Thông tư 48/2011/TT-BYT

CIRCULAR

PROMULGATING PRINCIPLES OF "GOOD DISTRIBUTION PRACTICE"

Pursuant to the Pharmacy Law No.34/2005-QH-11 dated June 14, 2005;

Pursuant to the Decree No.188/2007/ND-CP dated December 27, 2007 of the Government regulating functions, duties, powers and organizational structure of Ministry of Health;

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

Ministry of Health promulgates the principles of "Good distribution practice" as follows:

Article 1. Subjects of application

The principles of "Good distribution practice" issued with this Circular shall apply to the establishments to participate in the process of drug distribution on the territory of Vietnam, including the production establishments, event the establishments producing intermediate products, finished products of drugs, the establishments of supply, import, export, distribution, wholesale, the transport establishments, the forwarding agents, the hubs of storage, distribution of drugs of the national health programs.

Article 2. Interpretation of terms

In this Circular, the following terms are construed as follows:

1. GDP means the abbreviation of Good Distribution Practices – good practices of drugs distribution.

2. Drug distribution means the division and migration, storage of drugs from the warehouse of drugs production establishments or from distribution centers to the users or to the places of distribution, intermediate storage or between the places of distribution, intermediate storage by the different means of transportation.

3. Special reserve means the state that drugs are placed separately, in an isolated area or by administrative measures in order to wait for the decision to allow storing, of stock disbursement for the preparation, packing, distribution, or cancellation.

Article 3. Dossier of registration for the first inspection of the principles of "Good Distribution Practices" is made into a set, including:

1. An application for inspection of "Good distribution practice" (Form No.1/GDP);

2. A copy of establishment license or certificate of business registration or investment certificate (or copy certified, signed and stamped and certified by the establishment);

3. An organization chart of the establishment (including personnel organization, organization of distribution system (facilities, branches, warehouses, dealers)), the chart must clearly indicate names, titles, qualifications of the key managers of the establishment and the subordinate units;

4. A chart of geographic location and design of drugs warehouses;

5. A list of storage equipment, means of transportation, distribution of the establishment. In case of drugs transport is done under the form of contract, it must have document to introduce on legal entity, equipment, means of transportation, storage of the contract- receiving party.

Article 4. Dossier of registration for the re-inspection of the principles of "Good Distribution Practices" is made into a set, including:

1. An application for re-inspection under the principles of "Good distribution practice" (Form No.2/GDP" (Form No.2/GDP);

2. A report of the establishment’s changes in 03 years of implementing "good distribution practice" and related documents, if any;

3. After the establishment files dossier of registration for re-inspection, it shall be allowed trading drugs under the extent specified in the certificate of "good distribution practice" that have been issued and certificate of qualification of drug trade (in valid).

Article 5. Dossier of registration for inspection of the principles of "good distribution practice", where there are change/supplementation of business scope, change of business location, drugs storage is made in a set, including:

1. An application for registration for inspection of change, supplementation to certificate of "good distribution practice" (Form No.3/GDP);

2. An organization chart of the establishment (including personnel organization, organization of distribution system (facilities, branches, warehouses, dealers)), the chart must clearly indicate names, titles, qualifications of the key managers of the establishment and the subordinate units;

3. A chart of geographic location and design of warehouses;

4. A list of storage equipment; means of transportation, distribution of the establishment. In case of drugs transport is done under the form of contract, it must have document to introduce on legal entity, equipment, means of transportation, storage of the contract- receiving party;

Article 6. Competence to inspect, component of inspection team

1. Competence to inspect and issuance of certificate”

Health Departments of the provinces and centrally-run cities (referred to as the Health Department) are responsible for receiving dossiers, dossier evaluation, establishment of inspection team, conducting actual inspection and issuance of certificates "Good distribution practices".

2. Standards of the inspectors "Good distribution practices"

a) The head of inspection team must have an pharmaceutical university degree, with experience in the management of drugs for 2 years or more;

b) Members of the inspection team must have a university degree or higher.

3. Component of the inspection team comprises head of team, secretary and members of the team shall be decided by the Director of Health Department.

Article 7. The order of registration, inspection, and accreditation of achieving GDP

1. After the establishments self-inspect and evaluate that they reach "Good distribution practices", then send the applications for registration for inspection of "Good distribution practices" to the Health Departments where the establishments have drugs warehouses.

