Decree 88/2023/ND-CP amending Decree 54/2017/ND-CP detailing the Pharmacy Law and Decree 155/2018/ND-CP

DECREE

Amending and supplementing a number of articles of the Government’s Decree No. 54/2017/ND-CP of May 8, 2017, detailing a number of articles of, and providing measures for implementing, the Law on Pharmacy, and the Government’s Decree No. 155/2018/ND-CP of November 12, 2018, amending and supplementing a number of regulations on business investment conditions under the state management of the Ministry of Health^[1]

Pursuant to the June 19, 2015 Law on Organization of the Government; and the November 22, 2019 Law Amending and Supplementing a Number of Articles of the Law on Organization of the Government and the Law on Organization of Local Administration;

Pursuant to the April 6, 2016 Law on Pharmacy;

At the proposal of the Minister of Health;

The Government promulgates the Decree amending and supplementing a number of articles of the Government’s Decree No. 54/2017/ND-CP of May 8, 2017, detailing a number of articles of, and providing measures for implementing, the Law on Pharmacy, and the Government’s Decree No. 155/2018/ND-CP of November 12, 2018, amending and supplementing a number of regulations on business investment conditions under the state management of the Ministry of Health.

Article 1. To amend and supplement a number of articles of the Government’s Decree No. 54/2017/ND-CP of May 8, 2017, detailing a number of articles of, and providing measures for implementing, the Law on Pharmacy

1. To amend and supplement Clause 1, Article 91 as follows:

“1. The list of medicinal ingredients being pharmaceutical ingredients, excipients, capsule shells, semi-finished drugs or semi-finished traditional medicinal ingredients not yet granted marketing authorization certificates and used for manufacturing drugs under a dossier for registration of a drug that has been granted a certificate of marketing authorization in Vietnam shall be made according to Form No. 46 provided in Appendix III to this Decree and publicized on the website of the licensing agency  within 15 days after the marketing authorization certificate is granted or extended. Medicinal ingredients on publicized lists may be imported without having to undergo import licensing procedures, except medicinal ingredients subject to special control.”.

2. To amend and supplement the titles of Clauses 2, 3 and 4 of Article 92 as follows:

a/ To amend and supplement the title of Clause 2 as follows:

“2. Customs clearance for import of drugs and medicinal ingredients that have been granted certificates of marketing authorization in Vietnam and medicinal ingredients on lists of pharmaceutical ingredients, excipients, capsule shells, semi-finished drugs and semi-finished traditional medicinal ingredients under dossiers for registration of drugs with certificates of marketing authorization in Vietnam, except traditional medicinal ingredients:”.

b/ To amend and supplement the title of Clause 3 as follows:

“3. Customs clearance for import of traditional medicinal ingredients and semi-finished traditional medicinal ingredients that have been granted or have yet to be granted certificates of marketing authorization in Vietnam, except semi-finished traditional medicinal ingredients used for manufacture of drugs under dossiers for registration of drugs with certificates of marketing authorization in Vietnam:”.

c/ To amend and supplement the title of Clause 4 as follows:

“4. Customs clearance for import of drugs and medicinal ingredients that have yet to be granted certificates of marketing authorization in Vietnam, except those specified in Clauses 2 and 3 of this Article:”.

3. To amend and supplement Point e, Clause 1; Clauses 3 and 4 of Article 93 as follows:

a/ To amend and supplement Point e, Clause 1 as follows:

“e/ It is a semi-finished traditional medicinal ingredient, unless it is manufactured by the drug manufacturer for manufacturing a finished drug or semi-finished traditional medicinal ingredient used for manufacture of drugs under dossiers for registration of drugs with certificates of marketing authorization in Vietnam, semi-finished products used for testing, research or manufacture of drugs for export.”.

b/ To amend and supplement Clause 3 as follows:

“3. Excipients used for manufacture of drugs with standards elaborated by their manufacturers which are neither applied nor included in the Pharmacopoeia of Vietnam or not applied national standards or regulations on drugs or foreign pharmacopoeias in Vietnam under the Minister of Health’s regulations shall be subject to marketing authorization, except those used for manufacturing drugs of which marketing authorization certificates remain valid in Vietnam and excipients used for testing, research or manufacturing drugs for export. If wishing to make marketing authorization registration for these excipients, manufactures shall comply with Section 1, Chapter V of this Decree.”.

c/ To amend and supplement Clause 4 as follows:

“4. Capsule shells used for manufacturing drugs shall be subject to marketing authorization registration, except those used for manufacturing drugs of which marketing authorization certificates remain valid in Vietnam and capsule shells used for testing, research or manufacturing drugs for export. If wishing to make marketing authorization registration for these capsule shells, manufacturers shall comply with Section 1, Chapter V of this Decree.”.

4. To add Point d to Clause 3, Article 96 as follows:

“d/ Drug and medicinal ingredient manufacturers of exporting countries that do not apply Good Manufacturing Practices’ principles and standards applicable to drugs and medicinal ingredients promulgated and announced for application or recognized by the Minister of Health as specified at Point c, Clause 1, Article 97 of this Decree.”.

