IT ' S SMART

Pharmaceutical business regulation

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The Law of Pharmacology. Stain. 34/2005 / QH1 1 June 14, 2005;

Base of Protocol 79 /2006/NĐ-CP August 9, 2006, the Government rules out the details of the details. Stain. The laws of the Law and the Decree Stain. 89/20 1 2/ND-CP October 24, 20 1 2 of the Government Yeah. a socket i, b socket sung some of the things of the Decree 79 /2006/NĐ-CP August 9, 2006;

Base of Protocol 63 /2012/NĐ-CP August 31, 20 1 2 of the Government rules the functions, duties, powers, and organizational structure of the Ministry of Health;

On the recommendation of the Director of the Bureau of Health Medicine,

The Minister of Health for the Department of Health Department of Health Regulations Fuck. Pharmaceutical business.

Chapter I

COMMON RULES

Number one. Adjustment range

This information provides for the operations of the pharmaceutical business including: export, import, wholesale, retail, and pharmaceutical preservation services.

Article 2. Subject applies

1. This information applies to business, cooperative, household, individual (later known as the basis) of the pharmaceutical business and the management of the pharmaceutical business operations in Vietnam.

2. This message does not apply to:

a) The basis of the raw pharmaceutical business; the pharmaceutical is not used for the purpose of making drugs evident on the invoice, certificate;

b) The basis of the disease, the healer, the drug-making, the medicine for use at the facility itself.

Third. Explain the word

In this Information, the words below are understood as follows:

1. Raw pharmaceutical (s) Stain. Ng) is the natural source of natural origin from plants, animals, minerals that can be used as drugs but not yet through the preparation, processing.

2. Pharmacy is the natural source of natural origin from plants, animals, minerals, and the standard of making drugs according to the standard of Vietnam.

3. Pharmacy i It's a Boob Use as an antidote It is a pharmaceutical portfolio used as a medication in Vietnam by the Minister of Health.

4. The old medical medicine. It ' s a raw drug, a medicinal medicine or a drug that ' s been processed to be used as a drug.

5. Sister. What? is test and classify raw materials, remove impution, dip, brew, wash, dry, clean, dry, break, cut or scatter.

6. The ball. What? n is the process of making changes in the substance and quantity of raw materials or pharmaceuticals that have been in the form of ancient medicine according to the theory and method of ancient medicine.

Chapter II

EXPORT, IMPORT, WHOLESALE, RETAIL AND THE PHARMACEUTICAL SERVICE.

What? 4. General conditions for the export base, import, wholesale, retail, and pharmaceutical and pharmaceutical protection services.

1. An export, import, wholesale, retail, and pharmaceutical-preservation service must be issued certificates of certified drug business that has a pharmaceutical business range.

2. Charter level certification is eligible for a drug business that has a pharmaceutical business range:

a) The expertise manager of the facility must have a prescribed pharmacy certificate at Article 15 of the number. 79 /2006/NĐ-CP 09/08/2006 The government rules out certain provisions of the Law of Pharmacy, except for cases of regulation at Article 11 of this.

At a business location of a business facility, there are many forms of drug business that require only one professional manager to meet regulatory requirements at this point.

b) There is sufficient conditions for each type of business specified in the terms 5, 6, 7, and 8.

What? 5. Export, Import Pharmaceuticals

1. The Vietnamese facility that imports the pharmacy must have enough of the following conditions:

a) It has been granted a license to qualify for drug business with the wholesale range of pharmaceuticals.

b) Achive the "Practice of Good Practice" principles for the prescribed pharmacy in this Notice by the Ministry of Health.

c) The pharmaceutical business facility is not eligible for direct import to the import of an import trust contract with the base that is eligible for import by regulation and that the import mandate base name must be expressed on the import order.

2. In addition to the stipulation conditions at Clause 1 This, the basis of the import of pharmaceuticals when registering the Customs Post must first publish and submit to the firm ' s stamped copy of the business for the following papers to make the customs proceedings. -

a) The medical import permit issued by the Bureau of Medicine, the Department of Medicine, by the Ministry of Health, under the provisions of this information.

b) The Certificate of Commodity Land (C/O) of the pharmacology is due to the competent organization of the exporting country. In the case of the International Convention, Vietnam is a stipulated member of the receipt of the Certificate of Imported Goods from Electronics, and the Customs Agency accepted the evidence.

c) Since 01/07/2016, the import pharmacy in the category must have the test-test of each pharmaceutical batch (accompanied by the English or Vietnamese translation) of the production facility if that facility reaches the standard "Good Practice Production" (GMP) standard, for the facility. manufacturing has not reached the standard GMP, which must have the test of the agency or organization with the authority of the export water. Every year, the Ministry of Health publishes a pharmaceutical portfolio that must have a test of the agency or organization with the jurisdiction of the export water.

