Circular 03/2016/tt-Byt: Regulations On Medicinal Business Operations

Original Language Title: Thông tư 03/2016/TT-BYT: Quy định về hoạt động kinh doanh dược liệu

Read the untranslated law here: https://www.global-regulation.com/law/vietnam/2952803/thng-t-03-2016-tt-byt%253a-quy-nh-v-hot-ng-kinh-doanh-dc-liu.html

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The CIRCULAR regulates pharmaceutical business activities _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Pharmacy pursuant to the law No. 34/2005/QH11 on June 14, 2005;
Pursuant to Decree No. 79/2006/ND-CP dated 9 August 2006 from the Government detailing the implementation of some articles of the law and Decree No. 89/2012/ND-CP dated 24 October 2012 of the Government revising, supplementing a number of articles of Decree 79/2006/ND-CP DATED September 8, 2006;
Pursuant to Decree No. 63/2012/NĐ-CP on April 8, 2012 of the Government functions, tasks, powers and organizational structure of the Ministry of health;
At the suggestion of the Director of medical management, traditional Medicine, the Minister of Health issued a circular regulating business activities.
Chapter I GENERAL PROVISIONS article 1. Scope this circular regulates pharmaceutical business activities include: export, import, wholesale, retail and services for preservation of medicinal herbs.
Article 2. Application object 1. This circular applies to cooperative businesses, households, individuals (hereinafter referred to as the base) has business activities in pharmaceutical management agency and business activity pharmaceutical in Vietnam.
2. This circular does not apply to: a) medicinal business establishments; non-medicinal uses for the purpose of doing drugs is clearly shown on the invoices and vouchers;
b) consultation, healing facility has manufactured, processed the drug (the drug product, the traditional medicine) to use in that basis.
Article 3. Explanation of terms In this circular, the terms below are interpreted as follows: 1. Medicinal (pharmaceutical) is of natural origin ingredients from plants, animals, minerals may be used but is not yet over, preliminary processing.
2. Medicinal herbs are natural origin materials from plant, animal, mineral, qualifying standard Vietnam Pharmacopeia drug.
3. toxic medicinal use as drugs are pharmaceutical list toxic medicinal use as drugs in Vietnam by the Minister of health regulations.
4. The traditional medicine is medicinal, pharmaceutical preparation or medicinal herbs were in processing can be used as drugs.
5. Preliminary processing is checked and classified medicinal, remove impurities, soaking, washing, drying, exposure, annealed, cleaned, dried, powdered or approval.
6. processing is the process of changing the quality and quantity of medicinal or pharmaceutical has preliminary into the traditional medicine according to the reasoning and methods of traditional medicine.
Chapter II export, import, WHOLESALE, retail and SERVICES PRESERVE PHARMACEUTICAL article 4. General conditions for the export basis, import, wholesale, retail and services preserve medicinal 1. The basis of the export, import, wholesale, retail and services for preservation of medicinal herbs must be certified eligible business smoking medicinal business scope.
2. Conditions for the certification of qualified business smoking medicinal business scope: a) the Manager of a professional basis must have a certificate to practice pharmacy as defined in article 15 of Decree 79/2006/ND-CP dated 09/08/2006 detailing the Government's implementation of some articles of the law on Pharmacy , except in the cases specified in article 11 of this circular.
At a business location of a business but there are many forms of drug business, only require the facility to have a professional manager that meet conditions specified at this point.
b) have qualified respectively for each type of business rules in articles 5, 6, 7 and 8 of this circular.
Article 5. Export, import of pharmaceuticals 1. Vietnam imported pharmaceutical establishments should have the following conditions: a) has been granted the certificate of eligible drug business with the pharmaceutical wholesale range.
b) reach the principle "good storage practice" for medicinal herbs prescribed in this circular by the Ministry of health check.
c) medicinal business establishments not yet eligible to import directly must sign contracts with import trustee of establishments that qualify as regulated imports and import trust facility name must be on the order of import.
