Decree No. 88/2023/ND-CP amends and supplements some articles of Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government detailing certain provisions and measures for implementing the Medicine Law and Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government amending and supplementing certain regulations related to investment and business conditions within the scope of management under the Ministry of Health.

DECREE

AMENDING AND SUPPLEMENTING CERTAIN PROVISIONS OF THE GOVERNMENTAL DECREE NO. 54/2017/NĐ-CP OF MAY 8, 2017 ON DETAILING CERTAIN PROVISIONS AND MEASURES TO IMPLEMENT THE DRUG LAW AND THE GOVERNMENTAL DECREE NO. 155/2018/NĐ-CP OF NOVEMBER 12, 2018 AMENDING AND SUPPLEMENTING CERTAIN PROVISIONS RELATED TO INVESTMENT BUSINESS CONDITIONS WITHIN THE SCOPE OF MANAGEMENT OF THE MINISTRY OF HEALTH

Pursuant to the Law on Organization of the Government dated June 19, 2015; the Law Amending and Supplementing Certain Provisions of the Law on Organization of the Government and the Law on Organization of Local Administration dated November 22, 2019;

Pursuant to the Drug Law on April 6, 2016; At the proposal of the Minister of Health;

The Government promulgates this Decree amending and supplementing certain provisions of the Governmental Decree No. 54/2017/NĐ-CP of May 8, 2017 detailing certain provisions and measures to implement the Drug Law and the Governmental Decree No. 155/2018/NĐ-CP of November 12, 2018 amending and supplementing certain provisions related to investment business conditions within the scope of management of the Ministry of Health.

Article 1. Amending and supplementing certain provisions of the Governmental Decree No. 54/2017/NĐ-CP of May 8, 2017 detailing certain provisions and measures to implement the Drug Law

1. Amending and supplementing Clause 1 of Article 91 as follows:

“1. Raw materials for drugs are drug substances, excipients, capsules, semi-finished drug products, and semi-finished herbal products without a Registration Certificate for Circulation in Vietnam produced according to the drug registration dossier with a Registration Certificate for Circulation in Vietnam published on the website of the Licensing Authority in Model No. 46 attached as Appendix III of this Decree within fifteen days from the date of issuance or extension of the Registration Certificate for Circulation in Vietnam. Raw materials for drugs listed in the published list may be imported without import permit, except for raw materials for drugs that require special control.”

2. Amending and supplementing the names of Clause 2, Clause 3, and Clause 4 of Article 92 as follows:

a) Amending and supplementing the name of Clause 2 as follows:

"2. Clearing imported drugs, raw materials for drugs with a Registration Certificate for Circulation in Vietnam, and raw materials for drugs listed in the published list of drug substances, excipients, capsules, semi-finished drug products, and semi-finished herbal products according to the drug registration dossier with a Registration Certificate for Circulation in Vietnam, except for herbal products:"

b) Amending and supplementing the name of Clause 3 as follows:

"3. Clearing imported herbal products, semi-finished herbal products with a Registration Certificate for Circulation or without a Registration Certificate for Circulation in Vietnam, except for semi-finished herbal products for producing drugs according to the drug registration dossier with a Registration Certificate for Circulation in Vietnam:"

c) Amending and supplementing the name of Clause 4 as follows:

"4. Clearing imported drugs, raw materials for drugs without a Registration Certificate for Circulation in Vietnam, except for the cases stipulated in Clauses 2 and 3 of this Article:"

3. Amending and supplementing Point e of Clause 1, Clause 3, and Clause 4 of Article 93 as follows:

"a) Amend and supplement Point e of Clause 1 as follows:"

"e) Semi-finished herbal products, except when these products are produced by the manufacturing facility itself for finished drug production or semi-finished herbal products for producing drugs according to the drug registration dossier with a Registration Certificate for Circulation in Vietnam, semi-finished products for testing, research, or exporting drugs."

b) Amend and supplement Clause 3 as follows:

