Inpharmatis

📌 Peculiarities of Procedure in

In the procedure for in accordance with the , one of the requirements is to conduct Product Information Leaflet ( ) Readability User Testing ( ) in the national language in the country of the Union. As a rule, in the EAEU countries the results of are provided for the draft PIL, which, if the PIL is corrected by the regulator, may lead to the need for repeated user testing.

The provision of user testing results in is carried out according to a different algorithm - testing is conducted after the final version of the PIL has been approved upon. This allows to avoid additional costs for re-testing, and in some cases reduce the overall time of the registration process. The PIL RUT is given 90 working days to agree and execute, provided with an -based response to the expert’s request.

scheme in :
✅ Beginning of the Examination in accordance with the rules of the EAEU
✅ Initial request from the Regulator:
🔹Coordination of the adjusted PIL and a summary of product characteristics (SmPCs) with the Department of Pharmacological Examination Management
🔹 Coordination of the authenticity of the translation of the PIL and the SmPC with the translation management department
🔹 Conducting PIL RUT on the layout of the instruction agreed with the Regulator
✅ Response to the Regulator’s request with the provision of technical documentation for the approved instructions

Inpharmatis Group is one of the leading experts in conducting according to the in , , and (including in the Kazakh language). More than a hundred successful PIL RUTs have been carried out for many pharmaceutical companies in the , and countries, as well as for leading international manufacturers.

PIL RUT with Inpharmatis is a focus on the Client’s needs, a separate team of experts and experienced interviewers, optimal timing and flexible prices.

⏩ For more information, please contact us: [email protected].

🌐 Learn more about services on Inpharmatis website - https://inpharmatis.com/readability-user-testing/

⚠️ Until 31 January 2025, Russia retains the possibility of according to national legislation, which allows for the conduct of clinical trials in accordance with the Order of the Ministry of Health of Russia No. 885n "On Approval of the Procedure for Conducting the Conformity Assessment of Medical Devices in the Form of Technical Trials, Toxicological Studies, and Clinical Trials for the Purpose of State Registration of Medical Devices". This procedure, known as clinical evaluation, often involves the analysis of clinical data without human participation.

However, as the deadline for submission of documents under the national legislation approaches, manufacturers are increasingly paying attention to new rules approved by the Eurasian Economic Commission Council.

✅ Read more about clinical trials requirements for medical device registration ⏩ https://inpharmatis.com/clinical-trials-requirements-for-medical-device-registration-in-russia/

Inpharmatis provides medical device registration services in the countries ( , , , and ), which include solutions for the successful completion of the medical device registration both according to in the CIS countries and according to . Our comprehensive approach includes , of documentation and its preparation, as well as and .

▶ Receive a personal offer for medical device registration or request additional information about the service via [email protected].

Inpharmatis Team participated in the Euro Convergence 2024 - a conference fostering insightful exchanges, presenting the latest trends, and innovations shaping the regulatory landscape in healthcare.

We extend our gratitude to all who visited our booth during this event! At Inpharmatis, we have expanded our network of clients, developed valuable connections, and engaged in conversations that drive our company forward.

✏ If you have any further inquiries or wish to explore for , reach out to us at [email protected].

🌐 For more details about Inpharmatis , please visit our website at www.inpharmatis.com. Explore how we can empower your business with our expertise and tailored solutions.

📢 Join us at Euro Convergence 2024 on 6-8 May in , Germany.

Inpharmatis experts, led by dr. Polina Dombure, CEO of Inpharmatis Group, will be delighted to welcome you at , located on Level A of the Berlin Congress Center. Our table is situated to the right of the Entrance and opposite the Registration Area.

Our Team is looking forward to discussing your individual regulatory requirements and presenting you with the best Inpharmatis can based on many years of successful experience in , and .

✏ Schedule a meeting in advance by sending us an email at: [email protected].

Check out for a waiting for each visitor at our table!

Learn more about Inpharmatis and provided services on our website - https://inpharmatis.com

Looking forward to meeting you in Berlin!

❇ Dr. Polina Dombure, Inpharmatis CEO, participated in the Europe Annual Conference held on 16-18 April 2024 in Lisbon. This Conference brings together and biopharmaceutical professionals at all levels to discuss the industry’s most important topics.

During the conference dr. Polina Dombure had meetings with industry leaders, as well as current and prospective partners, for networking and knowledge exchange.

The active participation of dr. Polina Dombure underscores Inpharmatis Group’s fostering collaborative partnerships and enhances its position in the EU and CIS markets as a leader in and fields.