2. In addition to the conditions prescribed in paragraph 1 of this article, the base import medicinal herbs when registering customs declaration also must present original and submitted to the customs authority a stamped copy of the business for the following papers to do the customs clearance of goods: a) the importing pharmaceutical license by the Medical Department Manager Traditional Medicine, the Ministry of Health issued under the provisions of this circular.
b) certificate of origin (c/o) of medicinal herbs by the competent institutions of the country of export. The case of the international treaties to which Vietnam is a member of a decree on the filing of the certificate of origin of imported goods is electronic vouchers, the Customs authorities accept the vouchers.
c) From 01/07/2016, pharmaceutical imports in the category have to have test Votes of each batch of medicinal herbs (accompanied by a translation into English or Vietnamese) of production facilities if the basis that standard of "good manufacturing practice" (GMP), for the production base has not yet reached the standard of GMP to Vote the Agency's testing or the competent organizations of the country export levels. Every year, the Health Ministry announced the category medicinal herbs must get the votes of the testing agency or organization has the authority of the country of export.
3. export Vietnam pharmaceutical establishments should have the following conditions: a) the conditions specified in point a of Paragraph 1 of this article.
b) The regulation of the conditions in the country of import medicinal herbs (if available).
Article 6. Conditions for wholesale pharmaceutical establishments 1. The principle of "good practice" for the preservation of medicinal herbs prescribed in article 9 and the principle of "good practice" drug distribution for medicinal herbs prescribed in article 10 of this circular.
2. The facility has been certified eligible drug business with the scope of wholesale pharmaceutical business services is the preservation of medicinal herbs and do additional business scope.
Article 7. Conditions for retail pharmaceutical establishments 1. On campus: a) has a fixed location, an area of matching business scale, a minimum of 25 m2, separate; arranged in high place drain, cool, safe, far from the source of pollution, ensure the prevention of fire and explosion; to display area, the area of the preservation of medicinal herbs.
b) have adequate equipment to preserve the drug to avoid the adverse effects of light, heat, humidity, pollution, the intrusion of insects, including:-cabinets, counters, shelving for sure, smooth, easy, convenient for hygiene, conservation medicine.
-Thermometers, humidity, dehumidifier to control the temperature, humidity in the retail pharmaceutical facility, lighting, exhaust fans.
-Preserving equipment consistent with preservation requirements indicated on the label. Preservation conditions at room temperature maintained at 30° C, humidity does not exceed 75%.
2. Personnel: a) has sufficient suitably qualified employees with work, including at least one who qualified from the nurse.
b) all employees are regularly trained, professional training, updates the new rules of the State of preservation, medicinal management.
3. retail establishments just sold the medicinal herbs that are purchased at the base are qualified pharmaceutical business; have clear and origin have packaging, labelling as defined in paragraph 1, section B, part II of circular No. 03/2008/TT-BYT on 12/5/2008 of the Minister of health on drug labeling guidelines; not sell the toxic medicinal unprocessed as specified in circular No. 33/2012/TT-BYT dated 28/12/2012 of the Minister of Health issued listing toxic medicinal use as drugs in Vietnam.
Article 8. Terms for business establishment services preserve pharmaceutical business service establishments to preserve medicinal herbs must reach the principle "good storage practice" for medicinal herbs prescribed in article 9 of this circular.
Article 9. The principle of "good storage practice" for medicinal 1. Human condition with the preservation repository: a) store keeper must have qualified from the pharmaceutical intermediate.
b) have enough suitably qualified employees with work, including at least one who qualified from the nurse.
c) all employees in storage are regularly trained, professional training, updates the new rules of the State of preservation, medicinal management.
2. Location of the depot maintenance: a) are built in high places, safe, have the system drains, ensure medicinal herbs to avoid the influence of groundwater, rain and floods.
b) have identified, in the place where traffic convenience for the pharmaceutical import export.
3. Design, building warehouses for preservation: a) warehouse area preserving medicinal herbs are wide enough, in accordance with the scale of the business, to preserve the order of the various types of products, the total area a minimum of 300m2, the minimum capacity is 1,000 cubic meters, up to 01/01/2017 of the minimum area is 500 m 2 , the minimum capacity is 1,500 m3 (if has been checked, to confirm the principle of achieving "good storage practice" only have to apply when checking back), including the areas: reception area; medicinal conservation area; the area of the preservation of medicinal herbs were in processing; the waiting area to check out the import; the waiting area processed medicinal herbs; the area of the preservation of medicinal herbs have toxicity.
b) check waiting area enter; preserving medicinal area separated from other areas to avoid cross-infection, influence of dirt.
c) preservation areas is prevention of the infiltration of insects, rodents and other animals, prevent the growth of mold, termites and prevent cross-infection.
d) ceilings, walls, roof of the warehouse must be designed, built, surely, to avoid the effects of the weather as the Sun, rain, storms and flooding.
the repository must be enough Background) high, flat, smooth, hard, and sure enough be handled appropriately to avoid the influence of groundwater, secure the motor transport move easily; not have the slit, the chasm are where the accumulated dust, refuge of vermin, insects.