5. To add Point c to Clause 1, Article 97 as follows:

“c/ In case Good Manufacturing Practices’ principles and standards applicable to drugs and medicinal ingredients are not the principles and standards promulgated or announced for application by the Minister of Health as specified at Point a, Clause 1 of this Article, the Advisory Council for Grant of Marketing Authorization Certificates for Drugs and Medicinal Ingredients shall assess the conformity of the principles and standards of the exporting country with those promulgated or announced for application by the Minister of Health. After obtaining the conformity assessment result, the Minister of Health shall issue a decision to recognize the conformity with Good Manufacturing Practices’ principles and standards of the exporting country for use as a basis for assessing the manufacturer.”.

6. To amend and supplement the title of Clause 4, Article 131 as follows:

“4. Receipt and announcement of declared or re-declared drug prices:”.

7. To amend and supplement Article 132 as follows:

“Article 132. Rights and responsibilities of state management agencies in charge of drug prices in the implementation of regulations on declaration and re-declaration of drug prices

1. State management agencies in charge of drug prices have the following rights:

a/ To request in writing pharmaceutical trading establishments subject to price declaration to report on the declared/re-declared prices’ conformity with market prices of similar drugs and with fluctuations of price constituents to serve price stabilization, state management of drug prices, and examination and inspection in accordance with law;

b/ To examine and inspect drug prices in pharmaceutical trading establishments in accordance with law;

c/ To transfer cases of violation to competent agencies for handling in accordance with law if detecting the following violations of regulations on management of drug prices of drug trading establishments: failing to declare or re-declare drug prices; failing to fully declare drug prices under regulations or not adjusting declared prices and failing to make reports thereon as requested by state management agencies in charge of drug prices, for dossiers of declaration and re-declaration; untruthfully reporting price constituents or selling drugs at prices higher than valid declared or re-declared prices;

d/ To consider applying the following measures to pharmaceutical trading establishments that have committed violations two or more times in 1 year: halting the receipt of dossiers of request for certification of drug information or advertising contents; halting the receipt of dossiers of application for permission for import of drugs without marketing authorization certificates in Vietnam; and halting the receipt of dossiers of application for, or request for extension of, marketing authorization certificates of drugs or medicinal ingredients.

The halting of the receipt of dossiers specified in this Article may last between 3 and 12 months from the date a competent agency issues a notice of violation.

2. State management agencies in charge of drug prices have the following responsibilities:

a/ To comply with regulations on receipt of dossiers of declaration and re-declaration of drug prices as specified in Article 131 of this Decree;

b/ To review whether or not dossiers of declaration and re-declaration of drug prices are made by pharmaceutical trading establishments according to the forms specified in Clauses 1, 2 and 4, Article 130 of this Decree;

c/ To ensure confidentiality of prices declared or re-declared by organizations and individuals for the period when the declared or re-declared prices have yet to become valid in accordance with law.”.

8. To amend and supplement Article 133 as follows:

“Article 133. Rights and responsibilities of pharmaceutical trading establishments in implementation of regulations on declaration and re-declaration of drug prices

1. Pharmaceutical trading establishments have the following rights:

To purchase and sell every drug at the declared or re-declared price from the date a complete drug price declaration or re-declaration dossier is submitted by the concerned drug manufacturer or drug processing-ordering establishment or drug importer and received by a competent state management agency. In case the drug importer, manufacturer, or drug processing-ordering establishment adjusts the declared price of a drug to be lower than the last declared price, pharmaceutical trading establishments may immediately purchase and sell such drug at the reduced price and, concurrently carry out declaration of price reduction in conformity with the fluctuations of price constituents.

2. Pharmaceutical trading establishments have the following responsibilities:

a/ To comply with regulations on declaration and re-declaration of drug prices and notify prices in accordance with law and this Decree; to be held responsible before law for the accuracy and truthfulness of dossiers of declaration and re-declaration of drug prices; to comply with regulation on reporting on declared/re-declared prices at the request of state management agencies in charge of drug prices to serve price stabilization, state management of price, and examination and inspection; to abide by the examination and inspection of competent state agencies (if any);

b/ To refrain from wholesaling or retailing drugs at prices higher than the prices declared or re-declared by drug manufacturers, drug processing-ordering establishments or drug importers;

c/ When receiving a written request for reporting on the price of a drug it has declared or re-declared from a state management agency in charge of drug prices, within 30 days after receiving the request, to send a written reply, reporting on the declared price’s conformity with the declared prices of similar drugs in the market or fluctuations of price constituents or to adjust the declared or re-declared price in conformity with opinions of such state management agency. Past the above time limit, if the pharmaceutical trading establishment fails to make a written reply, the dossier of drug price declaration or re-declaration it has submitted will become invalid;

d/ To abide by the handling of violations concerning declaration of drug prices in accordance with law on sanctioning of administrative violations in the fields of prices, charges, fees and invoices.”.

