In fact, pharmaceuticals are a type of product that is prioritized for import and continuous renewal to meet human needs. On the other hand, imported drugs are also increasing exponentially. Therefore, many customers are still wondering how pharmaceutical import procedures are carried out? So Anlita would like to answer for you through the article below:

1. Regulations on importing pharmaceuticals to Vietnam

Procedures for importing pharmaceuticals have been specifically stipulated in section 2, chapter 2, in compliance with Decree No. 54/2017/ND – CP (amended and supplemented by Decree No. 155/2018/ND – CP). In particular, drugs are only licensed for import when people fully meet the criteria such as:

1. Licensed for circulation in the country of manufacture, member country of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use – ICH or Australia.
2. Guidelines for diagnosis, disease prevention, and treatment are available, issued and fully approved by the Ministry of Health.
3. Medicines for emergency purposes, anti-toxicity, anti-graft rejection, etc.
4. Medicines used to diagnose, prevent or promptly treat group A infectious diseases, cancer, HIV/AIDS, viral hepatitis, tuberculosis, malaria and other diseases decided by the Minister of Health.
5. Comply with regulations on importing pharmaceuticals to Vietnam

2. Conditions for importing pharmaceuticals in Vietnam

In addition to being familiar with drug concepts, individuals, organizations or businesses must understand and comply with the conditions when carrying out pharmaceutical import procedures:

1. Enterprises that produce and trade drugs are required to possess a certificate of eligibility to produce and trade pharmaceuticals in accordance with regulations.
2. Professional managers of production and business establishments must be granted a pharmacy practice certificate. Not only that, they need to have professional ethics, practice health equipment and possess a certificate of eligibility to produce and trade drugs and pharmaceuticals.
3. The enterprise’s facilities meet standards. At the same time, the unit receiving the operation must also improve its professional qualifications and correspond to the form of trading in imported pharmaceutical and drug products.
4. Fully meets the conditions for importing pharmaceutical products

3. Legal procedures for importing pharmaceuticals to Vietnam

Currently, the legal document system already displays regulations on pharmaceutical import procedures. Specifically:

1. Pharmacy Law announced in 2016.
2. Decree 54/2017/ND – CP issued by the Government detailing a number of articles and measures to implement pharmaceutical law in 2016.
3. According to Decree No. 155/2018/ND – CP amending and supplementing Decree No. 54/2017/ND – CP.
4. Circular 03/2016/TT – BYT of the Ministry of Health provides general regulations on pharmaceutical business activities.
5. Any related legal documents.

4. Documents and procedures for importing pharmaceuticals

Anlita will reveal to everyone the correct and complete pharmaceutical import procedures as follows:

1. Import application paper (original).
2. Import orders.
3. Pharmaceutical product certificate (can be replaced by FSC and GMP). In cases where many facilities simultaneously cooperate in the drug production process, they are required to submit GMP certificates of all centers participating in the process of creating the finished product.
4. Standards and methods for checking drug quality.
5. The medicine label and instruction sheet are pre-stamped with the importer’s name. Includes 01 set of labels with original instructions for use currently in circulation in the place of origin (except vaccines and medical biological products), 02 sets of labels expected to be circulated in Vietnam with instructions for use of the service into Vietnamese.
6. Report drug inventory.
7. Prepare clinical and pre-clinical documents for drugs containing new pharmaceutical substances or drugs with a combination of some already circulating pharmaceutical substances.
8. Prepare accurate and complete import procedures documents

5. Detailed procedures for importing pharmaceuticals

When importing, businesses need to determine whether their pharmaceuticals have a circulation number in Vietnam or not. If not, the unit must apply for an import license and register a circulation number. Therefore, pharmaceutical import procedures are often divided into two types:

1. Procedures for importing pharmaceuticals with circulation numbers in Vietnam

For pharmaceuticals that already have a circulation number in Vietnam, businesses can directly carry out import procedures at the Customs office. Records include:

1. Complete commercial invoice.
2. Clear foreign trade contracts.
3. Bill of lading attached.
4. Certificate of origin (original).
5. Providing operating licenses for drugs and medicinal ingredients in Vietnam.
6. Complete list of imported drugs.
7. Product circulation permit or Decision on issuance of circulation registration book (original or notarized photocopy).

