How many years of apprenticeship must chief pharmacist of a facility manufacturing drugs have in Vietnam?

1. How many years of apprenticeship must chief pharmacist of a facility manufacturing drugs have in Vietnam?

Pursuant to Article 15 of the 2016 Pharmacy Law, conditions to be satisfied by the chief pharmacist and the person in charge of quality assurance of a facility manufacturing drugs and medicinal ingredients are as follows:

1. Conditions to be satisfied by chief pharmacist of a facility manufacturing drugs and medicinal ingredients that are active ingredients, excipients, or capsule shells:

a) The chief pharmacist of a facility manufacturing drugs must have any of the qualifications specified in Point a Clause 1 Article 13 hereof and at least 05 years’ apprenticeship at a suitable pharmacy establishment, except for the case in Point c of this Clause;

b) The chief pharmacist of a facility manufacturing medicinal ingredients that are active ingredients, excipients, or capsule shells must have any of the qualifications specified in Point a or Point dd Clause 1 Article 13 hereof and at least 03 years’ apprenticeship at a suitable pharmacy establishment;

c) The chief pharmacist of a facility manufacturing vaccines, biologicals, and ingredients thereof must have any of the qualifications specified in Point a, b or d Clause 1 Article 13 hereof and at least 05 years’ apprenticeship at a suitable pharmacy establishment.

2. Conditions to be satisfied by the person in charge of quality assurance of a facility manufacturing drugs and medicinal ingredients that are active ingredients, excipients, capsule shells:

a) The person in charge of quality assurance of a facility manufacturing drugs must have any of the qualifications specified in Point a Clause 1 Article 13 hereof and at least 05 years’ apprenticeship at a drug-manufacturing facility or drug-testing facility, except for the case in Point b and c of this Clause;

b) The person in charge of quality assurance of a facility manufacturing vaccines or biologicals must have any of the qualifications specified in Point a, b or d Clause 1 Article 13 hereof and at least 05 years’ apprenticeship at a facility manufacturing or testing vaccines or biologicals;

c) The person in charge of quality assurance of a facility manufacturing medicinal ingredients that are active ingredients, excipients, or capsule shells must have any of the qualifications specified in Point a or dd Clause 1 Article 13 hereof and at least 03 years’ apprenticeship at a facility manufacturing drugs or medicinal ingredients or a drug-testing facility.

3. Conditions to be satisfied by the chief pharmacist and the person in charge of quality assurance of a facility manufacturing herbal ingredients:

a) The chief pharmacist and the person in charge of quality assurance of a facility manufacturing herbal ingredients must have any of the qualifications specified in Point a or Point c Clause 1 Article 13 hereof and at least 02 years’ apprenticeship at a suitable pharmacy establishment, except for the case in Point b of this Clause;

b) The chief pharmacist and the person in charge of quality assurance of business household or cooperative manufacturing herbal ingredients must have any of the qualifications specified in Point a, c, e, g, i or l Clause 1 Article 13 hereof and at least 02 years’ apprenticeship at a suitable pharmacy establishment, except for the case in Point c Clause 2 Article 13 hereof;

c) The chief pharmacist of a facility manufacturing herbal ingredients may also be in charge of quality assurance therein.

Thus, in addition to regulations on professional qualifications, the person in charge of pharmacy expertise of a drug-manufacturing establishment must have at least 05 years’ apprenticeship at a suitable pharmacy establishment. Your case is required to have an apprenticeship period of 5 years at an appropriate pharmacy facility in Vietnam.

2. How many years of apprenticeship must chief pharmacist of a wholesaler of drugs/medicinal ingredients have in Vietnam?

According to Article 16 of the Law on Pharmacy 2016, conditions to be satisfied by the chief pharmacist of a wholesaler of drugs/medicinal ingredients are as follows:

1. The chief pharmacist of a wholesaler of drugs/medicinal ingredients must have any of the qualifications specified in Point a Clause 1 Article 13 hereof and at least 02 years’ apprenticeship at a suitable pharmacy establishment, except for the case in Clause 2 and Clause 3 of this Article.

2. The chief pharmacist of a wholesaler of vaccines/biologicals must have any of the qualifications specified in Point a, b or d Clause 1 Article 13 hereof and at least 02 years’ apprenticeship at a suitable pharmacy establishment.

3. The chief pharmacist of a wholesaler of herbal ingredients, herbal drugs, or traditional drugs must have any of the qualifications specified in Point a, c, I or l Clause 1 Article 13 hereof and at least 02 years’ apprenticeship at a suitable pharmacy establishment, except for the case in Point c Clause 2 Article 13 hereof.

According to this Article, chief pharmacist of a wholesaler of drugs/medicinal ingredients must have at least 02 years’ apprenticeship at a suitable pharmacy establishment in Vietnam.

Best Regards!