Nghị định 88/2023/NĐ-CP sửa đổi Nghị định 54/2017/NĐ-CP hướng dẫn Luật Dược

DECREE

AMENDMENTS TO DECREE NO. 54/2017/ND-CP DATED MAY 8, 2017 OF THE GOVERNMENT ELABORATING AND GUIDING THE LAW ON PHARMACY AND DECREE NO. 155/2018/ND-CP DATED NOVEMBER 12, 2018 OF THE GOVERNMENT ON AMENDMENT TO REGULATIONS RELATING TO BUSINESS CONDITIONS UNDER JURISDICTION OF THE MINISTRY OF HEALTH

Pursuant to the Law on Government Organization dated June 19, 2015; the Law on amendment to the Law on Government Organization and the Law on Local Government Organization dated November 22, 2019;

Pursuant to the Law on Pharmacy dated April 6, 2016; At request of the Minister of Health;

The Government promulgates Decree on amendments to Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government elaborating and guiding the Law on Pharmacy and Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government on amendment to regulations relating to business conditions under jurisdiction of the Ministry of Health.

Article 1. Amendment to Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government elaborating and guiding the Law on Pharmacy

1. Amend Clause 1 Article 91:

“1. Medicinal ingredients that are active ingredients, excipients, capsule shells, semi-finished drugs, semi-finished herbal ingredients that have not been registered for marketing authorization and are used for production of drugs that have been registered for drug marketing authorization in Vietnam shall be declared on website of registration authority using Form No. 46 under Appendix III attached to this Decree within 15 days from the date on which drug marketing authorization is issued or extended in Vietnam. Medicinal ingredients under List of medicine ingredients permitted for import shall not be required to be register for import permit other than medicinal ingredients under special control.”.

...

...

...

a) Amend Clause 2:

 “2. Regarding import of drugs and medicinal ingredients having marketing authorization in Vietnam, medicinal ingredients on the list of active ingredients, excipients, capsule shells, semi-finished products, semi-finished medicinal ingredients used for drug production having marketing authorization in Vietnam, except for herbal ingredients:”.

b) Amend Clause 3:

 “3. Regarding import of herbal ingredients and semi-finished herbal ingredients with or without marketing authorization in Vietnam, other than semi-finished herbal ingredients for manufacturing drugs with marketing authorization in Vietnam:”.

c) Amend Clause 4:

 “4. Regarding import of drugs or medicinal ingredients without marketing authorization in Vietnam, other than cases specified in Clause 2 and Clause 3 of this Article:”.

3. Amend Point e Clause 1, Clause 3, and Clause 4 Article 93:

a) Amend Point e Clause 1:

 “e) Semi-finished herbal ingredients, unless these semi-finished herbal ingredients are produced by the same facilities in order to produce finished drugs or semi-finished herbal ingredients for producing drugs with marketing authorization in Vietnam, semi-finished products for testing, research, or production of export drugs.”.

...

...

...

 “3. In the cases where quality standards applied to an excipient that are established by the manufacturer are not included in Vietnam’s pharmacopoeia or any Vietnam’s pharmaceutical standards or any foreign pharmacopoeia specified by the Minister of Health, such excipient must be registered for marketing authorization, unless the excipient is used for manufacturing of drugs with effective marketing authorization in Vietnam and excipient is used for test, research, or manufacturing of export drugs. Procedures for registering for marketing authorization shall conform to Section 1 Chapter V of this Decree.”.

c) Amend Clause 4:

 “4. Soft gel shells shall be registered for marketing authorization unless they are used for manufacturing of a drug that has an effective marketing authorization in Vietnam, for test, research, or manufacturing of export drugs. Procedures for registering for marketing authorization shall conform to Section 1 Chapter V of this Decree.”.

4. Add Point d to Clause 3 Article 96:

“d) Facilities manufacturing drugs, medicinal ingredients of exporting countries do not apply Good Manufacturing Practice principles, standards promulgated, applied, or recognized by the Minister of Health in accordance with Point c Clause 1 Article 97 hereof.”.

5. Add Point c to Clause 1 Article 97:

 “c) If GMP principles and standards do not fall under any of the principles and standards promulgated or declared by the Minister of Health in accordance with Point a Clause 1 of this Article, authorization advisory council shall evaluate conformity of principles, standards of exporting countries relative to principles, standards of the Minister of Health. Once conformity assessment results are produced, the Minister of Health shall issue decision recognizing conformity of GMP principles, standards of exporting countries in order to assess manufacturing facilities.”.

6. Amend Clause 4 Article 131:

 “4. Organization of reception, publishing of declarations and redeclarations:”.

...

...

...

 “Article 132. Rights and responsibilities of drug pricing authorities in implementing regulations on declaration and redeclaration of drug prices

1. Drug pricing authorities have the right to:

a) request pharmacy business establishments making declarations in writing to produce reports on declaration and redeclarations in conformity to declarations of similar commodities on the market, fluctuations of price factors to serve price stabilization, price management, examination, and inspection as per the law;

b) examine and inspect drug pricing in pharmacy business establishments as per the law;

c) request competent authority to take actions if pharmacy business establishments are found to: fail to declare or redeclare; fail to adequately declare price prices or fail to adjust prices and report at written request of competent drug pricing authority in respect of declarations and redeclarations of enterprises; fail to adequately declare price factors or sell drugs at a higher price than applicable declarations or redeclarations;

d) consider measures taken if pharmacy business establishments have committed at least 2 violations in a year: temporarily suspend reception of request for verification of drug information and advertising; temporarily suspend reception of request for import of drugs without marketing authorization in Vietnam; temporarily suspend reception of request for issuance, extension of drug, medicinal ingredient marketing authorization.