2. The Health Departments issuing the processes and complying with the processes of granting certificates reached "Good distribution practices", must ensure the principle:

a) Within 15 days after receipt of the application for recognition of the establishment achieving the principle of "Good distribution practices", Department of Health shall establish an inspection team and conduct the inspection at the establishment (according to the Checklist in Appendix I).

b) Health Department shall issue certificate of "Good distribution practices" for the establishment within 05 working days from the end of the inspection meeting requirements; or within 10 working days from the date that the Department of Health receives report on overcoming the shortcomings mentioned in the inspection minute.

c) In case of re-inspection, within 10 working days after receiving the report of remedy and recommendation of inspection, the Department of Health must conduct the inspection.

3. Inspection minutes must be signed to certify by the professional managers and heads of inspection teams and be made into 02 copies: 01 copy is stored at the establishment, 01 is kept at the Health Department of province, centrally-run city where the establishment operates. (Form No.4/GDP).

Article 8. The validity of certificate "Good distribution practices"

The certificate of "Good distribution practices" (Form No.5/GDP) has a valid term of 3 years from the signing date. The certificates that have been issued previously with a valid term of 2 years may continue to be extended operating time for 01 year from the expiration date. The Department of Health issues Decision of extension together with the list of the establishments to be extended validity of the certificate of "Good distribution practices".

Article 9. Effect

This Circular takes effect from February 05, 2012 and replaces Decision No.12/2007/QD-BYT dated 24/01/2007 on promulgating the principles of "Good distribution practices" and contents related to the principles of "Good distribution practices" in the Decision No.29/2007/QD-BYT dated 11/05/2007 amending and supplementing some Articles of the Decision No.12/2007/QD-BYT.

During the execution process, if any difficulty arises, the units should reflect promptly to the Drug Administration - Ministry of Health for study to amend and supplement properly./.

THE PRINCIPLES OF

“GOOD DISTRIBUTION PRACTICES”
(Issued together Circular No.48/2011/TT-BYT dated December 21, 2011 of Minister of Health)

1. Organization and management

a) The establishments of drug distribution must have legal status, issued certificate of qualification for drug trading under the current provisions of the Pharmacy Law, the laws, concerned legal documents, and have sufficient capacity to take responsibility for their activities.

b) The establishments of drug distribution must establish an appropriate organizational structure, illustrated by the organizational chart. Responsibility, authority, and relationships between the employees must be clearly defined.

c) It must allocate sufficient personnel to conduct all the tasks under the responsibility of the establishments of distribution.

d) The managers and technical managers must have sufficient authority and necessary resources to perform their duties and to determine and adjust the deviation from the quality management system.

đ) The responsibility of each individual must be clearly defined and must be stated in the job description of each individual. All employees must be trained and understand their responsibilities, works. The staffs who are in charge of the storage, distribution and transportation of narcotics, psychotropic drugs must have the qualification, capacity to meet the provisions of relevant regulations.

e) In case the distributors have fewer employees, they may authorize or contract the implementation of a number of tasks for their staffs or the organization accordingly.

g) There must be regulations on the safety of employees and properties, environmental protection, the integrity of the products.

2. Personnel

a) All employees engaged in activities related to trade, distribution of drugs must have appropriate qualifications for types of drugs to be distributed, to be trained on the requirements of "Good distribution practice", on the provisions of relevant laws, and able to meet those requirements.

b) Each establishment of distribution must have a person who is in charge of professional management, with appropriate certificate of pharmacy practice meeting the provisions of the Pharmacy Law and other concerned legal documents. This person is responsible and has sufficient power to be specified to ensure the application and maintenance of quality systems.

c) The key personnel involved in the storage and distribution of drugs must have the ability and experience in accordance with assigned responsibilities to ensure that drugs are stored, distributed properly.

- Drugs storekeeper must have qualifications from secondary school or higher pharmacist. For the establishments of distribution of oriental medicament, the storekeepers must have degrees from vocational college of traditional medicine or higher or physicians, traditional pharmacists. For the establishment of drugs distribution that require special management (narcotic drugs and psychotropic drugs, precursor substances used as drugs), the storekeepers must meet the provisions of the relevant regulations.

