Chapter II
CLINICAL PHARMACOLOGY ORGANIZATION
Article 3. Clinical pharmacology unit and number of persons in charge of clinical pharmacology
1. Clinical pharmacology unit:
a) The clinical pharmacology unit, which is affiliated to the pharmacy department of each healthcare establishment, shall carry out clinical pharmacology activities at the establishment to serve outpatients having health insurance and inpatients;
b) Healthcare establishments that do not have a pharmacy department in accordance with regulations of law on medical examination and treatment (hereinafter referred to as “healthcare establishments without a pharmacy department”) must have a clinical pharmacology unit to carry out clinical pharmacology activities serving outpatients having health insurance and inpatients;
c) For healthcare establishments operating a pharmacy, pharmacies on the premises of these healthcare establishments shall carry out clinical pharmacology activities in the pharmacies to serve drug buyers.
2. Number of clinical pharmacology supervisors and clinical pharmacologists:
a) Healthcare establishments with at least 200 hospital beds shall have 01 clinical pharmacology supervisor, at least 01 clinical pharmacologist for every 200 inpatient beds and at least 01 clinical pharmacologist for every 1.000 prescriptions given to outpatients having health insurance in a day;
b) Healthcare establishments with fewer than 200 hospital beds or healthcare establishments without a pharmacy department shall have at least 01 clinical pharmacology supervisor cum clinical pharmacologist serving inpatients (if any) and at least 01 clinical pharmacologist for every 1.000 prescriptions given to outpatients having health insurance in a day;
c) A pharmacy on the premises of a healthcare establishment must have at least 01 clinical pharmacologist for every business location of the pharmacy. The chief pharmacist of the pharmacy may also be in charge of clinical pharmacology therein.
3. Roadmap to increase of number of clinical pharmacologists in healthcare establishments:
a) By January 01, 2026 at the latest, hospitals of class II and higher must ensure sufficient number of clinical pharmacologists with at least 01 clinical pharmacologist for every 150 inpatient beds and at least 1,5 clinical pharmacologists for every 1.000 prescriptions given to outpatients having health insurance in a day;
b) By January 01, 2031 at the latest, healthcare establishments must ensure sufficient number of clinical pharmacologists with at least 01 clinical pharmacologist for every 100 inpatient beds and at least 02 clinical pharmacologists for every 1.000 prescriptions given to outpatients having health insurance in a day.
Article 4. Requirements for clinical pharmacologists
1. Clinical pharmacologists working at healthcare establishments shall hold a bachelor’s degree in pharmacy or higher (conferred upon or recognized in Vietnam), unless otherwise provided for by Clause 2 herein.
2. Clinical pharmacologists working at traditional medicine establishments must hold one of the following degrees (conferred upon or recognized in Vietnam):
a) A degree meeting the requirement stated in Clause 1 herein and one of the degrees/certificates in traditional medicine provided for in Points i and l Clause 1 Article 13 of the Law on Pharmacy;
b) A bachelor’s degree in traditional pharmacy or higher;
c) A bachelor’s degree in traditional medicine or higher.
3. Clinical pharmacologists working in pharmacies on the premises of a healthcare establishment must meet the requirement stated in Clause 1 herein. Chief pharmacists who are also in charge of clinical pharmacology shall meet the requirements provided for in Clause 1 Article 18 of the Law on Pharmacy.
Article 5. Clinical pharmacology supervisors
1. Clinical pharmacology supervisors working at healthcare establishments must meet the requirements stated in Article 21 of the Law on Pharmacy and hold a pharmacy practice certificate according to regulations in Clause 3 Article 11 of the Law on Pharmacy.
2. Content of apprenticeship served by clinical pharmacology supervisors:
a) Clinical pharmacology supervisors working at healthcare establishments must complete an apprenticeship in bioequivalence testing; clinical trial; clinical pharmacology and pharmacological research; or pharmacovigilance at a drug information and adverse drug reactions monitoring center;
b) Clinical pharmacology supervisors working at traditional medicine establishments must complete an apprenticeship in clinical trial; clinical pharmacology and pharmacological research; or pharmacovigilance at a drug information and adverse drug reactions monitoring center for traditional drugs;
3. Clinical pharmacology supervisors shall serve an apprenceticeship of at least 2 years. Persons holding a doctoral degree or second level specialists in apprenticeship-related areas shall serve an apprenticeship of at least 6 months. Persons holding a master’s degree or first level specialists in apprenticeship-related areas shall serve an apprenticeship of at least 12 months.
4. Unless otherwise provided for in Clause 5 herein, clinical pharmacology supervisors working at healthcare establishments shall serve their apprenticeships at one of the following facilities:
a) Providers of clinical trial services or bioequivalence study services; non-commercial bioequivalence testing facilities or clinical trial institutions;
b) Pharmacology or clinical pharmacology departments or centers of schools providing undergraduate medicine/pharmacy programs;
c) National or regional drug information and adverse drug reactions monitoring centers;
d) Healthcare establishments the clinical pharmacology units and activities of which are in compliance with regulations in this Decree or regulations of law taking effect prior to the entry into force of this Decree.
5. Clinical pharmacology supervisors working at traditional medicine establishments shall serve their apprenticeships at hospitals and institutes having hospital beds, practicing traditional medicine and having clinical pharmacology units and activities in compliance with regulations in this Decree or regulations of law taking effect prior to the entry into force of this Decree.
Tìm kiếm
Nghị định 131/2020/NĐ-CP (Bản Word)
Nghị định 131/2020/NĐ-CP (Bản Pdf)
