Inpharmatis

Inpharmatis Inpharmatis is an international pharmaceutical consulting company with more than 20 years of proven e Our area of expertise lies in the European & CIS market.

Inpharmatis Group is proud to announce a strategic partnership with Life Sciences Group, a global leader in Regulatory...
28/05/2026

Inpharmatis Group is proud to announce a strategic partnership with Life Sciences Group, a global leader in Regulatory Information Management (RIM) solutions, including market-leading capabilities for the Life Sciences industry.

As an official LORENZ Partner, Inpharmatis is authorised to promote and implement LORENZ and Regulatory Information Management (RIM) solutions, such as LORENZ , LORENZ and LORENZ for pharmaceutical companies in: , , , , Belarus, Kazakhstan, Kyrgyzstan, , Tajikistan, Uzbekistan, Turkmenistan, , Latvia, Lithuania, and Estonia.

Through this collaboration, Inpharmatis will enable pharmaceutical companies to from advanced regulatory technology combined with strong regional expertise:
🔹 Access to top-tier LORENZ and RIM software
🔹 Comprehensive Regulatory and , supporting full for pharmaceutical companies worldwide, including in the , , , and
🔹 Flexible service models, scalable to meet your needs from individual submissions to global multi-market projects
🔹 Stringent quality control

Click here for the press release: https://inpharmatis.com/inpharmatis-becomes-an-official-lorenz-partner-for-ectd-rim-solutions/?utm_source=facebook&utm_medium=social&utm_campaign=lorenz_partnership&utm_content=press_release

⚠️ If you are planning a , submitting , or a within the , it is essential to consider the updated requireme...
19/02/2026

⚠️ If you are planning a , submitting , or a within the , it is essential to consider the updated requirements for the Summary of Product Characteristics ( ) and ( ), which are already applied in regulatory practice. These changes directly affect the structure and content of product information as well as approaches to preparing regulatory documentation.

The last updates were introduced by of the Council of the Eurasian Economic Commission No.18 dated 21 February 2025. The document amended previously applicable requirements and aims to standardise approaches, improve transparency of information for healthcare professionals and patients, and further align EAEU practices with .

🔶 Key Changes in Practice

The amendments affect the structure and content of and sections, clarify certain wording requirements, update expectations for presenting , and , and further standardise terminology and document format.

As a result, applicants should review their current templates and internal medical writing practices to ensure alignment with the updated requirements.

🔶 Practical Implications for MAHs and Applicants

In practice, companies are expected to conduct of existing SmPCs and PLs, review submitted and planned dossiers and update internal medical writing and processes.

The revised requirements are particularly important when preparing new registrations, variations, and dossier alignment procedures within the EAEU framework.

🔶 Bringing Documentation into Compliance

Companies should prioritise documents requiring updates, assess potential regulatory risks, and plan revisions accordingly. In some cases, this may involve revising and sections, including indications, warnings, interactions, and clinical pharmacology information, in line with the updated regulatory expectations.

🔶 Key Challenges and Approaches to Documentation Updates

Regulatory experience shows that non-compliance with updated requirements is often identified during expert review, leading to additional questions and procedural delays. Therefore, companies should focus not only on formal document updates but also on implementing consistent approaches to document preparation across internal teams and external vendors.

📍 How to Minimise Regulatory Risks

Inpharmatis Team supports applicants at all stages of working with and in the – from expert review and assessment to preparation of updated documents and support during and update procedures. This support reduces regulatory risks and ensures timely compliance with current requirements.

🌐 More details - https://inpharmatis.com/smpc-and-package-leaflet-requirements-in-the-eaeu/

On 16 February 2025, it will be a year and a half since the on the of for medical purposes came into effect in ...
13/02/2026

On 16 February 2025, it will be a year and a half since the on the of for medical purposes came into effect in . Law of Ukraine No. 3528-IX officially entered into force on 16 August 2024.

Key Provisions of the Law
🔹 Medical Use: The law permits the use of - for treating conditions such as chronic pain, cancer, and post-traumatic stress disorder.
🔹 Prescription Requirement: Cannabis-based are available only via doctor’s prescription.
🔹 Cultivation and Production: Cannabis can be cultivated and processed by licensed entities under strict regulations, including 24-hour video surveillance and compliance with ( ) standards.
🔹 Regulatory Oversight: The Ministry of Health is responsible for approving the list of qualifying medical conditions and overseeing the implementation of the law.
🔹 Industrial and Scientific Use: The law also allows cannabis cultivation for industrial and scientific purposes, with the maximum permissible tetrahydrocannabinol (THC) content in dried h**p straw set at 0.3% from 16 February 2027.

Also, the State Expert Centre of Ukraine presented methodological recommendations on the use of medical cannabis "Medical cannabis: clinical and pharmacological characteristics and regulations for use". The document is based on the latest and (Israel, Canada and other countries) and will become a practical guide for doctors when prescribing therapy to patients.

🌐 More info - https://inpharmatis.com/methodological-recommendations-for-doctors-on-the-use-of-medical-cannabis-have-appeared-in-ukraine/

⚠️ In today’s fast-evolving regulatory environment, - ( ) has become a cornerstone of pharmaceutical compliance and ...
09/02/2026

⚠️ In today’s fast-evolving regulatory environment, - ( ) has become a cornerstone of pharmaceutical compliance and patient safety. Health authorities worldwide are placing increased emphasis on continuous – of after their initial approval.