🖋 For more information about Inpharmatis Group and its provided services, please contact us at [email protected] or on the website https://inpharmatis.com.

☝Meet Inpharmatis Group CEO Dr. Polina Dombure at , 16-18 April 2024, Lisbon.

Looking forward to catching up with European and Global current and potential partners and clients to discuss the industry’s latest topics, as well as .

📌 Don't miss out - find Polina Dombure at the conference and let's explore how we can collaborate!

Inpharmatis is the leader in with 20+ years of experience in EAEU & EU - https://inpharmatis.com/quality-management/

⚠ Challenges of in the

Entering the market of the Eurasian Economic Union (EAEU) has specific challenges. The is quite complex, and legislation is still evolving, which means new requirements or changes take place regularly.

Here are some of the that manufacturers or their authorized representatives are most likely to encounter:
🔸 Mandatory manufacturing sites inspections: for all high-risk medical products (2b and 3), plus sterile products of risk class 2a require a production inspection
🔸 Necessity to conduct clinical trials with human participation: they are mandatory for about 45% of medical products (all MD of risk classes 2b and 3, all implantable MD, a new type of MD, fundamentally new materials of manufacture, new and complex techniques)
🔸Extended Timelines: the registration process can last from 12 months (for risk class 1 and non-sterile MD class 2a) or even from 28 months (for risk classes 2b and 3, implantable MDs)

✅ Cooperating with a is usually the main choice for international medical device companies entering the EAEU market.

Inpharmatis expertise in the EAEU (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia) regulatory environment provides you with for of medical devices.

Inpharmatis regulatory affairs specialists keep up with the latest and updates, engage in , prepare documentation, and communicate with the regional Regulatory Authorities. Inpharmatis local team guides you through every step, from the initial application to final approval, minimizing risks and simplifying the registration process.

✅ Receive a for or request additional information about the service, reach out to us at [email protected].

🌐 Explore more information on the Inpharmatis website - https://inpharmatis.com/challenges-of-medical-devices-registration-in-the-eaeu/

📌 New Amendments in Federal Law “On of ” in Russia

On 30 January 2024, Federal Law No. 1-FZ was adopted, introducing amendments to Law No. 61-FZ "On the of " in . These changes aim to bring Russian legislation with unified requirements within the Eurasian Economic Union ( ) and improve existing regulatory frameworks. The Law comes into effect from the day of its official publication, except for provisions with specified timelines.

According to the new Law, the amendments address various aspects of , including the protection of data, electronic government services, , etc.

Significant changes have also been made to the conditions for the circulation of orphan and high-tech medicines, introducing a new definition for high-tech medicinal products and these imports in foreign packages.

✅ Check the key amendments in the article - > https://inpharmatis.com/new-amendments-in-federal-law-on-circulation-of-medicines-in-russia/

Inpharmatis specializes in the of across the countries (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia). The experienced local team provides for with the requirements of the Eurasian Economic Union considering all .

⏩Receive a personal proposal for medicines registration or request additional information about the services, reach out to us at [email protected].

⚠ In , Companies That Have Not Provided a are Facing New Risks

Currently, marketing authorization holders ( ) who have not submitted valid on time receive letters from the Regulation Agency for Medical and Pharmaceutical Activities about the suspension of the and the requirement to submit .

If your company has not timely provided a ⏩ https://inpharmatis.com/in-georgia-pharmaceutical-companies-that-have-not-provided-a-gmp-certificate-are-facing-new-risks/

⏩ For more information, please contact us at [email protected].

📌 EAEU is Mandatory

All pharmaceutical companies operating in the market ( , , , , ) have to obtain the by the 31st of December 2024.

The process of EAEU is a challenge for many international companies. That is why it is highly recommended to be prepared for inspection in advance and to conduct pre-audit of the respective manufacturing site. This will identify the possible gaps regarding the EAEU before the official inspection.

Inpharmatis has over 15 years of experience in conducting pre-audits and successfully supporting and companies with official GMP inspections. Additionally, Inpharmatis has full competence in supporting EAEU regulatory procedures.

Inpharmatis covers all EAEU countries with highly qualified, multilingual, full-time employees who operate under a .

⏩ For more information, please contact us at [email protected].

🌐 Explore full on the Inpharmatis website - https://inpharmatis.com/quality-management/

☝ Dr. Polina Dombure, MD, CEO of Inpharmatis Group and a member of the TOPRA, engaged in the held on February 15, 2024, in London.

