CIRCULAR guide implementation Decree No. 11/1999/ND-CP dated 3/3/1999 of the Government on goods banned circulation, commercial services banned; goods, trade service limiting business, business conditions in the Văcxin field, products _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ pursuant to Decree No. 11/1999/ND-CP dated 3/3/1999 of the Government on goods banned circulation, commercial services banned; goods, trade service limiting business, business condition, this circular specific guidance about business conditions văcxin, products defined in section I, category 3 attached to Decree No. 11/ND-CP dated 03/03/1999 as follows: chapter I GENERAL PROVISIONS article 1.
In this circular, the terms below are interpreted as follows: 1. Văcxin is the Antigen-containing preparations of natural origin or synthetic, used to induce active immunity.
2. B. immune products (products) are products of biological origin are used for prevention, diagnosis and cure of infections in humans.
3. Văcxin, b. are allowed to circulate legally is the văcxin, born product is the Ministry of Health issued the registration number or allow import demand official prevention or treatment or specific diagnosis.
4. business văcxin, products are made the consumption of văcxin, products on the market aimed at profitable.
5. Business Enterprise văcxin, biological function of business is buying, selling văcxin, born.
Article 2. This circular applies to the type of business: 1. State enterprise whose business văcxin Pharmacy business, was born.
2. enterprises established under the business law to business văcxin, biological or pharmaceutical enterprises have business văcxin, born.
3. Business for foreign-invested manufacturing base văcxin, born only to be văcxin by products, business units produced in Vietnam.
Article 3. Prohibiting the private pharmacies, drug agents or objects other than the object specified in article 2 of this circular business văcxin, born.
Article 4. The officials and public servants are held or are doing the following tasks is not involved the work of văcxin business, products 1. The servant of the Vietnam drug administration and Service of preventive medicine.
2. the Director, Deputy Director of the National Center for medical products.
3. The Director, Deputy Director of the provincial health department, central cities (called the).
4. The Director, Deputy Director of the provincial preventive medicine center.
5. The Chief Inspector, Deputy Chief Inspector, specialized inspectors in the Ministry of health and hygiene and the Health Department.
6. the officers doing the management văcxin, born immune products at the provincial health department.
Article 5. Those in the audience were forbidden to establish or participate in corporate management under the provisions of the law are not allowed to establish or participate in business management are established under the law on business to business văcxin, born.
Chapter II BUSINESS CONDITIONS, STANDARD VĂCXIN, BIOLOGICAL article 6. Traders have a business registration certificate and certified eligible and pharmaceutical practice conditions.
Article 7. The facilities, equipment and technical-business office: + distinct, stable, if the rental house is to have a legal lease for at least a year.
+ Device Office page enough to serve the administration of enterprise activity.
+ You as required (full name by Vietnamese under license, can record the transaction name in a foreign language but stimulate the Vietnamese name must be less than).
-Warehouse văcxin, born: + Warehouse must be sure, dry, clean and airy.
+ Warehouse must have ventilation systems, air conditioning, maintenance conditioning, equipment thermometer keep track of daily temperature meets requirements to preserve văcxin, born.
-Import documentation: books + tag for each type of repository, văcxin, warehouse card stating the condition of preservation, expires.
+ Have shared văcxin import export, products.
+ Full of invoices, vouchers, văcxin import export products.
+ Have shared updated văcxin import export, products.
Must-have equipment for cold preservation and tracking device, check the temperature văcxin, born on transportation, consistent with the need to preserve văcxin, born.
Article 8. Managers, technicians must have the following conditions: – managers, executives and business activities;
+ The pharmacist or your doctor has at least 5 years of practice in a pharmaceutical business establishments, văcxin, born of legitimate products.
+ Not being disciplined in practicing medicine, văcxin,, not being prejudice to criminal responsibility.
-Store keeper: + must have professional level from intermediate y-up drug + not being disciplined in practice văcxin,, not being prejudice to criminal responsibility.
-Warehouse staff: the staff on duty to allocate must have professional level from beginning y-over, knowledge of văcxin and to the probiotics.
-Employees have a duty to văcxin shipping, products must have qualification on medicine from the middle school.
Article 9. Officers direct employees, the business must have a health certificate of medical authority district over, does not have the infectious disease.
Article 10. Have the equipment necessary to ensure the required fire prevention, safety, and ensure environmental hygiene.
Article 11. Quality assurance văcxin, born: must-have as văcxin, quality management, save copies of original test votes of each shipment type (stamped confirmation of import company văcxin, biological).
-Văcxin quality monitoring personnel, products are conducted regularly and periodically test the quality văcxin, born at warehouse (at least 1 month/1 times). After each test is recorded in the log book or report to follow.
-The business văcxin private enterprise, products can sign contracts with the quality control facility is accredited to test quality assurance văcxin, born of his business.
