To annul 13 administrative procedures in the pharmaceutical sector under the management of the Ministry of Health in Vietnam

To annul 13 administrative procedures in the pharmaceutical sector under the management of the Ministry of Health in Vietnam (Internet image)

Regarding this issue, LawNet would like to answer as follows:

On August 31, 2023, the Ministry of Health issued Decision 3419/QD-BYT on the announcement of newly issued administrative procedures and abolished administrative procedures in the pharmaceutical sector under the management functions of the Ministry of Health in Circular 16/2023/TT-BYT.

To annul 13 administrative procedures in the pharmaceutical sector under the management of the Ministry of Health in Vietnam

Specifically, administrative procedures are abolished in the pharmaceutical field under the management functions of the Ministry of Health as follows:

(1) Registration of processed drugs that have a valid registration number for circulation in Vietnam (drugs from medicinal herbs except oriental drugs)

(2) Registration of processed drugs that do not have a registration number for circulation in Vietnam (finished pharmaceutical products, vaccines, serum containing antibodies, medical biological products): Generic

(3) Registration of processed drugs that do not have a registration number for circulation in Vietnam (drugs from medicinal herbs except oriental drugs)

(4) Registration of processed drugs of that drug with a valid registration number for circulation in Vietnam (finished pharmaceutical drugs, vaccines, serum containing antibodies, medical biological products) - Drugs that have been implemented according to ACTD

(5) Registration of processed drugs of drugs that have a valid registration number for circulation in Vietnam (finished pharmaceutical products, vaccines, serum containing antibodies, medical biological products) - Drugs that have not been implemented according to ACTD

(6) Register processed drugs for export (not circulated in Vietnam)

(7) Registration of processed drugs that do not have a registration number for circulation in Vietnam (finished pharmaceutical products, vaccines, serum containing antibodies, medical biological products): new drugs

(8) Registration of processed drugs that have a valid registration number for circulation in Vietnam (diagnostic biological products)

(9) Registration of processed drugs that do not have a registration number for circulation in Vietnam (diagnostic biological products)

(10) Re-registration of processed drugs (diagnostic biological products, including semi-finished products)

(11) Re-registration of processed drugs (finished pharmaceutical products, vaccines, serum containing antibodies, medical biological products) - drugs registered for processing for the first time have been carried out according to ACTD.

(12) Re-registration of processed drugs (drugs from medicinal herbs, except oriental drugs)

(13) Re-registration of processed drugs (finished pharmaceutical products, vaccines, serum containing antibodies, medical biological products) - Drugs registered for the first time have not been carried out according to ACTD.

In addition to abolishing the above procedures, Decision 3419/QD-BYT also announced newly issued administrative procedures as follows:

- Procedures for granting circulation registration certificates for processed drugs and technology transfer drugs in case of drugs ordered for processing or the drug before technology transfer has a valid circulation registration certificate in Vietnam at the time of application submission

- Procedures for granting circulation registration certificates for processed drugs and technology transfer drugs in cases where drugs ordered for processing or drugs before technology transfer do not have a circulation registration certificate in Vietnam
or the registration certificate for circulation in Vietnam expires at the time of application submission.

- Procedures for granting circulation registration certificates for processed drugs with the transfer of drug production technology from the facility ordering the drug processing to the facility receiving the drug processing in case the processed drug has a valid registration certificate for circulation in Vietnam at the time of application submission

- Procedures for granting circulation registration certificates for processed drugs with the transfer of drug production technology from the facility ordering the drug processing to the facility receiving the drug processing in case the drug ordered for processing does not have a registration certificate for circulation in Vietnam or the registration certificate for circulation in Vietnam is expired at the time of application submission.

- Procedures for renewing circulation registration certificates for processed drugs and technology transferred drugs

- Procedures for changing and supplementing circulation registration papers for processed drugs and technology transferred drugs - Subject to major changes

- Procedures for changing and supplementing circulation registration papers for processed drugs and technology transferred drugs - Minor changes

- Procedures for changing and supplementing circulation registration papers for processed drugs and technology transferred drugs - Minor changes only require notification

More details can be found in Decision 3419/QD-BYT taking effect on October 1, 2023.

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