The licensed types of business activity in the Republic of Kazakhstan include the manufacture, wholesale, and retail sale of medicines; and the manufacture, storage in stock and sale of alcohol-containing products. Employees of Alatheya Law Firm specialize in providing assistance with these issues.
Pharmaceutical industry
To obtain a newly issued license, the following documents shall be required:
- statement consisting of two forms
- a copy of the registration certificate of the legal entity, or a copy of the identity card and a certificate of Individual Entrepreneur for an individual
- confirmation of license fee payment
- information on qualification requirements fulfillment
- plan of the reception and forwarding premises for distribution of manufactured medicines
Re-registration
If the licensee reissues the license, it shall justify its actions with a full set of documents. In particular, this is required when changing the name of the company, changing the address or other details. The justified reasons shall also include the accession, separation or transformation of a legal entity.
The following shall be required of the applicant:
- file the application (2 official forms)
- provide documentary information on the changes based on which the service is ordered, except for the information in official information systems
- pay a fee
Potential difficulties and professional assistance
With apparent simplicity, obtaining a license for pharmaceutical activities presents serious difficulties for the unprepared persons. The greatest percentage of failures during self-application is the inconsistency with the standards used in the work of buildings, equipment, inventory, instruments, and equipment. In practice, only qualified specialists can immediately and successfully lead customers through legislative difficulties.
There are also requirements for the warehouse and storage conditions for medicines. Warehouses are checked for specific conditions of medicine storage: refrigerators closed cabinets, and safes for potent and drug substances. When buying or renting the special equipment, attention should be paid to all profile features related to pharmacology.
Also, the pharmaceutical license is issued only to organizations staffed with employees having the profile education and practical experience in the field. Information about employees is documented. The lawyers will help to collect all the required documentation and arrange it in the right order.
Period for rendering the services and payment of fees
- Initial application – fifteen working days, 10 MCI
- Re-registration – ten working days, 1 MCI
Payment for the state collected fees is made in cash or by bank transfer, whichever is more convenient for the customer.
Only after the license is obtained, will the pharmacy activity actually commence. At any time from the time of application, the applicant must be prepared for inspections by regulatory bodies.
Types of registration
Due to the efforts of the management of the Republic of Kazakhstan, the pharmaceutical license is now issued in digital or paper form, at the choice of the applicant. With remote registration, the future licensee certifies the submitted files with the electronic digital signature (EDS). Certification of papers is made as usual using the signature of the chief officer and the stamp of the company. Customer service specialists help you choose the most comfortable and economical option. Currently, the majority of applicants prefer virtual registration due to lower costs and delivery time for media.
Alcohol-containing products
In Kazakhstan, wholesale and retail trade in alcohol-containing beverages is licensed. If you need a license to sell alcoholic beverages at retail (except for beer), you are required to submit:
- application
- confirmation of payment of license fee
- copy of the certificate of registration of a limited liability partnership or a certificate of an Individual Entrepreneur
- copy of the purchase and sale contract or lease (availability of a separate room)
- copy of the technical passport for a separate room
- completed form of information for qualification requirements
Warehouse or commercial premises may be owned or officially leased from the legitimate owners.
The building must have such premises:
- for acceptance of goods
- for storage and preparation for marketing
- salesroom with shop windows, shelves and other equipment
Working conditions must comply with the standards, regulations, and rules, so as to prevent loss of product quality. This relates to the temperature, placement of other products nearby, sanitary, and hygienic norms. Availability and serviceability of devices controlling the temperature and humidity conditions shall be confirmed by a certificate, invoice, and inspection materials. The shop shall be obliged to have electricity, water, and sewage supply.
The applicant must confirm compliance with the qualification requirements during the working decade from the date of submission of the request. The license for the retail sale of alcohol is issued only when the requirements are fully observed. Subsequently, the licensed point shall successfully pass any verification that is inevitably carried out by the controlling services.
Legal assistance
During the consultation, Alatheya Law Firm lawyers will explain whether it is necessary to show the originals of documents, and how to make and certify copies. As for time, obtaining a license for alcohol sales in the Republic of Kazakhstan takes a maximum of 15 days (working). In most cases - 1-2 calendar weeks. According to government sources, the period should be reduced by the end of 2018.
The lawyers’ duties shall include:
- checking the documentation provided
- inventory preparation
- filling in applications with the customer’s details
- control of submitting the mandatory payments
Our lawyers will follow the correctness of the implementation of actions established by law. Specialists in alcohol licensing achieve successful results on the first attempt in almost 100% of customer requests. If some details make it difficult to get a license for alcohol sales, the lawyers will notify the customer in advance and assist in eliminating the shortcomings. The customer will comply with the procedures quickly, conveniently and confidently with the help of our professionals. The costs and means shall be minimal.
How to obtain a duplicate?
If the alcohol license has already been issued, the recipient is entitled to be given a second copy. A new inspection is not required by requesting a duplicate. It is only necessary to write an application in any form and pay a 100% fee, the same as issuing the first copy.
How to re-register?
Re-registration is a separate legal procedure. In this case, the former licensee alienates the rights to sell the alcohol-containing products in favor of another person, or the same subject remains, but the details change. Alienation occurs together with the trading object. Different options for property relations are possible depending on whether the former seller owns or rents the premises.
During re-registration, the transferring licensee writes a special letter expressing consent. The letter also provides justification for changes in possession of the sales point and the transferring licensee pays a fee equal to 10% of the license fee.
Amounts of state fees
The amount paid to the budget for acquisition of the right to sell the alcohol-containing drinks at retail depends on the status of the place where the activity occurs:
- in the capital, cities of state and regional importance – 100 MCI
- in towns and settlements of district significance – 70 MCI
- in rural administrative units – 30 MCI
The paid amount covers the first 12 months of commercial activity. Further payments in favor of the state are similar amounts charged annually.
A wholesale license for the sale of alcohol and its storage costs in 200 MCI, regardless of the location of the property involved in the business. The requirements for the shops, in this case, are replaced by the corresponding claims for the warehouses where the ready products are stored.