News

Posted by Vladimir

August, 12th 2026.

Participation in “Establishment of the National Medicines Verification System” online education


The team at KK Pharma Leader d.o.o. participated in an online education on 31 July 2026, entitled “Establishment of the National Medicines Verification System.”

The training covered a number of important topics, including falsified medicines and the implementation of the Falsified Medicines Directive, key measures for preventing falsified medicines from entering the legal supply chain, the European Medicines Verification System, national medicines verification systems, and other relevant topics. 

Posted by Marijana

April 27th, 2026.

Participation in the Thirteenth Workshop of the Medicines and Medical Devices Agency of Serbia


The team at KK Pharma Leader d.o.o. participated in the Thirteenth Workshop of the Medicines and Medical Devices Agency of Serbia, held on April 27 at the eGovernment House. The workshop focused on standard thematic areas related to the enhancement of the ADIS portal, advertising of medical devices, as well as the assessment of product status, along with their classification and categorization.

The workshop concluded with a discussion on medical devices, during which views were exchanged on key issues in this field. 

Posted by Stefanija

April 2nd, 2026.

Participation in the Twelfth Workshop of the Medicines and Medical Devices Agency of Serbia


The team at KK Pharma Leader d.o.o. participated in the Twelfth Workshop of ALIMS, held on March 31 at the eGovernment House. The workshop covered the enhancement of the ADIS portal, advertising of medical devices, as well as the determination of product status, and the classification and categorization of medical devices.

A useful panel discussion was also held with ALIMS experts on issues related to medical devices within the Agency’s competence. 

Posted by Marijana

December 26th, 2025.

Participation of the KK Pharma Leader d.o.o. team in the Second Cycle of IDMP Workshops at the Chamber of Commerce and Industry of Serbia


The KK Pharma Leader d.o.o. team participated in the second cycle of IDMP workshops organized by the Chamber of Commerce and Industry of Serbia in cooperation with the Medicines and Medical Devices Agency of the Republic of Serbia.

The workshops were dedicated to the development of the new Register of Human Medicines within the RIMS system, in accordance with the ISO IDMP standard, and included assisted data entry and training on the application of controlled EU vocabularies (EMA SPOR database), with a focus on parenteral medicinal products.

Participation in these workshops enabled our team to enhance practical knowledge and strengthen competencies for working in compliance with ISO IDMP standards. 

Posted by Marijana

December 12th, 2025.

Participation of Our Company’s Team at the eleventh ALIMS Workshop on the topic “Panel Discussion – Regulatory Processes within the Competence of ALIMS in the Field of Medical Devices”


Our company’s team participated in a panel discussion on regulatory processes under the authority of the Medicines and Medical Devices Agency of Serbia (ALIMS) in the field of medical devices, held on December 11th. During the discussion, topics related to registration, renewal of registration, variations and amendments to registration, as well as periodic safety update reports, were addressed.

Through active participation in professional events, we strengthen our knowledge of regulatory changes and further enhance the level of support we provide to our partners. 

Posted by Jovana

December 1st, 2025.

Participation of Our Company’s Team at the Fourth Annual Conference of the Institute for Medicines and Medical Devices of Montenegro


The team of KK Pharma Leader d.o.o. participated in the Annual Conference of the Institute for Medicines and Medical Devices of Montenegro (CInMED), held from November 27th to 29th in Budva.

This year’s conference program focused on the regulation of medicines and medical devices, with particular emphasis on the new Law on Medicines. In addition, the program covered topics related to pharmacovigilance, good manufacturing and distribution practices, as well as the importance of harmonization with European Union legislation. 

Posted by Aleksandra

November 28th, 2025.

Participation of Our Company’s Team at the tenth ALIMS Workshop on the topic “Panel Discussion – Regulatory Processes within the Competence of ALIMS in the Field of Medical Devices”


Our company team attended the tenth ALIMS workshop, held on November 27th, 2025, where representatives of the Center for Medical Devices of the Medicines and Medical Devices Agency of Serbia addressed participants’ questions as part of a panel discussion.

This format of direct communication between assessors and Agency clients enabled the clarification of numerous questions and uncertainties related to regulatory procedures for medical devices, while also providing announcements of important technical improvements expected to be introduced on the medical devices portal in the coming period.

Participation in such events allows us to stay aligned with regulatory developments and further enhance the quality of support we provide to our partners. 

Posted by Aleksandra

November 26th, 2025.

