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Welcome to the official website of AEM Services!

 

We offer Drug registration services (Marketing authorization) and assistance in monitoring for an all steps of registration process in the Republic of Kazakhstan.

Provided Services:
Marketing authorization for drugs

Marketing authorization for Medical devices service

Registration of Complementary and Homeopathic products

Registration of General Sale products

Our company has been working in this service for 10 years. We have registered  hundreds products.


Registration of medicines

The registration of medicines in Kazakhstan is the obligatory condition to enter the market in the Republic of Kazakhstan. It is required to obtain marketing authorization for new medicines. If you do this procedure yourself, it will take a lot of time and effort. We offer to entrust this to the specialists of our company. We offer professional services of registration of medical products in the Republic of Kazakhstan at beneficial price, as we have an individual approach to each project.

What drugs are subject to registration?

State registration of medical products is an unavoidable procedure when introducing new medical products to the market of the Republic of Kazakhstan. Medicinal products produced in the republic, as well as imported into the country are subject to registration.

Medical products registered in the country of origin and (or) in the country of Marketing Authorization Holder, and (or) in the country that holds the registration certificate (with the exception of medical products intended for prevention and treatment of socially significant and orphan diseases, that are not registered (if justified) in manufacturing country and (or) in the country of MAH, and (or) the country that holds registration certificate) are subject to examination procedure for state medicine registration in Kazakhstan). 

Registration of medical products  (Drug registration) in the Republic of Kazakhstan is required for:

Original medicines

Generics

Orphan drugs

Biosimilars

Autogenerics

Ammunobiological preparations (UPS)

Herbal medicines

Homeopathic preparations

Medical bulk products

Immunobiological bulk products

Radiopharmaceuticals

Natural crude drugs (non-pharmacopoeial)

Drug of biological origin.

 

What medicines do not need registration?

There are a number of medicines that are not subject to state registration in the Republic of Kazakhstan. Drugs that are manufactured by pharmacies, including veterinary pharmacies, as well as individual entrepreneurs holding pharmaceutical license, are not subject to state registration. This also applies to the following categories:

  • Medicines bought by the citizens outside the republic for personal use.
  • First-aid means vitally important for first aid provision to certain person.
  • Drugs that are imported into the country for pharmacological studies and testing.
  • Specific pharmaceutical substances, as well as radiopharmaceutical agents.
  • Medical preparations that are manufactured in the Republic of Kazakhstan for exportation to other countries.

Medicines registration in Republic of Kazakhstan having different composition and pharmacological effects but with the same trade name is prohibited. This prohibition also applies to registration of a single drug from a particular manufacturer as two or more medicines with different trade names.

 

What is the procedure of medicines registration?

The registration of medicines and medical devices in Kazakhstan is a complex and long process. The first stage is collection, verification and submission of documentation to the registering authority. In addition to the application for state registration, the package of documents includes certificates, medicine review, and numerous reports on its characteristics. A complete list of required documents will be provided during consultation.

The samples of medicine required for examination are provided to registration authority together with accompanying documentation. The mandatory stage of registration procedure in Kazakhstan is the examination of the drug. The examination includes four stages:

  1. Primary examination of the drug.
  2. Analytical testing.
  3. Specialized examination (pharmaceutical and pharmacological studies)
  4. Administrative part: drawing up of documents.

After above-stated examinations, the comittee issues the conclusion on quality, efficacy and safety of medicine. Each next stage is followed only after a successful execution of the previous one. This eliminates the risk of registering a poor-quality product that may cause harm to human body, or on the contrary, has no pharmacological effect.

If the Medicines marketing authorization in Republic of Kazakhstan is successful, the applicant is provided with documents confirming the safety and identity of medicine. The applicant recieves the conclusion of safety and effeciency of medicine. The registered name of medicine is entered in State Register of medical products. After that, it may be entered to the market in the Republic of Kazakhstan.

After registration the information about this medicine is entered into a single database. It contains the name of product, dosage, pharmaceutical form, composition, information about the nature of the container. Other information includes composition, properties, information whether it is addictive or is a vital drug. Also the data on manufacturer is entered to the database.

 

Reasons for refusal of registration

The registration authority refuses to register a medicine for valid reasons only. Frequent obstacle is the lack of positive therapeutic effect on human body. Nevertheless, in presence of such positive therapeutic effect, the registration will be denied due to side effects and risks. Another reason is a failure to comply with the basic rules when submitting an application, documents and samples of the medicine. To avoid this, please contact our company.

 

Entrust the work to professionals

AEM Services offers outsourcing Medical product registration in Republic of Kazakhstan of medicines in Kazakhstan. The only thing for the client is to provide the documents and samples of medicines, the rest will be done by specialists. The reasons to seek our services:

  • Guarantee of successful result for high-quality medicines (in case of doubts about the success of the procedure, our specialists will inform you about the risks)
  • Minimum time required - we carry out the procedure in a possible short time.
  • Reasonable prices - you will not have to pay a lot for registration of medicines.
  • A wide range of design services for pharmaceutical market.
  • The principle of "turnkey registration".

Assign state registration of medicines and medical devices in the Republic of Kazakhstan to professionals. This is the best way to avoid abandoning the registration authorities and get the desired result as soon as possible.