"3. Excipients used as drugs with a basis standard established by the excipient manufacturing facility without applying or not included in the Vietnamese Pharmacopoeia, national standards, or foreign pharmacopoeias applied in Vietnam according to the regulations of the Minister of Health must be registered for circulation, except when the excipients are used to produce drugs already issued with a Registration Certificate for Circulation still valid in Vietnam and excipients used for testing, research, or exporting drugs. In case the facility wishes to register for circulation, it shall comply with the provisions in Section 1 of Chapter V of this Decree."

c) Amend and supplement Clause 4 as follows:

"4. Capsules used as drugs must be registered for circulation, except when the capsules are used to produce drugs already issued with a Registration Certificate for Circulation still valid in Vietnam, capsules used for testing, research, or exporting drugs. In case the facility wishes to register for circulation, it shall comply with the provisions in Section 1 of Chapter V of this Decree."

4. Supplementing Point d into Clause 3 of Article 96 as follows:

"d) A drug manufacturing facility or raw material manufacturing facility of the exporting country does not apply Good Manufacturing Practice (GMP) principles and standards for drugs and raw materials for drugs issued by the Minister of Health, announced for application or recognized according to Point c of Clause 1 of this Article."

5. Supplementing Point c into Clause 1 of Article 97 as follows:

"c) In case the GMP principles and standards for drugs and raw materials for drugs do not belong to any of the principles and standards issued by the Minister of Health or announced for application according to Point a of Clause 1 of this Article, the Advisory Council for Issuing Registration Certificates for Drugs and Raw Materials for Drugs will evaluate the suitability of the exporting country's principles and standards compared to those issued by the Minister of Health or announced for application. After obtaining the evaluation results, the Minister of Health will issue a decision recognizing the suitability of the exporting country's GMP principles and standards as a basis for evaluating the manufacturing facility."

6. Amending and supplementing the name of Clause 4 of Article 131 as follows:

"4. Organization receiving and announcing declared drug prices, re-declared prices:"

7. Amending and supplementing Article 132 as follows:

"Article 132. Rights and responsibilities of state management agencies regarding drug pricing in implementing regulations on declaring and re-declaring drug prices

1. State management agencies regarding drug pricing have the following rights:

a) Issuing written requests to pharmaceutical business establishments to declare prices and report declared and re-declared prices that are consistent with the market price level of similar items, consistent with price formation factors to serve price stabilization, state management of prices, inspection, and supervision according to the law;

b) Conducting inspections and audits of pharmaceutical business establishments regarding drug prices according to the law;

c) Transfer to the competent authority for handling violations according to the provisions of the law if discovering that a pharmaceutical business violates regulations on drug price management in the following cases: failing to declare, re-declare; declaring prices incompletely as prescribed or not adjusting prices without reporting according to the request document of the state management agency on drug prices regarding the declaration and re-declaration files of enterprises; reporting inaccurately the factors forming prices or selling drugs at a higher price than the declared or re-declared prices which are still effective.

d) Consider applying measures in cases where a pharmaceutical business has violated two or more times within one year: temporarily suspend acceptance of applications for confirmation of information content and drug advertisements; temporarily suspend acceptance of importation applications for drugs without a Drug Registration Certificate in Vietnam; temporarily suspend acceptance of applications for issuance and extension of Drug Registration Certificates and raw material drug registration certificates.

The suspension period specified herein shall be from three to twelve months starting from the date the competent authority issues the notification of violation.

2. The state management agency on drug prices shall have the following responsibilities:

a) Implement the provisions on accepting drug price declaration and re-declaration files as stipulated in Article 131 of this Decree;

b) Review drug price declaration and re-declaration files submitted by pharmaceutical businesses in accordance with the prescribed forms under Clause 1, Clause 2, and Clause 4 of Article 130 of this Decree;

c) Maintain confidentiality of declared and re-declared prices of organizations and individuals until such prices become effective according to the law.”

