New regulations on responsibilities of pharmacy business establishments in implementing regulations on declaration and redeclaration of drug prices in Vietnam

New regulations on responsibilities of pharmacy business establishments in implementing regulations on declaration and redeclaration of drug prices in Vietnam (Internet image) 

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

On December 11, 2023, the Government issued Decree 88/2023/ND-CP amending Decree 54/2017/ND-CP guiding the Law on Pharmacy 2017 and Decree 155/2018/ND-CP amending regulations related to business investment conditions under the state management of the Ministry of Health.

New regulations on responsibilities of pharmacy business establishments in implementing regulations on declaration and redeclaration of drug prices in Vietnam

In declaration and redeclaration of drug prices, pharmacy business establishments have the following rights and responsibilities:

(1) Pharmacy business establishments have the right to:

Purchase, sell drugs at declared, redeclared price from the date on which manufacturing facilities, processing service buyers, importing facilities submit adequate declarations or redeclarations to competent authority as per the law. Purchase, sell drugs at a lower price while declaring price reduction if importing facilities, manufacturing facilities, or processing service buyers lower declared price relative to previous declarations.

(2) Pharmacy business establishments have the responsibility to:

- adequately comply with regulations on declaration and redeclaration of drug price, notify price in accordance with regulations and this Decree; assume total legal responsibility for accuracy and veracity of drug price declarations, redeclarations; produce reports on declared, redeclared price at request of drug pricing authorities; comply with examination and inspection of competent authority (if any);

- not sell drugs in bulk or retail drugs at a price higher than declared or redeclared price which has been declared, redeclared by manufacturing facilities, processing service buyers, importing facilities;

- if competent authority request pharmacy business establishments to produce reports on drug prices declared and redeclared by the pharmacy business establishments, the pharmacy business establishments shall respond in form of reports on declared prices conforming to price level of similar products on the market or fluctuations of price factors within 30 days from the date on which request of competent authority is issued or adjust declared, redeclared prices in accordance with feedback of drug pricing authority. If pharmacy business establishments fail to respond in writing within the time limit above, submitted declarations and redeclarations shall be voided;

- comply with actions taken against drug price declaration in accordance with regulations on administrative penalties in prices, fees, charges, and invoices

Conditions for issuance of Certificate of eligibility for pharmacy business in Vietnam

Specifically, Article 33 of the Law on Pharmacy 2017 stipulates the conditions for issuance of Certificate of eligibility for pharmacy business as follows:

(1) Infrastructure, equipment, and personnel conditions:

- Every manufacturer of drugs/medicinal ingredients must have the premises, factory, laboratory, storage of drugs/medicinal ingredients, auxiliary systems, equipment, machinery for manufacture, testing, storage of drugs, quality control system, technical documents and personnel that fulfill GMP requirements;

- Every importer and exporter of drugs/medicinal ingredients, provider of drug/medicinal ingredient storage services must have the premises, drug storage, storage equipment, transportation, quality control system, technical documents and personnel that fulfill Good Storage Practice requirements;

- Every wholesaler of drugs/medicinal ingredients have the premises, drug storage, storage equipment, transportation, quality control system, technical documents and personnel that fulfill Good Distribution Practice requirements;

- Every drug retailer must have the premises, a storage area, storage equipment, technical documents and personnel that fulfill Good Retailing Practice requirements; Retailers of herbal ingredients, herbal drugs, traditional drugs shall comply with Point b Clause 2 Article 69 of the Law on Pharmacy 2017;

- Every provider of drug/medicinal ingredient testing services must have the premises, a chemical/microbiological/biological laboratory, auxiliary systems, testing equipment, chemicals, reagents, quality control system, technical documents and personnel that fulfill Good Laboratory Practice requirements;

- Every provider of clinical trial services must have the premises, a clinical laboratory, testing laboratory, bio-chemical testing equipment, quality control system, technical documents and personnel that fulfill Good Clinical Practice requirements;

- Every provider of bioequivalence services must have the premises, a laboratory for biological fluid analysis, equipment for biological fluid analysis, an area for drug users to stay and undergo bioequivalence assessment, quality control system, technical documents and personnel that fulfill Good Laboratory Practice requirements in the biological fluid analysis stage and fulfill Good Clinical Practice requirements in the clinical trial stage.

Where a provider of bioequivalence study service only fulfills Good Laboratory Practice requirements in biological fluid analysis, it must sign a contract or cooperate with a provider of clinical trial services that fulfills Good Clinical Practice requirements to carry out clinical trial in the process of bioequivalence study.

(2) The chief pharmacist and the persons holding the positions specified in Article 11 of the Law on Pharmacy 2017 must pharmacy practice certificates suitable for the pharmacy business establishments as prescribed in Clause 2 Article 32 of the Law on Pharmacy 2017.

(2) The assessment of infrastructure, equipment and personnel specified in Clause (1) shall be carried out every 03 years or on an ad hoc basis under regulations of the Minister of Health or international treaties to which Vietnam is a signatory.

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