3. Vietnam ' s facilities export the pharmacy must have enough of the following conditions:

a) The conditions specified at the Point of One Article.

b) The regulatory conditions of the water import (if any).

What? 6. Conditions for pharmaceutical wholesale facilities

1. Reaching the principles of "Practice of Good Protection" for the prescribed pharmacy at Article 9 and the principle of "Good Practice of the Distribution" for the pharmaceutical provisions at Article 10.

2. The facility has been granted sufficient certification of the drug business with the wholesale range of pharmaceuticals, and is operated by the pharmaceutical business, and not the addition of the business scope.

What? 7. Conditions for the pharmaceutical retail facility

1. On the basis of matter:

a) There is a fixed location, the area is consistent with business scale, a minimum of 25 m ² , separately; the layout is high, cool, safe, away from the source of pollution, which ensures anti-fire prevention; there must be a display area, the pharmaceutical reserve area.

b) There is sufficient equipment to preserve the adverse effects of light, heat, humidity, contamination, insect intrusion, including:

-The closet, the counter, the shelving price, smooth, easy to protect, convenient for the sale, the pharmacy.

-The thermometer, the moisture, the humidity machine to control the temperature, humidity at the pharmaceutical retail base, the lighting system, the ventilation fan.

-The preserved device is consistent with the labeling requirement on the label. The maintenance conditions at room temperature remain below 30 ° C, humidity does not exceed 75%.

2. On HR:

a) There are sufficient qualifications personnel with the assigned work, including at least one person qualified from the pharmacy.

b) All employees must regularly be trained, specialized training, updating the new regulations of the state in terms of preservation, management of pharmaceuticals.

3. The retail facility is only sold on pharmaceuticals purchased at facilities that are eligible for the pharmaceutical business; there is a clear and foreskin origin, labeled as prescribed at Clap 1, Section B, Part II Digital. 04 /2008/TT-BYT December 12, 2008, of the Minister of Health on the guidance of the label, not to sell the pharmaceutical drugs that are not yet processed by regulation at the Digital Information. 33 /2012/TT-BYT December 28, 2012, of the Minister of Health on the Department of Health of the Ministry of Health, the toxicology is used as a drug in Vietnam.

What? 8. Conditions for abs in Pharmaceutical services business

The pharmaceutical services business facility must reach the "Practice of Good Practice" principle for the regulatory pharmacy in Article 9 of this.

What? 9. Principles of "Good Practice" Bitch. o administration "for medicinal herbs"

1. Human conditions with the repository:

a) The warehouse must have a degree from the center of the pharmacy back up.

b) There are sufficient qualifications personnel with the assigned work, including at least one person from the pharmacy.

c) All employees in the warehouse must regularly be trained, specialized training, updating the new regulations of the state in terms of preservation, management of pharmaceuticals.

2. Location store location:

a) Built in the high, safe, drainage system of drainage, ensuring that the medicinal herbs avoid the effects of groundwater, heavy rain, and flooding.

b) There is a specified address, where it is convenient for export, importing, and importing.

3. Design, build the repository:

a) The pharmaceutical repository area must be wide enough, in accordance with the business scale, to preserve the order of different types of products, the minimum total area of 300m. ² , minimum capacity is 1,000 meters. ³ , as of 01/01/2017 total minimum area must be 500m ² The minimum capacity must be 1,500 m. ³ (if checked, the confirmation of the principle of "Good Practice Protection" is only applicable to re-examination), including areas: the reception area; the area of raw pharmaceutical preservation; the protected area of pharmaceuticals has been processed; the area waits for entry; Pharmaceutical processing area; the pharmaceutical reserve is toxic.

b) The area of waiting for the protection; the area of protection of raw materials is separated from other areas to avoid cross-contamination, dust impacts.

c) The protected area must be defended against the intrusion of insects, rodents and other animals, preventing the growth of mold, termites and anti-contamination.

d) Chen, wall, warehouse roof must be designed, built for sure, ventilation, to avoid the effects of weather such as sunshine, rain, storm flooding.

The vault must be high enough, flat, smooth, sturky, hard enough and processed appropriately to avoid the effects of the groundwater, ensuring the motor transport is easily moved; there are no slots, broken cracks are where the dust accums, the shelter of worms, insects, etc. Yeah.

