This article briefly describes the procedure, timelines, and list of documents for the registration of medicines (“MMDs”) and medical devices (“MDs”), the grounds for refusal of the state registration service, as well as the administrative-legal liability for the sale of unregistered MMDs and MDs.
Prior to registration, medicines (“MMDs”) undergo expert evaluation. The evaluation applies to MMDs produced in the Republic of Kazakhstan as well as those imported into its territory.
The expert evaluation of MMDs is carried out by the Republican State Enterprise on the Right of Economic Management “National Centre for Expertise of Medicines, Medical Devices and Medical Equipment” of the Committee for Quality and Safety Control of Goods and Services of the Ministry of Healthcare of the Republic of Kazakhstan (hereinafter, “NCELSM”).
To conduct such evaluation, a person must submit the following documents to NCELSM:
The expert evaluation of MMDs is conducted within a period not exceeding two hundred ten calendar days in total, and an accelerated evaluation is conducted within a period not exceeding one hundred twenty calendar days.
After receiving a conclusion on the safety, quality, and efficacy of MMDs as a positive result of the expert evaluation, the person may proceed with the registration of the MMDs.
State registration of MMDs or MDs is also carried out by NCELSM. For the purpose of registration, the applicant must submit an application to NCELSM via the “electronic government” web portal in interaction with the Drug Supply Management System of the Unified Information Health System of the Republic of Kazakhstan (“SULO”).
To register MMDs and MDs, the applicant must submit the following documents to NCELSM:
The deadline for provision of the state service via the portal is five working days.
Upon a positive decision on registration of MMDs or MDs, the portal generates the following electronic documents, signed with the electronic digital signature of the head of the state authority:
After receiving the registration certificate, the person is entitled to sell MMDs and MDs in Kazakhstan.
The grounds for refusal of registration of MMDs and MDs include:
• a negative conclusion from NCELSM due to detection of non-compliance with declared indicators of quality, safety, and efficacy during evaluation, in accordance with procedures established by the authorised health authority;
• establishing the inaccuracy of documents submitted by the person for obtaining the state service or the data therein;
• non-compliance of the person or submitted materials, objects, data, and information necessary for the state service with applicable requirements;
• there is a final and binding court decision (judgment) prohibiting the person’s activities or certain types of activities requiring the state service;
• there is a final and binding court decision depriving the person of a special right related to obtaining the state service.
Upon refusal of state registration of MMDs or MDs in the Republic of Kazakhstan, the portal issues a refusal in the prescribed form.
Sale of unregistered MMDs and MDs by persons violates:
It should be noted that the authority to hear administrative offence cases and impose administrative penalties under Article 426 of the CAO is vested in the territorial departments of the Republican State Enterprise “Committee for Quality and Safety Control of Goods and Services of the Ministry of Healthcare of the Republic of Kazakhstan.”
- Conducting Expert Evaluation of MMDs at NCELSM
Prior to registration, medicines (“MMDs”) undergo expert evaluation. The evaluation applies to MMDs produced in the Republic of Kazakhstan as well as those imported into its territory.
The expert evaluation of MMDs is carried out by the Republican State Enterprise on the Right of Economic Management “National Centre for Expertise of Medicines, Medical Devices and Medical Equipment” of the Committee for Quality and Safety Control of Goods and Services of the Ministry of Healthcare of the Republic of Kazakhstan (hereinafter, “NCELSM”).
To conduct such evaluation, a person must submit the following documents to NCELSM:
- an application in the prescribed form for the expert evaluation of the medicine;
- a registration dossier in electronic form as an interoperable electronic document;
- a list of documents submitted for evaluation by manufacturers in the Republic of Kazakhstan;
- a list of documents submitted in the Common Technical Document format, in the prescribed form;
- information confirming payment by the applicant to the NCELSM’s settlement account of the amount for conducting the evaluation;
- samples of MMDs, standard samples of chemical substances, standard samples of biological preparations, test strains of microorganisms, cell cultures in quantities sufficient for triple laboratory tests with a residual shelf life of no less than twelve months (except where laboratory testing is not required), as well as specific reagents and consumables used in laboratory testing of medicines, which the applicant must provide within five (5) working days from the date of application submission.
The expert evaluation of MMDs is conducted within a period not exceeding two hundred ten calendar days in total, and an accelerated evaluation is conducted within a period not exceeding one hundred twenty calendar days.
After receiving a conclusion on the safety, quality, and efficacy of MMDs as a positive result of the expert evaluation, the person may proceed with the registration of the MMDs.
- State Registration of MMDs and MDs
State registration of MMDs or MDs is also carried out by NCELSM. For the purpose of registration, the applicant must submit an application to NCELSM via the “electronic government” web portal in interaction with the Drug Supply Management System of the Unified Information Health System of the Republic of Kazakhstan (“SULO”).
To register MMDs and MDs, the applicant must submit the following documents to NCELSM:
- an application for state registration of MMDs in the Republic of Kazakhstan in the forms established by the state service standard, as an electronic document certified by the digital signature of the person submitting the application;
- an electronic copy of the payment document confirming payment of the registration fee, except payment through the “electronic government” payment gateway;
- an electronic copy of the NCELSM conclusion; information on state registration of the legal entity, and the certificate of state registration of the applicant as an individual entrepreneur.
The deadline for provision of the state service via the portal is five working days.
- Results of Registration of MMDs and MDs
Upon a positive decision on registration of MMDs or MDs, the portal generates the following electronic documents, signed with the electronic digital signature of the head of the state authority:
- a registration certificate;
- the registered label (package insert) for medical use of the MMDs or MDs and the summary of product characteristics in Kazakh and Russian;
- registered packaging layouts, labels, and stickers for MMDs and MDs in Kazakh and Russian.
After receiving the registration certificate, the person is entitled to sell MMDs and MDs in Kazakhstan.
- Grounds for Refusal of State Registration of MMDs and MDs
The grounds for refusal of registration of MMDs and MDs include:
• a negative conclusion from NCELSM due to detection of non-compliance with declared indicators of quality, safety, and efficacy during evaluation, in accordance with procedures established by the authorised health authority;
• establishing the inaccuracy of documents submitted by the person for obtaining the state service or the data therein;
• non-compliance of the person or submitted materials, objects, data, and information necessary for the state service with applicable requirements;
• there is a final and binding court decision (judgment) prohibiting the person’s activities or certain types of activities requiring the state service;
• there is a final and binding court decision depriving the person of a special right related to obtaining the state service.
Upon refusal of state registration of MMDs or MDs in the Republic of Kazakhstan, the portal issues a refusal in the prescribed form.
- Administrative-Legal Liability for Sale of Unregistered MMDs and MDs
Sale of unregistered MMDs and MDs by persons violates:
- the prohibition on sale of unregistered MMDs established in Articles 67 and 69 of the Code of the Republic of Kazakhstan “On Public Health and the Healthcare System,” which prohibits production and wholesale and retail sale of medicines and medical devices that have not undergone state registration in the Republic of Kazakhstan;
- and entails liability under the sanction of Article 426 of the Code of Administrative Offences of the Republic of Kazakhstan — “Violation of pharmaceutical activity rules and the circulation of medicines and medical devices” for unlawful introduction into civil circulation of unregistered, unapproved MMDs and MDs.
It should be noted that the authority to hear administrative offence cases and impose administrative penalties under Article 426 of the CAO is vested in the territorial departments of the Republican State Enterprise “Committee for Quality and Safety Control of Goods and Services of the Ministry of Healthcare of the Republic of Kazakhstan.”