Quyết định 12/2007/QD-BYT

MINISTRY OF HEALTH -------	SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness ---------
No.: 12/2007/QD-BYT	Hanoi, January 24, 2007

 

DECISION

ON PROMULGATING THE PRINCIPLE OF “GOOD DISTRIBUTION PRACTICE OF DRUG”

MINISTER OF HEALTH

Pursuant to the Law on Pharmacy dated 14/6/2005;

Pursuant to the Decree No.49/2003/ND-CP dated 15/5/2003 of the Government stipulating the function, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the Decree No.79/2006/ND-CP dated August 09, 2006 detailing the implementation of a number of Articles of the Pharmacy Law;

Pursuant to the Resolution No.108/2002/QD-TTg dated 15/8/2002 of the Prime Minister on approving "The Pharmacy Development Strategy in the period toward 2010";

At the proposal of Director of the Vietnam Drug Administration,

DECIDES:

Article 1. Issuing together with this Decision is the Principle “Good practice of drug distribution” applying to the establishments which participate in activities of drug distribution in the territory of Vietnam.

Article 2. The implementation of applying the principle “Good practice of drug distribution” upon schedule is the condition for granting Certificate of sufficient condition for drug business to the drug distributors.

Article 3. This Decision takes effect 15 days after its publication in the Official Gazette.

Article 4. Mr. Director of the Vietnam Drug Administration is responsible for the implementation of applying the principle, standard “Good practice of drug distribution” in accordance with the current provisions.

Article 5. The Mr., Ms Chief Office, the Chief Inspector of the Ministry of Health, Director of Vietnam Drug Administration, heads of units under the Ministry, the Directors of the Departments of Health in provinces and cities directly under the Central Government, Health-branch are responsible for the implementation of this Decision.

 

MINISTER Tran Thi Trung Chien

 

THE PRINCIPLE

OF “GOOD PRACTICE OF DRUG DISTRIBUTION”
(Issuing together with the Decision No.: 12/2007/QD-BYT dated January 24, 2007 of Minister of Health)

PART I. GENERAL PROVISIONS

1. OBJECTIVE.

To ensure supply of quality drug to the users requiring conducting the good assurance of comprehensive quality, including the stages related to production, preservation, storage, circulation, and distribution of drug.

"Good practice of drug distribution" is part of the comprehensive quality assurance to ensure drug quality to be maintained over the full control of all activities related to drug distribution process.

The principle provides the basic principles, general guidelines on "Good practice of drug distribution", raising the necessary requirements for the transportation, storage, distribution of drug to ensure the provision of drug to consumers in a timely, adequate and quality manner as expected.

2. SUBJECTS OF APPLICATION:

This decision applies to the establishments participating in the process of drug distribution in the territory of Vietnam, including production establishments, including production establishments of intermediate products, finished drug-products, the suppliers, exporters, importers, distribution, wholesale, transport establishments, the forwarding agents, the establishments of key storage, drug distribution by the national health programs.

3. INTERPRETATION OF TERMS

The terms used in this principle are construed as follows:

a) GDP: Good Distribution Practices stand for - good practice of drug distribution.

b) Distribution of drug: means the division and displacement, preservation of drug from the warehouse of the drug production establishments or from the distribution centers to the users or to locations of distribution, the intermediate preservation or between the locations of distribution, the intermediate preservation by the different means of transportation.

c) Special storage: mean the status of the drug kept separately, in an isolated area or by administrative measures in order to wait for the decision to be allowed to enter the storage or delivery for the preparation, packaging, distribution, or destruction.

PART II: GOOD PRACTICE OF DRUG DISTRIBUTION

1. IMPLEMENTATION AND MANAGEMENT

a) The drug distribution establishment must have legal entity status, granted certificate of sufficient conditions for drug business practice under the current provisions of the Pharmacy Law and the concerned Laws, legal documents and must have enough capacity to take responsibility for their activities.

b) Distribution establishment must establish an appropriate organizational structure, illustrated by the organizational chart. Responsibility, powers, and relationships between employees must be clearly defined.

c) Distribution establishment must allocate sufficient staffs to carry out all tasks under their responsibility.

d) The managers and technical managers must have sufficient powers and necessary resources to carry out their duties and to determine, adjust the deviation from the quality management system.

e) Responsibility of each individual must be clearly defined and must be included in the job description of each individual. All employees must be trained and understand clearly their responsibilities, and works. The staffs that are responsible for the preservation, distribution and transportation of the narcotics, psychotropic drug must have qualification, capacity to meet the provisions in the concerned regulations.

e) In cases the distributors have very few employees, they may authorize or sign contract for performing some tasks with the staffs or the organizations accordingly.

g) It must have regulations on the safety of employees and of property, environmental protection, the integrity of the products.

2. PERSONNEL

a) All employees participating in activities related to drug distribution, business must be qualified in accordance with the categories of distributed drug, trained on the requirements of "Good Distribution Practices", on the provisions of relevant laws, and sufficient capacity to meet those requirements.

b) Each distribution establishment must have a person in charge of professional management, certified to practice pharmacy in accordance with the provisions of the Pharmacy Law and concerned legal documents. This person is responsible for and sufficient powers to be specified to ensure the application and maintenance of quality systems.

c) The key personnel participating in the preservation and distribution of drug must have sufficient ability and experience in accordance with assigned responsibilities to ensure the drug to be stored, distributed properly.

