Thien Di's Service for Registering the Circulation of Pharmaceutical Ingredients

1. What are Pharmaceutical Ingredients?

2. Registration Forms for Pharmaceutical Products

3. Procedures for Registering the Circulation of Pharmaceutical Ingredients in Vietnam

• Law on Pharmacy No. 105/2016/QH13
• Decree No. 54/2017/ND-CP dated May 8, 2017, of the Government detailing a number of articles and measures implementing the Law on Pharmacy
• Circular No. 32/2018/TT-BYT dated November 12, 2018, on the registration of circulation of drugs and pharmaceutical ingredients
• Circular No. 29/2929/TT-BYT dated December 30, 2020, amending and supplementing.

3.1. Subjects and requirements for registration of pharmaceutical ingredients (Article 54 of the Law on Pharmacy 2016)

• Pharmaceutical ingredients that are active substances for drug manufacturing according to drug registration dossiers that have been granted a Certificate of Free Circulation in Vietnam.
• Pharmaceutical ingredients imported in accordance with Clause 3, Article 60 of the Law on Pharmacy.

• Entities that manufacture, wholesale, export, or import pharmaceutical ingredients in Vietnam.
• Foreign entities trading in pharmaceutical ingredients and having a representative office in Vietnam.

• Ensures safety and efficacy requirements.
• Manufactured by a pharmaceutical ingredient manufacturing facility that meets the prescribed conditions.
• Manufactured according to a pharmaceutical ingredient manufacturing process and meets quality standards.

• Evaluation of the dossier related to the Conditions for Manufacture.
• Mutual recognition of inspection and control results of the state drug administration agency for the requirement to meet GMP for pharmaceutical ingredients.
• Inspection at the pharmaceutical ingredient manufacturing facility.

3.2. Dossier for Registering Pharmaceutical Ingredients (Article 24, Circular 32/2018/TT-BYT)

• Registration application form according to Form 6/TT enclosed with this Circular.
• Power of attorney (if any) according to Form 8/TT.
• Certificate of eligibility for pharmaceutical business for Vietnamese registration entities.
• Legal documents for foreign registration entities. (Not required if the registration entity has been published or if the registration entity is a manufacturing facility with its name and address listed on the CPP of the registered drug).
• Certificate of establishment of a representative office in Vietnam for foreign registration entities. (Not required if the registration entity has been published).
• Specimen label of the planned circulating ingredient and excipient.
• Specimen label of the actual circulating ingredient and excipient in the country of manufacture or circulation.
• Documentation of GMP compliance for cases specified in Article 95 of Decree 54/2017/ND-CP for foreign pharmaceutical and pharmaceutical ingredient manufacturing facilities when registering for circulation in Vietnam. (not required if the facility has been evaluated and published).
• Legal documents of the manufacturing facility for pharmaceutical substances, excipients, capsules, pharmaceutical semi-finished products, and medicinal herbs. (implemented according to the roadmap).
• Certificate of pharmaceutical ingredient authorized for manufacture or circulation in the country of manufacture.
• GLP certificate of the testing facility for cases specified in Clause 17, Article 23 of Circular 32/2018/TT-BYT.
• Certificates, protection titles, technology transfer contracts, documents certifying the origin of raw materials (GACP, CEP, domestic medicinal herbs, imported medicinal herbs, ...), and other relevant documents (if any).

• Not more than 36 months from the date of the written notice of the Department of Drug Administration - Ministry of Health for cases where preclinical, clinical, bioequivalence, and stability studies need to be supplemented.
• Not more than 12 months from the date of the written notice of the Department of Drug Administration - Ministry of Health for all other cases. The time for the establishment to amend and supplement the dossier is not counted in the time limit for reviewing the dossier. If the above deadline is exceeded, the registration dossier will be invalid and the establishment must re-register.
• In case of refusal to grant a license, the Department of Drug Administration - Ministry of Health must respond in writing and state the reasons.

• The application dossier for drugs and pharmaceutical ingredients must be written in Vietnamese or English.
• The package insert and the Summary of Product Characteristics must be written in Vietnamese.

• The application dossier for drugs and pharmaceutical ingredients must be prepared on A4 paper and securely bound (except for online applications).
• The dossier must have a cover page (Form 3/TT), a product information sheet (Form 4/TT) arranged in the correct order of the table of contents (Form 5/TT), with separation between sections. The sections must be numbered for easy reference and have the stamp of the registration authority or the manufacturing establishment of drugs and pharmaceutical ingredients on the first page of each section in the entire dossier (the stamp of the representative office is accepted for foreign drugs).

• A set of documents consists of 01 original and 02 copies of the following documents: Application form; standards and testing methods; 02 sets of labels for drugs and pharmaceutical ingredients. The sections of the dossier (Administrative dossier, Quality) are separated and accompanied by 01 Product Information sheet.
• The roadmap for applying online dossiers as announced by the Minister of Health.