8. Amend and supplement Article 133 as follows:

“Article 133. Rights and Responsibilities of Pharmaceutical Businesses in Implementing Regulations on Declaring and Re-declaring Drug Prices

1. Pharmaceutical businesses have the following rights:

They have the right to purchase and sell drugs at declared or re-declared prices from the day the production facility or the commissioned manufacturing facility or the importing facility submits complete declaration or re-declaration files in accordance with the regulations and such files are accepted by the competent state management authority. In case the importing facility, production facility, or commissioned manufacturing facility reduces the declared price compared to the previous declaration, the business may immediately purchase and sell at the reduced price simultaneously with the implementation of the price reduction declaration consistent with the decrease in pricing factors.

2. Pharmaceutical businesses have the following responsibilities:

a) Fully implement regulations on declaring and re-declaring drug prices, report prices as prescribed by law and this Decree; bear full responsibility before the law for the accuracy and truthfulness of the declaration and re-declaration files; comply with reports on declared and re-declared prices as required by the state management agency on drug prices for stabilizing prices, managing drug prices, inspection, and audit; comply with inspections and audits by authorized state agencies (if any);

b) Shall not wholesale or retail drugs at a higher price than the declared or re-declared price by the same production facility or commissioned manufacturing facility or importing facility;

c) In case the competent state management agency requests a pharmaceutical business to report on the price of a drug item declared or re-declared by the business within thirty days from the date of the agency's document, the business must submit a report on the declared price consistent with the market price level of similar items or consistent with changes in pricing factors or adjust the declared or re-declared price appropriately according to the opinion of the state management agency on drug prices. If the pharmaceutical business does not submit a response document within the above period, the submitted declaration and re-declaration files will lose their validity;

d) Comply with forms of handling price declarations according to the law on administrative penalties in the field of prices, fees, and invoices.”

9. Amend and supplement Article 134 as follows:

“Article 134. Contents of Review of Declared and Re-declared Drug Prices Already Announced

1. Contents of review of declared and re-declared drug prices already announced:

a) Information about the drug in the price declaration file is consistent with the information of the drug according to the Decision on Issuing the Drug Registration Certificate or Import Permit;

b) Declared and re-declared drug prices are consistent with the market price level of similar drug items (if applicable).

2. In necessary cases, based on the contents of the review of declared and re-declared drug prices stipulated in Clause 1 of this Article, the state management agency on drug prices may seek opinions from the Vietnam Social Security Agency, the state management agency on prices, and related agencies to conduct post-review of declared and re-declared drug prices.”

10. Amend Model No. 05, Model No. 06, Model No. 07, Model No. 08, Model No. 09, and Model No. 10 of Appendix VII promulgated together with Decree No. 54/2017/NĐ-CP in Appendix I promulgated together with this Decree.

Article 2. Amend and supplement some articles of Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain provisions related to investment and business conditions under the management of the Ministry of Health

1. Amend and supplement Point b Clause 47 Article 5 as follows:

"b) Amend and supplement Points d and đ Clause 1 Article 87 as follows:

d) A certified copy of the Drug Business License issued by the competent authority of the home country, legalized and apostilled according to regulations. In cases where the home country does not issue a Drug Business License for drug material supply units or semi-finished drug materials, such units shall submit a certified copy of the Business License or equivalent legal documents issued by the competent authority of the home country with a scope of drug material business. Foreign drug material supply units or semi-finished drug material units are not required to comply with Clause 15 Article 91 of this Decree if they have all the aforementioned documents;

đ) A certified copy of the Good Manufacturing Practice Certificate issued by the production facility's competent authority of the home country, legalized and apostilled according to regulations. In cases where the home country does not issue a Good Manufacturing Practice Certificate, the unit shall submit a certified copy of the Production License or equivalent legal documents with a scope of drug material or semi-finished drug material production;"