Participation of Our Company’s Team at the tenth ALIMS Workshop on the topic “Panel Discussion – Regulatory Processes within the Competence of ALIMS in the Field of Medical Devices”


The Chamber of Commerce and Industry of Serbia, in cooperation with the Medicines and Medical Devices Agency of Serbia, organized an education on November 25th, 2025, for responsible persons in the field of medical device vigilance. During the training, members of our company’s team had the opportunity to attend lectures on important topics in this field, including the roles and responsibilities of all market participants, as well as practical examples presented through case studies.

The purpose of an effectively established vigilance system is to improve and safeguard the health and safety of patients, users, and other persons through timely information in order to reduce the risk of incident recurrence. This education provided us with additional guidance to apply these principles even more consistently in our daily work, as authorized representatives of foreign medical device manufacturers. 

Posted by Aleksandra

November, 18th 2025.

Participation of our company’s team in the continuous education “Improving the ADIS System for Medical Devices”


The Chamber of Commerce and Industry of Serbia, in cooperation with the Medicines and Medical Devices Agency of Serbia and the Office for IT and eGovernment, organized an education session on November 17, 2025, where our team had the opportunity to learn about the improvements made to the ADIS MS system.

During the education session, a presentation by the Office for IT and eGovernment titled “eGovernment Services (eID, eInbox) in the Application of the ADIS MS System” was discussed, and participants were shown practical examples of user login to the ADIS MS system using an eID account. This education further strengthened our team’s competencies for faster and more reliable application of the ADIS MS system in business processes. 

Posted by Marijana

November, 12th 2025.

Participation of KK Pharma Leader d.o.o. team in the Chamber of Commerce of Serbia education “Basics of Pharmacovigilance for Marketing Authorization Holders”


Our company team, KK Pharma Leader d.o.o., participated on November 5, 2025, in the education program titled “Basics of Pharmacovigilance for Marketing Authorization Holders”, held at the premises of the Chamber of Commerce of Serbia.

The education provided participants with insights into key aspects of pharmacovigilance, including risk planning, reporting of adverse reactions to medicines, and the functioning of the pharmacovigilance system for marketing authorization holders. Participation in such education programs allows our team to continuously enhance their expertise and contribute to patient safety and product quality. 

Posted by Dajana

November, 9th 2025.

Participation of the KK Pharma Leader d.o.o. team in IDMP workshops at the Serbian Chamber of Commerce


At the beginning of November, the KK Pharma Leader d.o.o. team participated in IDMP workshops organized by the Serbian Chamber of Commerce in cooperation with the Medicines and Medical Devices Agency of Serbia.

The workshops aimed to familiarize participants with the IDMP data structure for medicines and the process of entering this data. This training represents an important step in the development of the new Human Medicines Register within the RIMS system and includes the application of controlled EU terminologies (EMA SPOR database).
Participants, through practical exercises, had the opportunity to directly enter and edit data in the system, thereby gaining practical knowledge for working in the system. 

Posted by Ljiljana

October, 31st 2025.

Participation of the KK Pharma Leader d.o.o. team in the education “Digitization of GxP Activities in the Human Medicines Supply Chain” at the Chamber of Commerce of Serbia


The team of KK Pharma Leader d.o.o. participated in the education titled “Digitization of GxP Activities in the Human Medicines Supply Chain”, held on October 30, 2025, and organized by the Serbian Chamber of Commerce.

During the education, the importance of computerized systems in the pharmaceutical industry was presented. These systems monitor all processes throughout the entire lifecycle of a medicine, from research and registration to production, marketing, and distribution, playing a crucial role in the entire medicines supply chain. Our team had the opportunity to expand their knowledge in this field, concluding that electronic systems facilitate compliance with regulatory requirements and enhance process efficiency. 

Posted by Dajana

October, 20th 2025.

Participation of the KK Pharma Leader d.o.o. team at the 51st FASUS


Our company’s team had the opportunity to participate in the 51st Pharmaceutical Meetings (FASUS), held on October 17, 2025.

We were very pleased to be part of this important event, where we had the opportunity to further expand our knowledge in the fields of medicine and pharmacy, as well as to exchange experiences with our colleagues. Our team attended a number of highly engaging lectures delivered by outstanding speakers, covering current topics and modern therapeutic approaches, which contributed to the advancement of our professional expertise. 

Posted by Ljiljana

October, 20th 2025.

Participation of KK Pharma Leader d.o.o. team at the XX ALIMS Symposium


The Medicines and Medical Devices Agency of Serbia (ALIMS) organized the XX Symposium, held from October 16 to 18, 2025, at Kopaonik, with the participation of representatives from the European Medicines Agency (EMA), the World Health Organization (WHO), the European Directorate for the Quality of Medicines (EDQM), national regulators from the region and Europe, as well as experts from academia and the pharmaceutical industry.

