Cases in which drugs are classified as proprietary drugs or reference biologicals in Vietnam

Cases in which drugs are classified as proprietary drugs or reference biologicals in Vietnam (Internet image) 

What is the proprietary drugs, reference biologicals?

Pursuant to Clause 11, Clause 16, Article 2 of the Law on Pharmacy 2016, regulations on reference biologicals and proprietary drugs are as follows:

- Reference biological means a biological licensed for free sale in Vietnam based on sufficient data about its quality, safety, and efficacy.

- Proprietary drugs means the first drug that is licensed for free sale based on sufficient data about its quality, safety, and efficacy.

Cases in which drugs are classified as proprietary drugs or reference biologicals in Vietnam

According to the provisions of Clause 2, Article 9 of Circular 08/2022/TT-BYT, criteria for classification and cases in which proprietary drugs and reference biologicals are declared in Vietnam include:

* Cases in which drugs are classified as proprietary drugs or reference biologicals

- The drug which has been declared as a proprietary drug or reference biological by the Ministry of Health of Vietnam and has been wholly manufactured in the country of one of the regulatory authorities mentioned in Clause 9 Article 2 of Circular 08/2022/TT-BYT shall continue to be classified as proprietary drug or reference biological in one of the following cases:

+ The marketing authorization of the drug has not yet expired or has been renewed or revised in cases other than the one specified in Point b Clause 2 Article 55 of the Law on Pharmacy 2016. The applicant shall not be required to submit an application for classification of proprietary drug or reference biological;

+ The drug is granted a new marketing authorization in the form of re-registration as prescribed in the Circular 44/2014/TT-BYT and has the same formula, manufacturing processes, quality specifications of materials and finished drug products with the declared proprietary drug or reference biological or has any changes in the said contents approved by the Drug Administration of Vietnam or its home country.

The applicant shall submit an application for update of classification of proprietary drug or reference biological as prescribed in Appendix II enclosed herewith;

+ The drug manufacturer is changed and the drug has been granted a new marketing authorization according to Point c Clause 1 of Article 9 of Circular 08/2022/TT-BYT. The applicant shall submit an application for update of classification of proprietary drug or reference biological as prescribed in Appendix II enclosed with Circular 08/2022/TT-BYT

+ The drug which has been manufactured in a foreign country and declared as a proprietary drug or reference biological by the Ministry of Health of Vietnam, and has not been wholly manufactured in the country of one of the regulatory authorities mentioned in Clause 9 Article 2 of Circular 08/2022/TT-BYT but has been granted the marketing authorization in the country of one of the regulatory authorities mentioned in Clause 9 Article 2 of Circular 08/2022/TT-BYT shall continue to be classified as proprietary drug or reference biological in one of the following cases:

+ The marketing authorization of the drug has not yet expired or has been renewed or revised in cases other than the one specified in Point b Clause 2 Article 55 of the Law on Pharmacy 2016;

+ The drug is granted a new marketing authorization in the form of re-registration as prescribed in the Circular No. 44/2014/TT-BYT and has the same formula, manufacturing processes, quality specifications of materials and finished drug products with the declared proprietary drug or reference biological, or has any changes in the said contents approved by Vietnam’s regulatory authority or its home country;

+ The drug manufacturer is changed and the drug has been granted a new marketing authorization according to Point c Clause 1 of Article 9 Circular 08/2022/TT-BYT;

The applicant shall submit an application for update of classification of proprietary drug or reference biological in the said 03 cases as prescribed in Appendix II enclosed with Circular 08/2022/TT-BYT.

- The drug which has been declared as a proprietary drug or reference biological by the Ministry of Health of Vietnam and of which all manufacturing processes are carried out in Vietnam or one or some manufacturing processes are carried out in Vietnam and others are carried wholly in the country of one of regulatory authorities mentioned in Clause 9 Article 2 of Circular 08/2022/TT-BYT shall continue to be classified as proprietary drug or reference biological in one of the following cases:

+ The marketing authorization of the drug has not yet expired or has been renewed or revised in cases other than the one specified in Point b Clause 2 Article 55 of the Law on Pharmacy 2016. The applicant shall not be required to submit an application for classification of proprietary drug or reference biological;

+ The drug is granted a new marketing authorization in the form of re-registration as prescribed in the Circular 44/2014/TT-BYT and has the same formula, manufacturing processes, quality specifications of materials and finished drug products with the declared proprietary drug or reference biological, or has any changes in the said contents approved by Vietnam’s regulatory authority or its home country.