- The drug store keeper must have qualifications from middle class pharmacists or more. For the herbal medicine distributors, the store keeper must have qualifications from middle class of traditional medicine or herbalist or more. For drug distribution establishments required for special management (narcotics, psychotropic drug and substances used as drug), the store keeper must meet the provisions in the relevant regulations.

- Personnel of inspecting, controlling drug quality must have qualification of university-pharmacist.

- For the establishments of distributing vaccines and bio-health products, the store keeper must have qualification from the medical-pharmaceutical intermediate or more; employees who are responsible for transportation must have qualification in pharmacy from high school or more; the staffs on duty of delivery must have qualification from medical-pharmaceutical primary or more.

d) Employees must be trained initially and trained ongoing in accordance with the assigned tasks under a training program in writing. Training records must be kept for archiving.

đ) Employees must ensure their health and must be periodically examined for health. The employees of infectious diseases ... must be separated from the areas of drug storage, trafficking.

e) Developing and implementing the process of personal hygiene for staffs in accordance with the activities conducted. The contents of that process must mention to the issues of health, hygiene, and clothing of staffs.

g) Employees participating in drug distribution must wear protective clothing or uniforms properly to the works that they carry out. Employees exposed to hazardous drug (eg, the products are highly active, toxic, easy to infection or allergens) must be provided necessary protective clothing.

h) It must have the procedures and first aid equipment to tackle the accidents that could happen affecting the safety of employees.

3. QUALITY MANAGEMENT

a) The distribution establishments must have the quality policy by written description of the purpose and general policy of the distributors on the quality issues, the policies that must be approved and published formally by the boards of leaders of the establishments.

b) Quality Management includes:

- Infrastructure or "quality system" matches, including organizational structure, processes, methods and resources;

 - The necessary systematic activities for ensuring a product (or service) and records and documents meeting the quality requirements which have been predetermined. Gathering all these activities called as "quality assurance".

c) All parties involved in the production and distribution of drug must share responsibility for the quality and safety of products to ensure the products suitable to its use’s purpose.

d) Upon the application of electronic commerce (e-commerce) in the drug business, it must develop the processes and appropriate systems to ensure the access to the source and verification of the drug quality.

đ) It must have the procedures of supply and delivery which have been approved to ensure that drug is purchased from lawful vendors that were evaluated, approved, and distributed to the establishments, legal entities with license of sufficient conditions for pharmaceutical business as prescribed by law.

e) Developing and implementing the system of appropriate records, documents to ensure the ability to retrieve the original manufacturers, drug importers and intermediates distributors, and the establishments, individuals have purchased as well.

The information must be always available to provide for the management agencies and users even though at the beginning or end of the distribution channel.

g) Building the workflows for all activities on administration and techniques. The workflows must be approved and officially promulgated by competent officials of the establishment.

h) All medicines must be circulated legally, and must be purchased, provided as well sold, delivered, sent by the establishments of legitimate production, pharmaceutical business, meeting the provisions of law.

4. FACILITIES, STORAGE, AND MANAGEMENT

a) All drug distribution establishments must have the conditions on warehouses, drug storage facilities complying with the principles of "Good Storage Practice" (GSP). The storage must have the areas of preservation, receipt, and shipment, sampling location, conditions, and requirements in the storage, receipt, inventory turnover, and control of out of date pharmacy.

Preservation area

b) It must have measures to prevent people who are not permitted, no duty to go into the drug storage areas.

c) The drug storage areas must meet sufficiently area to allow ordered storage of various products, such as products waiting for packaging, special storages products, shipped products, the discarded, returned, or recovered products. The minimum area is 30 m2; the minimum capacity is 100 m3.

d) The storage areas must be designed and modified to ensure the conditions of drug storage. In particular, the storage areas must be clean, dry and maintained within the appropriate temperature.

đ) Equipping with the appropriate shelves system. The distance between the warehouse floor and the shelves containing drug should be large enough for easy cleaning and drug inspection. Drug storage shelves should be in good condition, clean. Not to leave drug directly on the storage floor.

e) The storage areas must be clean and free from accumulated waste, dirt, and rodents and insects. It must have documents on sanitation programs, and methods of conducting sanitary, cleaning warehouses, storage areas...

- The substances, pest control equipment must be ensured safety and have no risk of drug contamination. It must have appropriate procedures to clean any dirt to ensure complete elimination of all risk of pollution.

g) If the sampling is done in drug storage areas, it must be conducted so that may prevent contamination or cross contamination. It must have proper sanitation procedures for sampling location.

