State registration of medicines

in Kyrgyzstan

Select country for information

State registration of medicines

Service available for:

  • Russia
  • Kazakhstan
  • Kyrgyzstan
  • Uzbekistan

The purpose of the state registration procedure is to protect the country’s inner market from poor-quality medicines

During the registration process in the Kyrgyz Republic, medicines are examined for compliance with the claimed characteristics and undergo preclinical and clinical trials as well as pharmaceutical expert examination for identification of all types of risks. The procedure is implemented to exclude the possibility of unexpected side effects and other effects before using a new medicine. Moreover, registered medicines are guaranteed to be efficient and safe

Items subject to registration

All medicines except those manufactured according to pharmacy prescriptions, radiopharmaceuticals, and medicines that are purchased abroad or manufactured in the territory of the Kyrgyz Republic for non-commercial purposes are subject to state registration

  • New medicines and new combinations of medicines registered before

  • Medicines that were registered previously but manufactured in other dosage forms

  • Reproduced medicines

  • Homeopathic medicines

  • Food supplements

  • Medical immunobiological medicines

  • Medicinal cosmetics

  • Medicines for veterinary use

Medicines manufactured in pharmacies according to prescriptions of doctors and medicines imported into the Kyrgyz Republic through humanitarian aid are not subject to registration

Registration of medicines with various medicinal substances under the same trade name and registration of medicines from the same manufacturer having the same composition of medicinal substances under different trade names is not allowed

What problems may arise if you decide to do the registration yourself?

You will have a lot of work, the nuances of which are unknown to you: 

The procedure may take a long time

You may not know the details of the regulatory environment

You may not know the nuances of communication in regulatory bodies or in the country

The benefits of registration with the MedExpert company:

We will undertake all the routine work.

You save time and therefore money

We have a team of professionals in different areas of regulatory affairs

We select individual solutions for each project

We guarantee confidentiality

We guarantee that we provide a complete and highly qualified assistance and that we meet the timing and control requirements of the process

List of services

Consulting

Introducing changes to the registration certificate

Introducing changes to the registration dossier

Preparation and collection of the registration dossier

Development and analysis of normative documentation

Interactions with registration bodies

Registration stages

According to the current rules in the Kyrgyz Republic, the registration of medicines includes the following stages:

  1. Collection of the dossier
    and receipt of the samples

  2. Signing a contract with
    the state body

  3. Primary expert examination,
    which assesses the completeness, contents, and accuracy of the paperwork submitted by the applicant in the registration dossier

  4. Specialized expert examination,
    which is implemented by studying the documents of the registration dossier for safety, efficacy, and quality of medicines

  5. Analytical expert examination,
    including the testing of medicine samples and determination of the reproducibility of analytical procedures

  6. Inspection of
    medicine manufacturing

  7. Safety Statement,
    which generates a summary report on the safety, efficacy, and quality of the medicine

  8. Assigning a registration number
    and issuing a registration certificate for the medicine

The final cost and terms will be calculated at your request

By pressing the “Send” button, you confirm that you give the company your consent for processing your personal data

Questions and Answers

1. Is it possible to suspend or revoke the registration certificate of a medicine?

The validity of the registration certificate is suspended by the authorized body from the date of the finding:
• documented facts of the inconsistency of the qualitative and quantitative composition of the released batches of the medicine with the declared composition, except in cases submitted by the applicant to the authorized body for an application to amend the registration dossier on the composition of the medicine;
• unfavorable benefit–risk ratio proved after expert examination conclusion or identification of documented insufficient therapeutic efficacy of the medicine under the conditions of its use described in the instruction for medical use;
• non-elimination by the holder of the registration certificate of the identified non-conformities of production and control methods declared in the registration dossier within the period established by the authorized body;
• a fact that the medicine is unsafe (the drug is dangerous and poses a risk of harm to human health) under the conclusion of a specialized expert examination

Cancellation (revocation) of the registration certificate is performed by the authorized body based on the following:
• identification of cases when the applicant submits false information that could not be determined during the registration of medicines;
• a court decision that has entered into legal force;
• obtaining and confirmation of new systemic data on the superiority of risks associated with the use of the medicine over its benefit

2. When is it not possible to conduct the laboratory tests?

Laboratory testing of samples is not conducted if there is a certificate issued by the regulatory authorities of the countries of the region of the International Council for Harmonization of Technical Requirements for Medicines for Human Use (ICH) and confirming the compliance of the production site with good manufacturing practice or upon presentation by the applicant of a certificate/protocol of analysis/testing of the claimed medicines over the past 6 months conducted by a laboratory internationally accredited under the international standard ISO 17025 and located in the territory of the EEU countries, the accreditation scope of which provides for the analysis/testing of the claimed medicines.