What are the prohibited acts of pharmaceutical sale representatives in Vietnam?

What are the prohibited acts of pharmaceutical sale representatives in Vietnam? (Internet image)

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

1. Who is sale representative of the pharmacy?

According to Clause 1, Article 21 of Circular 07/2018/TT-BYT, the sale representative of the pharmacy is granted a sale representative card by the head of the pharmacy business establishment to introduce drugs to medicine practitioners.

Specifically,

The sale representative shall satisfy the following requirements:

- Having a college degree or higher in medicine or pharmacy.

- Being recruited and trained by the pharmacy business establishment for professional skills related to introducing drugs and understanding the legislative documents on Pharmacy.

(Clause 2, Article 21 of Circular 07/2018/TT-BYT)

2. What are the prohibited acts of pharmaceutical sale representatives in Vietnam?

Specifically, in Clause 5, Article 22 of Circular 07/2018/TT-BYT, prohibited acts of pharmaceutical sale representatives in Vietnam include:

- Informing drugs information that is not as accurate as the applied information or the information verified by the regulatory authority. Publishing the drugs information or documents that are not verified by the regulatory authority.

- Introducing drugs that are not assigned to introduce by the pharmacy business establishment.

- Using material benefits to affect the medical practitioner or drugs user to make them give more prescriptions or purchase more drugs.

- Introducing or providing drugs information that is not appropriate according to Clause 3, Article 76 of the Law on Pharmacy.

Article 76. Drug information content and responsibility

...

3. The basis for formulating drug information includes the following documents, except for the information specified at Point c, Clause 5 and Point a, Clause 6 of this Article:

a) Vietnam's National Pharmacopoeia;

b) The drug instruction sheet approved by the Ministry of Health;

c) Documents and professional instructions related to drugs issued or recognized by the Ministry of Health.

- Comparing and/or introducing the drugs from his/her establishment with another establishment without providing scientific proof documents which are approved by the competent authority.

- Introducing products other than drugs.

- Having activities related to selling and purchasing drugs with the medical practitioners.

- Approaching the patient, collecting information regarding the medical records and drugs prescriptions of the patient; discussing or requiring information related to the patient.

- Providing documents and/or information of drugs to the entities that are not permitted by the competent authority of Ministry of Health.

3. Responsibilities of the heads of pharmacy business establishments that employ pharmaceutical sale representatives in Vietnam

The head of a pharmacy business establishment with a drug recommender has the following responsibilities:

- Take full responsibilities for the sale representative’s practice and drug information they provide.

- Provide training for the sale representative in accordance with Clause 2, Article 21 of Circular 07/2018/TT-BYT.

- Provide adequate information regarding the legal and technical documents for the sale representative to make sure the introducing process is carried out legally as stipulated in Circular 07/2018/TT-BYT. 

- Issue the sale representative card using form No. 08 in Appendix hereto for the sale representative who satisfies the requirements stipulated in Clause 2, Article 21 of Circular 07/2018/TT-BYT.

- No later than 07 (seven) working days from the date issuing the sale representative cards, the head of the establishment shall send the list of holders of the cards using form No. 09 in Appendix I to Circular 07/2018/TT-BYT, or update that list online and send it to the Department of Health where the sale representative introduces drugs.

If there are amendments to the list of sale representatives, the head of the establishment shall issue or change the cards, and update these changes in accordance with the procedures for first time issuing the cards.

- Revoke the sale representative card from the representative that:

= Has his/her labor contract terminated.

= Stops introducing drugs.

= Falls into the cases stipulated in Clause 3, Article 21 of Circular 07/2018/TT-BYT.

= Violates one of the regulations stipulated in Clause 5, Article 22 of Circular 07/2018/TT-BYT.

- Within 07 (seven) working days from the date revoking the sale representative card, the head of the establishment shall send the list of those who have their cards revoked using form No. 10 in Appendix I to Circular 07/2018/TT-BYT, or update that list online and send it to the Department of Health where the sale representative introduces drugs.

- The head of the establishment shall not issue the sale representative card within 12 (twelve) months from the date on which he/she revoked the card from those that fall into the cases stipulated in point d, Clause 6 of Article 23 of Circular 07/2018/TT-BYT.

(Article 23 of Circular 07/2018/TT-BYT)

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