- For the establishments of distributing raw materials and excipients to make drug, it must be arranged a separate sampling area. This area must be designed and built with appropriate controlled environment conditions (on the clean level, temperature, humidity ...) and the appropriate sampling equipment to ensure the prevention of potentially cross-contamination and infection.

h) The receipt, delivery area must be able to protect drug from the adverse weather conditions. The receipt area must be designed, built, and equipped appropriately to clean up the package transported before being entered into the warehouse.

i) If there are the areas dedicated for products reserve, the areas must have clear signage, and only authorized persons allowed to enter the areas. Any alternative physical measure must be guaranteed to provide the above safety levels. For example, it can be used the computer system to manage if the system is evaluated, appraised that it ensures security.

k) It must have the physical isolation measures or equivalent (e.g: electronic system) for the storage of medicines discarded, expired, withdrawn or returned. The concerned products or storage areas must have appropriate signage and clear.

l) The radioactive, narcotic, psychotropic drug, and other sensitive, hazardous products, and the drug with risk of being abused, causing fires, and explosions as well (eg, flammable, explosive liquid, solid, the compressed air vessels ...) must be stored in the separate areas, and must have additional measures to ensure safety and security.

- For the establishments of distributing raw materials and excipients for making drug, must have separate storage for the storage of raw materials and excipients for making drug. The storage must have the preservation conditions suitable to the requirements of each type.

- For the establishments of distributing vaccines and bio-health products, it must be established a system cold chain (cold chain) (including cold storage, portable refrigerators, and cold vehicles ...) for the storage areas, transportation, distribution in order to maintain synchronous temperature for each product from manufactured until used.

+ Cold storage must have enough appropriate volume to arrange rationally the products.

+ It must be equipped with instruments, devices to monitor continuously temperature and humidity. It must have automatic recording equipment and alarm system when the temperature is beyond the permissible limits.

+ It must be equipped with enough backup power for the operation of cold storage, if necessary.

m) The drug must be processed, preserved well enough to avoid contamination, cross contamination, confusion.

n) It must have a system to ensure that first expired products will be firstly out (FEFO is abbreviated as First Expire, First Out). When drug are not recorded its date, it must be applied the principle of First-in, First-out (abbreviated as FIFO - First In, First Out). However, in the specific cases, it may be accepted the deviations from these principles, with the conditions that these deviations are only temporary nature and applied accordingly.

o) The discarded drug must be properly labeled and controlled in special storage areas to prevent re-use until having final decision on the basis of the nature of the violation.

p) The drug required for special control (narcotic, psychotropic substances, pre-substance used as drug) must be preserved in accordance with the provisions of international conventions to which Vietnam is a member, of the Pharmacy Law, the Law on Prevention and Combat of Drug and other concerned legal documents.

q) The drug which is broken, damaged must be removed from the drug storage area where meets the requirements, and is stored separately.

r) It must have the means and methods of ensuring occupational safety such as fire protection systems ... The storage areas must have enough light to ensure activities carried out accurately and safely.

Preservation condition:

s) Preservation condition of all types of drug must be in accordance with the preservation conditions stated in the drug brands.

Monitoring of preservation condition:

u) The drug storage conditions must be monitored and recorded to be reviewed later. Monitoring equipment must be checked periodically, and the checking results must be recorded and stored. All recorded to monitor documents must be kept at least one year after the expiry of drug or as prescribed by law.

v) It must be assessed the stability temperature of the storage area.

- Temperature monitoring device must be placed in the areas where temperature changes most.

- For drug required for special storage conditions, such as vaccines and bio-health products, it must be built the warning value and the value of action for monitoring storage temperature. Any changes beyond the permitted limit or any repair work over maintenance equipment and monitoring of storage conditions must be recorded, and assessed impact on quality of drug.

x) Monitoring device of storage conditions must be calibrated periodically properly.

Inventory revolving control:

y) Periodically inventory to compare drug inventory with record books.

z) All of the significant disparities of drug stored in the warehouse must be investigated to ensure that unnecessary confusion shall not occur.

5. MEANS OF TRANSPORTATION AND EQUIPMENT

a) All vehicles and equipment used in storage, distribution, and treatment of drug must be in accordance with the use purpose and protect drug to avoid conditions which may negatively affect stability, integrity of packaging, drug and prevent the contamination.

b) The design and use of vehicles and equipment must minimize the risk of errors and allow for cleaning, efficient maintenance to avoid contamination, accumulation of dirt and any bad impact for the quality of drug during transportation and distribution.

c) If possible, it should have the vehicles and equipment used exclusively for drug. When not using these vehicles and equipment, it must have the appropriate processes to ensure that it shall not be adverse impacts on product quality. The appropriate cleaning procedures with checks and notes must be performed.

- For the establishments of distributing vaccines and bio-health products, they must be equipped with means of transportation; specialized preservation vehicles such as cold vehicles, the kinds of mobile fridge ... Must assess the stability on temperature in this storage means. The preservation conditions during the transport must be maintained within permissible limits and must be monitored continuously, recorded. In case of the absence of these facilities, the insulation foam tank with cooled ice bag can be used (dry ice, dry gel…) to preserve vaccines and bio-health products. The amount of ice bags to freeze and use time must be evaluated to maintain the temperature within the permissible limits. In case of unable to use automatic temperature monitoring device, use more labels which can change color due to the temperature’s affect.