- Staffs who inspect and control quality of drugs must have degrees of university pharmacist.

- For the establishments of distribution of vaccines and medical biological products, the storekeepers must have degrees from vocational college of traditional medicine or higher; staffs who are in charge of task of transport must have professional qualifications of pharmacy from intermediate level or more; the staffs who are in charge of task of allocation must have professional qualifications from primary level of medicine or higher.

d) Staffs must be trained initially and trained ongoing consistent with the assigned tasks, according to a training program in writing. Training records must be archived.

đ) Staffs must ensure their health and must be conducted periodic health examination. Employees suffering from contagious diseases must be separated from areas of storage, transport of drugs.

e) It must set up and implement the processes of personal hygiene for employees in accordance with the activities that they are carrying out. Contents of the processes must include health issues, hygiene, and clothing of staffs.

g) Staffs who are engaged in drugs distribution must wear protective clothing or uniforms in accordance with works that they are carrying out. Employees who are exposed to hazardous drugs (such as products that are highly active, toxic, easy to cause infection or allergen) must be provided necessary protective clothing.

h) There must be procedures and first aid equipment to handle the cases of accidents that can occur affecting the safety of employees.

3. Quality Management

a) The establishments of distribution must have quality policies in writing describing the purposes and general policies of the distributors on quality problems, these policies must be formally approved and published by the establishments’ management boards.

b) Quality Management includes:

- Appropriate infrastructure or "quality system", including organizational structure, processes, methods and resources;

- The systematic activities which are necessary to ensure a product (or service) and dossiers, documents meeting the quality requirements specified in advance. Gathering all these activities are called as "quality assurance".

 c) All concerned parties in the production and distribution of drugs must share responsibility for the quality and safety of the products to ensure the products consistent with the purpose of use.

d) Upon the application of electronic commerce (e-commerce) in the trade of drugs, it must develop the processes and appropriate systems to ensure retrieving of the origin and verification of quality of drugs.

đ) There must be process of supply and stock disbursement which has been approved to ensure that drugs are purchased from lawful suppliers that were evaluated, approved, and distributed to the establishments, entities having licenses of qualification for pharmacy trade as prescribed by law.

e) It must set up and implement the system of appropriate records, books to ensure the retrieving of the original manufacturers, drugs importers and intermediate distributors, as well as the establishments and individuals purchased. This information shall always be available to provide for the management agencies and users whether at the beginning or end of distribution channel.

g) It must set up the working processes for all administrative and technical activities. The working processes must be approved and officially promulgated by the competent officials of the establishments.

h) All drugs should be circulated legally, and must be purchased, provided as well as sold, delivered, sent goods by the lawful establishments of manufacturing, trading pharmacy legal meeting the provisions of law.

4. Establishments, warehouses and storage

a) All establishments of drugs distribution must have the conditions of warehouse, drug storage facilities to comply with the principles of "Good Storage Practice" (GSP). Warehouse must have the areas of storage, receiving and shipping goods, the sampling area, must meet conditions and requirements in the storage, receiving goods, inventory turnover and control of expired pharmaceutical products.

Storage areas

b) There must take measures to prevent persons not permitted, not involved in to go into the drugs storage areas.

c) Drugs storage areas must meet the area to allow orderly storage of various products, such as products pending for packing, special-reserve products, and products of factory disbursement, discarding, returning, or recovery. The minimum area is 30 m2, minimum capacity is 100 m3.

d) Storage areas must be designed and adjusted to ensure the drug storage conditions. In particular, the storage areas must be clean, dry and maintained at the proper temperature limit.

đ) It must be equipped with appropriate shelves. And the distance between the stock floors and the shelves for putting drugs should be large enough for easy cleaning and drug inspection. The shelves for putting drugs should be in clean, good condition. Not to put drugs directly on the stock floors.

e) Storage areas must be clean and free from accumulated waste, dirt, rodents, and insects. It must have written sanitation program, and methods of conducting sanitary cleaning warehouses, storage areas.

- The substances, pest control equipment must ensure safety, and have no risk of drug contamination. It must have the appropriate processes to clean any stains to ensure complete removal of all the risks of pollution.