Dr. Polina Dombure exchanged opinions with industry leaders and discussed key success factors essential for shaping the future of a safe system.

During the , dr. Dombure had the opportunity to meet with current and potential partners to discuss the industry’s challenges, as well as .

As a leading in regulatory affairs, Inpharmatis Group continues to expand collaborations and strengthen its position in the market.

For more information about Inpharmatis Group and its provided , please visit the Inpharmatis website https://inpharmatis.com/services/

📌 Key Contrasts in 's Modes: vs.

According to Georgian legislation, products can be approved via two modes: National or Recognition.

Considering your business goals, Inpharmatis experts will assist you in selecting the most appropriate mode and ensure a prompt and professional registration process.

👉 Curious about between the and Modes?

Here's a snapshot:

Mode:
✔ Register products from any country
✔ Duration: 3 months (+/-2 months)
✔ Scientific requirements: Complete dossier and possible laboratory examination
✔ Post-registration options: All regulatory life cycle procedures (renewal, variations, etc.)

Mode:
✔ Eligible countries: EU, UK, Switzerland, Norway, Iceland, Turkey, USA, Canada, Japan, Israel, South Korea, Australia, New Zealand
✔ Duration: 7 working days (+/-14 days)
✔ Simplified scientific process: Partial dossier and expedited assessment of documents only
✔ Post-registration options: Only first import procedure - packaging and labelling changes are available.

Whether the National or Recognition mode is more applicable, Inpharmatis team will provide support throughout the entire process.

In , Inpharmatis has local full-time, highly qualified, experienced, multilingual employees with many years of practical experience and on and services for and companies.

Inpharmatis is an international consulting company specializes in providing , and services with full coverage of all , , and countries: Uzbekistan, Kazakhstan, Russia, Belarus, Kyrgyzstan, Moldova, Armenia, Georgia, Tajikistan, Turkmenistan, Ukraine, Azerbaijan, Mongolia, Latvia, Lithuania, Estonia and others.

📧Need expert support for your product registration? Reach out to us at [email protected].

🌍 More information on Inpharmatis website - https://inpharmatis.com/services/

🔔 of the Procedure for into with the Rules

As of December 20, 2023, changes in the Rules for Registration and Examination of Medicines in the EAEU, established by Decision No. 114 of the Eurasian Economic Commission (EEC) on October 20, 2023, have come into effect. They focus on simplifying the procedure for bringing the registration dossiers of medicinal products with the Rules of the Eurasian Economic Union.

"These create favorable conditions for the industry and enable companies to interact more efficiently with regulatory authorities, contributing to the development of the industry in the context of the new EAEU rules," says Arshat Kadrushev, a regulatory affairs specialist at Inpharmatis. He also believes that:

✅ The reduction in the list of required documents significantly simplifies the process of bringing into compliance, as well as time and financial costs for pharmaceutical companies.
✅ The introduction of repeated requests provides additional opportunities to correct identified deficiencies and helps improve the quality of the provided data.
✅ The ability to make changes concurrently with the procedure of bringing into compliance substantially reduces the risk of rejections and increases flexibility in project management.
✅ Expanded possibilities for obtaining indefinite Marketing Authorization ensure the stability of companies in the market and create conditions for long-term planning.

Inpharmatis specializes in the of in the market. The experienced and qualified team is ready to provide professional in bringing your product registration dossiers into compliance with the requirements of the Eurasian Economic Union.

⏩ Request detailed information at [email protected].

⚠️ Enhancing : The Importance of for Public Health

plays a crucial role in maintaining public health by monitoring and evaluating the safety of medications after they reach the market, ensuring ongoing patient protection. This field is essential for the early identification of adverse drug reactions ( ), which can range from mild side effects to severe health risks, thereby preventing widespread health issues.

Historical incidents like the Thalidomide tragedy of the 1950s and 60s underscore the importance of pharmacovigilance in detecting the harmful effects of drugs and have also contributed to stricter requirements for clinical trials and the establishment of drug regulatory authorities.

Read the article and discover, how Inpharmatis contributes to global and rapid response, ensuring comprehensive systems ⏩ https://inpharmatis.com/enhancing-drug-safety-the-importance-of-pharmacovigilance-for-public-health/

🟢 Solutions in the EAEU, CIS & EU

Navigating the regulatory affairs landscape demands precision and expertise. Inpharmatis offers comprehensive regulatory affairs services to the Life Science Industry including and Vigilance Services to , medical device, food supplements, cosmetic, and biotech companies.

