Vietnam: What are the prohibited acts in the pharmacy business? What are the job positions requiring pharmacy practice certificates?
What are the prohibited acts in the pharmacy business in Vietnam?
Prohibited acts in the pharmacy business are specified in Article 6 of the Law on Pharmacy 2016 as follows:
- 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 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, or falsifying shelf life of drugs except for those specified in Clause 3 Article 61 of Law on Pharmacy 2016.
- Holding the positions specified in Article 11 of 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, and 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.
What are the job positions requiring pharmacy practice certificates in Vietnam?
According to the provisions of Article 11 of the Law on Pharmacy 2016, the job positions requiring pharmacy practice certificates in Vietnam include:
Positions requiring pharmacy practice certificates
1. The chief pharmacist of a pharmacy business establishment.
2. The person in charge of quality assurance of a facility manufacturing drugs or medicinal ingredients.
3. The person in charge of clinical pharmacology of a health facility.
Accordingly, the job positions requiring pharmacy practice certificates in Vietnam include:
- The chief pharmacist of a pharmacy business establishment.
- The person in charge of quality assurance of a facility manufacturing drugs or medicinal ingredients.
- The person in charge of clinical pharmacology of a health facility.
What are the conditions for issuing pharmacy practice certificates in Vietnam?
Pursuant to Article 13 of the Law on Pharmacy 2016, the conditions for issuing pharmacy practice certificates in Vietnam are:
- Have any qualifications issued or recognized in Vietnam suitable for his/her position and the pharmacy business establishment. Such qualifications include:
+ Bachelor’s degree in pharmacy (hereinafter referred to as pharmacist degree);
+ Bachelor’s degree in general medicine;
+ Bachelor’s degree in traditional medicine or traditional pharmacy;
+ Bachelor’s degree in biology;
+ Bachelor’s degree in chemistry;
+ College degree in pharmacy;
+ Associate degree in pharmacy;
+ College degree or associate degree in medicine;
+ Associate degree in traditional medicine or traditional pharmacy;
+ Basic diploma in pharmacy;
+ Certificate of traditional physician or pharmacist, certificate of hereditary remedy, or other traditional medicine qualifications issued before the effective date of this Law.
The products qualifications specified in Point 1 of this Clause required as a condition shall be specified by the Ministry of Health according to socio-economic development, the people’s need for medical examination and treatment in each area and each period.
- Have served an apprenticeship at a pharmacy business establishment, the pharmacy of a health facility, a pharmacy training school, a pharmacy research institute, a facility specialized in testing drugs and medicinal ingredients, a pharmacy authority, or a representative office in Vietnam of a foreign trader engaged in pharmacy (hereinafter referred to as pharmacy establishment); a health facility suitable for the practitioner’s expertise as follows:
+ For a person whose pharmacy practice certificate is revoked as prescribed in Clause 9 Article 28 hereof, the apprenticeship is not required. However, he/she must take a refresher course in pharmacy;
+ For a person having a postgraduate degree suitable for the scope of practice, the apprenticeship duration may be shortened as prescribed by the Government;
+ For a person having any of the qualifications specified in Point l Clause 1 Article 13 hereof, the apprenticeship duration shall be specified by the Minister of Health.
- Have a certificate of suitable health for pharmacy practice issued by a competent health facility.
- Fail to fall under the following cases:
+ Be facing a criminal prosecution, serving a court’s sentence or ruling; be suspended from practice or doing works related to pharmacy under the court’s sentence or ruling;
+ Have limited legal capacity.
- Any person who wishes to take an examination to obtain a pharmacy practice certificate must fully satisfy the conditions specified in this Article.
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