Chương III Thông tư 13/2009/TT-BYT: Hồ sơ, trình tự thủ tục tiếp nhận hồ sơ thông tin, quảng cáo thuốc

Chapter III

DOSSIERS, ORDER AND PROCEDURES FOR RECEIPT OF DOSSIERS OF DRUG INFORMATION PROVISION AND ADVERTISING

Article 27. Agencies receiving and processing dossiers of drug information provision and advertising

1. The Ministry of Health (the Drug Administration of Vietnam) shall receive and process drug advertising registration dossiers and registration dossiers of drug information provision for medical workers.

2. Provincial-level Health Departments shall receive and process registration dossiers of drug introduction seminars for medical workers and grant cards to drug introducers.

Article 28. Dossiers, order and procedures for grant of drug introducer cards

1. A dossier of application for a drug introducer card for university degree holders comprises:

a/ An application for a drug introducer card (made according to a set form);

b/ Resume (certified by the applicant-managing agency or local administration);

c/ Valid copy of diploma under Point a. Clause 2. Article 11 of this Circular;

d/ Health certificate;

e/ List of products to be introduced by the applicant;

f/ Written commitment of the applicant on his/her conversance and compliance with relevant legal documents on pharmacy.

2. A dossier of application for a drug introducer card for holders of professional secondary degree comprises the papers specified in Clause I of this Article and the following:

a/ Certificate of drug introducer training granted by a training institution under the Ministry of Health's regulations:

b/ Certificate of the applicant's seniority of working at a lawful medical or pharmaceutical establishment for at least two years;

3. Order and procedures to grant drug introducer cards:

a/ Employers of drug introducers shall submit dossiers under regulations to provincial-level Health Departments of localities where their headquarters or representative offices are based;

b/ Within 20 working days after receiving complete and valid dossiers, provincial-level Health Departments shall, based on these dossiers, grant drug introducer cards (made according to a set form). In case of refusal, they shall reply in writing clearly stating the reason.

4. A drug introducer card is valid for two years from the date of grant. To obtain new cards, employers of drug introducers shall submit dossiers again one month before the expiry of drug introducer cards.

5. Employers of drug introducers shall revoke and return drug introducer cards to card-granting provincial-level Health Departments in the following cases:

a/ Drug introducers work for other employers:

b/ Drug introducers are no longer tasked to introduce drugs;

c/ Drug introducer cards have expired.

6. Provincial-level Health Departments shall revoke drug introducer cards when drug introducers violate one of the provisions of Article 5 of this Circular.

7. When drug introducers operate in other provinces, their employers shall report in writing to provincial-level Health Departments of concerned localities on the time, places and work plans of drug introducers.

Article 29. Dossiers, order and procedures for processing of registration dossiers of drug introduction seminars for medical workers

1. Before holding a drug introduction seminar for medical workers of a locality, a unit shall submit a registration dossier to the Health Department of that locality. Such a dossier comprises:

a/ Registration form of a drug introduction seminar for medical workers (made according to a set form);

b/ (Tentative) venue and agenda of the seminar ;

c/ Contents of each report, names and scientific titles of rapporteurs;

d/ Documents planned for display and distribution at the seminar;

e/ Documents on drugs to be introduced at the seminar;

f/ Reference documents (if any).

2. All documents in a dossier must be appended with the dossier compiler's seal.

3. When receiving complete and valid dossiers under this Circular, provincial-level Health Departments shall give a dossier receipt slip (made according to a set form) to dossier submitting units. The date of the receipt slip is the date provincial-level Health Departments receive full and valid dossiers. Fifteen working days after provincial-level Health Departments receive dossiers, units may hold seminars according to registered contents if provincial-level Health Departments make no written request for modification and supplementation of dossiers.

4. When registration dossiers of drug introduction seminars are incomplete or invalid, within 15 working days, provincial-level Health Departments shall request in writing seminar registering units to supplement, modify or complete their dossiers.

5. When a provincial-level Health Department makes a written request for a unit to modify and supplement a dossier:

a/ Its request must specify and detail documents to be added or contents to be modified or supplemented.

b/ The unit shall modify and supplement contents as requested and submit revised contents to the provincial-level Health Department. When the unit makes modifications and supplements as requested, the provincial-level Health Department shall give the unit a dossier receipt slip. The date of this slip is the date the provincial-level Health Department receives the supplemented dossier. Five working days alter the provincial-level Health Department receives revised contents of seminar registration, the unit may hold the seminar according to the revised contents if the provincial-level Health Department makes no written request for further modification and supplementation.

6. Units submitting seminar registration dossiers shall report in advance (for at least one day) on specific venues and times of seminars to provincial-level Health Departments receiving their dossiers.