4. conditions, sanitary equipment meets the provisions in Section 2.3; Section 3, part 2 of the appendix attached to decision No. 2701/2001/QD-BYT on 29/6/2001 of the Minister of health about the deployment applied the principle of "good storage practice".
5. process to preserve and document profile:

General maintenance procedures and guidance document profiles must follow the instructions in section 4, item 7, section II of the principles of "good practice" storage attached to decision No. 2701/2001/QD-BYT on 29/6/2001 of the Minister of health about the deployment applied the principle of "good practice" storage.
6. check the jurisdiction principles of "good practice" for the preservation of medicinal herbs: a) held Ministry of health tested the principle of "good practice" for the preservation of medicinal herbs for the preservation of medicinal herbs of the basis of the import operation and maintenance service facility.
b) health department inspect the principle "good storage practice" for medicinal herbs for the preservation of medicinal herbs of the other pharmaceutical businesses, except in cases specified in point a of this paragraph.
Article 10. The principle of "good practice" for drug delivery pharmaceutical principles of "good practice" drug distribution for pharmaceutical application of the principle of "good practice" medicine distribution specified in circular No. 48/2011/TT-BYT on 21/12/2012 of the Minister of Health issued the "guidelines of good practice in distribution of drugs"; separate provisions on the preservation of medicinal herbs follow the provisions in paragraphs 2, 3 and 4 article 9 of this circular.
Article 11. Medicinal business in villages, traditional villages, traditional medicinal business city 1. Form of the export, import, wholesale, service, preservation of medicinal herbs in villages, traditional villages, traditional medicinal business city must follow the rules for business type respectively in articles 4, 5, 6 and 8 of this circular.
2. Form of retail business pharmaceutical in villages, traditional villages, traditional medicinal business city must follow the provisions of article 7 of this circular; professional curator or own home base of retail in villages, traditional villages, traditional medicinal business city must have the qualifications specified in point c of paragraph 3 article 15 of Decree 79/2006/ND-CP or certificate or certificate training in medicine, traditional medicine due to the base-level training function.
Chapter III CONDITIONS for PROCESSING MEDICINAL HERBS article 12. Pharmaceutical processing conditions 1. The basis of eligible drug business with the pharmaceutical business scope if the operation processing medicinal herbs must satisfy the conditions prescribed in this chapter.
Before performing operations and processing of medicinal herbs for at least 30 days, the basis of eligible drug business with the scope of business activity processing medicinal herbs medicinal herbs must have written notice of a qualifying facility for processing medicinal herbs according to the form prescribed in Appendix No. 7 attached to this circular for health administration Traditional-Medicine, Health Ministry to test according to the regulations.
2. The Ministry of Health held a qualifying facility inspection and processing of medicinal herbs periodically for 3 years, and sudden checks in case of need.
Article 13. Human condition 1. The person in charge of the professional processing of medicinal herbs are available from the College of pharmacy, pharmacy practice certificate as prescribed by law.
2. People directly involved in the processing of medicinal herbs must have qualified from the nurse and was training regularly, update professional knowledge of the processing of medicinal herbs.
Article 14. Physical conditions 1. The factory, the equipment must be designed, build, repair and maintenance in accordance with the operation in the production process and the scale of production bases, namely: a) conservation area pharmaceutical input must satisfy the conditions prescribed in item 2, 3 article 9 of this circular.
b) production and processing area: depending on the scale of production, pharmaceutical production areas are arranged to facilitate the path of raw materials in the manufacturing process consists of two areas: the area of preliminary processing, complex area.
The area of preliminary processing medicinal herbs, including some parts: remove impurities; washing, drying, cutting, Thai; an area of ≥ 9 m2 and capacity ≥ 27 m3.
