Saturday, April 21, 2018

Renewal of medicine registration

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
  1. Specification and Control method of finished product;
  2. Specification and Control method of all ingredients which are not listed in the pharmacopoeia;
  3. 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:
  1. 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;
  2. 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.

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