Key New Points of the Law on Pharmacy 2016

Law on Pharmacy 2016 has several fundamental amendments compared to Law on Pharmacy 2005 as follows: Regarding the regulations on drug registration, supplementing the form of extending the drug circulation registration certificate, the material for making drugs replaces the reissuance of the drug circulation registration certificate, shortening the issuance period for this form (from 6 months to 3 months).

The new Law on Pharmacy takes effect from January 1, 2017. Illustration: Chinhphu.vn

For establishments engaged in pharmaceutical activities not subject to certification of eligibility for pharmaceutical business, including establishments engaged in pharmaceutical activities but not for commercial purposes; business establishments with organized drug counters.

Establishments cultivating and harvesting medicinal plants; medical facilities under the People's Armed Forces that provide drugs in ethnic minority areas, mountainous areas, islands, areas with particularly difficult socio-economic conditions.

Additionally, the Law on Pharmacy 2016 also introduces new regulations on drug recall, including:

- Voluntary recall is carried out by the drug registration establishment, manufacturing establishment, importing establishment, or entrusted import establishment;- Mandatory recall is implemented as per the decision of the competent state agency in cases specified in Article 62 of the Law on Pharmacy 2016.

Tightening the management of drugs to protect users. Illustration: TTXVN.

According to new regulations, handling of recalled drugs as stipulated by law will be decided by the Ministry of Health in mandatory recall cases and in voluntary recall cases when the drug violates level 1 or level 2.

The decision to recall drugs must be made within 24 hours from the conclusion that the drug falls under the recall category and the level of violation or from the conclusion that the voluntary recall is not commensurate with the level of violation.

The head of the drug registration establishment, domestic drug manufacturing establishment, drug processing, formulating, manufacturing establishment, importing establishment, or entrusted import establishment decides on the recall of drugs in voluntary recall cases where the drug violates level 3 after obtaining the opinion of the Ministry of Health.

The decision to recall drugs must be made within 24 hours from obtaining the opinion of the Ministry of Health.

Source: Vietnam Education Electronic Newspaper

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