This year’s symposium focused on the digitalization of regulatory processes as a base for greater efficiency and transparency, combating falsified medicines through local solutions to a global threat, harmonization with European and international regulatory standards (EU, WHO, ICH), and the application of new technologies and strengthening transnational cooperation to improve patient health. 

Posted by Dajana

October, 15th 2025.

Participation of our company’s team at the event “World United Against Falsified and Substandard Medical Products”


On October 14, 2025, the Medicines and Medical Devices Agency of Serbia (ALIMS), in cooperation with the Serbian Chamber of Commerce, organized an international conference titled “World United Against Falsified and Substandard Medical Products.”

At this important event, our company’s team had the opportunity to participate in discussions and exchange experiences with experts from both Serbia and abroad. The conference emphasized the importance of raising awareness and improving the detection of falsified and substandard medical products through the exchange of knowledge and examples of good practice at the national, regional, and global levels. 

Posted by LJiljana

September 23th, 2025.

Participation of our company’s team at the event “Digital Transformation of Regulatory Affairs for Medicines: RIMS Variations, PMS (IDMP), and ePI”


At the presentation held on September 22, 2025, at the Serbian Chamber of Commerce, the Medicines and Medical Devices Agency of Serbia (ALIMS) introduced the procedure for submitting variation applications for marketing authorizations of human medicines via the RIMS portal.

As part of the RIMS IDMP module presentation, special emphasis was placed on the development of electronic product information (ePI), which will play a key role in improving access to up-to-date medicine information for both healthcare professionals and the general public. 

Posted by Ana

June, 10th 2025.

Participation of the KK Pharma Leader team in the panel discussion “Personal Data Protection from the Perspective of Business Processes” at the Serbian Chamber of Commerce


On June 9, 2025, the KK Pharma Leader team participated in a panel discussion organized by the Serbian Chamber of Commerce in cooperation with the Association of Corporate Lawyers. The discussion focused on the most common challenges faced by businesses in the field of personal data protection.

The Commissioner for Personal Data Protection addressed the participants, and his associates presented common issues and proposed solutions. 

Posted by Dajana

May 20th, 2025.

Participation of the KK Pharma Leader d.o.o. team in the education “Pharmaceutical Quality System in the Medicine Supply Chain” at the Chamber of Commerce of Serbia


The team of KK Pharma Leader d.o.o. participated in the education titled “Pharmaceutical Quality System in the Medicine Supply Chain”, held on May 12, 2025, and organized by the Serbian Chamber of Commerce.
During the education, the Business Code for Responsible Persons for Quality in the Supply Chain of Medicines for Human Use was presented, while our team had the opportunity to gain in-depth insight into the principles and procedures of the Pharmaceutical Quality System implemented throughout the entire supply chain – starting from manufacturers of medicines and active pharmaceutical ingredients (APIs), through galenic laboratories and wholesalers, all the way to pharmacies and hospital pharmacy departments. 

Posted by Dajana

April 11th, 2025.

Participation of our company’s team in the education organized by the Chamber of Commerce of Serbia titled “The Issue of Illicit Trade in Food Supplements in the Republic of Serbia”


On April 10, 2025, the Chamber of Commerce of Serbia held the education on the topic “The Issue of Illicit Trade in Food Supplements in the Republic of Serbia” which was attended by our company’s team. During the education, all necessary steps for registration food supplements in the Ministry of Health’s database were highlighted, along with the potential risks associated with the illicit trade in food supplements. Additionally, the measures that should be taken to ensure a high level of protection of human health and to prevent the use of unsafe and non-compliant products were emphasized.

Posted by Aleksandra

April 4th, 2025.

Participation of our company's team in the ALIMS digitalization process presentation  


At a presentation held on 03.04.2025 at the Chamber of Commerce and Industry of Serbia, the Medicines and Medical Devices Agency of Serbia (ALIMS) presented its plans for implementing key digital initiatives in 2025.

Our company's team had the opportunity to learn about the plans for implementing the centralized Human Medicines Registry (RIMS PMS), electronic product information (ePI), and improvements in post-authorization procedures. Additionally, the Backlog Cleaning process for the variations was announced to enhance efficiency and align with EU standards.

Posted by Aleksandra

March 25th, 2025.

Participation of our company’s team at the eighth ALIMS Workshop on “Registration and Renewal of Medical Devices”


Our company team attended the 8th ALIMS workshop held on March 20, 2025, where key information and updates regarding the registration and renewal of medical devices were presented. The topic of system registration in accordance with Article 22 of the MDR and Article 12 of the MDD was particularly significant and provided additional guidance on preparing a complete dossier for system registration in compliance with these articles of EU regulations. Additionally, the process of searching the ALIMS registers for medical devices was once again clarified, which will also be highly beneficial in future procedures.