- In case of transportation under contract with the transport unit, the vehicles must also be evaluated. The preservation conditions during transport must also be monitored and recorded (preferably by automatically measured equipment).

e) Not to use the vehicles and equipment broken. It must be removed or clearly labeled that they were broken.

f) It must have the operating procedures and maintenance for all vehicles and equipment participating in the process of distribution, including the process of cleaning and safety prevention maintenance.

g) The means of transportation, packaging of transportation and the equipment must be kept clean, dry, and free from accumulated waste. It must have a sanitation program in writing, specifying the frequency and method of cleaning.

h) The means of transportation and packaging must be protected from rodents, moth, birds, and other insects. It must have written programs providing for measures to control those animals. The use of detergents, anti-insect ... does not adversely affect the quality of drug. The cleaning equipment for means of transportation must be selected and used so as not to be sources of contamination.

i) It must pay special attention to the design, use, cleaning and maintenance of machinery used to handle types of drug not be covered by cardboard boxes or large packages.

k) During the transportation, if having the requirements on special storage conditions (eg temperature and specific humidity), it must ensure that conditions have been checked, monitored and saved as records. All records monitoring storage conditions shall be kept at least one year after the products expired. It must measure the temperature at the different locations of the transportation means to demonstrate consistency of the temperature at anywhere in the vehicle. The measurement data must be stored for review later.

l) Equipment used to monitor environmental conditions in the means of transportation or containers, for example, the monitoring of temperature and humidity must be calibrated periodically.

m) The means of transportation and crates must be large enough to be able to arrange, preserve orderly the different drug during the transportation.

n) During the transportation, it must take measures to isolate the drug that is removed, withdrawn, or returned.

o) It must take measures to prevent those who are not on duty to enter, ransack vehicles, equipment, and prevent from the theft as well.

6. PACKAGING AND LABELS ON PACKAGING

a) Drug must be stored and distributed in the packaging without causing negative impacts on product quality and afford to protect the products from outside influences, including infections.

b) Labels on packaging must be clear, not be ambiguous, be pasted reliably on the package and cannot be erased. The information on the labels must be in accordance with the provisions of the law on drug label, packaging.

c) For packaging transported by vessels (containers), may not be fully labeled as required, but must have enough information on conditions of treatment and preservation of drug and the attention to ensure the products processed (storage, transportation ...) properly at any time.

d) The conditions of preservation, special transportation must be indicated clearly on the label. This is especially necessary for products as vaccines and bio-health products. If a product is intended to transfer out of the control of manufacturer's the products management system, the label must be included the name and address of manufacturer, the special transportation conditions and any other special legal regulations, including safety symbols.

đ) Not to write on the labels the acronyms, name, or code without approval. If used, use only the acronym, name, or code accepted in the international transactions, or the country.

e) It must especially careful when using dry ice to place in drug packaging. Besides safety issues because dry ice can cause adverse effects to product quality, it must ensure that the drug shall not be contacted with dry ice.

g) It must have available written procedures for the handling of the packaging damaged or broken. In particular, it takes special attention to hazardous or dangerous products.

7. DELIVERY AND FORWARDING

a) Drug is only sold and/or distributed to the legal pharmaceutical establishments that are allowed to purchase those products in accordance with the law regulations. It must have documents to prove the legitimacy of the individual, the establishment before it is sent.

b) Prior to delivery-forwarding, the drug distribution establishments must ensure that individuals or organizations that transport drug, including the receiving party of drug transport contracts, understand and comply with the preservation conditions and conformity transportation.

c) The implementation of delivery- forwarding and transportation of drug after receiving effective evidence according to the establishment’s regulations, such as delivery orders.

This delivery order must then be saved as records.

d) It must set up workflows for the delivery-forwarding. The workflows must take into account the nature of the drug, as well as any special attention to care.

đ) It must prepare profile of delivery- forwarding, which must include at least the following information:

- Date of sending;

- Name and address of the legal entity that is responsible for transportation, or the name of the forwarder.

- Name and address of the consignee;

- The description of products, including stating name, dosage form and content (if appropriate);

- The quantity and quality of products;

- Lots number and expiry date of products;

- The preservation and transportation conditions;

- Code for determining the delivery order.

e) A delivery-forwarding records must have sufficient information to ensure the access to the path of the products from stage to provide to the buyers or users of the products.

The records must ensure the quick recall of a lot of product when necessary. All parties related to the process of drug distribution are responsible for ensuring this access.

g) It must be carefully chosen method of transportation, including means of transportation, taking into account local conditions, regional climate, and seasonal variations known. For drug that is required temperature control, the delivery must be made in accordance with conditions of storage and transportation required, possibly by most prompt means.

h) It must set up a delivery schedule and conduct to schedule route, taking into account the needs and local conditions. The delivery schedule and route schedule must be feasible and systematic. It must note the number of delivered drug not exceeding the storage capacity of the consignees.

i) The loading on the barrel and means of transportation must be carefully and systematically according to the principle of first unloading/later loading to save time while unloading and prevent damage to the goods. It should be additional measures when loading and unloading cartons to ensure not broken.