2. Amend and supplement Point b Clause 49 Article 5 as follows:

"b) Supplement Points e, g and h Clause 2 Article 92 as follows:

e) In cases of importing drugs and raw materials for drugs specified in Point đ Clause 1 Article 59 of the Medicine Law and which require an Import Permit, the importer must present the transport document of the drug or raw material batch showing that the goods were exported from the exporting country's port before the expiry date of the Registration Certificate for Circulation and the Import Permit to be cleared for customs;

g) In cases of importing raw materials for drugs listed in the directory of medicinal substances, excipients, capsules, semi-finished drugs, and semi-finished drug materials for producing drugs based on registration files already having a Registration Certificate for Circulation of Drugs in Vietnam and not requiring an Import Permit, the importer must present the transport document of the raw material batch showing that the goods were exported from the exporting country's port before the expiry date of the Registration Certificate for the drug used to declare the raw material (in cases where the Registration Certificate for the drug used to declare the raw material has expired at the time of customs clearance);

h) In cases of importing raw materials for drugs listed in the directory of medicinal substances, excipients, capsules, semi-finished drugs, and semi-finished drug materials for producing drugs based on registration files already having a Registration Certificate for Circulation of Drugs in Vietnam and requiring an Import Permit, the importer must present the transport document of the raw material batch showing that the goods were exported from the exporting country's port before the expiry date of the Registration Certificate for the drug used to declare the raw material and the Import Permit for the raw material (in cases where the Registration Certificate for the drug used to declare the raw material or the Import Permit for the raw material has expired at the time of customs clearance)."

3. Change the name and supplement the content of Note of Form No. 46 of Appendix III, amend Forms No. 01, No. 02, No. 03, and No. 04 of Appendix VII promulgated together with Decree No. 54/2017/NĐ-CP amended and supplemented in Appendix II of Decree No. 155/2018/NĐ-CP in Appendix II promulgated together with this Decree.

4. Repeal Clause 71, Clause 72, Clause 73, Clause 74, and Clause 75 Article 5.

Article 3. Effectiveness

This Decree takes effect from the date of issuance.

Article 4. Transitional Provisions

Documents submitted before the effective date of this Decree shall continue to be processed according to the regulations at the time of submission, except in cases where the entity requests to follow the provisions of this Decree.

Article 5. Responsibility for Implementation

The Ministers, Heads of Ministries equivalent to ministries, Heads of government agencies, Chairmen of provincial People's Committees under the central city, and related organizations and individuals shall be responsible for implementing this Decree./.

ANNEX I

AMEND THE FORMS OF DECREE NO. 54/2017/NĐ-CP OF MAY 8, 2017
(Attached to Decree No. 88/2023/NĐ-CP of December 11, 2023 of the Government)

Form No. 05 Appendix VII

REQUEST TO CHANGE/SUPPLEMENT INFORMATION FOR DECLARED DRUGS, RE-DECLARED PRICES

Respectfully submitted to: Ministry of Health.

(Name of entity) respectfully requests the Ministry of Health to consider changing/supplementing information declared, re-declared for the drug that has been published on the Ministry of Health’s electronic portal as follows:

Attached documents:

1. Approval document from the competent state management agency regarding changes/supplements to information for drugs already issued with a registration certificate or import permit.

2. Product registration certificate (MA), Decision on issuance of product registration certificate.

3. Other documents: …

The entity commits and takes responsibility under the law for the accuracy of the declared information; retains relevant files and documents for post-audit purposes.

DIRECTOR OF IMPORTING ENTITY

(In case of imported drugs)

Form No. 06 Appendix VII

1. Declaring entity:

2. Type of price declaration:

First time .……….………………………………………………………

Address: …

Phone: …

Registration certificate number/ .…………….……………

Manufacturing entity, country of manufacture

Other documents (Specify clearly):

Note:

PERSON RECEIVING THE FILE

PEOPLE'S COMMITTEE OF PROVINCE/CITY …

Form No. 07 Appendix VII

1. Declaring entity:

3. Re-declared drug information:

First time .……………….…………….…………………………………..

Address: …

Phone: …

Registration certificate number .…………….……………………….…….…………..