3.3. Regulations on Importing Pharmaceutical Raw Materials into Vietnam (Article 91 of Decree No. 54/2017/ND-CP)

• Pharmaceutical raw materials are active pharmaceutical ingredients, excipients, and semi-finished medicinal products (excluding semi-finished herbal medicinal products) used to manufacture drugs according to registered drug dossiers that have been granted a Certificate of Drug Circulation Registration in Vietnam by the Minister of Health and published within 15 days from the date of issuance or renewal of the Certificate of Drug Circulation Registration in Vietnam.
• Pharmaceutical raw materials that are active pharmaceutical ingredients, excipients, and semi-finished medicinal products included in the List of Published Imports that do not require an import license, except for pharmaceutical raw materials that are subject to special control.
• Pharmaceutical raw materials that have been registered for circulation in Vietnam, including herbal materials, semi-finished herbal products, excipients, capsules, and semi-finished medicinal products (excluding semi-finished medicinal products subject to special control) can be imported without an import license.
• Medical and pharmaceutical training institutions, research institutes, and drug testing laboratories are allowed to import drugs, pharmaceutical raw materials, and standards for training, research, and testing purposes conducted by the institution itself.
• Representative offices in Vietnam of manufacturing facilities, registration holders, owners of clinical trial drug circulation licenses, bioavailability assessment drugs, bioequivalence testing drugs; clinical trial receiving facilities, bioavailability assessment receiving facilities, and bioequivalence testing receiving facilities are allowed to import drugs, pharmaceutical raw materials, and standards for clinical trials, bioavailability assessment, and bioequivalence testing.
• Traders are allowed to import packaging that comes into direct contact with drugs.
• Drugs and pharmaceutical raw materials can only be imported through international border gates, except for drugs that are licensed for non-commercial import.

3.4. Regulations on Specialized Documents Required for Customs Clearance of Pharmaceutical Raw Material Import (Article 92 of Decree No. 54/2017/ND-CP)

• Present the original or certified copy and submit a copy with the confirmation stamp of the exporting establishment of the Certificate of Good Manufacturing Practice (GMP) for the exporting establishment if the exporting establishment is a pharmaceutical business establishment.
• Submit a copy of the export license with the confirmation stamp of the exporting establishment and present the original or certified copy for comparison in case of exporting medicinal herbs on the list of rare, precious, endemic species and varieties of medicinal herbs that must be controlled; special controlled drugs except for the case specified in point c of this clause;
• Submit a certified copy of the prescription, outpatient medical records, or a copy with the signature of the person requesting the export license or a copy with the stamp of the organization requesting the export license and present the original for comparison in the case of special controlled drugs in the personal luggage of organizations and individuals leaving the country sent by waybill, goods carried by organizations and individuals leaving the country for medical treatment for themselves with the export quantity not exceeding the maximum usage of 07 days for addictive drugs; 10 days for psychotropic drugs, precursor drugs; 30 days for combination drugs containing addictive substances, combination drugs containing psychotropic substances, combination drugs containing precursors, toxic drugs, drugs in the list of drugs and substances banned from use in some industries and fields according to the dosage stated in the prescription attached.

• Present the original or certified copy and submit a copy with the confirmation stamp of the importing establishment of the Certificate of Good Manufacturing Practice (GMP) for the importing establishment if the importing establishment is a pharmaceutical business establishment.
• Submit a copy with the confirmation stamp of the importing establishment of the import license and present the original or certified copy for comparison in case of importing special controlled drugs;
• Submit the original or a copy of the Certificate of Analysis for each batch of imported pharmaceutical raw materials with the stamp of the importing establishment; if it is a copy, the original must be presented for comparison when clearing customs.

4. Registration fees for medicines and pharmaceutical ingredients 

• First registration and re-registration: 5,500,000 VND/dossier.
• Renewal: 3,000,000 VND/dossier.
• For dossiers of changes/supplements to medicines and pharmaceutical ingredients with existing circulation licenses: 1,000,000 VND/dossier.

- Granting of import license for finished medicines without a registration number (except for importing rare medicines, medicines for special treatment needs...): 800,000 VND/item.

- Granting of import license for medicinal herbs and traditional medicines: 200,000 VND/item.

- Declaration of cosmetic products and pharmaceutical standards: 500,000 VND/item.

