The 2016 Law on Pharmacy was passed by the National Assembly on April 6, 2016, and came into effect on January 1, 2017 (replacing the 2005 Law on Pharmacy). Some of the basic new points amended compared to the 2005 Law on Pharmacy are as follows:
Article table of contents
Regulations on Drug Registration and Raw Materials for Drug Production
- Supplementary regulations on the form of extending the validity of drug registration certificates and raw material registration certificates instead of re-issuing these certificates, thereby shortening the issuance time for this procedure (from 6 months to 3 months).- Specific regulations on the time frame for issuing drug registration certificates for each case, specifically: not more than 03 months for extension, change, or addition to the drug registration certificate; not more than 12 months for the issuance of a new drug registration certificate to ensure it aligns with practical, regional, and global integration trends.
Several Pharmaceutical Establishments to Operate Without Business License Certification
Pharmaceutical establishments that do not require a Business License Certification include:
- Establishments involved in pharmaceutical activities but not for commercial purposes;- Businesses with a designated medicine shelf;- Facilities for growing, harvesting medicinal herbs;- Medical establishments of the people's armed forces providing medicine in areas inhabited by ethnic minorities, mountainous regions, islands, and areas with particularly difficult socio-economic conditions.
The operational conditions for these establishments are defined as follows:
- Establishments involved in pharmaceutical activities but not for commercial purposes must comply with the business conditions stated in Clause 1, Article 33 of the Law on Pharmacy 2016;- Businesses with a designated medicine shelf must have a business registration, appropriate drug storage conditions as stated on the drug label, a responsible person with a professional qualification in pharmacy, and can only sell drugs listed in the medicine shelf directive as specified by the Minister of Health;- Facilities for growing, harvesting medicinal herbs must follow Good Agricultural and Collection Practices (GACP);- Medical establishments of the people's armed forces providing medicine in areas inhabited by ethnic minorities, mountainous regions, islands, and areas with particularly difficult socio-economic conditions must have appropriate drug storage conditions as stated on the drug label, and a responsible person with a professional qualification in pharmacy.
Several New Regulations on Drug Recall
New regulations regarding drug recall include:
- Types of drug recall:- Voluntary recall initiated by the drug registration establishment, production establishment, import establishment, or import entrustment establishment;- Mandatory recall as per the decision of the competent state authority in cases outlined in Article 62 of the Law on Pharmacy 2016.- Levels of drug violations include:- Level 1: Drugs that pose a serious risk to health or affect the life of users;- Level 2: Drugs that lack sufficient therapeutic efficacy or safety issues for users, but not to the extent of causing serious harm to health or life;- Level 3: Cases not falling under the above levels but due to other reasons without impacting therapeutic efficacy and safety.- Scope and time required for drug recall:- Recall from all pharmaceutical businesses, medical examination and treatment establishments, and users for Level 1 violations. The recall must be completed within 03 days from the recall decision date;- Recall from all pharmaceutical businesses, medical examination and treatment establishments, and users for Level 2 violations. The recall must be completed within 15 days from the recall decision date;- Recall from all pharmaceutical businesses for Level 3 violations. The recall must be completed within 30 days from the recall decision date;- In case of Level 1 violations beyond the recall capacity of domestic production establishments, import establishments, or import entrustment establishments, and if the recall is not executed within the stipulated time, compulsory recall will be enforced as per legal regulations.- Handling of recalled drugs:- Drugs recalled under points a and b, Clause 2 of this Article must be destroyed;- Drugs recalled under point c, Clause 2 of this Article can be remedied, re-exported, or destroyed if remediation is not possible.
Additionally, the authority to issue drug recall decisions and the recall procedures are as follows:
- The Ministry of Health will issue drug recall decisions in cases of mandatory recall and voluntary recall for Level 1 and Level 2 violations.
The time to issue a recall decision is no more than 24 hours from the conclusion that a drug falls under a recall category or that a voluntary recall is inconsistent with the violation level.
- The head of the drug registration establishment, domestic production establishment, drug mixing, processing, preparation establishment, import establishment, or import entrustment establishment will issue a recall decision for Level 3 voluntary recall violations, after consulting with the Ministry of Health.
The time to issue a recall decision is no more than 24 hours after receiving the Ministry of Health’s opinion.