Complex areas of medicinal preparations, including a number of areas: stars, laced, annealing; an area of ≥ 9 m2 and capacity ≥ 27 m3.
The production area is wide enough, ventilation, easy, secure and convenient operation production, have clean water supply system serves the production of medicinal herbs.
c) quality control area: the area of quality control of raw materials and finished products have to be separated from production areas. Quality control area must be designed in accordance with the activity test.
2. auxiliary systems: a) air conditioning systems: base system installation to handle the air conditioner or separate for the area.
b) water treatment system: depending on the requirements of each form of medicinal processing methods, the source of water used for production purposes at least must reach the national technical regulation about living water.
c) wastewater treatment system, emissions and solid waste: the basis must be the appropriate measure of waste water, waste gas and waste during processing, ensure safety and hygiene.
d) system of fire: the base is equipped with sufficient tools, fire equipment, fire under the regulations on fire prevention.
Article 15. The condition of the equipment 1. The facility must have adequate equipment necessary for processing of medicinal herbs. This equipment must ensure safe operation, ease of cleaning and maintenance, cross infection, avoid the accumulation of dust and dirt, to avoid the adverse impacts that affect product quality. The base is built and full compliance with the operating instructions, for equipment.
2. quality control area must be equipped with the machines, equipment and instruments suitable for the sampling, analysis, calibration and data processing. The analysis must match the method tested and must meet the requirements of quality inspection units.
Article 16. Pharmaceutical quality in processing of medicinal herbs used in the course of processing must be tested according to the standard quality defined in Vietnam Pharmacopeia circular No. 03/2009/TT-BYT dated 28/4/2010 of the Minister of health regarding quality management guide medication. The facility must establish bad track record of quality pharmaceutical warehousing, warehouse, inventory.
Article 17. Stages of processing 1. Weight and allocate: before conducting weight, medicinal, facility allocation must proceed to examine the environmental hygiene conditions, temperature, humidity, weight area and weight, allocations are made correctly. Staff must wear the dress under the provisions of labour law on safety, hygiene and labour.
2. Processing: a) the facility must arrange suitable employees, dressed in costumes appropriate for the processing operation and have appropriate measures to monitor the processing operation.
b) all equipment before use must be checked. The equipment weight, measurement and calibration must be have a precision fit with the material needed weight, swung.
c) must have a process, the diagram of processing of each type of medicinal herbs in the base according to the method of processing medicinal herbs prescribed by Ministry of health decision No. 3989/QD-BYT on 08/10/2010 about issuing method of processing 85 quality assurance position Oriental medicine and decision No. 3167/QD-BYT on 16/9/2014 regarding enactment method of processing quality assurance position 18 Oriental medicine. 3. Control during processing: a) build process to control the quality of the intermediate product, finished product in the correct processing.
b) record all test results in the process of processing and environmental control.
4. Labelling, packaging: a) Has a private area for packaging and labelling, to be separated mechanically to avoid confusion of the product and the packaging.
b) label templates and samples of packaging has been printing must be saved in the record batch.
Article 18. Preservation of finished products (processed medicinal) are stored in warehouses for preservation of finished products have to meet the conditions specified in paragraph 2, paragraph 3 article 9 of this circular. The total area of the minimum finished product preservation area is 200m2, capacity is 600 m3.
Article 19. Hygiene and sanitation facility to implement the principle of guaranteed factory hygiene and personal hygiene during processing of medicinal herbs including factory hygiene, personal hygiene, hygiene, equipment and machine tools, packaging materials, packaging. Implementation of the requirements on hygiene and sanitary conditions as defined in article 6 circular No. 17/2011/TT-BYT on 19/4/2011 by Secretary of the Ministry of health stipulates the manufacture of medicines from medicinal herbs and routes apply principles, "the standard of good manufacturing practice" (GMP) for the manufacturing of medicines from medicinal herbs.
Article 20. Record of processing 1. The profile for each batch processed in which specify: the name, the volume of the product; day processing; the batch number, batch; the full recipe of lot/batch; the standard operation procedures for each stage of processing has been conducted (SOPs); the standard operation procedure of operation and sanitary devices used; all the samples, test results during processing, test results of environmental conditions, check the equipment before the start and during the processing, packaging and label templates stored on the final packaging.
