Chapter IV
ORDER OF AND PROCEDURES FOR DRUG REGISTRATION, AND COMPETENCE TO GRANT, SUSPEND AND WITHDRAW REGISTRATION NUMBERS
Article 30. Order of and procedures for receiving and appraising drug registration dossiers
1. The Drug Administration of Vietnam under the Ministry of Health shall receive drug registration dossiers submitted directly to it or by post in the following cases:
a/ Drug first-time registration and re-registration dossiers, except those specified in Clause 2 of this Article;
b/ Dossiers of registration of major changes, minor changes or other changes within the validity duration of circulation registration numbers of drugs, for all drugs with registration numbers.
2. Provincial-level Health Departments of the localities in which manufacturers are based shall receive first-time registration and re-registration dossiers submitted directly to them or by post, for domestically manufactured drugs for external use as specified in Appendix V to this Circular (not printed herein).
3. The Drug Administration of Vietnam shall appraise the dossiers specified at Point a, Clause 1 of this Clause and submit them to the Advisory Council for the Grant of Drug Registration Numbers under the Ministry of Health; issue written replies to requests for major changes, minor changes or other changes, for drugs with registration numbers which remain valid under Point b. Clause 1 of this Article.
4. Provincial-level Health Departments shall appraise dossiers specified in Clause 2 of this Article and send official letters enclosed with lists of drugs to the Drug Administration of Vietnam, requesting the grant of registration numbers.
Article 31. Competence to grant registration numbers
1. The Minister of Health may authorize the director of the Drug Administration of Vietnam to sign decisions promulgating lists of drugs to be granted registration numbers for:
a/ Drug registration dossiers received and appraised by the Drug Administration of Vietnam under Point a. Clause 1, Article 30 of this Circular;
b/ Drug registration dossiers received and appraised by provincial-level Health Departments under Clause 2, Article 30 of this Circular.
2. The Drug Administration of Vietnam shall issue written replies to requests for major changes, minor changes or other changes, for drugs with registration numbers which remain valid under Point b. Clause 1 of Article 30; and settle matters related to drug manufacture, registration and circulation.
Article 32. Time limit for granting registration numbers or issuing replies for dossiers of registration of major changes, minor changes or other changes
1. Within 6 months after receiving complete and valid dossiers, the Ministry of Health shall grant circulation registration numbers for drugs registered for the first time or re-registered. In case the conditions for such grant are not or not yet fully satisfied, it shall issue written replies clearly stating the reason.
2. Within 3 months after receiving complete and valid dossiers, provincial-level Health Departments shall examine them and send official letters enclosed with lists of drugs requested for the grant of circulation registration numbers under Clause 2, Article 30 to the Ministry of Health for consideration and grant of circulation registration numbers. If having insufficient grounds for the grant of circulation registration numbers, provincial-level Health Departments shall issue written replies to registration establishments, clearly stating the reason.
3. Within 2 months after receiving complete and valid dossiers, the Ministry of Health shall examine them and issue written replies for dossiers of registration of major changes or minor changes.
4. For requests for other changes, their dossiers are the same as re-registration dossiers and the time limit for issuing replies is prescribed in Clauses 1 and 2 of this Article.
5. The Ministry of Health shall consider and grant registration numbers or issue written replies before the expiration of the time limit specified in Clauses 1 and 3 of this Article at the proposal of registration establishments in the following cases:
a/ Drugs meeting special treatment requirements on the Health Ministry's list of rare drugs;
b/ Drugs meeting treatment requirements in cases of emergency, natural disasters or epidemics;
c/ Drugs domestically manufactured on GMP-standard new chains within 18 months from the date of grant of GMP certificates.
For drugs registered under Clause 5 of this Article, drug registration establishments shall clearly state in registration applications the requests for priority consideration and grant of registration numbers (made according to a set form).
6. The Drug Administration of Vietnam shall establish procedures to specify the supplementation of drug registration dossiers to suit practical conditions in each period.
Article 33. Cases subject to withdrawal of registration numbers of drugs
Within the validity duration of registration numbers, the Ministry of Health shall consider and decide to withdraw registration numbers for drugs with circulation registration numbers in the following cases:
1. Drugs manufactured not according to circulation registration dossiers already approved by the Ministry of Health, except cases permitted by the Ministry of Health;
2. Drugs with 2 manufactured lots failing to satisfy quality standards or drugs once seriously breaching quality standards as concluded by a state management agency in charge of drug quality;
3. Manufacturers or registration establishments requesting the withdrawal of registration numbers for circulation of drugs in Vietnam;
4. Drugs with registration numbers withdrawn in host countries;
5. Drugs containing active ingredients which are unsafe for users as recommended by the WHO and/or competent Vietnamese or foreign functional agencies;
6. Drugs concluded by competent agencies to infringe upon intellectual property rights.
Article 34. Cases subject to suspension of receipt of drug registration dossiers and grant of registration numbers for submitted dossiers
1. The Ministry of Health will suspend receiving drug registration dossiers and granting registration numbers for the submitted dossiers in the following cases:
a/ Drug registration establishments and/or manufacturers having 2 or more drugs suspended from circulation for one year;
b/ Drug registration establishments and/or manufacturers with drugs having registration numbers withdrawn for breaching Clause 1,5 or 6. Article 33 of this Circular; or falling into the case specified in Clause 4, Article 33 of this Circular, without notifying such to the Ministry of Health;
c/ Drug registration establishments and/or manufacturers committing any of the prohibited acts defined in Article 3 of this Circular;
d/ Drug registration establishments and/or manufacturers providing dossiers, data and information relating to technical dossiers, including quality standard, manufacturing methods and stability, without basing on their practical research, experiment or manufacture conditions;
e/ Drug registration establishments and/or manufacturers providing dossiers, data and information on drugs' effects and safety without scientific documents or proof;
f/ Drug registration establishments and/or manufacturers submitting samples of to-be-registered drugs other than those indicated by them in their manufacture registration dossiers.
2. Drug registration establishments and/or manufacturers falling into the case specified at Point c. Clause 1 of this Article are also subject to criminal or administrative handling under current relevant laws.
Article 35. Competence to decide, responsibility to notify, and time limit for withdrawing circulation registration numbers or suspending the receipt of dossiers or grant of circulation registration numbers for drugs
1. The Minister of Health may authorize the director of the Drug Administration of Vietnam to decide to withdraw circulation registration numbers or suspend receiving dossiers or granting registration numbers nationwide.
2. Provincial-level Health Departments and health agencies of sectors may notify their decisions withdrawing registration numbers or suspending the receipt of dossiers or grant of registration numbers in localities under their management.
3. The maximum time limit for suspending the receipt of drug registration dossiers and grant of circulation registration numbers for the submitted dossiers is 2 years, for cases specified at Points a. b and c. Clause 1, Article 34 of this Circular, from the date of signing second decisions to withdraw registration numbers or suspend the circulation of drugs or handling decisions of competent state management agencies, for establishments committing the acts specified at Point c, Clause 1, Article 34 of this Circular.
4. The maximum time limit for suspending the receipt of drug registration dossiers and grant of circulation registration numbers for the submitted dossiers in the cases specified at Points d, e and f, Clause 1, Article 34 of this Circular is one year from the date of obtaining final notices of the violations of the above regulations committed by registration establishments.
Tìm kiếm
Thông tư 22/2009/TT-BYT (Bản Word)