REPRESENTING THE MANUFACTURER FOR DRUG CIRCULATION REGISTRATION IN VIETNAM

The pharmaceutical market is becoming increasingly rich and diverse, as can be seen. The medicinal products that are manufactured on a daily basis have helped to meet some of people's needs. Its benefits have assisted the pharmaceutical industry. Pharmaceutical products are those that are ingested directly into the human body. As a result, they must be produced in a reliable, accurate, and safe manner. The product will only be of the highest quality if this is done. As the demand for drugs increased, so did the number of new businesses that sprang up to meet it. Doanh Tri Law Firm, as a provider of this service, will act as a guide and representative for foreign pharmaceutical companies seeking to register drugs, medical equipment, and medical biologicals in Vietnam. As a result, Doanh Tri Law Firm provides an article titled ‘Representing The Manufacturer For Drug Circulation Registration In Vietnam' to assist clients in understanding this issue.

I. Legal basis

- Law on Pharmacy 2016;

- Circular No. 35/2018/TT-BYT stipulating good manufacturing practices for drugs and medicinal ingredients;

- Decree No. 54/2017/ND-CP detailing a number of articles and measures to implement the pharmaceutical law;

- Circular 32/2018/TT-BYT regulating the registration of circulation of drugs and medicinal ingredients.

II. Definition

Drug means a preparation that contains active ingredients or herbal ingredients used for prevention, diagnosis, treatment, alleviation of diseases in humans, regulation of human physiological functions, including modern drugs, herbal drugs, traditional drugs, vaccines, and biologicals.

III. The application dossier

1.Administrative dossier

The administrative dossier includes:

- The application;

- The authorization letter;

- The Certificate of Eligibility for Pharmacy Business (for Vietnamese applicants);

- Legal documents (for foreign applicants);

- The license to establish a representative office in Vietnam (for foreign applicants);

- The CPP;

- The label sample, the package insert of the to-be-marketed drug;

- The label sample, the package insert of the drug marketing in the country of origin or the country in which the CPP is issued;

- Summary of product properties for new modern drugs, vaccines, and biologicals;

- Assessment of GMP compliance in the cases mentioned in Article 95 of Decree No. 54/2017/ND-CP (for foreign drug/medicinal ingredient manufacturers applying for the marketing authorization in Vietnam);

- Legal documents of the manufacturer of active ingredients, excipients, capsule shells, semi-finished and finished herbal ingredients;

- The certificate that the medicinal ingredient is permitted to be manufactured or marketed in the country of origin;

- The GLP certificate of the testing laboratory in the cases mentioned in Clause 17 Article 23 of this Circular;

- The risk management plan;

- The technology transfer agreement (in case of pharmaceutical technology transfer);

- The safety and efficacy report;

- The marketing report;

- Any certificate, patent, industrial property transfer agreement, the document proving the origin of ingredients (GACP, CEP, domestic herbal ingredients, imported herbal ingredients, etc.) and relevant documents;

- A copy of the marketing authorization granted in Vietnam.

2. Quality documents

Quality documents shall comply with Part II – ACTD or 3-ICH-CTD and the following regulations:

- For vaccines, antiserum, blood extracts, and human plasma;

- For rare drugs and drugs serving special treatment;

- If the manufacturer uses medicinal ingredients that are have been approved for marketing authorization in Vietnam;

- Pharmaceutical technology transfer;

- Secondary packaging in Vietnam;

- For simplified validation procedures.

3. Non-clinical documents

Non-clinical documents shall comply with Part III or ACTD or 4-ICH-CTD.

Non-clinical documents are not required for probiotics with origins, bacterial strain, concentration or content, indications, doses that are similar to biologicals licensed by one of the regulatory bodies.

4. Clinical documents

Clinical documents shall comply with Part IV or ACTD or 5-ICH-CTD.

Clinical documents are not required for probiotics with origins, bacterial strain, concentration or content, indications, doses that are similar to biologicals licensed by one of the regulatory bodies.

In addition, for each different drug, the application dossier will also have different regulations on documents in the dossier. Doanh Tri Law Firm will provide more detailed assistance after receiving information from clients.

IV. The registration procedure

1. Step 1: The establishment submits 01 application for the issuance of a circulation registration certificate (registration application) to the Department of Management. Pharmacy - Ministry of Health (receiving agency).

2. Step 2: When receiving the application for registration with sufficient components, satisfactory form and full fee, the Drug Administration of Vietnam - the Ministry of Health shall issue to the registrant the application receipt form.

3. Step 3: Within 12 months from the date on which the application is received, the Drug Administration of Vietnam - the Ministry of Health is responsible for: a) Organizing the appraisal of the registration dossier; b) Submitting to the Advisory Council for the grant of a drug registration certificate for the application for issuance, not to be granted or to request the Council's appraisal and advice. c) Issuing circulation registration certificates according to the conclusions of the appraisal and advisory council for issuance of circulation registration certificates after approval of the leaders of the Ministry. In case of applying the rapid appraisal process, the shortened appraisal time is 6 months.

4. Step 4: - In case the application is not satisfactory, within the time limit for considering the application for registration, the Drug Administration of Vietnam - the Ministry of Health must give a written reply clearly stating the reason.

- Time for registration establishment to amend and supplement dossiers:

+ No more than 36 months from the date of receipt of a document from the Drug Administration of Vietnam - the Ministry of Health, for cases requiring additional pre-clinical and clinical documents, bioequivalence, stability study

+ No more than 12 months from the date of receipt of a document from the Drug Administration of Vietnam - Ministry of Health for the remaining cases. The time for the registration establishment to amend or supplement the dossier is not included in the time limit for considering the dossier. If the above time limit is exceeded, the registration dossier is no longer valid and the establishment must re-implement the registration procedure.

- In case of refusal, the Drug Administration of Vietnam - the Ministry of Health must reply in writing and clearly state the reason.

5. Step 5: Additional documents are submitted online, by post, or directly to the Drug Administration of Vietnam. The order of settlement shall be carried out from Step 1. Within 6 months from the date of receipt of sufficient additional documents, the Drug Administration of Vietnam - Ministry of Health shall issue a circulation registration certificate or reply clearly stating the reason. In the case of applying the rapid appraisal process, the shortened appraisal time is 3 months.

The above information is about the 'Representing The Manufacturer For Drug Circulation Registration In Vietnam.' For more information and advice on this issue, please contact Doanh Tri Law Firm directly via:

Hotline: (+84) 911.233.955 - (024) 6293 8326

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