k) Not to receive or provide products which have been expired or nearly expired to ensure the drug is still in the use limit and quality assurance to the users

8. TRANSPORTATION AND DRUG DURING THE TRANSPORTATION

a) The course of transportation of drug must be kept the integrity and quality of drug.

b) The drug manufacturers must notify all of the conditions relating to the preservation and transportation of drug to the party that is responsible for transportation. The transporter must meet all conditions during the transportation and at all intermediate preservation stages.

c) During the transportation, the transportation and preservation of drug must be made in accordance with the process of transportation to ensure that:

- Not to lose the information that helps to identify the products;

- The products do not cause infection and are not be contaminated by other products;

- Products are not fallen, embezzled, or stolen;

- The conditions of proper temperature, humidity are maintained during transportation and storage, e.g using refrigeration systems for sensitive drug to temperature.

d) The preservation conditions prescribed for the drug must be maintained within permissible limits during transportation; it is not to be out of permissible limits of private preservation conditions of the products or if outside, it is just temporary, not longer than the allowed time. Any changes from required preservation conditions must be the consent of the owner of licenses of circulation or the manufacturer.

đ) During the transportation, if there are special storage requirements other than environmental conditions known (e.g, temperature, humidity), the conditions must be secured, followed-up and recorded.

e) The process of preservation is not adversely affected the integrity and quality of drug.

g) It must have written procedures for handling violations on preservation conditions such as temperature violations.

h) The radioactive or highly active drug, dangerous drug, and substance with risk of being abused, flammable or explosive (e.g liquids, flammable solids, and compressed air) must be protected and transported in the region, packaging, and means of transportation of safety, dedicated and ensuring security. In addition, it must comply with the provisions of the Laws and the relevant international agreements.

i) The drug containing narcotics, psychotropic substances must be stored and transported in the region, packaging, and means of transportation of safety, dedicated and ensuring security. In addition, it must comply with the provisions of the Laws and the relevant international agreements.

k) The drug spilled must be cleaned as quickly as possible to prevent possible contamination, cross contamination and other threats. It must have written procedures for handling incidents mentioned above.

l) It must have the mechanical isolation measure or equivalent measures (e.g electrons) to preserve and reserve specially the drug discarded, expired, suspected counterfeit drug, withdrawn and returned in the transportation. Such drug must be separated, packed in the secure packages, clearly labeled, and accompanied by documents identifying appropriately.

m) The toxic and flammable materials must be stored and transported in the packaging which are properly designed, isolated and closed, subject to the provisions of national law and international treaty which Vietnam is a member.

n) Inside of the means and packaging of transportation must be kept clean and dry while transporting drug.

o) Packaging materials and cartons for transportation must be appropriate to prevent damage during the transportation.

p) It must ensure safety so that the product is not theft and lost. It must prevent the unauthorized persons to access to the products while being transported.

q) It must comply with common international regulations on safety (e.g fire, explosion, environmental pollution, etc. ...).

r) Any damage to the container used to transport and the incidents during the transportation must be recorded and reported to the department, organization, or concerned agency.

s) It must have the appropriate documents attached during transportation of drug products.

9. DOCUMENTS, RECORDS

a) It must have the available rules and regulations related to drug-trading activities, appropriate professional documents to look up, regulations, procedures, records and documents to ensure the compliance with the requirements on preservation, drug distribution and supply to the competent authorities upon request.

b) Purchasing orders of the wholesalers are only sent to the legal establishments with functions of providing drug like other drug wholesalers, manufacturers, and importers of drug.

The processes:

c) It must have written procedures of guidance describing all the different acts in the drug distribution activities, including import-export activities, such as ordering, receiving and checking the receipt and delivery, preservation, cleaning, maintenance of workshops, recording the conditions of preservation and security of the warehouse and the course of transportation, delivery, records of orders, forwarding, returned production, recalled products.

d) It must develop and implement the processes of compilation, control, and review and change control for all documents related to the distribution process. These processes are used for internal documents and external documents as well.

đ) The documents, particularly the guidelines and procedures related to any activity that affects the quality of drug must be designed, reviewed, approved, and distributed carefully.

e) Every document must have a title, nature, and purpose of using document. The contents of the documents must be clear, not vague causing confusion. Documents must be presented orderly for easy inspection.

g) All documents must be completed, approved, signed, and dated by the competent person who is responsible for management and not to be changed without permission.

Recorded documents:

h) The records of all activities related to storage and transportation, delivery of drug, drug storage conditions must be recorded at the time taking place each act and in a way that all activities or important events may be searched. The records must be clear and must be kept for archiving.

i) It must have records of every sale and purchase with date of purchasing or providing, drug name and quantity received or provided; the name and address of the suppliers or consignees for sale. For transactions between production establishments and wholesalers and between wholesalers with each other (i.e not including the delivery of goods, people, retailers, hospital pharmaceutical faculty… are entitled to provide drug ... to the public), the records must ensure the access of origin and destination of the products, for example using the lot number to identify all the drug providers or the establishments provided.

k) It must comply with the provisions of the laws on the nature, contents, and retention of documents related to the distribution of pharmacy. Records, documents must be retained for a period of at least 01 years, since the date of expired drug.

l) The distributors must develop and implement processes to identify, collect, to catalogue, access, preserve, maintain, handle and access to all relevant records and documents.

m) All books must be available for access, preserved and stored by means of security to prevent the change, damage, deterioration, loss of files and documents.

n) It must regularly review and update the system of files and documents. When a document has been amended, it must take measures to prevent inadvertent use of old versions of documents.

o) It must have mechanisms to allow transfer of information, including information on quality or regulations of drug management between manufacturers and consumers, as well as the transfer of information to management agencies upon request.

p) Records on drug preservation must be stored and easily accessible when required according to the provisions of Good Storage Practice.

q) When records are made and stored by electronic means, the copies must always be done and available to prevent data loss.

