The Ministry of Health of Vietnam promulgates the list of drugs manufactured by at least 03 domestic drug companies in processes that meet EU-GMP standards

The Ministry of Health of Vietnam promulgates the list of drugs manufactured by at least 03 domestic drug companies in processes that meet EU-GMP standards

On April 16th, 2024, the Minister of Health promulgates the Circular 03/2024/TT-BYT on a list of drugs manufactured by at least 03 domestic drug companies in processes that meet EU-GMP principles and standards or equivalents and technical specifications in accordance with regulations of the Ministry of Health concerning quality, price, availability.

The Circular 03/2024/TT-BYT takes effect from April 16th, 2024. It replaces the Circular 03/2019/TT-BYT and Article 1 of the Circular 15/2022/TT-BYT.

Pursuant to the Appendix issued together with the Circular 03/2024/TT-BYT stipulating the list of 93 drugs manufactured by at least 03 domestic drug companies in processes that meet eu-gmp principles and standards or equivalents and technical specifications in accordance with regulations of the ministry of health concerning quality, price, availability:

Notes:

[1] Regarding names of active ingredients of drugs:

- If the name of a drug is different from the name of the active ingredient (chemical name) in Column (2) and is written in specialized pharmaceutical documents (such as Pharmacopoeia, National Pharmacopoeia and other documents), the drug still belongs to the list (E.g. Paracetamol or Acetaminophen; Acyclovir or Aciclovir; Cefuroxime or Cefuroxim; Sodium or Natri; Hydrochloride or Hydroclorid, etc.).

- If the salt base of an active ingredient in Column (2) is not specified, different salts of this active ingredient, after being converted into bases with the same concentrations and content in Column (3) (with the same indications and dosage) still belong to the list.

[2] The bidding for a drug whose dosage form is different from that written in Column (4) shall comply with regulations on drug bidding.

[3] “Regarding dosage forms written in Column (4):

- Dosage forms "Tablets/capsules", "Injectables" written in Column 4 are conventional dosage forms (Pills: Tablets, Capsules; Injectables: Solution for injection, Suspension for injection, Emulsion for injection).

- Procuring units and health facilities are permitted to develop their own contractor selection plans in which bidding documents and request for proposals permit bidders to offer imported drugs with special dosage forms or drugs with bioavailability that is different from conventional dosage forms (E.g. Enteric-coated tablets/capsules, Controlled-release tablets/capsules, Fast disintegrating tablets/capsules, Effervescent tablets, Sublingual tablets; Lyophilized injectables, Liposomal/nano/lipid complex injectables, Intraocular injectables, Long-acting injectables, Metered-dose injection applicators, etc.)”.

[4] Imported drugs that fall into the Categories in Column (6) must not be offered.

The Ministry of Health of Vietnam promulgates the list of drugs manufactured by at least 03 domestic drug companies in processes that meet EU-GMP standards - image from internet

What are principles of compiling the list of drugs manufactured by at least 03 domestic drug companies in processes that meet EU-GMP standards in Vietnam?

Pursuant to Article 2 of the Circular 03/2024/TT-BYT stipulating principles and criteria of compiling the list of drugs:

Principles and criteria of compiling the list of drugs

Each drug included in the list must satisfy all the principles and criteria bellows:

1. There are at least 03 (three) Marketing authorization approval certificates of at least 03 (three) domestic drug companies meeting EU-GMP principles and standards or equivalents and technical specifications of Category 1 and/or Category 2 in accordance with regulations in Circular prescribing bidding for supply of drugs for public health facilities promulgated by the Minister of Health of Vietnam.

2. The domestic drug price (arithmetic mean of successful bids) must not exceed the price for imported drugs with equivalent specifications (in conformity with regulations of the Law on Bidding on incentives for domestically manufactured drugs).

3. This drug must be adequate for health facilities.

As regulated above, principles of compiling the list of drugs manufactured by at least 03 domestic drug companies in processes that meet EU-GMP standards in Vietnam include:

- There are at least 03 (three) Marketing authorization approval certificates of at least 03 (three) domestic drug companies meeting EU-GMP principles and standards or equivalents and technical specifications of Category 1 and/or Category 2 in accordance with regulations in Circular prescribing bidding for supply of drugs for public health facilities promulgated by the Minister of Health of Vietnam.

- The domestic drug price (arithmetic mean of successful bids) must not exceed the price for imported drugs with equivalent specifications (in conformity with regulations of the Law on Bidding on incentives for domestically manufactured drugs).

- This drug must be adequate for health facilities.

What types of drug are banned from advertising in Vietnam?

Pursuant to Article 7 of the Law on Advertising in 2012 stipulating products, goods and services banned from advertising:

Products, goods and services banned from advertising

1. Goods and services banned from trade as prescribed by law.

2. Cigarettes.

3. Wine that contains 150 alcohol or above.

4. Dairy being breast milk substitute for children under 24 months old, dietary supplements for children under 06 months old; artificial feeding bottles and pacifiers

5. Prescription drugs, non-prescription drugs recommended by competent State agencies to use restrictively or under the doctor’s supervision.

6. Pornographic products.

7. Shotguns and cartridges, sporting weapons and products that might incite violence.

8. Other products, goods and services banned from advertising specified by the Government depending on the actual requirements.

As regulated above, following types of drug are banned from advertising in Vietnam:

- Prescription drugs;

- Non-prescription drugs recommended by competent State agencies to use restrictively or under the doctor’s supervision.

Best regards!