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

- For the establishments of distribution of raw materials, excipients to make drug, it must arrange a separate sampling area. This area must be designed and built with environmental conditions to be appropriately controlled (on clean level, temperature, humidity ...) and with the appropriate sampling equipment to ensure to prevent the possibility of contamination and cross contamination.

h) The areas of reception, allocation must be able to protect the drugs from the adverse weather conditions. Reception areas should be designed, built, and equipped appropriately to clean the transport packaging before storing.

i) If there is an area dedicated for special reserve of products, this area must have clear signboard, and only competent persons are permitted to enter that area. Any alternative physical measure must be ensured to provide the safe levels as above. For example, it can use computer system to manage if it is evaluated to be ensured security.

k) It must have the physical isolation measure or equivalent measure (eg electronic system) for storage of discarded drugs, expired drugs, recalled or returned drugs. The concerned products or the storage areas must have clear, appropriate signboards.

l) The radioactive drugs, narcotic, psychotropic drugs, and other sensitive, toxic products, as well as drugs at the risk of being abused, causing fire or explosion (eg, liquid, solid, easy to fire, the compressed air vessels ...) must be stored in dedicated areas, and take the additional measures to ensure safety and security.

- For the establishments of distribution of raw materials, excipients to make drug, there must be warehouses for the storage of raw materials and excipients to make drug. Warehouses must have conditions of storage consistent with the requirements of each type.

- For the establishments of distribution of vaccines and medical biological products, it must establish cold chain system (cold chain) (including cold storage, mobile refrigerators, and cool vehicle ...) for storage areas, transport, distribution in order to maintain synchronous temperature levels for each product from production until use.

+ Cold warehouse must have appropriate volume to arrange reasonably the products.

+ It must be equipped with tools, equipment continuously monitoring temperature, humidity. It must have an automatically recording device and alarm system when the temperature is beyond the permissible limit.

+ It must be equipped with sufficient backup power generator for the operation of cold storage, if needed.

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

n) There must be a system to ensure that expired products will be firstly distributed (FEFO abbreviated by First Expire, First Out). When drugs are not recorded use duration, it must apply principle of First-in, First-out (referred to as FIFO - First In, First Out). However, in the particular cases, it may accept deviations from these guidelines, provided that the deviations are only temporary and applied accordingly.

o) The drugs which are removed must be clearly labeled and controlled in special reserve areas to prevent re-use until a final decision on the basis of the nature of the violation is made.

p) The drugs required the special control (narcotic drugs, psychotropic drugs, precursor substances used as drugs) must be preserved in accordance with the provisions of international conventions to which Vietnam is a member, in the Pharmacy Law, Law on Prevention and Combat of Drugs and the relevant legal documents.

q) The drugs which are broken, damaged must be removed from the drug storage area meeting the requirements, and be stored separately.

r) It must have the means and methods to ensure occupational safety such as system of fire protection and fighting ... storage area must have adequate lighting to ensure the activities to be carried out correctly, safely.

Storage conditions:

s) Storage conditions of the drug must be consistent with the storage conditions indicated on the drug label.

Monitoring of storage conditions:

u) Drug storage conditions must be monitored and recorded for possible later review.

Monitoring equipment must be checked periodically properly, and inspection results must be recorded and archived. All monitoring records must be kept at least one year after the expiry of drugs or as prescribed by law.

v) It must assess uniformity of temperature of the warehouse area.

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

- For the drugs required special storage conditions, such as vaccines and medical bio-products, it must build warning value and the value of actions for monitoring storage temperature. Any changes outside the allowable limits or any repair activity to equipment of storage, monitoring storage conditions must be recorded, and assessed impact on quality of drugs.

x) Equipment for monitoring storage conditions must be periodically calibrated accordingly.

Control of warehouse turn round:

y) It must periodically conduct inventory, cross-check stored drugs with records, books.

z) All of the significant difference of drugs preserved in warehouse must be investigated to ensure that confusion is not occurred.