The applicant shall submit an application for update of classification of proprietary drug or reference biological as prescribed in Appendix II enclosed with Circular 08/2022/TT-BYT;

+ The drug manufacturer is changed and the drug has been granted a new marketing authorization according to Point c Clause 1 of Article 9 of Circular 08/2022/TT-BYT. The applicant shall submit an application for update of classification of proprietary drug or reference biological as prescribed in Appendix II enclosed with Circular 08/2022/TT-BYT.

- The drug which has been declared as a proprietary drug or reference biological by the Ministry of Health of Vietnam, has one or some manufacturing processes carried out in Vietnam and others not carried wholly in the country of one of regulatory authorities mentioned in Clause 9 Article 2 of Circular 08/2022/TT-BYT but has been granted the marketing authorization in the country of one of the regulatory authorities mentioned in Clause 9 Article 2 of Circular 08/2022/TT-BYT shall continue to be classified as proprietary drug or reference biological in one of the following cases:

+ The marketing authorization of the drug has not yet expired or has been renewed or revised in cases other than the one specified in Point b Clause 2 Article 55 of the Law on Pharmacy 2016;

+ The drug is granted a new marketing authorization in the form of re-registration as prescribed in the Circular 44/2014/TT-BYT and has the same formula, manufacturing processes, quality specifications of materials and finished drug products with the declared proprietary drug or reference biological, or has any changes in the said contents approved by Vietnam’s regulatory authority or its home country;

+ The drug manufacturer is changed and the drug has been granted a new marketing authorization according to Point c Clause 1 of Article 9 of Circular 08/2022/TT-BYT;

The applicant shall submit an application for update of classification of proprietary drug or reference biological in the said 03 cases as prescribed in Appendix II enclosed with Circular 08/2022/TT-BYT.

- If the drug has been declared as a proprietary drug or reference biological by the Ministry of Health of Vietnam, and wholly manufactured in the country of one of regulatory authorities mentioned in Clause 9 Article 2 of Circular 08/2022/TT-BYT, and the drug processing is conducted in Vietnam or one, some or all of its manufacturing processes are transferred to a manufacturer in Vietnam, the drug which is processed or manufactured in Vietnam and granted a new marketing authorization shall continue to be classified as a proprietary drug or reference biological provided that it satisfies the criteria in Point b Clause 1 of Article 9 of Circular 08/2022/TT-BYT.

The applicant that places processing order or transfers manufacturing processes to a manufacturer in Vietnam shall submit an application for update of classification of proprietary drug or reference biological as prescribed in Appendix II enclosed with Circular 08/2022/TT-BYT;

- If the drug has been declared as a proprietary drug or reference biological by the Ministry of Health of Vietnam, has not been wholly manufactured in the country of one of regulatory authorities mentioned in Clause 9 Article 2 of Circular 08/2022/TT-BYT but has been granted the marketing authorization in the country of one of the regulatory authorities mentioned in Clause 9 Article 2 of Circular 08/2022/TT-BYT, and the drug processing is conducted in Vietnam or one, some or all of its manufacturing processes are transferred to a manufacturer in Vietnam, the drug which is processed or manufactured in Vietnam and granted a new marketing authorization shall continue to be classified as a proprietary drug or reference biological provided that it satisfies the criteria in Point b Clause 1 of Article 9 of Circular 08/2022/TT-BYT.

The applicant that places processing order or transfers manufacturing processes to a manufacturer in Vietnam shall submit an application for update of classification of proprietary drug or reference biological as prescribed in Appendix II enclosed with Circular 08/2022/TT-BYT;

- The drug which has not yet been declared as a proprietary drug or reference biological by the Ministry of Health of Vietnam shall be classified as a proprietary drug or reference biological if it satisfies the criteria in Point b Clause 1 of Article 9 of Circular 08/2022/TT-BYT.

The applicant shall submit an application for update of classification of proprietary drug or reference biological as prescribed in Appendix II enclosed with Circular 08/2022/TT-BYT.

Nguyen Pham Nhut Tan

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