Vietnam: When shall the Certificate of marketing authorization of bioproducts be revoked?

This is a notable content specified in Decree No. 60/2016/NĐ-CP of Vietnam’s Government providing for certain regulatory requirements for trade and investment in the environment and natural resource sector.

According to Decree No. 60/2016/NĐ-CP of Vietnam’s Government, Certificate of marketing authorization of bioproducts shall be withdrawn or revoked in the following circumstances:

- Certificate of marketing authorization of bioproducts is issued in contravention of applicable regulations;

- There is any change to ingredients of bioproducts;

- Competent regulatory authorities have verified that those bioproducts which have been registered for marketing authorization have been found in violation of industrial property rights.

Also according to Decree No. 60/2016/NĐ-CP, organizations or individuals subject to withdrawal or revocation of the certificate of marketing authorization of bioproducts shall be responsible for withdrawing and treating bioproducts which have been manufactured, imported and currently launched into the market.

When the certificate of marketing authorization of bioproducts is subject to withdrawal or revocation, the Vietnam Environment Administration shall bear a burden of displacing these bioproducts from the approved list of bioproducts used in waste treatment in Vietnam.

View relevant provisions at Decree No. 60/2016/NĐ-CP of Vietnam’s Government, effective from July 01, 2016.

- Thanh Lam -

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