5. Means of transportation and equipment

a) All means of transportation and equipment used in storage, distribution and treatment of drugs must suit to the use purpose and must protect drugs to avoid the conditions that may adversely affect stability, integrity of packaging, drugs and prevention of contamination.

b) The design and use of means of transportation and equipment must minimize the risk of errors and allow cleaning, effective maintenance to avoid contamination, accumulation of dirt and any negative effect for drugs quality during the process of transportation and distribution.

c) If possible, it should have the transportation means and special use equipment for drugs. When not using the transportation means and special use equipment, it must have the appropriate processes to ensure not being adverse impacts on product quality. It must perform the proper hygiene procedures, checked, and recorded.

- For the establishments of distribution of vaccines and medical biological products, it must be equipped with the means of transportation, dedicated storage such as cold vehicles; all kinds of mobile refrigerators ... must evaluate the consistency of the temperature in these storage facilities. Storage conditions during the transportation process must be maintained within permissible limits and must be monitored continuously, recorded. In case of having no these facilities, it can use the insulation foam box with cooled ice bag (dry ice, dry gel ..) to preserve vaccines and medical biological products. The amount of ice bags and use duration must be assessed to ensure to maintain temperatures within allowable limit. In case of unable to use the device of automatic temperature monitoring, it should use additionally labels that can change color due to the temperature’s influence.

- In case of transportation under contract with the transport unit, the means of transportation must also be evaluated. Storage conditions during the transport must also be monitored and recorded (by automatic measuring devices is the best).

d) Not to use the broken vehicles and equipment. It must be removed or clearly labeled as broken.

đ) It must have the process of operation and maintenance for all means of transportation and equipment involved in the distribution process, including process of hygiene and safety preventive maintenance.

e) The means of transportation, transport packaging, and 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.

g) Means of transportation, transport packaging must be protected from rodents, moth, birds and other insects. It must have a program in writing prescribing the control measures of such animals. The use of detergents, anti-insect substances... are not adversely affected the quality of drugs. The cleaning equipment for transportation means must be selected and used so as not to be sources of contamination.

h) It must pay special attention to the design, use, cleaning, and maintenance of machinery, equipment used to process drugs that are not covered by cardboard boxes or large packaging.

i) In the course of transportation, if there are requirements for special storage conditions (eg specific temperature and humidity), it must satisfy such conditions with inspection, monitoring and archiving in records. All the records monitoring the storage conditions must be kept at least one year after the products expire. It must make temperature measurements at the various places of the vehicle to prove consistency of the temperature at every place on the means of transportation. The measurement data must be archived for later review.

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

l) The means of transportation or containers must be large enough to be able to organize, preserve orderly different drugs during the transport.

m) In the course of transportation, it must take the isolation measure from the removed, recalled, or returned drugs.

n) It must take measures to prevent unauthorized people from entering, rummaging means of transportation and equipment; as well as from the theft.

6. Packaging and labels on packaging

a) Drugs must be preserved and distributed in the packaging which does not cause adverse impacts on product quality and which can afford to protect products to avoid external influences, including infection.

b) Labels on the packaging must be clear, not be vague, be pasted firmly on the packaging and cannot be erased. The information on the labels must comply with the provisions of the law on drug, packaging labeling.

c) For packaging transported by ongoing vessels (containers), it may not be fully labeled as prescribed, but must have sufficient information on the conditions of handling, storage of drugs and the attentions to ensure that products are handled (storage, transport ...) properly at all times.

d) The conditions of special storage, transportation must be indicated on the labels. This is especially necessary for the products as vaccines and medical biological products. If a product is intended to transfer out of control of manufacturer's product management system, it must state the name and address of the manufacturer on the label, the special conditions of transportation, and any regulation of any other special law, including safety symbols.

đ) Not to write on the label of packaging the abbreviated symbols, name or code without approval. If used, use only the acronym, name or code which are accepted in the international or national transactions.

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

g) It must be available the written processes for the handling of the broken, damaged packaging. In particular, it takes special attention to the toxic and dangerous products.

7. Delivery and shipment

a) Drugs are only sold and/or distributed to the lawful pharmacy establishments that are allowed to buy those products in accordance with the law provisions. It must have documents to prove the legitimacy of the individuals, the establishments before drugs are shipped.

b) Prior to delivery-shipment of goods, the establishment of drug distribution must ensure that the individual or organization of goods transportation, including the drug transportation contract receiving party understands and complies with the conditions of storage and transportation accordingly.

c) It is conducted delivery-shipment of goods and transport of drugs on after receiving the valid evidence according to the provisions of the establishment, such as delivery order. This delivery order must be saved to profile later.

d) It must set up the working processes for the delivery-shipment of goods. The processes must take into account the nature of the drugs, as well as any special considerations required to pay attention.

