Required documents:
I. Administrative records and product information
- Cover page (Form 1/TT)
- Table of content;
- Application for registration (Form 2A/TT);
- Authorization Letter (if any) (Form 3/TT);
- The Certificate of operating in medicine, medicine raw material in Vietnam;
- CPP Certificate;
- FSC Certificate if foreign medicine company does not have CPP;
- GMP Certificate of the foreign manufacturing company if the medicine registration unit hands the FSC or CPP Certificate without confirmation of GMP standards. In case many manufacturing units took place in the process of medicine manufacture, the medicine registration unit must hand GMP Certificates of all these manufacture units;
- Labeling materials: 02 sets of designed labeling materials. For foreign medicine, 01 original set of labeling materials circulating in country of origin is also required. These materials are enclosed into the A4 paper with stamp of registration unit or manufacture unit.
- Product information: Package insert for generic medicine with stamp of registration unit or manufacture unit.
- The overall record of manufacturer (Form 4/TT). In case one product is produced through many steps, overall record must be the record of all manufacturer joining processes of making the product before delivering to the market.
II. Quality record will be prepared under the guidance in Part II – ACTD and include the following documents:
- Table of content;
- General summary on quality;
- Content and figure;
- Reference materials;
For specific requirement of the quality record, please refer to the below for your preparation:
New requirements on quality record
I. Drug substance
1. General information
1.1 Nomenclature
1.2 Structure
1.3 General properties
2. Manufacturer
Name and add of the manufacturer
3. Characterisation
3.1 Elucidation of Structure and other characteristics
3.2 Impurities
4. Control of Drug Substance
4.1 Specification
4.2 Analytical procedures
4.3 Validation of Analytical procedures
5. Reference standards or materials
6. Stability
II. Drug product
1. Description and composition
2. Pharmaceutical development
2.2 Components of the drug product
2.3 Finished product
2.5 Container closure system
2.6 Microbiological Atrributes
2.7 Compatibility
3. Manufacture
3.1 Batch formula
3.2 Manufacturing process and process control
3.3 Control of critical steps and intermediates
3.4 Process validation and/or evaluation
4. Control of excipients
4.1 Specifications
4.2 Analytical procedures
4.3 Excipient of human or animal origin
5. Control of finished product
5.1 Specification
5.2 Analytical procedures
5.3 Validation of analytical procedures
5.5 Characterisation of Impurities
5.6 Justification of specification
6. Reference standards or materials
7. Container closure system
8. Stability
9. Interchangeability Equivalence evidence (not required if the pharmaceutical product is generic)
Time frame
Under the Vietnamese legal regulation, it takes 06 months, then the Ministry of Health will issue a Notification requesting the supplementation or amendment. Therefore, it normally takes up to 8-9 months to obtain visa number after accurate and sufficient amendment. However, after executing the new regulations on medicine registration, it may take 12-15 months to obtain visa.
Renewal of medicine registration Pharmaceutical product license
Please note that upon completion of renewal of medicine registration, a new visa number will be granted.
Required documents:
I. Administrative records and product information
Like the required documents as indicated in the above administrative records for medicine registration in Vietnam
II. Quality record
- Specification and Control method of finished product;
- Specification and Control method of all ingredients which are not listed in the pharmacopoeia;
- Specification and Control method of packaging material
III. Circulation report (Form 5A/TT)
01 original;
02 copies of application for medicine registration and specification of finished product.
Time frame
Under the Vietnamese legal regulation, it takes 06 months, but in reality, it may take up to 08-12 months to complete the renewal.
It if of important note that:
- Before 01/01/2012, for Quality records of a medicine for renewal, in case registration unit can not prepare according to ACTD format and ASEAN technical instructions enclosed this Circular, registration unit is entitled to re-submit documents of “specification” and “test method” like those as filed in the first registration application of that medicine;
- The dossier for renewal of medicine registration is advised to file in a good time (with 06 months before the expiry date of the visa) in order to avoid any forcible temporary interruption if you intend to export the registered medicine into Vietnam during the time you file dossier for such renewal. This is due to the fact that the Ministry of Health is receiving many dossiers for medicine registration as well as renewal. If the consideration process has not been completed while you have exported the products into Vietnam, it shall cause you a lot of troubles. Thus, to avoid any possible inconvenience, please kindly let me know the expiry date of your Marketing Authorization of your product in Vietnam.
For example, if the visa is expired on 01 January 2012, it is advised to immediately file the dossier for renewal on 01 July 2011.
REGULATION ABOUT THE PACKAGING
- According to the legal regulation of Vietnam, the followings must be indicated on the blister:
- Name of the medicine;
- Active ingredients and their contents: For a medicine being the mixture of not more than three active ingredients, each of the active ingredients and its content must be indicated:
- The manufacture batch number and expiry date;
- Name of the manufacturer, which may be abbreviated but must ensure that the manufacturer is identifiable.