4. Equipment site condition, sanitation meets regulation at Section 2.3; Section 3, Part 2 of the Appendix issued by Decision No. 2701 /2001/QĐ-BYT June 29, 2001, of the Minister of Health for the implementation of the "Good Practice of Drug Administration" principle.

5. Document Process and Document Profile:

The general preservation process and document profile guidelines must be made in accordance with Section 4, Section 7, Part II of the principle "Good Practice Protection" issued by Decision No. 2701 /2001/QĐ-BYT June 29, 2001, of the Minister of Health for the implementation of the "Good Practice of Drug Administration" principle.

6. The authority checks out the principle of "Good Practice Protection" for pharmaceuticals:

a) The Ministry of Health organizes examining the principle of "Good Practice Protection" principles for pharmaceuticals for pharmaceutical repositories of imported facilities and the facility as a pharmaceutical protection service.

b) The Health Department organizes the "Practice of Warranty Practice" principle for pharmaceuticals for the pharmaceutical repositories of other pharmaceutical business facilities, except for the case of regulation at this point.

What? 10. Principles of "Good Practice to distribute drugs" to pharmaceutical

The principle of "Practice of Good Distribution" for pharmaceuticals applies under the principle of "Practice of Good Distribution" regulations at Digital Information. 48 /2011/TT-BYT On December 21, 2011, the Minister of Health enacted the "Practice of Good Distribution" principle; the provisions for the preservation of the pharmaceutical are provided by provisions of these 2, 3 and 4 Articles 9.

What? 11. The pharmaceutical business in the village of the profession, the traditional village, the traditional pharmaceutical business

1. The export of export, import, wholesale, pharmaceutical preservation services in the village village, traditional village, traditional pharmaceutical business is required to follow regulations for the respective business types at the terms 4, 5, 6 and 8, respectively. Come on.

2. The form of retail sales of pharmaceuticals in the village, traditional village, and traditional pharmaceutical business is required to follow regulations at Article 7 of this Privacy; separately in charge of the expertise or owner of retail facilities in the village, the traditional village, The traditional pharmaceutical business system must have a prescribed degree at Point 3 Article 15 Decree No. 15. 79 /2006/NĐ-CP or certificate or certificate of pharmacology, the traditional medicine provided by the facility with the functional training function.

Chapter III

PHARMACEUTICAL PROCESSING CONDITIONS

What? 12. Drug processing conditions

1. The facilities that are eligible for drug business with the scope of the pharmaceutical business if there is a pharmaceutical processing operation are required to meet regulatory conditions at this Chapter.

Prior to the implementation of the pharmaceutical processing business for at least 30 days, the facility qualified for drug business with a pharmaceutical business range that would have had a written text on the basis of the sufficient basis for the preparation of the pharmaceutical processing. the prescribed form at Annex 07 issued by this message to the Bureau of Medicine, the certix Pharmacy-the Ministry of Health for examination by regulation.

2. The Ministry of Health organizes examining the basis of a three-year-a-time periodic drug processing and examination of the mutation in the case of necessity.

What? 13. Human conditions

1. The subject of the specialization of the pharmaceutical processing must have a degree from the university of pharmacy, which has a certificate of medicinal practice under the rule of law.

2. The person directly involved in the pharmaceutical processing must have a degree from the pharmacist and is regularly trained, updating the specialized knowledge of the pharmaceutical processing.

What? 14. Physical basis conditions

1. The workshop, equipment must be designed, built, repaired and protected in accordance with the actions during the production and production scale of the facility, namely the following:

a) The area for the protection of the pharmaceutical inputs must meet the conditions under the provisions of these 2, 3 Articles 9.

b) The area of production, processing:

Depending on the scale of production, the pharmaceutical production areas are positioned to facilitate the path of raw materials during production including two areas: the area of the preliminary, the complex area.

The pharmaceutical evacuation area, including some parts: remove impution; wash, thai, cut, dried; has an area of ≥ 9 m. ² And the volume ≥ 27 meters. ³ .

The pharmaceutical complex area, which includes several areas: star, sewed, brewed; has an area of ≥ 9 m ² And the volume ≥ 27 meters. ³ .

The manufacturing sector must be wide enough, clear, easy to protect, secure production and favorable operations, and have clean water supply systems serving the production of pharmaceuticals.

c) Quality inspection area:

The area of material quality testing and the product must be separate from the production area. The quality test area must be designed in accordance with the test activities.