Concentration/Content

- This receipt only confirms that the entity has completed the price declaration procedure for drugs in accordance with the provisions of Decree No. …

Note:

Situation of re-declaration of domestic-produced drug prices

PEOPLE'S COMMITTEE OF PROVINCE/CITY …

Form No. 08 Appendix VII

REPORT

Drug name, dosage form

Respectfully submitted to: Ministry of Health.

Expected wholesale price/

Note:

NAME OF IMPORTING ENTITY

…., day ….. month ….. year …

PRICE STRUCTURE EXPLANATION TABLE

Form No. 09 Appendix VII

Active ingredient, concentration or content: …

Dosage form, packaging specification: …

Name of manufacturing entity, country of manufacture: …

I. COMPREHENSIVE TABLE OF COST CALCULATION AND IMPORTED DRUG SALES PRICE FOR ONE SMALLEST PACKAGING UNIT

Cost item

(VND)

Import quantity

3. Special consumption tax (if applicable)

4. Other taxes and fees (if applicable)

5. Other monetary expenses as prescribed (if applicable)

6. Financial expenses (if applicable)

7. Sales expenses

8. Management expenses

9. Total cost of one smallest packaging unit

10. Anticipated profit

11. Value-added tax and other taxes (as applicable)

12. Expected wholesale price/expected retail price (if applicable)

13. Delivery/sales conditions

III. MARKET PRICE LEVEL OF SIMILAR DRUGS (IF APPLICABLE)

NAME OF MANUFACTURING ENTITY OR OUTSOURCED DRUG PRODUCTION ENTITY

(For domestically produced drugs)

Drug name, registration certificate number: …

Form No. 10 Appendix VII

Active ingredient, concentration or content: …

Name of manufacturing entity: …

I. COMPREHENSIVE TABLE OF COST CALCULATION AND DOMESTIC-PRODUCED DRUG SALES PRICE FOR ONE SMALLEST PACKAGING UNIT

I. COMPREHENSIVE TABLE OF COST CALCULATION AND IMPORTED DRUG SALES PRICE FOR ONE SMALLEST PACKAGING UNIT

Cost item

Unit price (VND)

Quantity for cost calculation

3. Special consumption tax (if applicable)

1. Direct raw material, materials, tools, fuel, energy costs

2. Direct labor costs

3. Depreciation costs of direct machinery and equipment (in cases where depreciation is allowed)

4. Production and business costs (not included above)

5. Common production costs (for enterprises)

9. Total cost of one smallest packaging unit

10. Anticipated profit

11. Value-added tax and other taxes (as applicable)

9. Total production and business costs

10. Costs allocated to by-products (if any)

11. Cost of one unit of product

12. Expected profit

13. Value-added tax and other taxes (if applicable) as prescribed

14. Expected wholesale price/expected retail price (if applicable)

15. Delivery/sales terms

Drug name, registration certificate number: …

ANNEX II

AMEND THE FORMS OF DECREE NO. 155/2018/NĐ-CP DATED NOVEMBER 12, 2018
(Attached to Decree No. 88/2023/NĐ-CP of December 11, 2023 of the Government)

Form No. 46 Appendix III

LIST (1)

Medicinal ingredients, excipients, capsules, semi-finished pharmaceutical products, semi-finished herbal products for producing medicines according to the registration dossier already having a Registration Certificate for Circulation in Vietnam that can be imported without obtaining an import permit (2)/Medicinal ingredients requiring special control for producing medicines according to the registration dossier already having a Registration Certificate for Circulation in Vietnam must obtain an import permit (3)

Note:

(1): The importing facility of medicinal ingredients, the medicine manufacturing facility importing medicinal ingredients according to the information in the list shall use them for the intended purpose in accordance with current regulations.

(2): Applies to the list of medicinal ingredients that can be imported without obtaining an import permit.

(3): Applies to the list of medicinal ingredients requiring special control that must obtain an import permit.

