This is aimed at ensuring that quality drugs reach consumers. In addition, good distribution practices are part of comprehensive quality assurance to ensure that drug quality is maintained through full control of activities related to the drug distribution process. The basic content of GDP is issued under Decision 12/2007/QD-BYT as follows:
*Management organization:
- Pharmaceutical wholesale enterprises must have legal status and the capacity to take responsibility for their activities. Here, it is necessary to clarify that the enterprise must have a business registration certificate.
- The enterprise must have a suitable organizational structure, clearly defining the tasks of each individual. Arrange human resources with sufficient qualifications and capacity. The responsibilities of each individual must be recorded in the job description.
- Management staff must have sufficient authority and necessary resources.
- In case the distributor has few employees, it can delegate or contract the performance of some tasks to suitable employees and organizations.
*Human resources:
- Have appropriate professional qualifications, training and ability
- There must be a person responsible for professional management, with a pharmacy practice certificate. There must be responsibility and sufficient authority as specifically prescribed to ensure the application and maintenance of the quality system.
- Key staff with appropriate capabilities and experience: drug quality control and inspection staff must have a university degree in pharmacy; drug storage warehouse keepers, vaccine and medical biological product transport staff must have a pharmacy degree from high school or higher, vaccine and medical biological product warehouse keepers must have a degree from intermediate medical pharmacy or higher...
Quality control and inspection staff must have a university degree in pharmacy.
Employees shall receive initial and continuing training appropriate to their assigned duties, in accordance with a written training program. Training records shall be maintained.
Personal hygiene procedures for personnel appropriate to the activities carried out must be established and implemented. Personnel handling hazardous drugs must be provided with the necessary protective equipment.
First aid procedures and equipment must be available to deal with potential accidents that may affect the safety of employees.
*Quality management:
- Appropriate processes and systems must be established to ensure traceability and verification of drug quality when participating in e-commerce in the drug business.
- Build and implement system profiles
- There must be approved supply and release procedures to ensure that drugs are purchased from legitimate suppliers that have been evaluated, approved, and distributed to licensed establishments and legal entities that are qualified to conduct pharmaceutical business in accordance with the law.
- A suitable system of records and books must be established and implemented to ensure that the original manufacturer, drug importer and intermediate distributors, as well as the establishments and individuals who purchased the drug, can always be traced. This information must always be available to management agencies and users, whether at the beginning or the end of the distribution channel.
*Facilities, warehouses and storage:
- The warehouse must have storage areas, receiving and shipping areas, sampling areas, conditions and requirements for storage, receiving goods, inventory rotation and control of expired pharmaceuticals.
- The storage area must have sufficient space to allow orderly storage of different products, such as products awaiting packaging, quarantined products,
products from the factory, discarded, returned or recalled. The minimum area is 30m2 , the minimum capacity is 100m3 . The storage area must be designed and adjusted to ensure the conditions for drug storage. The storage conditions of the drugs must be consistent with the storage conditions stated on the drug label. In particular, the storage area must be clean, dry and maintained within the appropriate temperature range. A suitable shelf system must be equipped, the distance between the floor and the shelves must be large enough to easily clean and check the drugs.
- Receiving and distribution areas must be protected from adverse weather conditions. The receiving area must be designed, constructed and equipped to allow for cleaning of shipping containers prior to storage.
- Drugs that require special storage conditions, such as vaccines and medical biological products, must establish warning values and action values for storage temperatures. This condition is mandatory for enterprises distributing vaccines and medical biological products because the goods have special storage requirements. If there are errors in storage issues such as power outages or equipment failures that are not detected in time, it will cause consequences to the patient's life.
- The means of transport and equipment used must ensure that the impact on the transportation and distribution of drugs is minimized. For drugs with special requirements such as vaccines and medical biological products, they must be transported by refrigerated vehicles to ensure the correct temperature of the drugs.
- Equipment used for monitoring during storage such as thermometers and hygrometers must have inspection stamps and be periodically re-inspected.
