200 1-09-30 00:00
I. Legal provisions and practices of drug management in Sierra Leone
(a) the implementation of drug classification management system
The management of drug production, sales and consumption in Cyprus inherits and imitates the British system, implements drug classification management and case approval system, strictly limits the qualifications of employees who produce, sell and equip drugs, and strictly monitors business premises (retail stores and wholesalers) and business processes. Its main legal basis is the Drug and Drug Administration Law passed in 1988.
It is stipulated that the name, meaning, identification, utility standard and classification of pharmaceutical ingredients should be based on the latest US Pharmacopoeia, British Pharmacopoeia and the international Pharmacopoeia of the same period. Serbia's administrative authorities classify drugs into three categories: A, B and C, among which Class A drugs are strictly formulated (such drugs contain toxic ingredients, and their loss, abuse or misuse may lead to death, disability or other serious consequences). Their supply, configuration, synthesis and use can only be carried out by qualified pharmacists, formulators or institutions, and the required qualifications are reviewed and awarded by the Serbian Drug Administration upon application. Serbia has the strictest control over the storage, transportation and supply of Class A drugs, and the most detailed regulations on the characteristics of such drugs. Class B drugs are general prescription drugs (misuse of such drugs may be less harmful to human body than Class A), and their supply, synthesis and configuration must be guided and monitored by personnel or institutions with the above qualifications. Class C drugs are over-the-counter drugs, which can be operated by general retail stores, and consumers can buy them from medical institutions or general retail stores as needed.
It is understood that among the influential drugs in China, cooling oil and essential balm should belong to Class C, quinine and artemether belong to Class A, while Ketaixin belongs to "compound drugs", and its classification needs to be determined by the Drug Administration. The accurate classification of drugs in China must be subject to the final written approval of the Drug Administration.
(2) Drug advertisements are restricted.
Serbia has a wide range of drugs that are prohibited from advertising, which is not conducive to the promotion of drugs. The diseases involved in banned drugs include asthma, tumor, cholera, diphtheria, menstrual disorder, prostate disease, obesity, hemiplegia or paralysis, plague, pneumonia, poliomyelitis, rabies, reproductive or sexual dysfunction, schizophrenia, dysentery, filariasis, nephropathy, glaucoma and cataract, sexually transmitted diseases, smallpox, sleep diseases, tuberculosis, yellow fever, typhoid fever, ulcer and tetanus.
However, we have noticed that drugs for treating endemic diseases such as malaria, dengue fever and Lassa fever are not among them. Of course, according to the law, the Serbian Minister of Health can modify them at any time, or add new names according to the proposal.
(3) Having a specialized anti-drug agency.
The Serbian Drug Administration is the agency in charge of drug abuse, directly under the Serbian Ministry of Health. The bureau consists of "Drug Control Committee", "Drug Classification Committee" and "Registration Office". The Drug Administration is responsible for proposing specific management measures such as drug classification and drug control to the Minister of Health, and implementing them after approval and signing, and engaging in the administrative work of drug management.
(four) the production and sale of drugs shall be subject to a licensing system.
The drug administration accepts applications for qualifications of practitioners or institutions, examines, approves and registers them, and is also responsible for drug inspection, registration and issuance of business licenses. Serbian law clearly requires that imported, wholesale and retail drugs must have a fixed business place and storage place, otherwise, the applicant or institution will not be granted the right to operate, and detailed provisions have been made on lighting, floor and wall moistureproof, hygiene, indoor temperature, room space and furnishings. In the process of applying for a business license from the drug administration, the drug administration is responsible for sending people to the business premises and drug storage sites for verification, and even under the normal operation of the Chinese Medicine Administration, it still exercises the right to check at any time. The production, import, export, wholesale and retail of drugs must be paid separately in the drug administration, and the business license must be issued one by one. The current charging standards are detailed in the following table:
Drug business license fee table
Project cost (USD) Project cost (USD) Remarks
Drug Application 100 Export License 500 The license is valid for 3 years.
Then apply for an extension of validity.
Drug quality inspection 50 import license 300
New drug registration 500 wholesale license 100
New drug registration extension 300 retail license 80
Production license 200 pharmaceutical license 50
In addition, Serbia's drug patent application is accepted and approved by the Drug Administration.