2. Supporting System:

a) Air processing system:

The facility must install the air handling system or separate seconation for the areas.

b) Water treatment system:

Depending on the requirements of each form of pharmaceutical processing, the source of water for production purposes is at least the national technical standard of living water.

c) The wastewater treatment system, emissions and solid waste:

The facility must have a proper measure of wastewater treatment, gas and solid waste during processing, safety and sanitation.

d) System of fire, fire extinguiking:

The facility had to be equipped with enough equipment, fire-room equipment, fire-based firefighting regulations.

What? 15. Equipment Site

1. The facility must have sufficient equipment required for the processing of the pharmaceutical. These devices have to be safe to operate, easy to protect and protect, to avoid cross-contamination, to accumulate dust and dirt, avoiding the adverse effects that affect the quality of the product. The facility must build and fully comply with the operational guidelines, sanitation for equipment.

2. Quality testing area must be equipped with machines, equipment, equipment suitable for sampling, analysis, calibration, and data processing. The analytical equipment must be consistent with the test method and must respond to the unit's quality inspection requirements.

What? 16. Quality pharmacy It's in processing.

The pharmaceutical used in the processing process must be checked into the quality according to the standard Vietnamese Pharmacodicts standard. 09 /2010/TT-BYT April 28, 2010, of the Minister of Health on the guidance of the management of the quality of the drug. The facility must file a trace of the quality of the drug in the repository, export, inventory.

What? 17. Mode processing

1. Weight and grade:

Prior to the process of balancing, the drug delivery, the facility had to conduct environmental conditions on hygiene, temperature, weight area humidity, levels and weight, the level of which was done correctly. Employees must carry a labor outfit under the rule of law on safety, sanitation.

2. variable:

a) The basis of the appropriate number of employees, dressed appropriately with processed and appropriate actions to monitor the processing operations.

b) All pre-use devices must be checked. The instruments of weight, measurement must be calibrated and have precision consistent with weight-needed materials.

c) There must be a process, the processing scheme of each pharmaceutical type at the basis of the pharmaceutical processing methods prescribed by the Ministry of Health at Decision 3759 /QĐ-BYT on 08/10/2010 on the board of the method of processing the quality of 85 drug-and-y drugs. Decision number 3635 /QĐ-BYT on 16 September 2014 on the board of the method of processing the quality of 18 pharmacy.

3. Control during processing:

a) Building the quality control process of the intermediate products, the product according to the processing process.

b) Record all test results in the processing and control of the environment.

4. Paste, packaging:

a) There is a separate area for packaging and labeling activity, which must be mechanoclated to prevent the confusion of the product and packaging packaging.

b) The labels and samples of the packaging that have been printed must be saved in the batch profile.

What? 18. Secure the finished product

A product (processed therapy) preserved in the finished repository meets the stipulation conditions at paragraph 2, paragraph 3 Article 9 of this. The total area size of the food preservation area is 200m ² The capacity is 600 meters. ³ .

What? 19. Sanitation and sanitary conditions

The facility must implement the principles of factory hygiene and personal hygiene during the processing of the pharmaceutical processing, including the sanitation of the factory, personal hygiene, machine hygiene, equipment and equipment, packaging materials, packaging materials. Implementing hygiene requirements and sanitary conditions under the regulation at Article 6 of the number of hygiene 16 /2011/TT-BYT April 19, 2011, of the Minister of Health on April 19, 2011, the Minister of Health rules the principle of drug production from pharmaceuticals and the application of the principle of principle, the "Good Food Production Standards" (GMP) for the drug production facility.

What? 20. Uh ... Go back.

1. The profile for each batch of processing in which is specified: name, volume of the product; date of processing; batch number, batch; full formula of log/m.; the standard operation processes of each processed processing (SOPs); standard operation procedures for operation and sanitation. Primary devices are used; all models, test results in processing, environmental conditions test results, pre-start equipment testing, and during processing, packaging, and label storage on the final packaging.

2. For the processing process to have a profile for all materials, the material is used; standard operation processes (SOPs); each batch and/or each batch processed and distributed; the equipment, including the operation, sanitation, maintenance and appraisal; records, and other applications. for sanitation, maintenance and environmental control of the processing area.

3. All records must be given the time and the person responsible for the task of signing and must be stored at work until the expiration of the product's expiration date.

