Chương IV Thông tư 44/2014/TT-BYT: Trình tự, thủ tục đăng ký thuốc và thẩm quyền cấp, tạm ngừng, rút sổ đăng ký

Chapter IV

PROCEDURES FOR DRUG REGISTRATION AND COMPETENCY IN ISSUANCE, SUSPENSION OF ISSUANCE OR REVOCATION OF DRUG REGISTRATION NUMBERS

Article 29. Procedures for receipt and verification of the application for drug registration

1. The Drug Administration of Vietnam shall:

a) Receive application for tax registration sent directly or by post regarding the cases below:

- The application for initial registration, re-registration, registration renewal, excluding the application for IVD product registration and application for registration of topical administration drugs manufactured domestically prescribed in Appendix V issued herewith.

- The application for major, minor, or other variation during the validity period of the drug registration number relating to registered drugs, excluding application for IVD product registration.

b) Verify the application for initial registration and re-registration, then send it to the Advisory council for drug registration number of the Ministry of Health; or verify the application for registration renewal, then request the Minister of Health to approve the list of drugs applying for renewal, these application must be sent directly or by post.

c) Verify and give response to the application for major, minor or other variation registration pertaining to registered drugs whose drug registration numbers are still valid which is sent directly or by post.

2. The Department of Medical Equipment and Health Works shall:

a) Receive the application for initial registration, re-registration, registration renewal of IVD products sent directly or by post; and application for minor, major, or other variation registration applying IVD products whose drug registration numbers are still valid;

b) Verify the application for initial registration and re-registration of IVD products, then send it to the Advisory council for drug registration number of the Ministry of Health;

c) Verify the application for registration renewal of IVD products, then send it to the Minister of Health for approval;

d) Verify and give response to the application for major, minor or other variation registration of IVD products whose drug registration numbers are still unexpired.

3. Services of Health of central-affiliated cities and provinces where the drug manufacturers are located shall:

a) Receive the application for initial registration, re-registration, or registration renewal of topical administration drugs manufactured domestically which is sent directly or by post as prescribed in Appendix V issued herewith;

b) Verify the application received as prescribed in Point a of this Clause, then send a official dispatch enclosed with the approved list of drugs to the Drug Administration of Vietnam in order to issue drug registration numbers.

Article 30. Competency in issuance of drug registration numbers

1. The Minister of Health shall authorize the Director of the Drug Administration of Vietnam to sign the Decision on issuance of list of drugs entitled to obtain drug registration numbers in the cases below:

a) The application for drug registration received and verified by the Drug Administration of Vietnam as prescribed in Point b Clause 1 Article 29 of this Circular;

b) The application for drug registration received and verified by the Service of Health as prescribed in Clause 3 Article 29 of this Circular;

2. The Minister of Health shall authorize to Director of Department of Medical Equipment and Health Works to sign the Decision on issuance of list of IVD products entitled to obtain drug registration numbers as prescribed in Clause 2 Article 29 of this Circular.

Article 31. Deadline for issuance or response to application for major, minor, other variation registration

1. The Drug Administration of Vietnam or Department of Medical Equipment and Health Works (regarding IVD products) shall consider issuing drug registration numbers within 06 months regarding the application for initial registration, re-registration and within 03 months regarding application for registration renewal from the day on which the satisfactory application is received . In case the application is rejected, the Ministry of Health shall provide explanation in writing.

2. Within 03 months from the day on which the satisfactory application is received, the Service of Health shall verify and send a Official dispatch enclosed the list of drugs applying for drug registration numbers with regard to application received by the Service of Health as prescribed in Clause 3 Article 29 of this Circular to the Drug Administration of Vietnam for issuance; if the application is rejected, the Service of Health shall provide explanation in writing.

3. From the day on which the satisfactory application is received, the Drug Administration of Vietnam or Department of Medical Equipment and Health Works (regarding IVD products) shall respond to the application for major or minor variation registration with the deadline as follows:

a) 90 days for registration of 02 or more major or minor variations that need approving; 60 days for registration of 01 minor variation that need approving.

b) Within 20 days regarding application for minor variation not subject to permission, if there is not any request of the competent agency.

4. Regarding the application for other variation registration, the application shall comply with regulation similarly to the application for initial registration and deadline for response prescribed in Clause 1 and Clause 2 of this Article.

