Contracted Manufacturing Drugs Granted Registration Numbers Valid for a Maximum of 5 Years

According to the provisions of Article 6 Circular 23/2013/TT-BYT, contract-manufactured drugs are granted a registration number with a maximum validity of five (05) years from the date of issuance of the decision to grant the registration number and shall not exceed the validity of the registration number of the drug to be contract-manufactured.

Also according to Circular 23, the validity of the transitional contract-manufactured drug registration number is equal to the remaining validity of the previous stage's drug registration number. In special cases, the Drug Registration Advisory Council - Ministry of Health will consider and propose to the Minister of Health for a decision.

Within six (06) months before and six (06) months after the contract-manufactured drug registration number expires, the establishment may submit a re-registration dossier. Beyond the stipulated time, the establishment must re-submit the dossier as for the first-time registration of contract-manufactured drugs.

Illustration (source: internet)

In addition, Circular 23 also stipulates that for drugs that have a circulation registration number in Vietnam and are contracted for manufacturing, the validity of the old registration number will terminate three (03) months from the effective date of the contract-manufactured registration number; contract-manufactured drugs produced before the old registration number's expiration date can be circulated until the expiration date of the drug.

Regarding the contract-manufacturing of drugs, it is also specified in Circular 23/2013/TT-BYT as follows:

- For drugs that have a circulation registration number in Vietnam: They may be contract-manufactured in one, several, or all stages of the production process at one or several contract-manufacturers;- For drugs that do not have a circulation registration number in Vietnam: The entire production process can be contract-manufactured and only at one contract-manufacturer.

Regarding forms of contract-manufacturing registration: Chemical drugs, medical biological products, vaccines, antibody-containing sera, In vitro diagnostic biological products, herbal drugs (excluding traditional medicine) can be registered for contract-manufacturing under the following forms:

- Initial contract-manufacturing registration;- Major change registration;- Minor change registration;- Re-registration;- Other change registration.

See detailed regulations at Circular 23/2013/TT-BYT, effective from October 1, 2013.

Thu Ba

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