2. With regard to the processing of the must-have application for all raw material used; standard operation procedures (SOPs); each batch and/or each batch processing and distribution; the equipment, including the operation, maintenance, housekeeping and appraisal; the profile for hygiene, maintenance and control of the region's environment.
3. All the records must be clearly stated time and be responsible for conducting the work and must be stored at work until the expiration of use of the product.
Chapter IV jurisdiction, application, PROCEDURE for CERTIFICATION of ELIGIBILITY for PHARMACEUTICAL DRUG BUSINESS, licensing, export IMPORT MEDICINAL HERBS section 1 AUTHORITY, records, CERTIFICATION PROCEDURES ELIGIBLE FOR PHARMACEUTICAL DRUG BUSINESS article 21. Issued, reissued, extend, supplement the business scope of the certificate of eligible drug business for business establishments, pharmaceutical

1. The Ministry of Health issued, reissued, extend, supplement the business scope of the certificate of eligible drug business to business service establishments to preserve medicinal herbs.
2. the Department of health, the central cities of the level, the level again, extend, supplement the range trading for the certificate of eligible drug business for business establishments pharmaceutical for other business forms, except in the case specified in clause 1 of this article.
Article 22. The record level, level back, extend, supplement the business scope of the certificate of eligible drug business for business establishment services for preservation of medicinal herbs, wholesale establishments, retail pharmacy data 1. The records suggest, again, extend, supplement the business scope of the certificate of eligible drug business for business establishment services for preservation of medicinal herbs, wholesale establishments, retail pharmacy data is made according to the provisions in paragraph 6 article 1 of Decree 89/2012/ND-CP on file form. separate recommendations are made according to the provisions in the annex No. 01a, 01b, 308B, 01d attached to this circular.
2. a technical documentation file under Point c Paragraph 6 article 1 of Decree 89/2012/NĐ-CP dated as follows: a) for business establishment services maintenance:-location and design of the treasures preserved;
-The preservation of equipment categories and objects stored in the repository.
b) wholesale establishments:-record of preserving medicinal herbs: location and design of the treasures preserved; The list of equipment maintenance of premises and objects stored in the repository.
-Records of pharmaceutical distribution: organizational chart of the facility include: organized distribution system (base, branch, warehouse, agents). Site map must show clearly the name, job title, level of expertise of the key staff of the facility and parts; Directory of transportation, distribution of the base. The case of the carriage of medicinal herbs is done in the form of the contract must have a document about the entity, equipment, transport, preservation of the contract.
-A declaration list according to the form prescribed in annex No. 2 attached to this circular.
c) retail establishments:-location and design of the display area, the preservation of medicinal herbs-list statements in the form specified in annex No. 2 attached to this circular.
3. As for the proposed facility certification eligible with much business scope includes drug business of finished products, raw materials and other medicinal herbs, then just make a record specified in paragraphs 1, 2 and are granted a certificate of eligible drug business.
Article 23. Procedure for certification of eligible drug business to business service establishments to preserve medicinal 1. Business service establishments to preserve medicinal filed 1 record level, level back, extend, supplement the business scope of the certificate of eligible drug business under the provisions in article 22 of this circular to medical administration, traditional Medicine-Department of health.
2. After receiving the records suggest, again, additional, renewal of the certificate of eligible drug business, receiver for receiving Votes base documents with the form prescribed in annex No. 3 attached to this circular.
3. Case profile suggested, again, additional, renewal of the certificate of eligible drug business is not yet valid, then within 10 working days from the date of receiving the application, the Agency receives the record must have the text notified to the Organization, the individual proposed to supplement , complete the profile.
4. within 10 working days from the date of receiving documents, medical administration, traditional Medicine-the Ministry of health to establish the mission profile, check conditions at the facility provides services for preservation of medicinal herbs, there are minutes of due diligence.
5. within 10 working days, after which a valuation, Director of medical management, traditional Pharmaceutical levels, level back, extend, supplement the certificate of eligible drug business for service providers to preserve medicinal herbs. If not, again, additional, extend, the medical administration, traditional Medicine must have a written reply stating the reason.
Article 24. Procedure for certification of eligible drug business wholesale establishments, retail pharmacy data 1. Wholesale, retail establishments pharmaceutical filed 1 record level, level back, extend, supplement the business scope of the certificate of eligible drug business under the provisions in article 22 of this circular to the provincial health department, central cities where the base headquarters.