Our area of expertise is in the countries, , , , , , , , , and the countries.

A multi-disciplinary team of qualified regulatory affairs consultants is available for all aspects of your marketing authorisation applications for active substances and human products.

Inpharmatis will provide full over the whole life cycle of your product:

✅ Development of a regulatory strategy for the product’s life cycle
✅ Submission preparation/review, filing, and management
✅ Regulatory strategy consulting
✅ Filing and product life cycle management

👉 Get a personalised offer by reaching out to us by email [email protected].

🌐 Explore full services on the Inpharmatis website - https://inpharmatis.com/regulatory-affairs/

🌲 Merry Christmas and a Happy New Year!

With the holidays approaching, we would like to take a moment to express our heartfelt thanks to you. We wish you a very Merry Christmas and New Year filled with happiness, good health, prosperity, and much success!

Warm Wishes from the Inpharmatis Team.

📢 Summary of the TOPRA CEE Webinar: Challenges in the CIS and Russia

On December 14, 2023, Inpharmatis experts participated in the webinar "Regulatory Challenges in the CIS and Russia" organised by in (Central Eastern Europe). During a two-hour discussion, webinar speaker Polina Dombure, CEO of Inpharmatis Group, and industry-leading experts reviewed actual regulatory issues in this strategically important region.

The landscape of the market in the CIS stands out as notably dynamic and intricate. The sector has faced significant regulatory challenges due to changes in global geopolitics.

Having over 20 years of experience in the Life Sciences Industry in Europe and the CIS, Polina Dombure considered current requirements and trends in the Eurasian Economic Union ( ) and other countries. She described potential risks and outlined effective regulatory strategies in the region.

There were Q&A sessions after each webinar topic. Region experts and heads of regulatory departments: Natalia Volovich (Gedeon Richter), Inga Klaus (Mayoly), Jelena Volperte (Olainfarm), and Natalia Starkova (Chiesi) answered questions. The exchange of experiences and practical knowledge provided webinar participants with a unique opportunity to communicate with industry leaders in regulatory affairs.

The webinar attracted a significant number of engaged attendees, demonstrating the crucial role of participation in the market in the CIS and Russia for businesses. Inpharmatis Group is going to continue to support the industry by providing expertise and solutions for pharmaceutical companies in the countries, , , , , , , , and .

More information on the Inpharmatis website - https://inpharmatis.com/regulatory-challenges-in-the-cis-and-russia-webinar-summary/

🌏 Global End-to-End System Development in , &

Creating a system is a task more intricate than it might seem at first glance. It involves considering numerous aspects, which can appear complex, especially when your primary focus is on your product development.

Key components of building a pharmacovigilance system include risk management planning, data collection, analysis, and reporting, signal management, PV audits, and inspections.

often face the following challenges:
⚠ Lack of understanding of the regulatory landscape in the EAEU, CIS, and Baltics
⚠ Shortage of experienced personnel
⚠ Lack of knowledge of local languages
⚠ Insufficient in-house resources

If you are expanding your network in , , and countries or introducing a new product to the market, partnering with Inpharmatis - a global end-to-end pharmacovigilance services provider with an established network of branches and experienced personnel - can be an excellent option for both time and resource efficiency.

👉 Get a personalised offer by reaching out to us by email [email protected].

📌 Regulatory Challenges in the and Russia - in Webinar

Join the Webinar on Thursday 14 December 2023 between 09:00-11:00 GMT / 10:00-12:00 CET organized by the TOPRA CEE Steering Committee. Stay up-to-date with the latest changes and developments in frameworks of the countries.

The market in the is one of the most dynamic and complex regions in the regulatory area. Due to global geopolitical changes, the pharmaceutical market in the CIS has also experienced significant regulatory challenges.

This webinar will cover the latest updates, requirements, and trends in the market (Belarus, Kazakhstan, Armenia, Kyrgyzstan, Russia), as well as in the markets of Ukraine, Moldova, Azerbaijan, Georgia, Mongolia, and Uzbekistan.

The webinar speaker is Dr. Polina Dombure MD, PhD, Member of the TOPRA CEE Steering Committee, CEO Inpharmatis Group. Dr. Polina Dombure has over 20 years of experience in the Life Sciences Industry and is a regionally experienced expert in the CIS and EU markets, with deep expertise in all types of products in Affairs, , and , continuously growing and expanding knowledge of the region into successful projects.

The webinar will be useful for Affairs Managers and Specialists from HQ and clusters responsible for , , and Russian markets.