Chapter III BUSINESS SCOPE and RESPONSIBILITY of the BUSINESS ESTABLISHMENTS, VĂCXIN, BIOLOGICAL article 12. Scope of business:-The business văcxin, products are only allowed to trade in these products, văcxin were allowed to circulate. The văcxin, biological treatment must have the certificate of quality standards by the national accreditation Center for medical products (or the facility is authorized).
-Văcxin business enterprises, products are not bought, sold the văcxin, born unknown original nguồc cosmetics, overdue, bad quality, văcxin, products not yet Ministry of health license legal circulation.
-Văcxin business enterprises, products are only allowed to sell văcxin products, for the health center, medical facilities are permitted to use văcxin, born immune products.
Article 13. The base business văcxin addition products, responsible for enforcing the regulations of the corporate law, commercial law and related laws of the Socialist Republic of Vietnam have to make the following regulations:-accepted way of health, the law on văcxin Vietnam's products, and the management of the technical expertise of the Ministry of health and the Department of health.
-Responsibility before the law and consumers about the quality of its products, văcxin.
-Compensation for damage due to văcxin, biological circulation does not guarantee the quality of the cause as required by law.
-Have a responsibility to report to the Ministry of health (Health Service), the Department of health on issues related to the quality of văcxin, biological, the complications and side effects of văcxin, born when the physician or the consumer notice.
-Served medical urgent requests.
-Study, understand and implement the law text of laws on medical technical expertise relevant to the scope of the business.
Chapter IV JURISDICTION and PROCEDURE for CERTIFICATION of ELIGIBLE VĂCXIN BUSINESS PRODUCTS, article 14. The Authority reviews the eligibility certification of business văcxin, born in Vietnam;
The Director of the Department of health review, certification of eligibility for domestic business base văcxin, under the management of local students.
The Department of Health established the Advisory Council to help the Director in consideration of criteria and conditions for certification.
Article 15. Application for business license văcxin, born in Vietnam, including: 1. the certification application is eligible văcxin business, was born.
2. business license, business license, certificate of standards and conditions of practice by the Ministry of health Pharmaceutical level.
3. documents of professional, technical and organizational work of the business.
4. Combination of local rent or the certificate of house property make the headquarters, shed 5. Profile of Directors, business directors and executives of business activities includes:-a copy of a certificate of professional qualification.
-A curriculum vitae confirmed by the management bodies or local authorities.
-Slip the health of medical authority district.
-The certificate has at least 5 years hands-on in the business văcxin, born of legitimate products.
6. A commitment to take responsibility for the quality of the products sold, văcxin.
7. A commitment to responsible compensation if văcxin, biological cause influencing health, computer network for users.
Your business profile is made up of 3 sets, of which 1 is the original, the 2nd is a copy. Records are sent to the Department of health of the province where the business headquarters for review.
Within 15 days of receipt of a valid application, the health department based on the results of the evaluation standard in the present circular, will answer in writing on the business level or do not agree to the certification.
Article 16 certificate of eligible văcxin business, products are made in 4 copies: 1 a sending Ministry of trade or the people's committees of the province (where the licensed establishment), 01 post, business health report (saved in the Service of preventive medicine), 1 a save in the Department of health of the province (where the enterprises are located).
If there are any changes in practice than the approved profile (change the category of văcxin, headquarters, products, changes in the Sphinx ...) must have dispatch send the Medical Facility where the certification to be reviewed and verified.
Certificate of eligible văcxin business, enterprise products worth 5 years from the date of issue. Before the expiration of 3 months, the enterprises must submit to the Department of health to review procedures, review level certificate.
After the certification, conduct business operations in accordance with the regulations of the law.
Article 17. The enterprise is certified eligible văcxin business, products have to pay as required by the current law on fees and charges.
Chapter V INSPECTION, test and HANDLE breach of article 18. Inspection, test-inspection the Ministry of health in collaboration with the Service of preventive medicine and the Service, the relevant Bureau to organize inspections, to check the implementation of the regulations of the law on business văcxin, born of all the business enterprise văcxin, born on nationwide.
-Inspection of the Department of health in collaboration with the Department of Health's pharmaceutical profession to organize inspections, to check the implementation of the provisions of the law on business văcxin, born of all the business enterprise văcxin, born on geographical scope.
The inspection, the inspection is conducted periodically or irregularly.
The business enterprise văcxin, biological needs and create favorable conditions for the inspectors, checked at its base.
Article 19. Handle violation of organizations, individuals and business văcxin, products violating the regulations of this circular and the regulations of the relevant law, then depending on the nature and extent of the violation that sanctioned administrative offense, or prejudice the criminal responsibility according to the law If damage compensation as required by law.
Chapter VI article 20 ENFORCEMENT PROVISIONS of this circular in force after 15 days from the date of signing.
In the process if there are difficulties and obstacles, the unit, local reports on the Department of health (Health Service), the Department of health to study the resolution.