(4): In cases where the drug used to declare the medicinal ingredient has an extension or maintenance of the validity of the Registration Certificate, if the new validity period has not been updated in the list published by the Ministry of Health, the validity period at column (4) may automatically apply the new validity period.

(5): The name of the medicinal ingredient may be the International Nonproprietary Name (INN) or according to the Vietnamese nomenclature and may include trade names.

(6): For medicinal ingredients applying pharmacopoeia standards, the importing facility is permitted to import medicinal ingredients with updated quality standards (newer year of issuance or higher version number of the pharmacopoeia). Example: The announced quality standard is USP 30/BP 2012, the facility is permitted to import medicinal ingredients with quality standards USP 30, 31, 32.../BP 2012, 2013, 2014...

(7): Applies only to narcotic drug substances, psychotropic drug substances, precursor substances used in drugs.

Form No. 01 Appendix VII

DECLARATION FORM FOR PRICES OF IMPORTED MEDICINES IN VIETNAM

Respectfully submitted to: Ministry of Health.

Attached documents:

- Price structure explanation table (According to Form No. 09 Appendix VII accompanying this Decree).

- Other attached documents (if any): …

The declarant commits and is responsible under the law for the accuracy of the declared information; retains the declaration documents and supporting evidence for each cost item constituting the declared price at the facility for inspection purposes.

Note:

- Foreign currency exchange rate: ... at Commercial Bank ... on .../.../...

PRICE STRUCTURE EXPLANATION TABLE

- Unit of measurement: Calculated based on the smallest packaging unit (tablet, tube, bottle, tube...).

- (*) Please specify clearly the type of import price: CIF or FOB or CIP...

Form No. 02 Appendix VII

DECLARATION FORM FOR PRICES OF DOMESTICALLY PRODUCED MEDICINES

Respectfully submitted to: Ministry of Health.

Attached documents:

- Price structure explanation table (According to Form No. 10 Appendix VII accompanying this Decree)

- Other attached documents (if any): …

The declarant commits and is responsible under the law for the accuracy of the declared information; retains the declaration documents and supporting evidence for each cost item constituting the declared price at the facility for inspection purposes.

Note:

- Unit of measurement: Calculated based on the smallest packaging unit (tablet, tube, bottle, tube...).

PRICE STRUCTURE EXPLANATION TABLE

Form No. 03 Appendix VII

RE-DECLARATION FORM FOR PRICES OF IMPORTED MEDICINES IN VIETNAM

Respectfully submitted to: Ministry of Health.

Attached documents:

- Comparison table of changes in price structure compared to the previous declaration.

- Letter analyzing the reasons, clearly stating the changes in factors affecting the expected wholesale price/expected retail price (if applicable) declared.

- Other attached documents: …

The declarant commits and is responsible under the law for the accuracy of the declared information; retains the declaration documents and supporting evidence for each cost item constituting the declared price at the facility for inspection purposes.

Note:

- Foreign currency exchange rate: ... at Commercial Bank ... on .../.../...

PRICE STRUCTURE EXPLANATION TABLE

- Unit of measurement: Calculated based on the smallest packaging unit (tablet, tube, bottle, tube...). (*) Please specify clearly the type of import price: CIF or FOB or CIP…

Form No. 04 Appendix VII

RE-DECLARATION FORM FOR PRICES OF DOMESTICALLY PRODUCED MEDICINES

Respectfully submitted to: People's Committee of Province/City …

Attached documents:

- Price structure explanation table (According to Form No. 10 Appendix VII accompanying this Decree).

- Comparison table of changes in price structure compared to the previous declaration.

- Letter analyzing the reasons, clearly stating the changes in factors affecting the expected wholesale price, expected retail price (if applicable) declared.

- Other attached documents (if any): …

The declarant commits and is responsible under the law for the accuracy of the declared information; retains the declaration documents and supporting evidence for each cost item constituting the declared price at the facility for inspection purposes.

Note:

- Unit of measurement: Calculated based on the smallest packaging unit (tablet, tube, bottle, tube...).

PRICE STRUCTURE EXPLANATION TABLE