Dear reader, today, we have decided to make all clear regarding the Medical and Pharmaceutical Business in Georgia. Hereby, we will depict what the person interested in the medical business must know. Moreover, I will list the frame How to start a medical supply company in Georgia. So, Investors who would like to set up a company in Georgia may take this note that today. Besides, Georgia has about 260 medical centers, hospitals, and clinics with 12 000 beds
It is not tough to guess that without a license it is not permitted to conduct your business activities in the medical field. It won’t be a surprise either that the Ministry of Health of Georgia issues the license. Besides, See wider about opening Medical and Pharmaceutical Business in Georgia in a blog.
Who Can Get Permission to Open Medical and Pharmaceutical Business in Georgia?
First of all, If you want to open a Medical and Pharmaceutical Business in Georgia, you should know as follows. Any legal entity, regardless of its range subordination, organizational-legal and ownership form., may obtain a medical activity permitted on the territory of Georgia if all the required documentation submit and if it meets
#the following requirements to open Medical and Pharmaceutical Business in Georgia:
- firstly, must be the subject of medical activity in the determined form by Ministry of Health of Georgia (medical cabinet,ambulatory, hospital, laboratory etc.)
- secondly, for operating medical activities must have relevant qualified specialists
- thirdly, should equip with all the necessary and licensed medical equipment
- fourthly, specialists must have relevant hygienic certificates
- lastly, the medical facility must, if necessary, have the appropriate permit.- from the state inspectorate for the control of legal turnover of narcotic and psychotropic substances
In conclusion, If your requirement about getting a medical license approves, they will let you know within 30 days. And, you can Open Medical Business In Georgia.
Checklist to consider before setting up Georgian Company
I would like to list some kind of operating and permitted medical activities within Georgia. before setting up Georgian company As you can guess, it will be a long list and to keep your attention. I will only be listing important things. they are:
- first, Pre-medical care
- second, Nursing care
- third, Primary medical care
- fourth, Emergency medical care
- fifth, Medical diagnosis
- sixth, Outpatient medical care for the population
- seventh, Outpatient care for the child population
- eighth, Inpatient medical care for the population
- ninth, Inpatient medical care for the child population
- tenth, tExport medical activities
- eleventh, Traditional medical activities
- twelfth, Sanatorium treatment
- thirteenth, Medical psychology
- fourteenth, Pharmaceutical activities of the institution
- fifteenth, Medical research activities
- sixteenth, Sanitary education
Prices to register medical business in Georgia
Importantly, Ministry of Labor, Health and Social Affairs of the services carried out by the following registers. here also you can find Prices to register medical business in Georgia :
- a pharmaceutical product for the recognition regime to register his first import. (except by the person concerned regardless of the purpose of importation of pharmaceutical products are proactive registration. and already registered pharmaceutical product packaging and labeling through private access) – 500 GEL;
- State registration of an innovative (new original) pharmaceutical product under the national regime – 2,500 GEL.
- Registration of generic and reproduced pharmaceutical products., blood preparations under the national state registration regime – 500 GEL
#other fees for Medical and Pharmaceutical Business in Georgia…
- registration of diagnostic means: test systems (according to nosologies), allergens, reagents .(for clinical biochemistry and clinical chemistry.) and serum kits under the national state registration regime – GEL 400. registration of each position included in them by the national state registration regime – additional 10 GEL.
- Registration of dental material under the national state registration regime – 500 GEL;
- Registration of medical subjects in the national state registration regime- 1,000 GEL;
- voluntary registration of complementary medicines under the national state registration regime – 400 GEL;
- voluntary registration of paramedical remedies under the national state registration regime – 500 GEL.
Benefits to Open Medical and Pharmaceutical Business in Georgia
Because of the attractive investment climate in Georgia, conditioned by the businessmen-centered policy in the region. Georgia manages to focus on a different kind of business development. For instance, One of the examples to start a business in Georgia is the intention of the world’s among the -.50 largest corporations of this field “Ferring Pharmaceuticals”.