Chapter IV

JURISDICTION, FILE, CERTIFICATE PROCEDURE QUALIFIED DRUG BUSINESS

FOR PHARMACEUTICALS, EXPORT LICENSE, IMPORT

Item 1

JURISDICTION, FILE, CERTIFICATE PROCEDURE

QUALIFIED DRUG BUSINESS FOR PHARMACEUTICALS

What? 21. Authority authority, reissue, extension, addition of business scope in the certificate of qualified drug business to the basic health care facility in Pharmaceutical business.

1. Ministry of Health, reissue, extension, adds business scope in the certificate of qualified drug business for the pharmaceutical business preservation business facility.

2. The provincial department of Health, the central-central city, resupply, extension, the addition of business scope to the certificate of receiving sufficient drug business for the pharmaceutical business base for other forms of business, except for the case of regulation at the site. This one.

What? 22. High profile, reissued, h ... Yes. n, add k range i The business in the paper certificates qualified drug business for the pharmaceutical sales business facility, the wholesale facility, the pharmaceutical retail and the pharmaceutical business.

1. Proposition filing, reissue, extension, addition of business scope in the Certificate of Qualified Drug Business on the basis of the pharmaceutical preservation service business, the wholesale basis, the pharmaceutical retail is done in accordance with the regulation at paragraph 6 Article 1. Number Protocol 89 /2012/NĐ-CP Alone in the recommended profile is carried out by regulation at the appendix 01a, 01b, 01c, 01d, 01d issued with this Privacy.

2. Technical documentation in the profile by Point 6 Article 1 Decree number 89 /2012/NĐ-CP The following:

a) For the preservation service business:

-Map of the location and design of the repository;

-The security equipment catalog of the facility and the object is preserved at the warehouse.

b) For the wholesale basis:

-Profile on pharmaceutical preservation: Map of the location and design of the repository; the Museum of Preservation of the facility and the object preserved at the warehouse.

-Profile on the distribution of pharmaceuticals: The organizational scheme of the facility consists of: organizing the distribution system (base, branch, warehouse, agent). The diagram must show the name, the title, the expertise of the key cadres of the base and parts; the transport catalog, the distribution of the facility. The case of the transfer of pharmaceuticals is done in the form of a contract that must have a document referrt to the legal, equipment, transport, and preservation of the contract.

-The prescribed list of characters by the prescribed form at Annex 02 issued by this message.

c) For the retail basis:

-Map the location and design of the exhibition area, the pharmaceutical reserve area.

-The prescribed list of characters by the prescribed form at Annex 02 issued by this message.

3. For the basis of a proposed Certificate of Qualified Certification with a variety of business ranges including product drug business, other materials and pharmaceuticals it only needs to make a regulatory filing at 1, 2 Articles and is granted in a separate paper. It's a medical condition.

What? 23. The procedure of issuing a certificate of certificate of drug business to the service of the pharmaceutical services business.

1. The service business facility preservers the pharmaceutical application filing, grants, extension, addition of business scope in the Certificate of qualified drug business in accordance with Article 22 of this Smart to the Bureau of Medicine, the Ministry of Health.

2. After receiving the proposed record, the addition, the extension of the certificate of the drug business, the receiving agency granted the certification facility to receive a prescribed sample of the prescribed form at Annex 3 issued by this message.

3. The case of a proposed, radical, complementary case, extension of the certificate of receiving unvalid drug business is in the 10-day period of work, since the date received the case, the agency recepts the case to have a notification text for the organization, the individual. offers to add, complete the profile.

4. For a 10-day period of work, since the date of the receiving of valid records, the Department of Health Management, the Ministry of Health must form a Case appraisal, which checks the conditions at the basis of the provision of the pharmaceutical preservation service, which has a appraisal of the appraisal.

5. During the 10-day period of work, after the receipt of the appraisal, the Director of the Bureau of Health Management, Pharmacy Medicine, the grant, the extension, the addition of a Certificate of Qualified Certificate of Medicine for the basis of the protection of the pharmaceutical protection service. If not granted, reissued, supplematuation, extension, the Department of Medicine, the Ancient Pharmacy must have a written answer and specify a reason.

What? 24. The procedure of issuing a Certificate of Medication Business facility Wholesale, pharmaceutical retail.

1. The wholesale facility, the pharmaceutical retaeup, filed for 1, in order, the extension, the addition of business scope in the certificate of qualified drug business in accordance with Article 22 of this Smart Article to the Provincial Health Department, the Central City of Central City where the facility It's the headquarters.

2. After receiving the proposed record, the addition, the extension of the certificate of the drug business, the receiving agency granted the certification facility to receive a prescribed sample of the prescribed form at Annex 3 issued by this message.