5. The Drug Administration of Vietnam or Department of Medical Equipment and Health Works (regarding IVD products) shall consider issuing drug registration numbers or responding in writing before the deadline as prescribed in Clause 1 and Clause 3 of this Article at the request of the applicant in the Application form using the form No.06/TT issued herewith in the cases below:

a) The drugs serving the special treatment in the List of scarce drugs issued by the Minister of Health;

b) The drugs serving the treatment in the state of emergency, natural disaster, or epidemic;

c) Domestical drugs manufactured on the new assembly line meeting GMP requirements within 18 months, from the day on which the GMP certificate is issued.

d) The vaccines passed the pre-evaluation conducted by WHO and issued the drug registration number through the reduced process formulated and issued by the Drug Administration of Vietnam.

Article 32. Revocation of drug registration numbers

Within the validity period of the drug registration numbers, the Ministry of Health shall consider deciding to withdraw the drug registration number of the registered drug (including IVD products) if:

1. The drug is manufactured in contravention of application for registration approved by the Ministry of Health.

2. The drug has 02 manufacturing lots not meeting quality standards or the drug committing violations against quality standards 01 time but the drug quality authority conclude that violation is serious.

3. The drug manufacturer or applicant applies for revocation of drug registration numbers in Vietnam.

4. The drug whose drug registration number is withdrawn in the home country.

5. The drug contains active ingredients which are unsafe for users as recommended by WHO or Vietnamese or foreign competent agency.

6. The drug infringes intellectual property rights according to a conclusion of the competent agency.

7. The applicant is not replaced as prescribed in Point I Clause 3 Article 3 or Point d Clause 2 Article 4 of this Circular after 02 months, from the day on which the applicant shuts down itself or by the competent agency.

Article 33. Suspension of receipt of new application for drug registration and suspension of issuance of drug registration numbers

The Ministry of Health shall suspend the receipt of new application for drug registration and suspend the issuance of drug registration numbers (including IVD products) if:

1. The applicant or drug manufacturer has at least 02 lots of drugs not meeting quality standards before being sold or suspended from sale within 01 year.

2. The applicant or drug manufacturer having the drug whose drug registration number is revoked as prescribed in Clause 1 Article 32 of this Circular; or one of cases in Clause 4, Clause 5 or Clause 6 Article 32 of this Circular but it fails to notify the Ministry of Health.

3. The applicant or drug manufacturer forges or intentionally modifies legal documents of competent agencies; or uses fake seals or forges signatures and/or seals of applicants, drug manufacturers and related establishments in the application;

4. The applicant or drug manufacturer provides documents, data, or information relating to technical dossier including reports on quality standards, manufacturing methods, stability without depending on the studies, experiment, or actual manufacture of the at the manufacturer’s facility or at the applicant’s facility;

5. The applicant or drug manufacturer provides documents, data, or information about the effect, safety and efficacy of the drug without any proved materials or scientific evidence;

6. The applicant or drug manufacturer submits the sample of the registered drug not studied or manufactured themselves which is stated in the application for manufacturing registration.

7. The applicant fails to update the drug information at the request of the Drug Administration of Vietnam as prescribed in Clause 4 Article 9 of this Circular.

Article 34. Competency in decision, notification and deadline for revocation of drug registration numbers, suspension of receipt of application and suspension of issuance of drug registration numbers

1. The Minister of Health shall authorize the Director of the Drug Administration of Vietnam to decide to revoke drug registration numbers, suspend the receipt of application, suspend the issuance of drug registration numbers and the Director of Department of Medical Equipment and Health Works to decide to revoke drug registration numbers, suspend the receipt of application, and suspend the issuance of drug registration numbers applying to IVD products nationwide.

2. The Service of Health of central-affiliated city or province or other health authorities shall notify the decision of the Ministry of Health (the Drug Administration of Vietnam or Department of Medical Equipment and Health Works regarding IVD products) on revocation or suspension of receipt of application and suspension of issuance of drug registration number in the province.

3. The maximum period in which the receipt of new application or the issuance of drug registration numbers is suspended is 02 years regarding cases prescribed in Clause 1, Clause 2 and Clause 3 Article 33 of this Circular, from the day on which the Decision on revocation of drug registration number or suspension of the second drug sale or the decision issued by the competent agency as prescribed in Clause 3 Article 33 of this Circular is issued.

4. The maximum period in which the receipt of new application or the issuance of drug registration numbers is suspended regarding cases prescribed in Clause 4, Clause 5 and Clause 6 Article 33 of this Circular is 01 year, from the day on which the final notification on violations against the above regulations committed by the applicant is issued.

5. The maximum period in which the receipt of new application or the issuance of drug registration numbers is suspended regarding cases prescribed in Clause 7 Article 33 of this Circular is 06 months, from the day on which the final notification on violations against the above regulations committed by the applicant is issued.