To register for the webinar, please visit the Webinar page on the TOPRA website - https://www.topra.org/TOPRA/TOPRA_Member/Events/Event_Display.aspx?EventKey=CISDEC23

🚀 in the : Challenges and Opportunities

The fast-growing market in the CIS countries presents a lot of opportunities for pharmaceutical manufacturers. However, it also comes with challenges.

For example, the legislative requirements for Pharmacovigilance ( ) and the appointment of or (Local Person for Pharmacovigilance) are different in the CIS countries.

The or must be appropriately qualified in including according to local legislation, in most cases a resident of the country with a deep understanding of local legislation and fluent command of the local language(s).

Moreover, in some CIS countries, there is no clear legislation and requirements for or , as well as division of responsibilities between the LPPV, , and manufacturer, leading to misunderstandings and challenges in the regulatory process.

Inpharmatis is your guide to Pharmacovigilance in the CIS countries:

✅ Covers all countries, eliminating the need to seek and manage partners in each country separately
✅ Acts as a local legal entity, where it is necessary, maintaining representative offices or branches
✅ Has local full-time, highly qualified, experienced, multilingual employees in CIS countries
✅ Provides personalized solutions, making your presence in the CIS markets straightforward, compliant, and efficient.

🚀 Request a consultation now at [email protected].

🌍 Explore full pharmacovigilance services on Inpharmatis website -> https://inpharmatis.com/pharmacovigilance/

🔔 Risk of Marketing Authorisation Suspension in

The Regulatory Authority diligently oversees the adherence to obligations held by for medicinal products within the territory of Kazakhstan. This oversight is crucial for maintaining an optimal balance between the benefits and risks associated with these products.

As part of pharmacovigilance, the Expert Organization evaluates the benefit-risk ratio of medicinal products indefinitely registered, and currently in circulation within the Republic of Kazakhstan. This evaluation is carried out annually based on an agreement with the MAHs and includes the following key elements:
✔ A Periodic Safety Update Report ( )
✔ Risk Management Plans ( )
✔Data derived from post-registration safety studies
✔ The Pharmacovigilance System Master File ( ).

⚠ If the MAH has not provided all the required information within the assigned timelines, the Regulator may take the following actions:
🔸 Conduct PV inspection at the expense of the MAH
🔸 Suspend the validity of the Marketing Authorisation
🔸 Revoke the Marketing Authorisation.

Inpharmatis Group has a branch in with full-time multilingual specialists. If you are seeking guaranteed highly qualified support from PV experts with over 15 years of experience, contact us: [email protected].

For detailed information about Services, visit the Inpharmatis website at https://inpharmatis.com/pharmacovigilance/

📌 SPECIAL AUTUMN OFFER - in EAEU

Only in November 2023, Inpharmatis announces the Special Autumn Offer - order any THREE Package Information Leaflet ( ) Readability User Testing ( ) and receive one of the following GIFTS:

🎁 One standard Readability User Testing,
🎁 Three analyses of Package Leaflets in compliance with the EAEU requirements.

Catch the perfect opportunity to benefit from the experience and expertise of Inpharmatis specialists. The Inpharmatis team will efficiently, quickly, and cost-effectively complete PIL RUT ( ) services in full compliance with EAEU rules.

Send your request or receive the Special Autumn Offer Flyer: [email protected].

More information on https://inpharmatis.com/pil-readability-user-testing-in-eaeu/

👆 Ensuring Pharmacovigilance in EAEU

Pharmacovigilance is one of the most important elements of the system for monitoring the safety, effectiveness, and quality of medicines.

All Pharmacovigilance ( ) activities in the countries ( , , , , ) are regulated by the Rules of Good Pharmacovigilance Practice ( ) of Eurasian Economic Union, Decision No. 87 of November 3, 2016.

According to this document, Marketing Authorization Holders ( ) are responsible for developing and setting up a System, which should be described in a Pharmacovigilance System Master File ( ).

📍 The development, implementation, and management of a PV system in the EAEU requires extensive experience, deep expertise, considerable resources, and local staff.

Make Pharmacovigilance simple, Inpharmatis' experts are ready to support in all stages:
✅ PV System Creation and Management
✅ Qualified Person for Pharmacovigilance ( and )
✅ Safety Data Management
✅ Pharmacovigilance Audits
✅ Medical Information Support
✅ Pharmacovigilance Trainings.

For more information contact us by email: [email protected] or https://inpharmatis.com/pharmacovigilance/