After registering the inspection dossier for the regulations on good drug distribution practices according to the guidance of Decision No. 12/2007/QD-BYT, the enterprise will be granted a Certificate of meeting the standards of "Good Drug Distribution Practice (GDP)" and this certificate is valid for 2 years from the date of signing. Also according to the roadmap stipulated in this decision, from January 1, 2008, drug wholesalers that have been granted a Certificate of eligibility for drug business must
Only those who meet the principles of "Good Distribution Practice" will have their drug business eligibility certificate renewed. In order to achieve the goal of bringing quality drugs to consumers, all stages of drug distribution business must also aim at common standard regulations and by January 1, 2011, all establishments involved in drug distribution must meet the principles of "Good Distribution Practice".
2.2.2.Registering business of exporting and importing pharmaceuticals:
According to the provisions of Article 3 of Decree 79/2006/ND-CP on forms of pharmaceutical business organization, pharmaceutical import and export activities have only one business form: " Pharmaceutical import and export enterprise".
The entities that have the right to export and import pharmaceuticals include Vietnamese traders and foreign traders. Depending on each business entity, the law has different regulations on the conditions for exporting and importing pharmaceuticals.
- For Vietnamese enterprises, conditions for importing pharmaceuticals include:
+ Enterprises with a Certificate of Eligibility for Pharmaceutical Business and a drug warehouse that meets the standards of "Good Storage Practice for Drugs" (GSP) are allowed to directly import and receive entrusted import of finished drugs, pharmaceutical ingredients, vaccines, medical biological products, and are licensed in accordance with the scope of business stated in the Certificate of Eligibility for Pharmaceutical Business and the Certificate of Good Storage Practice for Drugs (GSP).
+ Enterprises with a certificate of eligibility for pharmaceutical business and a certificate of meeting the standards of "Good Manufacturing Practice" (GMP) are allowed to import raw materials to produce their own drugs and sell them to other pharmaceutical manufacturing enterprises.
+ Enterprises have a Certificate of eligibility for pharmaceutical business and a license to conduct radiation work issued by a competent authority.
A valid license to directly import radioactive drugs is not exempt from declaration and licensing.
- For foreign traders including:
+ Foreign-invested enterprises investing directly in Vietnam with a Certificate of Eligibility for Pharmaceutical Business (scope of drug production) are allowed to import raw materials to serve the enterprise's own drug production. The Ministry of Health will guide the export and import of pharmaceuticals not serving the enterprise's drug production in other documents.
+ Representative offices of foreign traders with pharmaceutical business licenses in Vietnam, Vietnamese traders with Certificates of eligibility for pharmaceutical business are allowed to import pharmaceuticals for circulation registration purposes (including drugs for testing and inspection as required by drug registration).
- Organizations and individuals who are not traders are also allowed to export and import pharmaceuticals in specific cases. That is, on the basis of contracts signed in accordance with the provisions of law, they are authorized to export and import pharmaceuticals to serve the needs of that organization or individual, except for addictive drugs, psychotropic drugs, precursors used to make drugs and radioactivity, including:
+ Facilities with research and testing functions, and drug manufacturing facilities are allowed to import drugs for research and testing purposes.
+ Medical examination and treatment facilities of provinces, cities, health sectors and organizations of Vietnam (referred to as the Vietnamese side) are allowed to receive aid drugs from charitable organizations, non-governmental organizations, foreign individuals, and overseas Vietnamese (referred to as the foreign side) and are responsible for using the drugs effectively, safely, reasonably, and for the right purpose of aid.
+ Organizations and individuals with clinical trial drugs are allowed to import drugs to serve clinical trials according to clinical trial research protocols approved by the Ministry of Health.
+ Organizations and individuals with approved bioavailability and bioequivalence research outlines at specialized technical agencies authorized by the Ministry of Health are allowed to import drugs to serve bioavailability and bioequivalence research.
+ For foreign enterprises supplying drugs to Vietnam, they must be enterprises with licenses to operate in drugs and pharmaceutical ingredients in Vietnam, to supply excipients and packaging in direct contact with drugs, and the organizations and individuals listed above are not required to be enterprises with licenses to operate in drugs and pharmaceutical ingredients in Vietnam.
