; ( sample 1 - DKT )

2 - index profile ; ( sample 2 - DKT )

3 - Application for registration (Form 4B - DKT ) ;

4 - Certificate of eligible pharmaceutical or business license for foreign companies in the name of company registration ;

5 - Summary tatdactinhthuoc ( Form 6 - DKT ) ;

6 - License circulation of drugs in water produced by the competent authority ( FSC or CPP ) :

7 - Certificate of GMP ;

8 - Manufacturing Process ( daydu , chitiet ) ;

9 - Quality standards and testing methods ;

10 - Bill drug testing of production facilities ;

11 - Documents stability studies of the drug ;

12 - Drug labels ; ( designed or tied up ( Form 7 - DKT ) ;

13 - Form drugs : 01 units are scratching for an outstanding specification register

14 - Look trademarks or certificate of trademark protection for brand name drugs ;

All records must document the basis produce certify (signature and seal) . Profile foreign drug registration must be written in Vietnamese or English . Report summarizes drug characteristics must be written in Vietnamese .

b ) Soluongho Profile: 03bo ( 1 + 02 bocopy bochinh )

Thoihangiai uyet : Trongthoihan 06 thangketungaynhanduhosohople

Subjects of administrative procedures : Organizations

Implementing Agency administrative procedures : Drug Administration , Ministry of Health

Results of the implementation of administrative procedures : Registration Number

State Fees : Fee for appraisal records : 1,500,000 VNĐ

Name the form, declaration form ( Attachment procedures )

Trangbia : APPLICATION OF FOREIGN pharmaceutical

APPLICATION Mucluc pharmaceutical FOREIGN

FOREIGN DRUG APPLICATION

SUMMARY CHARACTERISTICS OF DRUGS

DRUG LABELS SAMPLES

The requirements and conditions for the implementation of administrative procedures ( if any) : None

The legal basis of administrative procedures

1 - LuatDuocso 34/2005/QH11 14/06/2005..Hieu lucthihanhtungay 01/10/2005 .

 - Decree No. 79/2006/ND-CP dated 09/08/2006 of the Government detailing the implementation of some articles of the Law on pharmaceuticals . Effect 15 days after publication in the newspaper .

3 - Decision dated 18.07.2001 3121/2001/QD-BYT of the Minister of Health Drug Registration Regulation . With effect from the date of signing

4 - Decision No. 07 59/2008/QD-BTC January 21 , 2008 the Minister of Finance amending Decision No 07 44/2005/QD-BTC January 12 , 2005 by the Minister Regarding financial regulation regime of collection , remittance, management and use of charges of trading conditions in the medical field , appraisal fees and standard conditions of medical practice . pharmaceutical production license fees , and import certificate to practice medicine and pharmacy . Effect after 15 days from the date of notice

5 - Thongtuso Health cuaBo 02/2007/TT-BYT on 24/01/2007 . Guide a few things about business conditions medicines and drugs prescribed by Law Decree 79/2006/ND-CP dated 09/08/2006 of the Government detailing the implementation of some articles of the Law on pharmaceuticals . Effect after 15 days from the date of notice