10. RE-PACKAGING AND RE-LABELING

a) The repackaging (including relabeling) of drug shall be made only by the distribution establishments granted permission for re-packaging, and must be made in accordance with principle on "Good Manufacturing Practice" (GMP). On the packaging of the products repackaged or relabeled, it must specify the name of the original production establishment next to the name of distributor/re-packaging.

b) For imported drug, the repackaging acts which are simple without affecting the quality of drug, such as adding additional labels stating the name of the importer, distributor, adding instruction in Vietnamese, can be done by the importer in the area reserved for these acts.

It must pay special attention to the following aspects:

- Beware of contamination, cross contamination and confusion;

- Implementation of hygiene and sanitation;

- Maintenance of the integrity of the lot;

- All of the labels peeled off from the original packaging while relabeling and the new label form must be kept in the lot records;

- If using many lots of labels in a batch repackaging/relabeling, it must keep samples of each batch;

- Maintenance of the integrity and ability to identify products.

c) It must provide testing instrument of the original manufacturer (original or copy). If retesting, it must provide the original testing instrument and the new testing instrument. Lot of products listed in the new testing instrument must have enough information to trace back the original testing instrument.

d) It must have the processes, appropriate measures to ensure the identity and maintenance of the quality of drug before and after conducting repackaging.

11. COMPLAINTS

a) It must have written procedures for handling complaints. It must distinguish between complaints on the products or product packaging and claims relating to the product distribution.

b) All complaints and other information relating to poor-quality drug must be carefully considered according to the written processes in which describes measures to be applied, including the ability to recover products when necessary.

c) Any complaint relating to an error of drug must be recorded and investigated thoroughly to define the source or cause of complaint (e.g repackaging, the original production process, etc. ...).

d) If detecting or suspecting an error relating to a type of drug, it must consider the inspection of other lots of the same product.

e) When necessary, to carry out following handling measures after the inspection and assessment of complaints

12. RECALL

a) It must establish a system, including written procedures, in order to recall quickly and effectively the drug determined or suspected as defect, and state specifically the person who is responsible for the recall.

b) The process of recall must be checked and updated regularly.

c) When recalling drug, it must notify the original manufacturer. When the recall is done by a legal entity that is not the original manufacturer, or a body who has the circulation permit, the recall legal entities must contact the manufacturer and/or the body who has the circulation permit.

d) The effectiveness of the recall method must be evaluated periodically.

đ) All of the recalled products must be stored in a private and secure area, waiting for handling.

e) During the transportation, the recalled drug must be clearly labeled as recalled product and preserved in isolation. When the isolation is not feasible, then the recalled drug must be safely packaged, clearly labeled and must be accompanied by appropriate documentation.

g) During the preservation and transportation, it must maintain the recalled drug preservation conditions as prescribed on the label until a final decision is made.

h) It must notify immediately of the recall of the product defected or suspected as defect to all clients and local health management agencies, where the products may have been distributed.

i) Persons who are assigned to recall drug must be provided records, documents with complete information on the drug, and lists of customers who bought drug.

k) The happening of process of recall must be recorded and having the final report, including the balance between the amounts of drug delivered and the amount of drug recalled.

13. DISCARDED AND RETURNED PRODUCTS

a) The products which are discarded and the products which are returned to the distributor must be identified properly and treated in accordance with a process in which at least those products must be kept in the special storage areas to avoid confusion and prevent redistribution until a decision on remedial measure is made. The preservation conditions which are applied to the discarded or returned drug must be maintained during the preservation and transportation until a final decision is made.
b) The assessment and making a decision on the handling of discarded drug, returned drug must be made by a person who is assigned in writing by a competent person. When conducting the assessment, it must take into account the nature of the returned product, the special preservation conditions, conditions and background as well as the time since the time of selling such products.

c) The returned products can be sent back for sale only when:

- Products are still in the original packaging unopened and in good conditions;

- Knowing that the goods have been stored and handled in accordance with appropriate conditions;

- The remaining time of lifespan ensures in compliance with regulations;

- The products have been tested and evaluated by competent persons.

d) When there is any doubt on the quality of the products, then not to be re-exported or re-use of such drug.

đ) It must have means and equipment to transport the returned drug safely and properly in accordance with the requirements on preservation and other related regulations.

e) It must have means and equipment to transport discarded drug, raw materials safely and properly before handling.

g) When necessary, the drug must be destroyed in accordance with the current regulations of the Ministry of Health and relevant regulations.

h) Records on the returned, discarded, and destroyed products must be archived in accordance with provisions.

