New registration, renewal and variations

Cratia provides professional services on establishment of new registration, renewals and variations, safety and quality management for medicines in 12 countries and the Eurasian Economic Union (EAEU):

Azerbaijan Georgia Moldova Turkmenistan
Armenia Kazakhstan Mongolia Uzbekistan
Belarus Kyrgyzstan Tajikistan Ukraine

All in-country activities (submissions, communication with competent authorities etc.) are performed out by our local employees with high qualifications and experience, knowledge of national legislation and language. All activities are coordinated by our central office, whose experts communicate with the Customer, verify and prepare documentation, control the quality and timelines.

The central office is located in Ukraine, the country with the most developed and high regulatory requirements among CIS region. Since 2005, the Ukrainian medicines regulatory legislation has been actively harmonising with European legislation, and in 2011 Ukraine joined the PIC/S. We have successfully applied the many years of experience and knowledge gained on the national market to scale services into other countries. Our experts have deep knowledge of the national legislation of each country, specific requirements for registration materials and approval procedures, use professional terminology and monitor all changes.

For more than 10 years for all our customers we distribute a free newsletters on the major regulatory changes in the region. We conduct seminars and webinars, write analytical articles and advice on various issues.

 

National requirements in brief:

Azerbaijan  Azerbaijan has a system of state registration of medicinal products which is at an early stage of harmonization with the European Union. The import share is about 98% of the pharmaceutical market. The registration dossier is submitted in the national format and is also accepted in the CTD format. The Applicant is not required to establish and maintain a pharmacovigilance system; and GMP confirmation inspections are not carried out.
Armenia Armenia is a member of the EAEU. The import share is about 84%. Registration is carried out according to the national procedure, which provides for simplified registration, as well as according to the EAEU rnified rules. The simplified procedure applies to medicinal products registered in the EU, USA, Japan or pre-qualified by WHO. The dossier is submitted in CTD format. The Applicant must establish and maintain a pharmacovigilance system in Armenia. Inspection of production during national registration is not required.
Belarus Belarus is a member of the EAEU, the country has strong state support and patronage of the national producer (import substitution policy). The import share is about 75%. Registration is carried out according to the national procedure, or according to the EAEU unified rules. The dossier is submitted in CTD format. The Applicant must establish and maintain a pharmacovigilance system in Belarus. Inspection of production is mandatory during first registration.
Georgia The legislation of Georgia is actively harmonized with the EU; in 2014, an Association Agreement with the EU was signed. In Georgia, a simplified authorization regime for medicinal products approved by countries with high regulatory requirements has been introduced, there is no VAT, import licensing has been canceled, parallel imports is allowed. The import share is about 85%. Medicinal products are registered either by recognition (shortened procedure) or by expert evaluation (full procedure). The dossier is submitted in the national format. The Applicant has no obligation to establish and maintain a local pharmacovigilance system. Production inspection is not carried out.
Kazakhstan Kazakhstan is a member of the EAEU. The import share is about 88%. Registration is carried out according to the national procedure, or according to the EAEU unified rules. The registration dossier is accepted in CTD format. The Applicant must establish and maintain a pharmacovigilance system in Kazakhstan. Production inspection is mandatory upon first registration.
Kyrgyzstan Kyrgyzstan is a member of the EAEU. The import share is about 97%. Registration is carried out according to the national procedure or according to the EAEU unified rules. The registration dossier is accepted in CTD format. The Applicant must establish and maintain a pharmacovigilance system in Kyrgyzstan. Production inspection is mandatory upon first registration.
Moldova The legislation of Moldova is actively harmonized with the EU; in 2014 the Association Agreement of Moldova and the EU was signed. The import share is more than 80%. Registration of medicinal products is carried out according to full or simplified procedure. Simplified registration is applicable for medicinal products registered in at least one of the countries of the European Economic Area or in Switzerland, USA, Canada, Japan, Australia. The registration dossier is accepted in CTD format. The Applicant must establish and maintain a pharmacovigilance system in Moldova. Production inspection is not carried out for manufacturers from countries with high regulatory requirements.
Mongolia  Mongolia has a separate legislation. Only a resident of the country can act as an applicant for marketing authorisation. The import share is more than 70%. Registration is carried out according to the standard or expedited procedure. The expedited registration procedure is used for medicinal products approved by the FDA, EMA, in the countries of EFTA, Japan, as well as for medicinal products produced in the countries of PIC/S. The dossier format is national, which differs significantly from the CTD format. The Applicant has no obligation to create and maintain a local pharmacovigilance system. Production inspection is not carried out.
Tajikistan Тhe import share is more than 97% of the pharmaceutical market in Tajikistan. Registration is carried out only according to the standard procedure. The registration dossier is submitted in the national format, the CTD format is accepted by prior agreement with the regulatory authority. The Applicant has no obligation to establish and maintain a local pharmacovigilance system. Production inspection may be required by the competent authority.
Turkmenistan In Turkmenistan, the import share is more than 90% of the pharmaceutical market. Registration is carried out only according to the standard procedure. The registration dossier is submitted in the national format, the CTD format is accepted by prior agreement with the regulatory body. The Applicant has no obligation to create and maintain a local pharmacovigilance system. Production inspection is not carried out.
Uzbekistan  The marketing authorization system of Uzbekistan is gradually harmonized with the EU. The import share is more than 80%. Registration is carried out according to a standard or simplified procedure. The simplified registration applies to medicinal products registered by the EMA and the competent authorities of the USA, Japan, Canada, Switzerland, Australia, Belgium, UK, Germany, Denmark, Ireland, Spain, Italy, the Netherlands, Norway, Slovenia, Finland, France, Sweden, Israel and Korea. The dossier is submitted in CTD format. The Applicant must create and maintain a pharmacovigilance system in Uzbekistan. Production inspection is not carried out.
Ukraine The legislation of Ukraine is actively harmonized with the EU; in 2014, an Association Agreement with the EU was signed. The import share is more than 50%. Since 2005 legislation has been introduced in the field of medicinal product registration based on the EU legislation. Since January 2011, Ukraine has been a member of PIC/S. Marketing authorization is carried out according to a standard or simplified procedure. There are several options for simplified/expedited registration: the recognition procedure for medicinal products registered by the competent authorities of countries with high regulatory requirements; the authenticity procedure (for procurement through international organizations); shortened procedure for socially significant and/or pre-qualified by WHO medicinal products. The dossier is submitted in CTD format. The Applicant must create and maintain a pharmacovigilance system in Ukraine. Production inspection is not required for sites with the PIC/S GMP certificate.
Eurasian Economic Union The EAEU includes 5 countries: Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia. The import share is about 87%. In order to create a common market, unified principles and rules for the marketing authorisation and circulation of medicinal products have been introduced. Authorisation of medicinal products according to the Union’s unified rules becomes mandatory from January 2021; and medicinal products registered by national procedures must be brought into line with the EAEU standards before the end of 2025. There are several types of registration procedures: harmonization of a registration dossier (for medicinal products registered under national procedures), registration under a mutual recognition procedure, registration under a decentralized procedure. The dossier is submitted in CTD format. The Applicant must create and maintain a pharmacovigilance system in the EAEU. Production inspection is mandatory upon first registration.

Cratia Ltd. performs expert work on state registration of medicinal products in Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Uzbekistan, Ukraine and the Eurasian Economic Union. We are well versed in the national legislation, we have the necessary experience and resources to carry out the work.

To start cooperation or get advice, please contact us by phone: +38 044 361-48-28, +38 044 221-71-29, by e-mail: info@cratia.ua, or visit our office

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