Posted by Aleksandra

December 27th, 2024.

Participation of our company’s team at the seventh ALIMS workshop on medical devices


On December 26, 2024, the Medicines and Medical Devices Agency of Serbia (ALIMS) held the seventh workshop on the topic "Changes and amendments in the Medical Device Registration Process." By organizing this educational event, ALIMS continued to demonstrate its commitment to patient safety, regardless of the holiday season.

During this session, our company’s team had the opportunity to learn more about the types of changes and amendments, regulatory requirements regarding documentation, and the processes for creating requests on the Agency's ADIS portal. Additionally, participants were provided with numerous useful practical examples and exceptions that will be of great benefit in future work. 

Posted by Aleksandra

December 5th, 2024.

Participation of our company’s team in the Chamber of Commerce of Serbia education on the vigilance system


Our company team attended the education titled “Medical Devices on the Market – Vigilance System,” held on December 4th, 2024, at the Chamber of Commerce of Serbia. The education focused on the importance of vigilance in monitoring and managing incidents related to medical devices on the market.

Our representatives had the opportunity to gain a detailed understanding of obligations and procedures in this area, with an emphasis on the critical role of vigilance in ensuring medical devices users safety and protecting public health. 

Posted by Ana

December 4th, 2024.

Participation of our company’s team in the education “Basis of Pharmacovigilance for Marketing Authorization Holders” 


The Serbian Chamber of Commerce held education on December 3rd on the topic “Basis of Pharmacovigilance for Marketing Authorization Holders”, which was attended by our company’s team. During the education, attention was drawn to the obligations and responsibilities of the persons responsible for pharmacovigilance and their deputies. Special emphasis was placed on requirements that these individuals must fulfill, the tasks required by their position as responsible persons, and the highlighted importance of continuous education in the field of pharmacovigilance.

Posted by Aleksandra

December 3rd, 2024.

Participation of our company’s team at the sixth ALIMS workshop on medical devices


Our company’s team attended the sixth workshop organized by the Agency for Medicines and Medical Devices of Serbia (ALIMS), held on December 2nd, 2024. The workshop focused on the Registration and Renewal of the registration of the medical devices and brought together a large number of authorized representatives and manufacturers of medical devices.

Our representatives had the opportunity to gain valuable insights into current procedures and regulatory requirements, as well as to become thoroughly acquainted with updates and strengthen their knowledge of practical operations in the ADIS MS portal. In addition to expert lectures, the workshop facilitated discussions and the exchange of experiences between participants and representatives of the Agency, further contributing to a better understanding of the registration and renewal processes for medical devices. 

Posted by Ana

December 2nd, 2024.

Participation of KK Pharma Leader d.o.o. at the Third Annual CInMED Conference


The team of KK Pharma Leader d.o.o. participated in the Third Annual Conference of the Medicines and Medical Devices Institute of Montenegro (CInMED), held from November 28th to 30th in Budva, under the title "15 Years of Trust in CInMED: Expertly, Strategically, European!"

The program of this year’s conference was marked by contemporary trends and innovations in EU regulations for medicines and medical devices. Additionally, there were discussions on the established quality standards in the pharmaceutical and medical device market in Montenegro, as well as the scientific achievements of the Institute's experts. 

Posted by Aleksandra

November 26th, 2024.

Participation of our company's team in GMP education at the Chamber of Commerce of Serbia


Our company team attended the education titled “GMP Guidelines for Medicinal Products for Human Use” held on November 25th, 2024, at the Chamber of Commerce of Serbia. The education provided a comprehensive overview of GMP standards and their importance in ensuring quality and compliance with regulatory requirements.

Our representatives had the opportunity to enhance their knowledge of key aspects of GMP procedures, including the implementation of standards in daily operations, which is crucial for medicinal product quality and safety. 

Posted by Aleksandra

October 29th, 2024.

Participation of our company's team in the education "GDP Guidelines for Human Medicines"


The Association for Pharmacy and Medical Activities of the Chamber of Commerce of Serbia organized another educational session on good practices in the distribution of medicines for human use on October 28th, 2024. During this year's GDP education, relevant inspectors from the Ministry of Health provided participants with an updated overview of the current state of monitoring the implementation of GDP guidelines. Additionally, during this education, our company's team had the opportunity to become familiar with the new Guide for Dealing with Counterfeit/Falsified Medicines from the National Regulatory Authority of Serbia, as well as the Business Code for Responsible Quality Assurance Personnel in the Supply Chain of Human Medicines.

