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State registration, re-registration and amendments in registration dossier of medicine or medical device

Как получить услугу
Online
Individuals

You can obtain a service via the Portal:

  1. Click “Order Online” button, then a new window will open of e-Licensing Portal
  2. Sign in or log in on e-Licensing Portal
  3. Click “Order Service Online” button on e-Licensing Portal page
  4. Fill in the fields of request
  5. Sign a request with digital signature
  6. You can track status of request in “My applications” section of Personal Account, status on obtainment of license in “My licensing documents” section and status on obtainment of notification in “My notifications” section.
Онлайн
Legal entities

You can obtain a service via the Portal:

  1. Click “Order Online” button, then a new window will open of e-Licensing Portal
  2. Sign in or log in on e-Licensing Portal
  3. Click “Order Service Online” button on e-Licensing Portal page
  4. Fill in the fields of request
  5. Sign a request with digital signature
  6. You can track status of request in “My applications” section of Personal Account, status on obtainment of license in “My licensing documents” section and status on obtainment of notification in “My notifications” section.
Результат оказания услуги

Registration certificate valid on the territory of the Republic of Kazakhstan.
Registered instructions (leaflet) for the medical use of a medicinal product or medical device and general characteristics of the medicinal product in the Kazakh and Russian languages.
Registered layouts of packages, labels, stickers for medicines, medical devices in Kazakh and Russian languages.
In case of refusal of state registration, re-registration of a medicinal product or medical device, making changes to the registration dossier of a medicinal product or medical device, a reasoned response about the refusal to provide a state service.

Часто задаваемые вопросы
Grounds for refusal to provide the public service established by the laws of the Republic of Kazakhstan
  1. Establishing the unreliability of the documents submitted by the service recipient for the receipt of the public service, and (or) the data (information) contained therein.
  2. Non-compliance of the service recipient and (or) the submitted materials, objects, data and information necessary for the provision of public services, in accordance with paragraph 3 of Article 23 of the Code of the Republic of Kazakhstan dated July 7, 2020 "On the health of the people and the healthcare system".
  3. In relation to the service recipient, there is a court decision (verdict) that has entered into legal force on the prohibition of activities or certain types of activities requiring the receipt of a certain public service.
  4. With regard to the service recipient, there is a court decision that has entered into force, on the basis of which the service recipient is deprived of a special right related to the receipt of a public service.
Grounds for institution of an administrative procedure
  • appeal;
  • initiative of an administrative body or official.

 General requirements for the appeal

The appeal submitted in hard copy or electronic form shall indicate:

  • Full name, IIN, postal address of a natural person, BIN of a legal entity;
  • name of administrative body, official to whom the appeal is submitted;
  • the essence of an appeal;
  • date of filing an appeal;
  • signature of the applicant or his representative;
  • other information provided for by legislation of the Republic of Kazakhstan.

If the administrative procedure is on a paid basis, the applicant must submit a document confirming the payment.

! It is barred to reject the receipt of an appeal.

  1. Once the appeal is submitted, the applicant is issued a receipt containing a unique number, indicating the date and time, last name and initials, and the position of the person who received the appeal.
  2. In the case of non-compliance with the requirements established by Article 63 Code, the administrative body and the official shall indicate to the applicant the requirements the appeal does not comply with, and set a reasonable time limit for bringing it into compliance with the requirements.
  3. Before a decision is made on the administrative case, the applicant may withdraw the appeal on the basis of his written application.

Referring the appeal to an authorized administrative body and official

An appeal received by an administrative body and official whose authority does not include the consideration of this appeal, within no later than 3 working days from the date of its receipt shall refer it to the authorized administrative body and official, with simultaneous notification of the participant in the administrative procedure.

  1. The timeframe of administrative procedure is 15 working days from the date of receipt of an appeal.

! The laws may set the other timeframe for consideration of appeals (For example, according to the Law “On Access to Information” a reply to a written enquiry is provided within fifteen calendar days from the date of receipt of the information by the owner).

  1. The period of administrative procedure may be extended by a reasoned decision of the head of the administrative body for not more than 2 months, consistently the participant in the administrative procedure is notified within 3 working days from the date of extension.

A participant in the administrative procedure has the right to file a complaint the administrative action (inaction) related to the adoption of an administrative act.

If an administrative body and official within the timeframe has not adopted an administrative act or committed an administrative action, then commencing from the date of expiry it is considered that the administrative body and official rejected to adopt the administrative act or commit the administrative action.

The complaint is submitted to the administrative body and official whose administrative act and administrative action (inaction) is being appealed.

An appeal to the court is allowed after a pre-trial appeal. If the law provides for the possibility of going to court without the need to appeal to a higher authority, the administrative act, administrative action (inaction) of the administrative body and official is being disputed, along with the revoke, submit to the court a reasoned position of the head of the higher administrative body and official.

! The Administrative Procedure Code not always rules the procedure of complaint; the industry laws may contain statutes indicating the appeal of the decision in the court, without pre-trial appeal.

  1. A complaint against an administrative act, administrative action (inaction) is submitted to the administrative body and official no later than 3 months from the day when the participant in the administrative procedure became aware of the adoption of the administrative act or the commitment of an administrative action (inaction).
  2. If the deadline is missed for a good reason, at the request of the participant in the administrative procedure, it may be renewed by the body considering the complaint.
  3. Missing the deadline for submitting the complaint is not a basis for rejection to receive the complaint by the body considering the complaint.

! Other laws may establish a special procedure and deadlines for appealing the decisions.

The period for consideration of the complaint is 5 working days from the date of receipt of the complaint.

! Other laws may establish a different period for appealing the decisions of administrative bodies.

 

 

Source: Administrative Procedural Code of Republic of Kazakhstan,
The Law of the RK "On Public services"

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Полное название
State registration, re-registration and amendments in registration dossier of medicine or medical device
Получатели услуги
Individuals
Legal entities
Стоимость услуги

11 МCI valid on the day of payment of the state registration fee

5 МCI, effective on the day of payment of the fee for state re-registration

Срок оказания услуги

5 working days

Услугу оказывает
Ministry of Healthcare of the Republic of Kazakhstan
Место предоставления услуги
Portal of electronic licensing
Portal of "electronic government"

Rules for providing state service

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