đ) It must prepare documents for delivery-shipping of goods, in which there are at least the following information:

- Date of shipping;

- Name and address of the legal entity in charge of transportation, or name of the shipper.

- Name and address of the consignee;

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

- The quantity and quality of products;

- Number of lot and expiry date of the products;

- The conditions of storage and transportation;

- Code to allow determination of the delivery order.

e) Documents for delivery – shipment of goods must have sufficient information to ensure the retrieving of the product path from stage of provision to the purchaser or product user. The documents must ensure the rapid withdrawal of a number of products lot as needed. All parties involved in the drug distribution process must be responsible for ensuring this retrieving implementation.

g) It must choose carefully the method of transportation, including means of transportation, taking into account local conditions and climate of that region and the known seasonal variation. For drugs required for temperature control, the delivery must be made in accordance with the conditions of storage and transport at requirements, possibly by the quickest means.

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

i) The goods loading into boxes and means of transportation have to be careful and systematic under the principle of first unload/later load to save time upon unloading goods and avoid causing damages to goods. It should take additional measures when loading, unloading paperboard cartons to ensure not be broken.

k) Not to take or provide products that have expired, or nearly expired in order to ensure that drugs are still in use term and to ensure quality when they are delivered to the users.

8. Transport and drugs during the transport

a) The transport process of drugs must maintain the integrity and quality of drugs.

b) Drug manufacturer must inform all the conditions relating to the storage and transportation of drug for the party in charge of transport. The transporter must meet all conditions during transport and at all intermediate stages of storage.

c) During the transport, the transport and storage of drugs must be made in accordance with the procedure of transport to ensure:

- Not losing the information to help the identification of the products;

- The product does not cause infection and are not contaminated by other products;

- Product is not be fallen, broken, embezzled or stolen;

- The conditions of temperature, appropriate humidity are maintained during the transport, storage, eg use of refrigeration systems for the drugs sensitive to temperature.

d) Storage conditions defined for drugs should be maintained within the permissible limits during the transport; not be outside the limits of its own storage conditions or if it is outside, it only bears the nature of temporary, not be prolonged beyond the allowed time. Any change compared to storage conditions is required to have the consent of the owner of the circulation permit or of manufacturer.

đ) During the transport, if there are special storage requirements other than the known environmental conditions (eg temperature, humidity), the conditions must be secured, monitored and recorded.

e) The storage process is not adversely affected the integrity and quality of drugs.

g) There must be a written procedure for handling violations of the storage conditions, eg temperature violations.

h) The radioactive or highly active drugs, dangerous drugs and the substance with risk being abused, flammable or explosive (eg liquids, flammable solids, and compressed air) must be preserved and transported in the areas, packaging; and dedicated safe means of transportation and ensured security. In addition, it must comply with the provisions of laws and concerned international treaties.

i) The drugs containing narcotics, psychotropic substances must be preserved and transported in the areas, packaging; and dedicated safe means of transportation and ensured security. In addition, it must comply with the provisions of laws and concerned international treaties.

k) The drugs which are fallen, spilled must be cleaned as quickly as possible to prevent contamination, cross-contamination and other risks. It must have written procedures for handling the incidents mentioned above.

l) It must have the measures of mechanical isolation or equivalent measures (eg electronic) for storage and special reserve of drugs which are removed, expired, drugs which are suspected as counterfeit drugs, the drugs which are recalled and returned during the transport process. These drugs must be separated, packed in the safe packaging, clearly labeled, and attached the appropriately identified documents.

m) The toxic substances and flammable materials must be preserved and transported in packaging which is properly designed, separated, and closed, complied with the provisions of national law and international treaties which Vietnam is a member.

n) Inside parts of the means of transport and packaging must be kept clean and dry while transporting drugs.

o) Packaging materials and boxes used to transport must be suitable for prevention of damaged drugs during the transport.

p) It must ensure safety for the products not being stolen and lost. It must prevent the persons who are not on duty to access to the products during the transport.

q) It must comply with the international general provisions on safety (eg fire, explosion, environment pollution, etc ...).

r) Any damage to the boxes used to transport and other occurred incidents during the transport must be recorded and reported to the concerned departments, organizations, or agencies.

s) It must have the appropriate documentation attached during the transport of medicinal products.