3. The case of a proposed, radical, complementary case, extension of the certificate of receiving unvalid drug business is in the 10-day period of work, since the date received the case, the agency recepts the case to have a notification text for the organization, the individual. offers to grant, reorder, renew, add a Certificate of Qualified Certificate of the drug business to complement, complete the profile.

4. For a 10-day period of work, since the date of the receiving of a valid case, the Health Department must form a Case appraisal, which checks the conditions at the wholesale facility, the pharmaceutical retail, which has a appraisal of the appraisal.

5. During the 10-day period of work, since the receipt of the appraisal, the Director of the Department of Health, grants, supplements, extension of the certificate of drug business to the wholesale facility, the pharmaceutical retail. If you do not grant, grant, renew, the Health Department must have a written answer and specify the reason.

Item 2

FILE, JURISDICTION, LICENSING PROCEDURE IMPORT PHARMACY

What? 25.

1. The import order by the prescribed pattern at Annex 04 issued this message. For the import of the trustee, on the import order must show the name of the mandate importation facility.

2. The standard of quality standards and the drug testing method, of the manufacturer or the standard of the quality standard of the quality of the pharmaceutical.

3. For pharmaceuticals to be an active ingredient in addiction, mental orientation, prescriptions for the medication must be included with the Prescribed Inventory report in Annex 05 issued by this message.

What? 26. Authority, procedure of issuing a license to import pharmaceuticals

1. Head of the Department of Health Management, the Department of the Antiquities Service issued a license to import pharmaceutical imports.

2. The import facility sends 1 set of prescribed records at Article 25 of this Notice to the Bureau of Medicine, the Antiquities Pharmacy-the Ministry of Health.

3. The case of a case of applying for an unincorporated pharmaceutical import is in the 10-day period of work, since the date of receiving the file, the agency receptions must have a notification text for the facility to complement, complete the profile.

4. During the 7-day period of work, since receiving full and valid records, the Department of Health Management, the Department of Health, the Department of Health review, issued a license to import the drug on the prescribed form at Annex 06 issued by this message. The case does not issue a license, the Department of Medicine, the cervix-the Ministry of Health has an answer to the business and specifies the reason.

5. The medicinal import permit has a maximum value of 1 year, since the date of the signing.

Chapter VI

PERFORMANCE EFFECT

What? 27.

1. This message has been in effect since 6 March 2016.

2. Repeal the regulations on export, import of the prescribed pharmacy at the Digital Information 47 /2010/TT-BYT December 29, 2010, of the Minister of Health on the direction of export operations, importing drugs and packaging directly to the drug, Digital News 38 /2013/TT-BYT November 15, 2013 of the Minister of Health amended, complements some of the provisions of the Digital Information 47 /2010/TT-BYT December 29, 2010, of the Minister of Health on the direction of export operations, importing drugs and packaging directly to the drug.

What? 28. The transition clause

1. The pharmaceutical business facilities have been issued certificates of qualifying for drug business, certificates of "Good Practice Protection" or "Good Practice distributing drugs" of the drug business range prior to this date ' s effective date in effect. is operating until the expiration of the validity of the certificate.

2. In the case of a Certificate of "Good Practice Protection"; "Good Practice of Distributing Drugs" expired before the Certificate of Medication Qualifying, the reappraisal of the Certificate of Qualified Certificate of the drug business in the direction of the drug. This is the announcement.

3. For the filing of the Certificate of Certificate of "Good Practice Protection" submitted before the date of this Private Day is valid, which is considered addressing in accordance with the regulations at No. 45 /2011/TT-BYT December 21, 2011, Secretary of Health.

4. For the filing of the Certificate of Certificate "Practice of Good Distribution" filed before the date of the Notice is valid, which is considered addressing in accordance with the regulations at No. 48 /2011/TT-BYT December 21, 2011, Secretary of Health.

What? 29. The reference clause

The case where the text of the message in this message is replaced or modified, the addition applies to alternate or modified text, the plugin.

What? 30.

1. Head of the Department of Health Management, the certix is responsible for organizing the deployment, testing, evaluating the implementation of this Information in the country.

2. Director of the Provincial Health Department, the Central City of the Central City responsible for organizing the deployment, testing, evaluating the implementation of this Information in the locality.

In the course of execution, if it is difficult to get involved, recommend the agency, the organization, the individual reflects in time to the Bureau of Medicine, the Pharmacy Pharmacy, the Ministry of Health to review the ./.