5. Authority for Granting, Renewing, Changing, and Supplementing Circulation Licenses for Medicines and Pharmaceutical Ingredients:

6. Validity of Drug and Pharmaceutical Ingredient Circulation Registration Certificates and Deadline for Submitting Renewal Applications

7. Online Declaration of Pharmaceutical Ingredients

• Drug circulation registration number
• Validity of drug circulation registration certificate
• Name of the declared pharmaceutical ingredient
• Quality standard of the ingredient
• Name of the ingredient manufacturing establishment
• Address of the ingredient manufacturing establishment (only applicable to ingredients that are addictive drugs, psychotropic drugs, and precursors used for drug production)
• Country of origin of the ingredient

8. Responsibilities of Drug and Pharmaceutical Ingredient Registration Establishment

• The establishment is responsible for making changes and additions to the content of drug labels and instructions for use in accordance with the requirements of the Ministry of Health (MoH) (Department of Drug Administration) during the validity period of the drug registration certificate without submitting a dossier for registration of changes and additions.
• The establishment must make changes and additions following the regulations in Clause 4 of Article 28 and Article 40 of this Circular during the validity period of the drug or pharmaceutical ingredient registration certificate.
• The establishment is responsible for ensuring the quality, safety, and efficacy of drugs and pharmaceutical ingredients in accordance with the registered dossier.
• The establishment is responsible for the legality and accuracy of all documents in the registration dossier.
• The establishment must cooperate with the manufacturing facility and the competent authority of the foreign country to respond to the requests of the Department of Drug Administration for verification of the authenticity of legal documents related to the drug registration dossier.
• The establishment must notify the Department of Drug Administration in writing within 30 days from the date of the decision to withdraw the marketing authorization in any country in the world for drugs or pharmaceutical ingredients that have been granted a marketing authorization in Vietnam and are still valid, and must state the reason for the withdrawal.
• The establishment must closely coordinate with the drug manufacturing facility to ensure that at least one of these two facilities must conduct research or provide additional information related to the registered drug when there is information or evidence related to the safety and efficacy of the drug during the marketing period as requested by the competent state management agency.
• The establishment must cooperate with the drug manufacturing, importing, and distributing establishments to monitor, supervise, collect, synthesize, evaluate, and send reports to the National Center for Drug Information and Adverse Drug Reaction Monitoring (National DI & ADR Center) on cases of post-vaccination reactions and adverse drug reactions in accordance with the regulations in Clause 5 of Article 77 of the Law on Pharmacy, the Guidelines on Good Pharmacovigilance Practices (GPP), national guidelines on pharmacovigilance, and related regulations.
• The establishment must maintain the operating conditions of the registration establishment during the validity period of the drug or pharmaceutical ingredient registration certificate. In case the establishment no longer meets the operating conditions, it must be responsible for changing the registration establishment in accordance with the regulations in Clause 4 of Article 28 and Article 40 of this Circular within 30 days from the date the registration establishment no longer meets the operating conditions.
• The establishment is responsible for issues related to intellectual property rights for drugs and pharmaceutical ingredients registered for circulation in Vietnam.
• The establishment must coordinate with the manufacturing facility to update the quality standards for drugs and pharmaceutical ingredients in accordance with Circular No. 11/2018/TT-BYT dated May 04, 2018 of the Minister of Health on the quality of drugs and pharmaceutical ingredients (hereinafter referred to as Circular No. 11/2018/TT-BYT) and Circular No. 13/2018/TT-BYT dated May 15, 2018 of the Minister of Health on the quality of medicinal herbs and traditional medicines.
• The establishment must implement the approved risk management plan in the dossier for the application for granting or renewing the marketing authorization for vaccines.
• The establishment is responsible, in accordance with Clause 2 of Article 57 of the Law on Pharmacy and the regulations in this Circular, for drugs and pharmaceutical ingredients registered by the establishment from the date the Department of Drug Administration signs the official dispatch allowing the change of the registration establishment, including drugs and pharmaceutical ingredients that have been put into circulation before the date the Department of Drug Administration issues the official dispatch allowing the change of the registration establishment, in accordance with the current regulations.
• The establishment must assume other responsibilities specified in this Circular and other relevant legal regulations.

9. Thiên Di's Drug and Pharmaceutical Ingredient Registration Services

9.1. Values that Thiên Di's services bring:

• Advised and answered questions
• Evaluated and checked ingredients
• Supported for testing at state-designated centers
• Assisted in preparing registration dossiers
• Assisted in submitting dossiers and monitoring results
• Provided with results and delivered to you
• Advised on post-drug registration issues

9.2. In addition, you can refer to some other services of Thiên Di such as:

• Trademark registration
• Trademark registration procedures
• Exclusive product registration
• Product exclusivity registration
• Intellectual property registration of trademarks
• Trademark and logo registration
• Trademark registration at the Intellectual Property Office
• Trademark registration at the Intellectual Property Office
• Food trademark registration
• Cosmetic registration
• Industrial design registration
• Copyright registration
• Medical device import license application service
• Medical equipment import license
• Medical equipment import procedures
• Application for medical device import license

 

 

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