Furthermore, As the “Caucasus Business Week” reports the company shows quite an interest to open Medical and Pharmaceutical businesses in Georgia. It is positive about the economic situation in Georgia and the attractive investment venue., and ready to carry out the investment.
As for Open Pharmaceutical Business in Georgia
What to consider to place pharmaceutical product on the Georgian market
Pay attention to the following guidelines:
1. In the beginning Admission of a pharmaceutical product to the Georgian market carries out in the following modes:
Recognition regime of state registration of a pharmaceutical product;
National regime of state registration of a pharmaceutical product.
2. Then, The basis for the application of the state registration regime for a pharmaceutical product. it is the differentiation of the state body regulating pharmaceutical products of another country. or interstate into differentiating ones by credibility., access to only high quality pharmaceutical products in its own markets.
3. After that, Georgia shall unilaterally recognize the requirements of safety., efficacy and quality for access to markets under its control.- by a State regulatory body for a pharmaceutical product of another country. or interstate, and shall not comply with the same or similar requirements for the safety., quality and therapeutic efficacy of the pharmaceutical product.
Terms for placing a pharmaceutical product on the Georgian market
As the code of Georgia “On medicine and pharmaceutical activities” imply, it is better to note two things:
1. The term of admission of a pharmaceutical product to the Georgian market shall be determin ed. in accordance with the recognition and national regimes of state registration* of a pharmaceutical product .
2. After the expiration of the period of admission to the Georgian market, allowed the circulation of a pharmaceutical product.(except for import.) before the expiration date of the pharmaceutical product already in circulation on the territory of Georgia.
*The state registration recognition regime for a pharmaceutical product applies to a pharmaceutical product that is authorized by another state or an interstate state regulatory body for pharmaceutical products in the relevant market
*little bit later will find out about National regime of state registration of pharmaceutical product
1. Different packaging of a pharmaceutical product already allowed on the Georgian market.- first import with labeling does not require re-registration.Moreover, Such a pharmaceutical product shall allowed on the Georgian market on the basis of the notification. surely, provided by the following criteria.
2. The notification shall contain the following information:
- Authorized translation of the instruction into Georgian and the original instruction in accordance with the rules. definitely, established by the Ministry.
- packaging of a pharmaceutical product – a marking sample in the form of an electronic version.
- A certificate issued by a person authorized to sell a pharmaceutical product in the respective country., which confirms the admission of the pharmaceutical product to the market under its control.- by the state body regulating pharmaceutical products of another country or interstate. The certificate must be accompanied by the identification information of the person authorized to sell;
- Unique (authorization) number of access to the relevant market of the pharmaceutical product.
3. After receiving notification:
- In addition,The agency is obliged to check the information provided by the interested person
- not receiving feedback automatically means the consent of the agency.
National regime of state registration of pharmaceutical product
1. State registration of a pharmaceutical product in order to Open Pharmaceutical Business in Georgia., under the national regime carries out as follows:
- A person interested in the national registration regime may be a manufacturer of a pharmaceutical product. or a holder of a trade license. In other words, The interested person shall submit the application and the attached documents to the Agency.
- Registration documents consist of administrative and scientific-technical parts; The agency carries out their administrative and scientific-technical expertise;
- The administrative part of the registration documents must submit in material form in Georgian .(along with the material form, a Georgian translation of the instruction must be submitted in electronic form., in Word format, on a compact disc., as well as a sample packaging and marking of the pharmaceutical product)., and the scientific-technical part in Georgian. In Russian or English, in three identical copies .(the identity of the person concerned is responsible for the identity of the copies.), in the form of an electronic version on a CD containing the trade name of the pharmaceutical product., manufacturer, trade license holder (if any), drug form and dosage of the pharmaceutical product Quantity., pharmaceutical product registration regime., date of submission of registration documents to the Agency., for the administrative part and the scientific-technical part;
- Within 20-40 calendar days, the Agency makes a decision on registration or refusal of a pharmaceutical product, which is formalized by an administrative act.