9. Records, documents

a) It must be available the regulations and provisions related to drug-dealing activities, suitable professional documents for lookup, regulations, procedures, records and documents to ensure compliance with the requirements on storage, distribution of drugs and supply to the competent authority upon request.

b) Orders of the wholesale establishments are only sent to the legal establishments with function of drugs provision like other wholesale establishments, manufacturers, importers of drugs.

The processes:

c) It must have written processes of instructions describing all the various manipulations in the drug distribution activity, including activities of stock disbursement, storing such as ordering, receiving, checking the receipt and delivery of goods, storage, cleaning, maintenance of workshops, recording of storage conditions, security of warehouses and of the transport, delivery of goods, records of orders, deliveries, products which are returned, recalled.

d) It must develop and implement written procedures, 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 drugs quality must be designed, reviewed, approved, and distributed carefully.

e) Each document must have its title, nature and purpose of use. The contents of the document must be clear, not be vague. Document must be presented orderly to facilitate the inspection.

g) All documents must be completed, approved, signed, and dated by the competent persons who are responsible for management and shall not be altered without permission.

The records:

h) The records of all activities related to storage and transportation for distribution of drugs, drugs storage conditions must be recorded at the time of each manipulation and in the manner which all activities or the important events can be looked up. The records must be clear and must be kept.

i) It must have records of every time of purchase and sale, with date of purchase or provision, drug name and quantity received or provided; the name and address of the supplier or consignee for sale. For transactions between production establishments and wholesale establishments and between the wholesale establishments together (means not including the delivery of goods, persons, retail establishments, the hospital pharmacy faculty that may provide drugs ... to the public), the records must ensure to lookup the origin and destination of the products, for example by using the number of lot to be able to identify all the establishments providing or provided drugs.

k) It must comply with the provisions of the law of the nature, content and archiving of documents related to drug distribution. Records and documents must be archived for a period of at least 01 year, since the expiration of drugs.

l) The distributors must develop and implement procedures to identify, collect, to catalog, access, preserve, maintain, handle and access to all kinds of related records, materials.

m) All records must be available for access, preserved and stored by facilities to ensure prevention of the change, damage, degradation, loss of records and documents.

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

o) It must have mechanisms to allow transfer of information, including information on quality or the drugs management processes between the manufacturers and customers, as well as the transfer of information to the management agencies at requests.

p) Records of drugs storage must be stored and may be easily accessible when required in accordance with the provisions in Good Storage Practice.

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

10. Repackaging and relabeling

a) The repackaging (including relabeling) to the drugs are only done by the distribution establishments that are granted permission for repackaging, and must be done in accordance with the conditions of the principles of "Good Manufacture Practice" (GMP). On the packaging of the products repackaged, or relabeled, it must specify name of the original production establishment next to the name of the distributor/repackager.

b) For imported drugs, the repackaging manipulations which are simple not affecting the quality of drugs, such as adding subsidiary labels stating name of the establishment of import, distribution, supplementing Vietnamese instruction, may be done by importing establishments in the area dedicated to these manipulations.

It must pay special attention to the following aspects:

- Prevent contamination, cross contamination and confusion;

- Perform sanitation and do hygiene well;

- Maintain the integrity of the lot;

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

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

- Maintain the integrity and ability to identify products.

c) It must provide testing slips of the original manufacturer (original or copy). If the retesting was conducted, it must provide the original testing slips and the new testing slips. Product lots stated in the new testing slips must contain sufficient information to trace back the original testing slips.

d) It must have procedures, appropriate measures to ensure the identification and maintenance of the quality of drugs before and after conducting re-packaging.

11. Complaints

a) It must have a written procedure for handling complaints. It must distinguish the complaints of the product or product packaging with the complaints related to product distribution.

b) All complaints and other information related to poor quality drugs must be carefully considered by the written procedures and describing the measures will apply, including the ability to recover products when necessary.

c) Any complaints related to a drug’s error must be recorded and investigated thoroughly to determine the origin or cause of complaint (eg repackaging procedure, the original production process, etc. ...).

