GENERIC DRUG REGISTRATION PROCESS IN VIETNAM | DOANH TRI LAW FIRM

As we can see, the pharmaceutical market is becoming more diverse and richer. The medicinal products that are manufactured on a daily basis have helped to meet some of people's needs. Its benefits have helped 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 provides our clients with an article on Generic Drug Registration in Vietnam to help them understand the 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. Dossiers

The administrative dossier, including:

1. Application form;

2. Power of attorney (if any);

3. Certificate of eligibility for pharmacy business, for Vietnamese registration establishments;

4. Legal papers for foreign registration establishments. (Not required if the registrant has been announced or the registrant is a manufacturer whose name and address are listed on the CPP of the registered drug);

5. License for establishment of a representative office in Vietnam, for foreign registration establishments. (Not required if the base of registration has been published);

6. Certificate of CPP according to Form 7/TT issued together with this Circular;

7. Samples of drug labels and instructions for use of drugs expected to be circulated;

8. Samples of drug labels and instructions for use of drugs are actually circulated in the country of manufacture or the country of CPP;

9. Documents on assessment of compliance with GMP for the cases specified in Article 95 of Decree No. 54/2017/ND-CP, applicable to foreign manufacturers of drugs and medicinal ingredients when registering for circulation in Vietnam Vietnam;

10. Legal papers of the manufacturer of pharmaceutical ingredients, excipients, capsule shells, semi-finished medicinal products, herbal ingredients. (follow the schedule);

11. GLP certificate of the testing establishment, for the case specified in Clause 17, Article 23 of Circular 32/2018/TT-BYT;

12. Certificates, protection titles, contracts on the transfer of industrial property object rights, papers certifying the origin of raw materials (GACP, CEP, domestic herbal sources, imported herbal sources, etc.), and related documents (if any).

Technical profile, including:

Quality documents: Quality documents comply with the guidance in Part II - ACTD or Component 3-ICH-CTD and the following specific regulations:

1. For vaccines, serum containing antibodies, derivatives of human blood and plasma:

a) The batch release certificate is issued by the competent authority of the country issuing the CPP according to regulations;

b) Test sheets, quality standards and testing methods certified by the National Institute for Accreditation of Vaccines and Medical Biologicals;

2. For rare drugs and drugs for special treatment needs:

a) Rare drugs for the treatment of rare diseases: Stability study data are available according to ASEAN or ICH guidelines;

b) Medicines needed for special treatment needs: available stability study data according to the guidelines of ASEAN or the ICH is decided by the Minister of Health on the basis of the opinion of the Advisory Council to issue a license. registration of circulation of drugs and medicinal ingredients in case the registration establishment proves that the drugs cannot be stored in climate conditions of zone IVb according to ASEAN guidelines.

3. In case a manufacturer uses medicinal ingredients that have been granted a certificate of free sale in Vietnam:

a) It is not required to submit quality documents related to raw materials and documents specified in Clause 11 Article 24 of this Circular in the application for registration of finished drugs.

b) The registration establishment must submit:

- 01 test sheet of medicinal ingredients, tested by the manufacturer of the finished drug product, must have all the quality criteria with a quality level equal to or more stringent than the quality level in the standards of the manufacturer of the drug. Whether; - 01 test sheet of medicinal ingredients tested by the manufacturer.

c) If the registration establishment requests the classification of the original brand name drug when submitting the application for a drug registration certificate, it shall comply with Article 9 of Circular 32/2018/TT-BYT.

- A set of documents includes 01 original and 02 copies of the following documents: Application form; testing standards and methods; 02 sets of samples of drug labels, medicinal ingredients, and instructions for use. No additional copies are required if submitting an online application.

- Profile sections (Administrative, Quality, Pre-Clinical, Clinical, BE) are separated and accompanied by 01 product information sheet.

III. Registration process

1. Step 1: The establishment submits 01 application for the issuance of a circulation registration certificate (registration application) as prescribed in Article 28 of Circular No. 32/2018/TT-BYT dated November 12, 2018, 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 according to Form No. 12/TT promulgated together with Circular No. 32/2018/TT-BYT dated 12/11/2018.

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 the 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 'Generic Drug Registration Process In Vietnam / Doanh Tri Law Firm.' For more information and advice on this issue, please contact Doanh Tri Law Firm directly via:

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