– is more than a regulatory obligation. It is essential for:
🔹 : Detecting rare or long-term adverse effects that may not have appeared during clinical trials
🔹 : Ensuring marketing authorisation holders ( ) meet obligations under key legislation
🔹 : Maintaining uninterrupted supply and avoiding suspensions or withdrawals due to compliance failures
🔹 and : Demonstrating proactive management of product’s safety profile to regulators, healthcare professionals, and patients

📍 Key Market Changes
Updates to EU frameworks have strengthened for to actively monitor product , , and efficacy throughout the product lifecycle, including:
🔹 Ongoing and
🔹 ( )
🔹 ( ) implementation and follow-up
🔹 – such as stability studies and variations

Inpharmatis provides a comprehensive range of – services, including:
🔸 Preparation and submission of and updates
🔸 and services and appointment
🔸 for
🔸 Coordination of – studies and stability programs
🔸 for and
🔸 Ongoing regulatory intelligence to keep you ahead of changes

Our team combines deep regulatory expertise with a proven track record of successful submissions across , and . By partnering with Inpharmatis, you can ensure that your – obligations are managed efficiently, safeguarding compliance, patient trust, and your product’s long-term market position.

📨 To discuss partnership opportunities, request a commercial proposal, or learn more about Inpharmatis services, please contact us at [email protected].

🌐 https://inpharmatis.com/post-approval-monitoring-why-it-matters-more-than-ever/

Merry Christmas and a Happy New Year! 🎄As we approach the New Year, we sincerely thank our Clients and Partners for you...
23/12/2025

Merry Christmas and a Happy New Year! 🎄

As we approach the New Year, we sincerely thank our Clients and Partners for your trust and collaboration.

For Inpharmatis, this year has been both challenging and full of new opportunities. We welcomed reliable new Partners, expanded our service geography and entered new markets, strengthened our Team.

We enter 2026 with ambitious plans and clear goals, ready to support our Clients in achieving continued success and growth.

Wishing you joy, good health, and prosperity in the upcoming 2026 Year from the Inpharmatis Team! 🎉

⚠️ of medicinal products in becomes on 1 January 2028 Cabinet of Ministers Resolution No. 1121 approved the on t...
17/12/2025

⚠️ of medicinal products in becomes on 1 January 2028

Cabinet of Ministers Resolution No. 1121 approved the on the for the of medicinal products and the for applying to the of medicines.

👉 Key Provisions

🔹 Operators of the pharmaceutical market may voluntarily apply safety features (2D codes etc.) and use the for the of from 1 January 2026.
🔹 of in Ukraine becomes on 1 January 2028.
🔹Medicinal products placed on the market before 1 January 2028, without safety features on their packaging, may be sold in Ukraine until their expiration date.
🔹By 1 January 2026, the Ministry of Health of Ukraine must approve the following lists:

🔸 to which safety features will not apply on a mandatory basis.
🔸 to which safety features will apply on a mandatory basis.

The include a and an anti-tampering device. The unique identifier must be applied in the form of a machine-readable two-dimensional barcode GS1 . The of the must ensure the identification of the medicinal product code, the packaging serial number, the batch number, and the expiration date.

The Resolution establishes a national organisation for the verification of medicinal products, which will create, maintain, and administer a for the of . The State Service of Ukraine on Medicines and Drugs Control is designated as the state verification control body.

If you are preparing for the of in Ukraine or assessing their impact on your product portfolio, Inpharmatis can support you navigate the new requirements efficiently and ensure compliance both in and across .

📨 Contact us at [email protected]

🌐 More information - https://inpharmatis.com/services/

⚠️ 1 January 2026 marks the introduction of marking for in . This regulatory change is part of Armenia’s align...
12/12/2025

⚠️ 1 January 2026 marks the introduction of marking for in . This regulatory change is part of Armenia’s alignment with (Eurasian Economic Union) pharmaceutical regulations.

Key Provisions

🔹 of : Only Armenian resident entities and importers will receive marking codes. Foreign manufacturers will not obtain them directly.
🔹 : The code must not obscure vital product data. Manufacturers are advised to reserve clear space in the packaging design for the .
🔹 Pilot program status: Since the start of the pilot on 31 October 2024, 1 095 applications have been submitted for marking, with 359 medicines registered so far.
🔹 : Until 31 December 2027 a temporary regime will allow manufacturers to file or make .

at the announcement conference observed that many manufacturers may struggle to update quickly, given that designs are often finalised well in advance. The advice was to proceed methodically rather than rushing changes.

If your organisation works in or plans to enter the , now is the time to review your readiness status. We invite you to reach out to Inpharmatis to explore how we can help you navigate the new marking model and maintain uninterrupted .

📨 For expert support and detailed information, please contact us at [email protected].

🌐 More information - https://inpharmatis.com/regulatory-affairs/

📌 Regulatory professionals often face when adapting their for in different markets. A thorough of documents mu...
04/12/2025

📌 Regulatory professionals often face when adapting their for in different markets. A thorough of documents must be performed before dossier submission to meet the specific target of the regulatory agency. By timely detecting deficiencies in registration documents and eliminating them before submission, helps mitigate risks and smoothens the approval process of submitted registration documents.

GAP Analysis Approach:
🔹 – review to assess if the dossier’s format and structure meet standards
🔹 – to ensure that the quality documentation fully complies with regulatory and guideline requirements, with no missing, inconsistent, or insufficient information that could compromise dossier approval
🔹 and non-clinical – bioequivalence studies, safety and effectiveness data assessment with regional expectations
🔹 and – to compare the current product information against the latest template and regulatory requirements, identifying , their impact, and preparing an to update the documents and ensure compliance before submission.

A strategically helps streamline the adaptation of the which reduces regulatory bottlenecks and aids in quicker approvals in the new region. This approach helps reduce the need for additional studies for resources and increases speed to market.

👉 Looking to expand into new markets? Let us help you get unfamiliar territories using a custom that will help manoeuvre complex regulations.

📨 Contact us now for assistance: [email protected].

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