2. Procedures for importing pharmaceuticals that do not have a circulation number in Vietnam

On the contrary, if the product does not have a circulation number, the unit must apply for an import license and register a circulation number. The sequence includes 3 steps:

Step 1: Apply for a pharmaceutical import license (required)

This is considered the most important step to import pharmaceuticals to register their circulation numbers in Vietnam. Therefore, businesses need to prepare documents to apply for an import license according to the form detailed in Clause 2, Article 65, Decree 54/2017/ND – CP. As follows:

1. Import order Form No. 15, 16 or 17 in Appendix III attached to Decree No. 54/2017/ND – CP (03 originals).
2. Pharmaceutical product certificate (original or certified copy).
3. The manufacturer’s stamped copy of quality standards and drug testing methods (photo).
4. Set of label samples and instructions for use being circulated in the country that issued the Pharmaceutical Product Certificate (1 original copy).
5. Set of label samples expected to be circulated in Vietnam with Vietnamese instructions for use stamped by the import facility (2 sets).
6. Report drug business results in case imported drugs are addictive drugs, psychotropic drugs, etc. according to Form No. 18 in issued Appendix III.
7. Good practice certificates of all facilities participating in the production of imported drugs in case the drugs are produced by many different enterprises (original or notarized photocopy).
8. License to carry out radiation work of the importing facility in case of importing radioactive drugs (certified copy or copy of the facility’s stamp).

Step 2: Register the pharmaceutical circulation number

As soon as the import documents are completed and submitted in accordance with legal regulations, the unit should begin the process of registering the circulation number for pharmaceuticals in Vietnam. On the other hand, registration procedures and documents are listed in Clause 2, Article 56 of Pharmacy Law 6. The detailed summary is as follows:

Administrative records:

1. Application for registration of circulation certificate and raw materials for drug processing.
2. Authenticated copy of a valid representative office establishment license for a drug business establishment or a valid Certificate of eligibility for pharmaceutical business.
3. Original or certified copy of valid Pharmaceutical Product Certificate for imported drugs.
4. Sample labels, raw materials, drug information and other documents related to business, circulation and raw materials.
5. Technical documents proving that drugs and medicinal ingredients must meet all requirements in Clause 4, Article 54 of the 2016 Pharmacy Law.

• New drugs, reference biological products, vaccines, etc. have indications for diseases on the list issued by the Minister of Health, so businesses must possess an additional set of clinical records proving safety and effectiveness.
• Similar biological products must have additional records demonstrating quality compared to a reference biological product.
• In addition, drugs requiring bioequivalence testing must have an additional report on bioequivalence study data of the drug.

Step 3: Make dossiers for importing pharmaceuticals

As Anlita just mentioned in the section “Documents are procedures for importing pharmaceuticals”, just completing this step is almost 100% complete.

3. HS code and pharmaceutical import tax

Complying with the legal regulations issued by the Vietnamese government, HS Code and taxes are recorded as follows:

HS Code

300410: Drug containing Penicillin with Penicillanic Acid structure.

300420: Antibiotics exist.

300432: Drugs containing Adrenal Hormones or their derivatives.

300440: Drugs containing Alkaloids or their derivatives but do not contain Hormones and antibiotics.

300450: Medicines containing vitamins or products in heading 29.36.

30049049: Anti-malarial drugs, pain relievers, dewormers, etc.

Have full HS code and pay taxes according to regulations

4. Tax

As announced by the Department of Management, pharmaceutical imports are subject to VAT at a rate of 5% when completing customs declaration procedures.

5. Q&A frequently asked questions about pharmaceutical import procedures

Q: What requirements do Vietnamese establishments importing drugs need to meet?

A: The unit must fully meet the following criteria:

Issue a certificate of satisfaction of drug trading conditions with the scope of trading medicinal herbs.

Meets the principle of “Good medicine storage practices” strictly inspected by the Ministry of Health.

Q: How many stages does the procedure for importing pharmaceuticals that do not have a circulation number usually go through?

A: The answer is 3 stages:

First, apply for a pharmaceutical import license.

Second, register for circulation of pharmaceuticals in Vietnam.

Third, carry out customs procedures to import pharmaceutical products that already have a circulation number.

Total gather all information to answer questions about pharmaceutical import procedures we sum up here hope it will be helpful to you pharmaceutical import process.

If you have any questions that you still don’t understand, contact the Hotline for advice and support!