+ In case the drugs are needed for disease prevention and treatment and the raw materials are needed for domestic drug production but the licensed pharmaceutical enterprises in Vietnam do not supply or do not supply enough, the Drug Administration of Vietnam - Ministry of Health will consider and decide to allow import from reputable drug suppliers in the world.
Thus, according to the conditions stated above, a business that has obtained a certificate of good storage practice for drugs (GSP) is a necessary condition for trading in the import and export of pharmaceuticals. In fact, the standard for good storage practice for drugs is the standard for good distribution practice for drugs with some more specific conditions. For storage conditions according to WHO, the storage conditions are usually dry, airy and at a temperature of 15 0 C to 25 O C and depending on the conditions of each region, this temperature can be up to 30 0 C. In addition, specific storage conditions are specified as follows: cold storage temperature does not exceed 8 0 C, refrigerator temperature is between 2-8 0 C, cold storage temperature does not exceed -10 0 C, cool storage temperature is from 8-15 0 C. This is quite suitable and
is clearly stated in Decree 79/2006/ND-CP, Article 24 stipulates the conditions for granting a certificate of eligibility for pharmaceutical business to import and export enterprises: "Pharmaceutical wholesale enterprises with a certificate of eligibility for pharmaceutical business and a drug warehouse that meets the standards of good storage practice (GSP) are allowed to import according to the provisions of the law on pharmaceuticals, regulations of the Ministry of Health and relevant legal provisions. Enterprises with a certificate of eligibility for pharmaceutical business are allowed to export pharmaceuticals ". This regulation has created openness as well as encouraged pharmaceutical enterprises to expand their business methods, creating diversification in pharmaceutical products, creating conditions for patients to access quality pharmaceuticals from both domestic and foreign countries. Thereby enhancing the ability to prevent and treat diseases, protecting people's health.
Currently, the conditions for pharmaceutical export and import business according to the Pharmaceutical Law have been expanded quite freely, but currently the number of enterprises registering for this type is not much and accounts for a relatively small proportion compared to pharmaceutical wholesale distribution enterprises. Accordingly, wholesale enterprises only need to meet GPs standards on good drug preservation practices to be able to export and import pharmaceuticals. According to statistics from the Hanoi Department of Health, the number of enterprises registering for export and import is as follows:[25]
Year
2011 | 2012 | 2013 | 2014 | 2015 | |
Business Registration Certificate Number | 53 | 64 | 48 | 72 | 83 |
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The number of these enterprises is still quite low compared to the number of enterprises engaged in wholesale distribution of pharmaceuticals. In addition, the majority of these enterprises only register to import pharmaceuticals under normal conditions. This will limit the mechanism of price competition when foreign pharmaceutical companies almost dominate the market share of imported pharmaceuticals.
2.2.3. Registration for pharmaceutical retail business:
Hanoi is the locality with the second largest number of pharmacies and drugstores in the country, after Ho Chi Minh City. According to statistics from the Hanoi Department of Health, the number of pharmacies in Hanoi in recent years is shown in the following table:
STT
Target | Year 2005 | Year 2006 | Year 2007 | Year 2008 | |
1 | Number of pharmacies | 1180 | 1355 | 1503 | 1989 |
2 | Percentage of next year compared to last year | 100 | 115 | 111 | 132 |
The above data shows that the number of pharmacies in Hanoi city is constantly increasing every year, from 10% to 32% year on year. This shows that with the increase in number, pharmacies will better meet the increasing health care needs of the people, creating favorable conditions for them to have more choices of products suitable for their health and economic conditions. Along with that development, to bring the pharmaceutical retail system into standards with the aim of ensuring the best pharmaceuticals to consumers; The Ministry of Health issued Decision No. 11/2007/QD-BYT on January 24, 2007. This Decision sets out the principles and standards for good pharmacy practice, along with the implementation roadmap that from July 1, 2007, pharmacies that add business functions or are newly established in inner-city districts and wards of Hanoi, Da Nang, Ho Chi Minh City and Can Tho must comply with GPP principles to be eligible for pharmaceutical retail business. From January 1, 2010, pharmacies in suburban districts and communes of provinces and centrally-run cities must comply with GPP principles to be eligible for pharmaceutical retail business.