Summary of prohibited acts in the pharmaceutical field in Vietnam

Summary of prohibited acts in the pharmaceutical field in Vietnam (Internet image) 

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

1. Summary of prohibited acts in the pharmaceutical field in Vietnam

- Running a pharmacy business without the Certificate of eligibility for pharmacy business or while being suspended or while the Certificate of eligibility for pharmacy business is suspended.

- Running a pharmacy business at a location other than the registered business location.

- Dealing in drugs and medicinal ingredients specified in Clause 26 Article 2 of the Law on pharmacy 2016, other drugs and medicinal ingredients for improper purposes or providing drugs and medicinal ingredients for entities that are not permitted by competent authorities.

- Running a pharmacy business beyond the scope written in the Certificate of eligibility for pharmacy business.

- Running a pharmacy business that involves:

+ Counterfeit drugs or medicinal ingredients;

+ Unqualified drugs or medicinal ingredients; drugs or medicinal ingredients that have to be recalled as requested by a competent authority; drugs or medicinal ingredients of unknown origins; expired drugs or medicinal ingredients;

+ Drugs or medicinal ingredients on the List of drugs and medicinal ingredients banned from import or manufacture;

+ Drugs for clinical trial;

+ Drugs or medicinal ingredients as samples for registration, testing, scientific research, or display at a fair or exhibition;

+ Drugs or medicinal ingredients that have not been licensed for free sale;

+ Drugs that belong to a National Target Program, drugs as aid and other drugs banned from selling;

+ Retailing prescription drugs without prescription; retailing vaccines;

+ Selling drugs at higher prices that declared or listed prices.

- Forging, falsifying documents or certificates of competent authorities and other entities in pharmacy activities.

- Changing, falsifying shelf life of drugs except for those specified in Clause 3 Article 61 of the Law on pharmacy 2016.

- Holding the positions specified in Article 11 of the Law on pharmacy 2016 without a pharmacy practice certificate or while the pharmacy practice certificate is suspended.

- Renting, borrowing, leasing out, lending the pharmacy practice certificate or Certificate of eligibility for pharmacy business, or allowing another person to use it to practice pharmacy or do pharmacy business.

- Advertising in the following cases:

+ Advertising drugs before a competent authority certify the advertising content or against the contents certified by the competent authority;

+ Using a certificate not recognized by the Ministry of Health; using material benefits, reputation of an organization or individual, symbols, images, positions, mails, letters of thanks to advertise drugs;

+ Using results of clinical trial or pre-clinical trial, testing results, results of bioequivalence study that are not recognized by the Ministry of Health to advertise drugs.

- Running sale promotion of drugs against the law.

- Profiteering by prescribing drugs.

- Manufacturing, concocting, selling traditional medicines combines with active ingredients without permission by a competent authority.

- Dispensing, selling expired drugs or drugs that are not stored in accordance with instructions on the labels, drugs that have to be recalled as requested by a competent authority, drugs of unknown origins.

- Providing information, advertising, marketing, prescribing, counseling, labeling, giving instructions that non-medicinal products can be used for prevention, treatment, diagnosis, alleviation of diseases or regulating human physiological functions, except for medical equipment.

- Exporting herbal ingredients on the List of controlled rare and special herbs before being licensed by a competent authority.

(Article 6 of the Law on pharmacy 2016)

2. Pharmacy authorities in Vietnam

- The Government shall uniform state management of pharmacy.

- The Ministry of Health is responsible to the Government for state management of pharmacy.

- Other Ministries and ministerial agencies shall carry out state management of pharmacy ex officio and cooperate with the Ministry of Health in state management of pharmacy as assigned by the Government.

- The People’s Committees shall carry out state management of pharmacy locally.

(Article 4 of the Law on pharmacy 2016)

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