The Agency cancels the registration of a pharmaceutical product in Georgia:
- at the request of the interested person;
- if a medicinal product has been found be harmful to humans or their offspring.
2. The circulation of a pharmaceutical product on the territory of Georgia allows for 5 years after its registration. Further, and after the expiration of the registration period – before the expiration date of the pharmaceutical product., as well as the different packaging-marking product added for the pharmaceutical product.
The administrative part of the registration documents must include:
- At first, Application with search of attached documents (with reference to pages)
- to clarify, should submit original application for registration of a pharmaceutical product under the national regime of state registration of a pharmaceutical product in Georgia
- Original of the document certifying the granting of representative authority to the natural or legal person by the interested person;
- Pharmaceutical product certificate in the form recommended by the World Health Organization (original), and in its absence – a document certifying the production of a pharmaceutical product according to the GMP (Good Manufacturing Practice) consequently, standard or a pharmaceutical product production license issued by the competent authority of the country of manufacture. Subsequently, In case of dental material, invasive mechanical contraceptive device, diagnostic device. – allowed to present the ISO certificate of the product manufacturer or the EC certificate or the free sale certificate;
- next, Standard packaging of the registered pharmaceutical product with standard marking (or in electronic form);
- Besides, In case of registration of a pharmaceutical product made in Georgia – instruction in Georgian language, and in case of registration of imported pharmaceutical product – instruction (for information on medical and pharmaceutical staff, as well as user information accompanying the pharmaceutical product – in case of differentiated versions of the instruction). And, the original instruction in accordance with the rules established by the Ministry;
- Document confirming the payment of the registration fee. (as it’s mentioned above it consists of = 1000 gel)
Exceptional cases of bypassing the access regimes of the pharmaceutical product to the Georgian market
A pharmaceutical product may be issue of import to the Georgian market., for non-commercial purposes by bypassing access regimes, in the following cases:
- for pre-clinical and clinical trials;
- for registration – in the form of a sample;
- for the individual needs of a natural person;
- for exhibition, symposium, conference, forum and congress – as a sample, without the right of sale;
- for re-export;
- for the purpose of storing goods in a customs warehouse / customs terminal and / or placing them in transit goods;
- as a non-packaged pharmaceutical product intended for local production;
- under special conditions (natural disaster, massive population damage, epidemic, rare disease.) for humanitarian purposes., as well as in the presence of other special state interests, with the consent of the Ministry.
Manufacturing of pharmaceutical product | Pharmaceutical Business in Georgia
All abovementioned was about importing and marking/registering some .kinds of pharmaceutical products on the Georgian market. here are ways How to start a medical supply company. Now let’t talk about Open Medical and Pharmaceutical Business in Georgia. Meanwhile, manufacturing within the country
How to star a medical shop?! Take the following criteria into account:
1. Firstly, The production of a pharmaceutical product is subject to a permit regime.
2. Secondly, Production of a pharmaceutical product not registered in Georgia is allowed for its registration., pre-clinical and clinical trials, export.
3. Thirdly, A permit for the production of a pharmaceutical product shall be issued by the Agency.
4. Fourthly, Georgia selectively recognizes the list of international, regional and national GMP (.Good Manufacturing Practice). standards recognized by the Government of Georgia.
5. next, The permit conditions for the production of a pharmaceutical product., determined by the legislation of Georgia.
#Keep your attention…
6. after that, For the purposes of this Law, a pharmaceutical product is not considered to be manufactured. and a production permit is not required for an authorized pharmacy that prepares the pharmaceutical product. – according to the master or official formula., as well as the pharmacy of the medical institution that packages the pharmaceutical product in the medical facility.