14. COUNTERFEIT DRUG:

a) Any counterfeit drug which was found in the drug supply network must be separated immediately from other drug and must be recorded.

b) It must immediately notify the circulation licensees, the pharmaceutical management agencies as well as other concerned state agencies on the drug which is determined or suspected as counterfeit drug.

c) The drug which is counterfeit or suspected as counterfeit drug must be clearly labeled, stored separately to avoid the mistakes leading to ​​re-circulation and re-distribution.

d) After the drug is determined officially as counterfeit drug, it must have a formal decision on the destruction of such counterfeit drug and must be filed.

15. IMPORT

a) The import and export of drug must be complied with the provisions of law on import and export of drug.

b) The imported drug must be packed in original packaging except for the products which are imported in the form of semi-finished products for packaging or producing finished products.

c) At the border gate, the lots of drug must be preserved in the appropriate conditions and stored in a period of time as short as possible.

d) The importing establishments must take all appropriate measures to ensure that drug is not improperly handled or stored in inappropriate conditions at the ports and airports.

e) When necessary, it must have personnel trained in medicine to participate in the process of conducting customs procedures.

16. ACTIVITIES UNDER CONTRACTS

a) Any activity related to drug distribution that is authorized to other individuals or organizations to make must be conducted as a written contract, agreed between the contracting party and contracted party.

b) The contract must clearly state the responsibilities of each party, including the requirement to comply with the principle of "Good Distribution Practices."

c) All contracted parties must comply with the provisions of this guidance.

d) It may accept sub-contract with the certain conditions on the basis of the written approval of the contracting party, especially for activities such as sampling, analysis, repackaging and relabeling.

đ) All contracted parties must be inspected, examined periodically.

17. SELF-EXAMINATION

a) Self-examination must be part of the quality assurance system. It must conduct self-examination to monitor the implementation of and compliance with the principles of "Good Distribution Practices" and recommend the necessary remedial measures.

b) Self-examination must be conducted independently and in detail by those who are qualified and appointed.

d) All of the self-examination times must be recorded in full. In the reports, they must be fully recorded the inspection process and recommended remedial measures, if required to implement. It must have the program to correct the errors found during the examination. The measures which were carried out must be recorded. The management division must evaluate the examination report and corrective action and to record.

PART III: IMPLEMENTATION GUIDANCE

1. Implementation route:

The establishments engaging in the drug distribution in the territory of Vietnam must develop investment plans to gradually upgrade and construct warehouses, means of transportation, train employees, implement activities relating to preservation, distribution, drug transportation upon the principle of "Good Distribution Practices”.

From the date of 01/01/2011, all establishments engaging in the drug distribution must achieve the principles of "Good Distribution Practices" as defined in this Decision.

After the effective date of this Decision, the drug wholesalers wishing for new establishment required meeting "Good Distribution Practices" may be granted certificates of sufficient conditions for drug trading.

From 01/01/2008, the drug wholesalers that have been granted certificates of sufficient conditions for drug trading required meeting the principle of "Good Distribution Practices" may be extended the certificates of sufficient conditions for drug trading.

Encouraging the wholesalers to apply the principle of "Good Distribution Practices", the wholesalers that achieve "Good Distribution Practices" shall be printed the line of words reaching "Good Distribution Practices" on signboards, packaging containing drug, advertising information, and posted information in the Pharmaceutical Information, to be given priority for participation in the tender offer for national drug supply, drug for hospital using the State funds.

2. Training:

a) The Vietnam Drug Administration shall disseminate, train content of "Good Distribution Practices", inspect, examine "Good Distribution Practices" the Department of Health of provinces and cities under central government, Pharmaceutical Corporation of Vietnam, Health of all branches and drug production, trading establishments.

b) The Department of Health of provinces and cities under central government, Pharmaceutical Corporation of Vietnam, Health of all branches are responsible for disseminating and coaching, and training the principle of "Good Distribution Practices" for the subordinate units and the drug distribution establishments in their area.

c) The drug trading establishments are responsible for researching, training, and guiding the implementation of the principle and standard "Good Distribution Practices" for all officers and employees in their units.

3. Examination registration procedures:

After the establishments conduct self-examination and evaluation its own establishments and achieving the standard "Good Distribution Practices" sending registration dossier for examination the " Good Distribution Practices" to the Health Department of provinces, cities where establishments locate. Registration dossier includes:

a) The examination registration "Good Distribution Practices" (form attached -GDP/MB).

b) Copy of business registration certificate or investment license.

c) Documentation, training programs, "Good Distribution Practices" at the establishment.

d) A brief report on coaching and training of the establishment.

đ) Structure outline of the establishment (including personnel organization, distribution system organization (establishment, branches, warehouses, and dealers). The outline must clearly indicate the name, title, professional degree of key staffs of the establishment and the subordinate units.

e) The outline on the location and design of the warehouse (enterprises, branches ...)

g) List of preservation equipment of establishment, means of transportation, distribution ... If drug transportation is done by contract, then must have the written introduction of legal entity, equipment, means of transportation, preservation.

h) List of objects preserved, supplied, and distributed.

i) The certification or fire prevention acceptance test.

k) The self-examination minute of the implementation of "Good Distribution Practices" (participants of self-examination, the contents, and the findings, the proposal of time and remedies...).