Temporary suspension under this Point shall last for 3 months to 12 months from the date on which violate notice is issued by competent authority.

2. Drug pricing authorities have the responsibility to:

a) adhere to regulations on receiving declarations and redeclarations in accordance with Article 131 hereof;

...

...

...

c) maintain confidentiality of declarations and redeclarations of organizations and individuals during the period in which declarations and redeclarations of organizations and individuals have not entered into effect as per the law.”.

8. Amend Article 133:

 “Article 133. Rights and responsibilities of pharmacy business establishments in implementing regulations on declaration and redeclaration of drug prices

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:

a) 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);

b) 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;

c) 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;

...

...

...

9. Amend Article 134:

 “Article 134. Review of published drug price declarations and redeclarations

1. Review of published drug price declarations and redeclarations shall cover:

a) Drug information under price declarations in respect of drug information under Decision on drug marketing authorization or drug import permit;

b) Declared, redeclared drug prices conforming to market price of similar drugs (if any).

2. If necessary, depending on review contents under Clause 1 of this Article, drug pricing authorities shall request Vietnam Social Security, pricing authorities, and relevant authorities to permit post-inspection review of declared, redeclared drug prices.”.

10. Amend Form No. 5, Form No. 6, Form No. 7, Form No. 8, Form No. 9, Form No. 10 under Appendix VII attached to Decree No. 54/2017/ND-CP by Appendix I attached hereto.

Article 2. Amendment to Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government on amendment to regulations relating to business conditions under jurisdiction of the Ministry of Health

1. Amend Point b Clause 47 Article 5:

...

...

...

d) Certified and consular legalized copies of license to practice pharmacy issued by competent authority of home countries. If competent authority of home countries does not issue license to practice pharmacy to suppliers of herbal ingredients and/or semi-finished herbal ingredients, the suppliers shall submit certified copies of business license or documents of equivalent legitimacy issued by competent authority of home countries covering pharmaceutical trading. Foreign suppliers of herbal ingredients and/or semi-finished herbal ingredients are not required to comply with Clause 15 Article 91 hereof if they possess adequate documents stated under this Clause;

dd) Certified and consular legalized copies of certificate of GMP of manufacturing facilities issued by competent authority of home countries. If competent authority of home countries do not issue certificate of GMP, facilities shall then submit certified copies of license to manufacture or documents of equivalent legitimacy as certificate of GMP covering production of herbal ingredients and/or semi-finished herbal ingredients;”.

2. Amend Point b Clause 49 Article 5:

“b) Add Point e, Point g, and Point h Clause 2 Article 92:

e) In case of importing drugs, medicinal ingredients under Point dd Clause 1 Article 59 of the Law on Pharmacy where import permit is required, importing facilities shall present bill of lading of the shipments of drugs, medicinal ingredients indicating that goods are exported from ports of exporting countries before the expiry of marketing authorization and import permit in order to obtain customs clearance;

g) In respect of importing medicinal ingredients under the list of active ingredients, excipients, capsule shells, semi-finished drugs, semi-finished herbal ingredients for manufacturing of drugs with drug marketing authorization in Vietnam where import permit is not required, importing facilities shall present bill of lading of shipments of the medicinal ingredients indicating that the goods are exported from ports of exporting countries before the expiry of drug marketing authorization in order to obtain customs clearance (if drug marketing authorization expires on the date on which customs clearance is granted);

h) In respect of importing medicinal ingredients under the list of active ingredients, excipients, capsule shells, semi-finished drugs, semi-finished herbal ingredients for manufacturing of drugs with drug marketing authorization in Vietnam where import permit is required, importing facilities shall present bill of lading of shipments of the medicinal ingredients indicating that the goods are exported from ports of exporting countries before the expiry of drug marketing authorization and import permit in order to obtain customs clearance (if drug marketing authorization or import permit expires on the date on which customs clearance is granted).”.

3. Amend title and add notes to Form No. 46 of Appendix III, amend Form No. 1, Form No. 2, Form No. 3, Form No. 4 of Appendix VII attached to Decree No. 54/2017/ND-CP amended by Appendix II of Decree No. 155/2018/ND-CP under Appendix II attached hereto.

4. Annul Clause 71, Clause 72, Clause 73, Clause 74, Clause 75 of Article 5.

...

...

...

This Decree comes into force from the date of signing.

Article 4. Transition clause

Request submitted before the effective date hereof shall conform to regulations applicable at the time of application unless applicants request conformity to this Decree.

Article 5. Responsibilities for implementation

Ministers, heads of ministerial agencies, heads of Governmental agencies, Chairpersons of People's Committees of provinces and central-affiliated cities, and relevant organizations, individuals shall be responsible for the implementation of this Decree./.

ON BEHALF OF. THE GOVERNMENT
PP. PRIME MINISTER
DEPUTY PRIME MINISTER




Tran Hong Ha