7. next, The manufacturer of a pharmaceutical product series is responsible for the safety, quality and effectiveness of the manufactured pharmaceutical product.
8. at last, The Government of Georgia will gradually ensure the introduction of the National GMP (.Good Manufacturing Practice) standard on the principle of risk management
Wholesale and retail sale of pharmaceutical product | Medical and Pharmaceutical Business in Georgia
1. at first, Retail sale of a pharmaceutical product is carried out by an authorized pharmacy, pharmacy, retail outlet and in cases established by the legislation of Georgia.- personnel with pharmaceutical education or a natural person subject to independent medical activity.
2. second, An authorized pharmacy is subject to permit control
3. after that, Most importantly, The sale of pharmaceutical products belonging to the second. and third groups is allowed in the pharmacy., and the sale of pharmaceutical products belonging to the third group is allowed only in the retail outlet. In addition, it is possible to have a separate, isolated pharmacy with a separate entrance., as well as a pharmacy. located in a retail outlet as an isolated area.
4. next, In order to improve the access of the population to the pharmaceutical product., the personnel with pharmaceutical education. or the subject of independent medical activity have the right to carry out the retail sale of the pharmaceutical product .(except for the pharmaceutical product under special control) in rural and small settlements.
#Other things to take into account about opening Medical and Pharmaceutical Business in Georgia
5. moreover, Commencement and completion of wholesale and retail sale of a pharmaceutical product., shall be subject to mandatory notification to the Agency.; The form and procedure of the notification shall be approved by the Minister.
6. further, Permission is not required to use a pharmaceutical product., that is part of a medical service subject to special control by a medical service provider.
7. after that, The permit conditions of the authorized pharmacy for the sale of a pharmaceutical product., subject to special control and the procedure for issuing this product shall be determined by the legislation of Georgia.
8. It is prohibited to sell a pharmaceutical product on the market and the market., as well as from an open type trade object and a non-stationary trade place.
9. next, It is prohibited to sell pharmaceutical products belonging to the first and second groups to minors.
10. Finally, It is prohibited to sell the following pharmaceutical products without a prescription:
- a pharmaceutical product belonging to the first group;
- a pharmaceutical product belonging to the second group.
Pharmaceutical products for advertising and retail sale are divided into three groups:
- The first group includes a pharmaceutical product under special control, as well as a medicinal product equal to it in terms of legal turnover regime.
- The second group includes a pharmaceutical product, the improper use of which may cause significant damage to human health and life and./or which can not be taken only in accordance with the instructions, without a doctor’s prescription.
- The third group includes a pharmaceutical product which, according to the instructions., can be taken without a doctor’s prescription and which is issued without a prescription.Therefore, The pharmaceutical product belonging to the third group is defined on the basis of international practice. above all, all other pharmaceutical products that are allowed on the Georgian market automatically belong to the second group.
Special controlled substances, remedies and their dosage forms
1. In the field of health care of the population and in accordance with the state policy of ensuring public order., narcotic and their containing drugs, poisons and poison-containing agents, certain psychotropic and potent substances are subject to special state control.
2. The list of substances under special control and the forms of their medicinal products., comply with the requirements of international conventions in this field.
3. Above all, The Ministry shall, if necessary., supplement the existing lists taking into account the local drug situation and the practice of the judicial-investigative bodies.
Illegal pharmaceutical activities in Georgia
1. Activities without pharmaceutical production, export or import of specially controlled pharmaceutical product., authorized pharmacy, clinical trial of pharmacological means – Will result in a fine of GEL 8,000.
2. The same action, committed repeatedly, -Will result in a fine of 16,000 GEL.
As a result, There are also another regulations and fines that somebody will carry out activities illegally., we do not list all of them here because we do not support contributing illegal activities :))
As for about market entry and barriers, besides so many things that one may will need to start medical business in Georgia, you can revise the guideline by clicking here.