9. To amend and supplement Article 134 as follows:

“Article 134. Contents of examination of announced declared and re-declared drug prices

1. Contents of examination of announced declared and re-declared drug prices

a/ Consistency between information about drugs in dossiers of declaration of drug prices and information about drugs under decisions on grant of drug marketing authorization certificates or drug import licenses;

b/ Conformity of declared or re-declared drug prices with market prices of similar drugs (if any).

2. In case of necessity, based on the contents of examination of announced declared and re-declared drug prices specified in Clause 1 of this Article, state management agencies in charge of drug prices shall consult the Vietnam Social Security, state management agencies in charge of prices and related agencies to examine the post-inspection of declared or re-declared drug prices.”.

10. To amend Forms 5, 6, 7, 8, 9 and 10 provided in Appendix VII to Decree No. 54/2017/ND-CP in Appendix I to this Decree.

Article 2. To amend and supplement a number of articles of the Government’s Decree No. 155/2018/ND-CP of November 12, 2018, amending and supplementing a number of regulations on business investment conditions under the state management of the Ministry of Health

1. To amend and supplement Point b, Clause 47, Article 5 as follows:

“b/ To amend and supplement Points d and dd, Clause 1, Article 87 as follows:

d/ A copy of the pharmaceutical business license granted by a competent agency of the host country, certified and consularly legalized under regulations. In case the host country does not grant a pharmaceutical business license to a traditional medicinal ingredient or semi-finished traditional medicinal ingredient supplier, the establishment shall submit a certified copy of its business license or an equivalent paper in the field of trading in traditional medicinal ingredients, granted by a competent agency of the host country. Foreign traditional medicinal ingredient and semi-finished traditional medicinal ingredient suppliers are not required to comply with Clause 15, Article 91 of this Decree if having all the papers specified in this Clause;

dd/ A copy of a Good Manufacturing Practices Certificate granted by a competent agency of the host country to the manufacturer, certified and consularly legalized under regulations. In case the host country does not grant the Good Manufacturing Practices Certificate, the establishment shall submit a certified copy of its production license or legal papers equivalent to the Good Manufacturing Practices Certificate in the field of manufacturing traditional medicinal ingredients or semi-finished traditional medicinal ingredients;”.

2. To amend and supplement Point b, Clause 49, Article 5 as follows:

“b/ To add Points e, g and h to Clause 2, Article 92 as follows:

e/ In case of importing drugs or medicinal ingredients specified at Point dd, Clause 1, Article 59 of the Law on Pharmacy and not falling into cases subject to import licensing, the importer shall produce the bill of lading of the goods shipment to show that the goods are exported from the port of departure of the exporting country before the marketing authorization certificate and the import license expire for customs clearance;

g/ In case of importing medicinal ingredients on the list of pharmaceutical ingredients, excipients, capsule shells, semi-finished drugs and semi-finished traditional medicinal ingredients used for manufacture of drugs under dossiers for registration of drugs with marketing authorization certificates in Vietnam and not falling into cases subject to import licensing, the importer shall produce the bill of lading of the goods shipment to prove that the goods are exported from the port of departure of the exporting country before the marketing authorization certificate of the drugs expire for customs clearance (in case the marketing authorization certificates of drugs used for ingredient announcement expire at the time of customs clearance);

h/ In case of importing medicinal ingredients on the list of pharmaceutical ingredients, excipients, capsule shells, semi-finished drugs, semi-finished traditional medicinal ingredients used for manufacture of drugs under dossiers for registration of drugs with certificates of marketing authorization in Vietnam and falling into cases subject to import licensing, the importer shall produce the bill of lading of the goods shipment to show that the goods are exported from the port of departure of the exporting country before the marketing authorization certificate of drugs used for ingredient announcement and import license of ingredients expire for customs clearance (in case the marketing authorization certificate of the drugs used for ingredient announcement and the import license of ingredients expire at the time of customs clearance).

3. To amend the titles and supplement the contents of notes in Form No. 46 of Appendix III, amend Forms No. 01, 02, 03, 04 provided in Appendix VII to Decree No. 54/2017/ND-CP, which was amended and supplemented in Appendix II to Decree No. 155/2018/ND-CP in Appendix II to this Decree.

4. To annul Clauses 71 thru 75 of Article 5.

Article 3. Effect

This Decree takes effect on the date of its signing.

Article 4. Transitional provisions

Dossiers submitted before the effective date of this Decree continue to comply with regulations effective at the time of dossier submission unless establishments request the application of regulations of this Decree.

Article 5. Implementation responsibility

Ministers, heads of ministerial-level agencies, heads of government-attached agencies, heads of provincial-level People’s Committees and related organizations and individuals shall implement this Decree.-

On behalf of the Government
For the Prime Minister
Deputy Prime Minister
TRAN HONG HA

*The Appendices to this Decree are not translated.