Article 30. Dossiers, order and procedures for processing registration dossiers of drug information provision and advertising

1. Before providing information on and advertising drugs, units shall submit registration dossiers of drug information provision and advertising to the Ministry of Health (the Drug Administration of Vietnam).

2. Such a dossier comprises:

a/ Registration form for drug information provision and advertising (made according to a set form);

b/ Expected form, contents of drug information provision and advertising;

c/ Documents for reference and verification of drug information and advertisement contents:

d/ Copy of the use instructions insert already approved by the Drug Administration of Vietnam;

e/ Copy of the production circulation permit granted by the Drug Administration of Vietnam or the decision on drug registration number of the Drug Administration of Vietnam;

f/ Copy of the certificate of satisfaction of drug trading conditions or license for operation in Vietnam of foreign companies;

g/ For advertising on radio or television, screenplay and video or audio tape. The screenplay must clearly describe images, words and music;

3. All documents in the dossier must be appended with the dossier compiler's seal. For the documents specified at Points d. e and f, Clause 2 of this Article, only their copies appended with seal of drug information and advertisement registering units are required.

4. Planned drug information and advertisement and screenplays shall be submitted in two copies. After they are completed, one copy shall be kept at managing agencies and the other shall be certified and stamped by the Drug Administration of Vietnam and handed to the units registering drug information provision and advertising.

5. The Drug Administration of Vietnam will not consider registration of drug information provision and advertising irrelevant to drugs under this Circular.

6. When receiving complete and valid registration dossiers under this Circular, the Drug Administration of Vietnam shall send dossier submitting units a dossier receipt slip (made according to a set form). The date of this slip is the date the Drug Administration of Vietnam receives complete and valid dossiers. Fifteen working days after the date of the receipt slip, units may provide information on and advertise drugs according to registered contents if the Drug Administration of Vietnam make no written request for modification and supplementation of dossiers.

7. When registration dossiers of drug information provision and advertising are incomplete or invalid under this Circular, within 15 working days, the Drug Administration of Vietnam shall make a written request for registering units to modify and complete their dossiers.

8. When the Drug Administration of Vietnam makes a written request for a unit to modify and supplement a dossier:

a/ Such request must specify and detail documents to be added or contents to be modified or supplemented.

b/ The unit shall modify and supplement contents as requested and submit revised drug information and advertisement to the Drug Administration of Vietnam. When the unit makes modifications and supplements as requested, the Drug Administration of Vietnam shall send the unit a dossier receipt slip. The date of this slip is the date the Drug Administration of Vietnam receives the revised dossier. Five working days after the Drug Administration of Vietnam receives revised drug information and advertisement contents, the unit may provide information on and advertise drugs according to the revised contents if the Drug Administration of Vietnam makes no written request for further modification and supplementation.

c/ Within 3 months after the Drug Administration of Vietnam makes a written request for supplementation and modification, if a drug information and advertisement registering unit fails to modify and supplement the dossier, such dossier is invalidated.

9. Order and procedures for registration and examination of dossiers of drug information provision and advertising eligible for dossier examination shall be carried out again in the following cases:

- Drug information providers or advertisers subject to dossier modification and supplementation fail to modify and supplement dossiers as requested.

- Drug information providers or advertisers have registered drug information and advertisement contents at the Drug Administration of Vietnam and obtained receipt slips, but fail to comply with Article 5 of this Circular.

In this case, the Drug Administration of Vietnam shall issue a notice to drug information and advertisement registering units disallowing them to provide information on and advertise drugs according to registered contents.

10. When units having registration dossiers of drug information provision and advertising fail to comply with Clause 14, Article 5 of this Circular, the Drug Administration of Vietnam shall issue written warnings to these units and stop receiving and examining their registration dossiers of drug information provision and advertising for between 3 and 12 months, specifically as follows:

a/ To stop receiving and examining for 3 months registration dossiers of drug information provision and advertising of units which fail to comply with Clause 14. Article 5 of this Circular.

b/ To stop receiving and examining for between 3 and 6 months registration dossiers of drug information provision and advertising of units which fail to comply with Clause 14. Article 5 of this Circular twice in a year.

c/ To stop receiving and examining for between 6 and 12 months registration dossiers of drug information provision and advertising of units which fail to comply with this Circular three times or more in a year.

In addition to the above measures, the Drug Administration of Vietnam shall publish violations of violators on its website; and report such to inspection agencies and competent functional agencies for consideration and handling under law.

Article 31. Validity of drug information documents

Drug information documents already registered at the Drug Administration of Vietnam are invalidated in the following cases:

1. Drug registration numbers have expired.

2. Drug registration numbers are withdrawn or drugs are subject to limited use under recommendations by competent state management agencies.

3. There are changes in drug information.