5. Procedures for foreign companies to enter the Serbian pharmaceutical market.
According to the above situation, if foreign companies want to enter the Serbian market and operate legally, they must first register a company in Serbia as required, and then the company will import drugs from the head office and directly wholesale or retail them locally (it must be noted that it is impossible to operate directly by setting up a representative office), or choose local agents who meet various requirements to import drugs. To set up a branch in Cyprus, you must apply for a business license from the Food and Drug Administration in advance as a necessary document for registering a company, and then apply for registering a company in accordance with the general requirements and procedures. In addition, professional pharmacists who are legally responsible for drug sales or disposal must be equipped, and their qualifications must be approved by the Drug Administration in advance. Business premises and warehouses must report in writing to the Drug Administration in advance and accept inspection and approval. Drugs must also be sent to the Drug Administration for inspection before they can be officially exported to Cyprus or produced or operated locally. According to the regulations, samples sent from abroad should not exceed 50 grams. Within/0/4 days after the imported drugs enter the country, the details of the drugs must be reported to the Drug Administration for the record.
If local agents do not have the right to operate drugs, they must go through the same procedures as required to apply for the right to operate drugs.
If you need to establish a production enterprise in Cyprus, you must go through the same procedures and apply for a production license from the Food and Drug Administration before applying for registration as a general enterprise.
(6) Plug has particularly strict requirements on the packaging and transportation of drugs.
Plug also has strict restrictions on the transportation and packaging of drugs. Moisture-proof, tight and easy to store are all common standards. Plug requires that the printed marks and all text descriptions on the package must be easy for consumers to understand. In the actual operation process, the content containing Chinese is easily identified as substandard, so domestic enterprises should pay attention to it and try to use English as much as possible.
(7) Others
The import tariff on drugs is not high, which is 3% of the CIF price. When you go through customs, you need to show your business license to the customs. Other aspects related to drug import are the same as general commodities except the transportation and packaging mentioned above.
Sales channels and market situation of drugs in Cyprus
The main suppliers of drugs in Cyprus are hospitals, clinics, health centers and private retail pharmacies. Some medical institutions in Cyprus belong to state-owned units, and their medical conditions are inferior to those of private medical institutions, with poor service and few kinds of drugs, but their prices are relatively low. Under the influence of privatization, many such clinics were purchased by private individuals or jointly organized with private individuals. The conditions of private medical institutions in Cyprus are generally better than those of state-owned units, and the medical expenses and medicine expenses are also higher.
Serbia's domestic processing and manufacturing industry has been very weak, so the drugs on the Serbian market mainly rely on the international market. The main sources of drugs are:
(1) International bidding procurement sponsored by the Ministry of Health;
(2) Donations from United Nations agencies such as UNICEF and WHO and the international community;
(three) enterprises or units with the right to import and wholesale.
The first two items are controlled and managed by the Serbian Ministry of Health, and it is estimated that they may account for more than 60% of the current market consumption in Serbia. According to the application of the relevant units, the Ministry of Health mainly distributes the drugs it manages to state-owned medical institutions or other departments free of charge or sells them at low prices. For a long time to come, the above two items controlled by the Ministry of Health will remain the main sources of medicines in Serbia, which means that the monopoly of the Serbian government in the market will be difficult to change for a while.
Because most people are poor, it is difficult for ordinary people to afford medicine. On the other hand, because drugs in Cyprus are heavily dependent on foreign supply, and its economy is quite tight, foreign exchange is in short supply, and government procurement is limited, drugs in the Serbian market are in short supply for a long time. Drug shortage and low purchasing power of consumers will remain the characteristics of the pharmaceutical market in Cyprus for a long time to come.
Drugs in the Serbian market mainly come from India and European countries such as Britain, France and Germany. At present, Indian businessmen are very active in the drug market in Serbia. They engage in both wholesale and retail, and almost monopolize the market except government procurement and wholesale. It is said that Indian businessmen deliver 40-foot containers of medicines to Freetown every month on average.
Opportunities and Challenges for China Drugs to Enter Serbian Market
It should be said that the sales volume of China drugs in Serbia market is not commensurate with my exports to Serbia, so it is urgent to increase the market share of my drugs in Serbia.
China's essential balm and cooling oil are well-known in Sierra Leone, and can be found in retail pharmacies in Sierra Leone, but there is still room for further improvement. Ketaixin is well-known, but compared with the plug market, it is an expensive drug, which is difficult for "ordinary people" to ask for. Other drugs entering the Serbian market include quinine and artemisinin, and the sales volume is not large.
(1) Opportunities for our drugs to enter the Serbian market
1. China and Sierra Leone have long been friendly. From Serbian government to ordinary consumers, there is a certain affinity for China products, so it should be said that China drugs are more popular. This is beneficial for Chinese enterprises and their drugs to be treated fairly when accepting my application or bidding.
2. Some drugs from China entered the Serbian market and were well received. This is conducive to further expanding China's pharmaceutical market in Cyprus.