2. After receiving the records suggest, again, additional, renewal of the certificate of eligible drug business, receiver for receiving Votes base documents with the form prescribed in annex No. 3 attached to this circular.
3. Case profile suggested, again, additional, renewal of the certificate of eligible drug business is not yet valid, then within 10 working days from the date of receiving the application, the Agency receives the record must have the text notified to the Organization, the individual grant proposal Refresh, renew, supplement the certificate of eligible drug business to supplement, complete the profile.
4. within 10 working days from the date of receiving the documents, the Department of health must establish the mission profile, checking the conditions in wholesale establishments, retail pharmacy, there are evaluation thereon.
5. within 10 working days, since the report on the evaluation, the Director of the Department of Health issued, reissued, complement, renew the certificate of eligible drug business for wholesale, retail establishments. If not level, level back, additions, renewals, the Department of health must reply in writing and stating the reason.
Section 2-PROFILE, authority, LICENSING PROCEDURES IMPORT MEDICINAL HERBS article 25. Profile import pharmaceutical licensing 1. Import order according to the form prescribed in annex No. 4 attached to this circular. For import authorization, on the import order must show the name of the import authorization basis.
2. A standard of quality and a medicinal test method, the manufacturer's or photocopy of the treatise the quality standards of pharmacopoeia.
3. for medicinal herbs have active ingredient addictive, mental direction, doing drugs precursors must submit inventory reports according to the form prescribed in annex No. 5 attached to this circular.
Article 26. The authority, licensing procedures import Pharmaceuticals 1. Director of medical management, traditional Medicine Department of health to license imports of medicinal herbs.
2. the import facility to send 1 record as defined in article 25 of this circular to medical administration, traditional Medicine-Department of health.
3. where the application for permission to import medicinal herbs is not yet valid, then within 10 working days from the date of receiving the application, the Agency receives the record must have the text message for the basis to supplement, complete the profile 4. Within 7 working days, from receipt of complete and valid dossiers, health administration, traditional Medicine-Department of health review, licensing imports of medicinal herbs according to the form prescribed in annex No. 6 attached to this circular. Case no license, medical administration, traditional medicine-the Health Ministry has answered text enterprise and stating the reason.
5. A licence to import medicinal herbs worth a maximum of 1 year from the date of signing.
Chapter VI FORCE ENFORCE article 27. Effect 1. This circular effect since March 2016.
2. Abolish the provisions on export, import of pharmaceutical regulation in circular No. 47/2009/TT-BYT on 29/12/2010 of the Minister of health on the manual operation of export, import and the packaging in direct contact with the drug, circular No 38/2013/TT-BYT on 15/11/2013 of Health Minister modify supplement some articles of circular No. 47/2009/TT-BYT on 29/12/2010 of the Minister of health on the manual operation of export, import and the packaging in direct contact with the drug.
Article 28. Transitional provisions 1. The pharmaceutical business establishments have been certified eligible drug business, certificate of "good practice to preserve the drug" or "good practices" drug distribution business scope of medicinal herbs before this circular effect continued to be active until the end of validity period of the certificate.
2. In the case of certificates of "good storage practice"; "Good practice in distribution of drugs" before the expiration of the certificate of eligibility, the drug business valuation level certificate of eligible business follow medication instructions in this circular.
3. With regard to the application for certification "good storage practice" filed before the date of this circular in force shall be considered settled according to the provisions in circular No. 45/2009/TT-BYT on 21/12/2012 of the Minister of health.
4. With regard to the application for certification "of good practice in distribution of drugs", filed before the date of this circular in force shall be considered settled according to the provisions in circular No. 48/2011/TT-BYT on 21/12/2012 of the Minister of health.
Article 29. Terms of reference case reference texts in this circular are replaced or modified, the supplement shall apply according to the replacement text or modify, Supplement.
Article 30. Responsibility 1. Director of medical management, traditional Medicine is responsible for organizing the deployment, testing, reviews the implementation of this circular in the whole country.
2. The Director of the Department of health, the central cities is responsible for organizing the deployment, testing, reviews the implementation of this circular.
In the process, if there are difficulties and obstacles, suggest the Agency, organization, personal reflections about timely health care administration, traditional Medicine, the Ministry of health to consider resolution./.