During the work, our company takes on the entire process, starting from the initial contact with the manufacturer (responsible person) and ending with obtaining a registration certificate. Our main advantages: speed, professionalism, flexibility, attention to detail. The main priority is the needs and wishes of the Client. You tell us what you want to import into the country and sell on the medical market, we take care of the rest!
Cost and prices for services for registration of medicines in the Republic of Kazakhstan, the Russian Federation and the Republic of Belarus – the EAEU countries
If you need to register medicines according to the EAEU rules, we recommend that you contact professionals, as you may encounter a number of problems. Our company’s specialists have experience in successfully registering medicines in Kazakhstan and in the EAEU countries. Our team has already registered more than 310 medicines/medical products in six countries. We are ready to provide a free consultation on registering medicines in Kazakhstan and the EAEU countries, including registering medicines according to the EAEU Rules.
The main problems of independent registration of medicines in the EAEU include:
- The opportunity to encounter a large amount of information
- The procedure for registering medicines in the EAEU may take several years or more
- Lack of communication knowledge in the country
- Possibility of encountering difficulties during paperwork
The advantages of examination and registration of medicines according to the rules and within the framework of the EAEU with the help of Blitz Medica specialists:
- The organization will take care of all issues related to the preparation of documentation.
- Saving time. At the same time, Blitz Medica specialists will try to register the medicine in the EAEU and the Republic of Kazakhstan in the shortest possible time.
- Qualified specialists understand different areas of activity. They are able to cope with a task of any complexity
- Professionals select an individual approach to each project
- The company guarantees confidentiality
Our company offers the service of registration of medicines within the EAEU at an affordable price. At the same time, we guarantee constant support and feedback, as well as meet all deadlines and control the process of work. Our company has a positive reputation, confirmed by numerous reviews from our partners, you can read the reviews here.
According to the rules in force in the Republic of Kazakhstan, the following goods are subject to mandatory recording and inspection:
- hybrid medicine
- reproduced medicine
- well-studied medicine
- original medicine
- combination medicine, etc.
- The sale of unregistered medicines is prohibited on the territory of the Republic of Kazakhstan
When a medicine is registered, the following information is included in the state registry:
- Registration number
- Order number
- Registration type
- Registration deadline
- The date on which the expiration date will occur
- Storage period and conditions
- Name of the medicine
- Brand and country where the product is manufactured
- Type of medication
- Composition and dosage
- Manufacturer and marketing authorization holder
Thanks to this information, in the section «State Register — Search for Medicines» you can find information about whether a particular medicine is registered. This list is updated daily.
The information contained in the state register allows health workers, pharmacists and consumers to navigate the medicines. Thus, some medicines will not be dispensed without a prescription.
Registration of medicines is necessary in order to provide the population of Kazakhstan with high-quality, effective and safe medicines, which in turn will lead to an improvement in the general health of the population. During the registration procedure of a medicine, the product is checked for the content of various impurities and additives that can harm human health. That is why preclinical and clinical trials are carried out during the registration of medicines in Kazakhstan.
- There is no need to register medicines in the EAEU if the drug was manufactured according to pharmacy prescriptions.
Registration of medicines in the Republic of Kazakhstan is carried out in several stages:
In the reference state:
| 1 | Collection of dossiers according to the list — deadlines depend on the provision of documents | 140 calendar days |
| 2 | Primary examination | 14 working days |
| 3 | Specialized examination | 90 calendar days |
| 4 | Laboratory quality assessment | 14 calendar days |
| 5 | Formation of the final expert report | 30 calendar days |
| 6 | Issue of a registration certificate | 30 calendar days |
In the state of recognition:
| 1 | Primary examination | 14 working days |
| 2 | Issue of a registration certificate after receipt of a draft final expert assessment report from the reference state | 10 working days |