Registration dossier is made in 02 sets

4. Registration dossier for re-examination:

Before the certificates expire 02 months, the establishments must apply registration dossier for re-examination including:

a) Written registration for re-examination "Good Distribution Practices".

b) Report of the changes of the establishment in 02 years of implementing "Good Distribution Practices".

c) A brief report on coaching and training of the establishment.

d) A self-inspection report and evaluation of the establishment in the most recent round of implementing "Good Distribution Practices".

5. Preparation and report when being inspected:

When the drug trading establishments are inspected under the standard “Good Distribution Practices", they must conduct to report by outline, diagram and brief data on the operation situation, the application of principles and standards of “Good Distribution Practices".

6. Competence to inspect and grant certificate:

The Department of Health is responsible for receiving and appraising registration dossiers for inspection, establishing the grassroots inspection team and granting certificate of the standard obtaining establishment "Good Distribution Practices".

a) The criteria of the inspectors "Good Distribution Practices":

- Having a university degree or higher, experience in the management of pharmacy in general and circulation of distributing drug in particular.

- Truthfulness, objective.

- Having scientific methods of work, determined to strictly abide the rules, regulations, able to rapidly detect the errors of the establishments, and point out the convinced measures that help the establishments to overcome their deficiencies.

- Having good health, no infectious diseases.

b) Appraisal of registration dossiers for inspection "Good Distribution Practices".

After receiving fully the registration dossier for inspection "Good Distribution Practices" of the establishment as specified in item 3 and 4 of this Part, the Department of Health appraises dossiers (with minutes of dossier appraisal). Within 30 days from the date of receiving complete and valid dossiers, the Health Department makes a decision to set up inspection team to inspect the implementation of the principles of "Good Distribution Practices" at the establishment. If the records have not met the requirements yet, the Health Department shall send a written reply to the establishment and state clearly the reasons.

c) Inspection:

- The composition of the inspection team includes: Pharmaceutical Management Department, Management Department of pharmaceutical practice (if any), pharmaceutical inspection, and pharmaceutical products-cosmetic testing center.

During the period from the effective date of this Decision until 31/12/2007, the Vietnam Drug Administration will participate in the composition of the inspection team to build model of drug distribution establishment obtaining standards "Good Distribution Practices". Within 07 days after the receipt of an application of registration for inspecting drug distribution establishment obtaining the principle of "Good Distribution Practices", the Departments of Health of provinces, cities directly under the central government notify to the Vietnam Drug Administration for assigning officials to participate.

- Content of inspection: The inspection team shall be responsible for examining all of the activities of the establishment under the principle of "Good Distribution Practices" and current professional regulations.

- The Minutes must be signed to certify by establishment’s head and inspection team head. Inspection minutes must indicate clearly the existence in the implementation of the principle of "Good Distribution Practices" at the establishment. The inspection records shall be made in 03 copies: 01 kept as archiving at the establishment, 01 filed at the Department of Health and 01 kept as archiving at the Vietnam Drug Administration if they participate in the inspection team. In the case the establishment disagrees with the opinions of the inspection team, the minutes must indicate clearly all reserved opinions of the establishment.

d. Handling of inspection results:

- For the first inspected establishment:

+ If the inspected establishment meets the principle of "Good Distribution Practices", the Department of Health grants certificate achieving standards "Good Distribution Practices". The certificate is valid in 02 years from the date of signing.

+ For the inspected establishment that meets basically principle of "Good Distribution Practices" and still has some existence but not affecting the quality of the drug and can be overcome in a short time, the inspection team would require the establishment to report the remedy, repair. Within two months from the date of inspection, the establishment must overcome, repair, and report the results of overcoming the existence which the inspection team has raised in the report submitted to the Department of Health. Head of the inspection team synthesizes, reports to the Department of Health for consideration to grant certificate "Good Distribution Practices" to the establishment.

+ For the establishment that has not satisfied the principle of "Good Distribution Practices", the establishment must conduct to correct the existence. After self-examination, evaluation meets the principle of "Good Distribution Practices"," the establishment conducts to apply registration dossier as the first registration for examination.

- For the establishment that is re-inspected:

+ Periodically inspect the "Good Distribution Practices" once every 02 years, except for irregular cases requested by the establishment or the Health Ministry (the Vietnam Drug Administration), or by the Department of Health.

+ If the establishment still maintains the meeting of the principle of "Good Distribution Practices", Department of Health will continue to issue certificate "Good Distribution Practices".

+ During the inspection process, if detecting the establishment to commit any violations that seriously affects the quality of a drug product or all products, the Health Department issues a written notice for terminating or suspending the certificate of sufficient pharmaceutical trading conditions, and notifies to the Drug Administration of Vietnam for the appropriate remedial measures.

 

MINISTER Tran Thi Trung Chien