Sign up for the production of pharmaceuticals in water

 Consultation procedures : Registration using medicines produced in the country


Apply for organizations producing pharmaceuticals in water

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 - Check the unit informed , decision issued registration number at reception

Method of implementation: By mail or submitted directly to the department clerical Drug Administration

Composition , the number of records

a) Composition profiles include:

1 - Cover Sheet (Form 1 DKT )

2 - Table of Contents Profile (Form 2 DKT )

3 - The application for registration (Form 4A DKT )

4 - Summary of drug characteristics ( Form 6 DKT )

5 - Manufacturing Process ( daydu , details ) ;

6 - quality standards and test methods ( full details ) ;

7 - form of the drug testing facility cuamot Testing Institute , tested campuses . Having manufacturing facilities with GMP , GLP laboratory at

8 Research Paper on Stability

9 - Drug labels ( designed or attached to Form 7 DKT )

10 - Samples of raw materials : 1 for 1 packing unit specifications circulation registration

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

b ) Number of records : 03 sets ( 1 set of main + 02 copies)

Time limit for settlement : Within 06 months from the date of receipt of a valid application

Subjects of administrative procedures : Organize

Implementing Agency administrative procedures : Drug Administration , Ministry of Health

Results of the implementation of administrative procedures : Sodangky

State Fees : Phithamdinhhoso : 1,500,000 VNĐ

Tenmaudon , declaration form ( Dinhkemthutucnay )

    Trangbia : DRUG APPLICATION DOMESTIC PRODUCTION
    Mucluc DRUG APPLICATION DOMESTIC PRODUCTION
    DRUG APPLICATION FOR DOMESTIC PRODUCTION
    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 .

2 - 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

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