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

đ) When necessary, it must take the measures following the investigation and assessment of complaints.

12. Recall

a) It must set up a system, including written procedures, in order to recover quickly and effectively the drugs to be confirmed or suspected to be defective, and specify the person who is responsible for recall.

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

c) When there is recall of drugs, it must notify the original manufacturer. When the recall is done by a legal entity that is not the original manufacturer, or person having circulation permit, the recalling legal entity shall have to contact with the manufacturer and/or the person having circulation permit.

d) The effectiveness of recall methods must be evaluated periodically.

đ) All of the recalled products should be stored in a separate, secure area, pending for handling.

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

g) During storage, transport, it must maintain recalled drug storage conditions as provided on the label until a final decision is made.

h) It must immediately notify the recall of defective products or products suspended defective to all clients and the local health management authorities, where the products may be distributed to.

i) Persons who are assigned the responsibility of drugs recall must be provided with records, documents with complete information on the drugs, and lists of customers who have purchased them.

k) It must record changes in the process of recall and have the final report, including balance between the number of drugs which have been distributed and quantity of drug recalled.

13. Removed and returned products

a) The products that are removed and returned to the distributors must be identified properly and treated in accordance with a process in which the products at least must be kept in special reserve areas to avoid confusion and prevent redistribution until a decision on treatment measures is made. Storage conditions applied for removed and returned drugs must be maintained during the process of storage and transport until a final decision is made.

b) The assessment and decision on the handling of removed and returned drugs must be made by a person who is assigned in writing by competent person. When evaluating, it must take into account the nature of the returned product, the special storage conditions, conditions and background as well as the time from selling such products.

c) The returned products are sent back to the selling area of goods when:

- Product is still in the unopened original packaging and in good condition;

- Known that the goods have been stored and handled in the suitable conditions;

- Time of remaining life ensures in compliance with regulations;

- Products have been tested and evaluated by competent persons.

d) When there is any doubt on the quality of the product, it shall not be re-exported or re-used such drug.

đ) It must have facilities and equipment to transport the retuned drugs safely and properly in accordance with storage requirements and other relevant regulations.

e) It must have facilities and equipment to transport the removed drugs, materials safely and appropriately prior to treatment.

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

h) Records of destroyed and returned, removed products must be stored according to regulations.

14. Counterfeit drugs

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

b) It must promptly notify the licensee for circulation; the pharmacy management agency as well as other state agencies related to the drugs which have been identified or suspected as counterfeit drugs.

c) The counterfeit drugs or drugs to be suspected as counterfeit drugs must be clearly labeled, stored separately to prevent confusion leading to the re-circulation and re-distribution.

d) After drugs are confirmed as counterfeit drugs, it must have a formal decision on the destruction of such counterfeit drugs and must be recorded.

15. Imports

a) The import and export of drugs must comply with the provisions of law on import and export of drugs.

b) Imported drugs must be packed in original packaging except for those that are imported under form of semi-finished products to package or to produce finished products.

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

d) The importing establishments must take all appropriate measures to ensure that drugs are properly handled or stored in suitable conditions in the ports or airports.

đ) When necessary, it must have people trained in medicine to participate in the process of handling customs procedures.

16. Activities under the contract

a) Any activity related to drug distribution authorized to individuals or other organizations to implement must be conducted in the form of a written contract, agreed between the contracting party and contract receiving party.

b) The contract must clearly state the responsibilities of each party, including requirements to comply with the principles of "Good distribution practices."

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

d) It may accept subcontract with certain conditions on the basis of the written consent of the contracting parties, particularly for activities such as sampling, analysis, repackaging and relabeling.

đ) All parties of the contract must be inspected, examined periodically.

17. Self-inspection

a) Self-inspection is part of a quality assurance system. It must conduct their own inspection to monitor the implementation of and comply with the principles of "good distribution practices" and suggest needed remedial measures.

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

c) All self-inspection times must be fully recorded. It must have fully records during the inspection process and recommend remedial measures in the report, if it is required to implement. It must have program to fix errors detected during the inspection. These measures that have made must be recorded in the records. The management department must evaluate the inspection report and the actions of correction and must record.