3. The production cost of drugs in China is still lower than that in Europe, which is undoubtedly a favorable factor.
(2) The challenge of Chinese drugs entering the embolism market.
In addition to the problems mentioned above, there are some unfavorable factors for China drugs to enter the Serbian market:
1. Cyprus has strict drug control, which makes it more difficult to export drugs to Cyprus. Sierra Leone and I have very different legal backgrounds, so it is difficult for China enterprises to operate. Therefore, it is very important for China drugs to enter the plug market. Besides the price and promotion factors, it is also very important to successfully and flexibly pass the plug control measures.
2. China is far away from Sierra Leone, and the transportation time and mileage are long, which increases the cost of exporting drugs to Sierra Leone from the aspects of packaging, transportation and quality assurance.
3. There are great cultural background and language barriers between China and Sierra Leone. The medical and health circles in Sierra Leone have been educated in western pharmacology for a long time. It is still a long time for pharmacists, formulators, doctors and consumers in Sierra Leone, as well as the government of Sierra Leone, which is currently the main buyer, to understand and accept China drugs.
4. China's main competitors are Europe and India, which have occupied most of the current Serbian market, with both traditional and market advantages. This invisibly increases the competitive pressure for China drugs to occupy the plug market.
Four. Suggestions on Developing China's Pharmaceutical Market in Cyprus
As a part of the African pharmaceutical market, Sierra Leone has its due position. China enterprises should seize the opportunity of the current political and economic situation in Cyprus and enter and develop the Serbian market in time. To this end, we suggest:
(1) Determine the marketing strategy of Cyprus. Relevant domestic enterprises, especially those that produce drugs for the prevention and treatment of tropical diseases, should quickly determine their marketing policies for Cyprus, or set up branches with the right to operate in Cyprus, or look for reliable local agents to import our drugs for a long time. Considering the difficulty of qualification examination of domestic employees and the operating cost of the company, I temporarily appointed a local agent to sell drugs in Cyprus, which is generally suitable.
(2) Actively and flexibly explore sales channels. Considering the important role of relevant departments of Serbian government in drug management and drug market in Serbia, our pharmaceutical manufacturers should do more work of government departments when they come to Serbia to inspect the market, so that they can know the drug situation in China and know the information and trends of bidding and purchasing in Serbia in time. This not only grasped the initiative of the plug market to a great extent, but also directly promoted the sales of plug drugs, and also had a very great publicity role.
In the long run, we should expand and consolidate the influence of our drugs in Cyprus by training Cypriot personnel. Considering the decisive position and role of relevant officials and professional medical personnel in the Serbian pharmaceutical market, it is suggested that powerful enterprises should fund relevant officials or local market agents, local pharmacists and pharmacists who promote our products to study Chinese and pharmacology in our company without violating China's foreign affairs regulations.
(D) Flexible management, avoiding control. Conditional pharmaceutical production or circulation enterprises should start to study the feasibility of direct investment in the production of drugs in Serbia. Serbia encourages direct investment, which is conducive to reducing operating costs, occupying the Serbian market for a long time and avoiding Serbia's cumbersome import control.
(5) Enter the Cyprus market together to avoid internal friction. We should try our best to avoid a single enterprise "going it alone" in Cyprus, because the strength of a single enterprise is small, the variety of drugs is monotonous, and the promotion cost is high, especially for a market with small macro capacity like Cyprus. Several enterprises jointly registered a company in Cyprus, supported by many parties, developed together, and increased their variety advantages and strength advantages. Or a more powerful enterprise sells some products in Cyprus, and other related enterprises give product support to avoid duplication of work or internal competition.
Timetable:
At present, some related charges implemented by the Drug Administration are as follows:
Drug application fee: each drug 100 USD.
Drug quality inspection fee: 50 dollars for each drug.
New drug registration fee: $500 for each drug.
New drug registration extension fee: $300 per drug.
Production license fee: each drug needs to pay 450,000 leones (equivalent to more than 200 US dollars).
Export license fee: $500 per drug.
Import license fee: 600,000 leones (equivalent to about US$ 300) are required for each drug.
Wholesale license fee: 200,000 leones (equivalent to about 100 USD) are required for each drug.
Retail license fee: each drug should pay 6.5438+0.5 million leones (equivalent to about $80).
Drugstore license fee: 654.38+ million leones (equivalent to about 50 dollars) should be paid for each drug.
All the above permits are valid for 3 years, after which an extension must be applied.
Commercial Counsellor's Office of the Embassy in Sierra Leone
200 1 10 month