Posted by Aleksandra

October 28th, 2024.

Participation of the KK Pharma Leader d.o.o. team at the 19th ALIMS Symposium


The Medicines and Medical Devices Agency of Serbia (ALIMS) held its 19th Symposium from October 24th to 26th, 2024, under the motto “2.Objectivity, 2.Operativness, 2.Organization, 2.Observation.” This significant event marked the Agency’s 20th anniversary, reflecting on past achievements and successes.

During the comprehensive three-day program, our company’s team attended presentations on the implementation of the new electronic RIMS platform for the Agency’s regulatory processes, new requirements regarding active substance quality, reliance processes in regulatory procedures, bioequivalence, and current topics in medical device regulation.

We congratulate the Medicines and Medical Devices Agency of Serbia on the excellent organization of the Symposium and the celebration of this important milestone! 

Posted by Stefanija

July 8th, 2024.

Participation of our company’s team in the education “Documents Accompanying Medical Devices on the Market”


The Serbian Chamber of Commerce held an education on July 3rd on the topic “Documents Accompanying Medical Devices on the Market,” which was attended by our company’s team. During the training, by comparing the requirements of Directive 93/42/EEC and Regulation 2017/745 regarding the content of the Declaration of Conformity and the EC certificate, as well as comparing these with national regulatory requirements, we had the opportunity to understand the most important information that must be included in the documents accompanying medical devices.
In addition, the importance of the content and validity of the ISO 13485 certificate was highlighted, as well as the responsibilities of the person responsible for regulatory compliance, which will undoubtedly be of great benefit for our future work. 

Posted by Aleksandra

April 17th, 2024.

Participation of our company's team in the fourth and fifth workshops of the Medicines and Medical Devices Agency on the topic "Changes and amendments to the registration of medical devices"


This year, Medicines and Medical Devices Agency of Serbia continued the practice of organizing workshops on current topics in the field of registration of medical devices. This time, our company team took part in two workshops that were held on March 28 and April 16 on the topic of "Changes and ammendments to the registration of medical devices".
Experts from the Medicines and Medical Devices Agency shared with the participants of the workshops the latest information on the requirements for the necessary documentation for the notification of changes and ammendments, gave a detailed explanation of the process of notification of changes and ammendments, and clarified the doubts of the participants from the practice. 

Posted by Aleksandra

March 8th, 2024.

Participation of the KK Pharma Leader team in the education "Risk assessment for medical devices"


Risk assessment for medical devices is a continuous process that represents an obligation, but also a moral and ethical duty of the manufacturer, and ensures that only safe medical devices that comply with the requirements of the current regulation come to the market. Recognizing the importance of this process, Chamber of Commerce and Industry of Serbia organized on March 1, 2024, an education on the topic "Risk assessment for medical devices".

At this education, our company's team had the opportunity to learn about the requirements of ISO 13485 and ISO 14971 in terms of risk assessment, but also to review the key segments that every medical device should have in the Risk Management File within its technical documentation. 

Posted by Katarina

Februar 27th, 2024.

Participation with presentation on Session of Manufacturers of Medical devices Group of Chamber of Commerce and Industry of Serbia, held on February 26th 2024.


At the invitation of the Chamber of Commerce of Serbia, our CEO Katarina Kovačević attended the session of the Group of Medical Device Manufacturers, where she gave a presentation entitled "Preparation of documentation for the registration of a medical device".

The presentation was held in order to share experiences and help manufacturers to better prepare documentation and adapt to the new regulations and the transition period from the Directive to the Regulation. 

Posted by Katarina

Februar 8th, 2024.

Participation with presentation on Session of Importers and Distributors of Medical Devices Group of Chamber of Commerce and Industry of Serbia, held on February 7th 2024.


At the invitation of the Chamber of Commerce of Serbia, our CEO Katarina Kovačević attended the meeting of the Group of Importers and Distributors of Medical Devices, where she gave a presentation entitled "Preparation of documentation for the registration of a medical device".

The presentation was held in order to share experiences and help the authorized representatives to better prepare the documentation and adapt to the new regulations and the transition period from the Directive to the Regulation. 

Posted by Katarina

December 20th, 2023.

Participation of KK Pharma Leader d.o.o on Second Annual Conference CInMED


The team of KK Pharma Leader d.o.o. participated in the Second Annual Conference of the Institute for Medicines and Medical Devices of Montenegro (CInMED) Synergy of Regulation and Science on the European Path, held from December 14 to 16 at the Avala Hotel in Budva.

The program of this year's conference was marked by current regulatory topics, and the large attendance and excellent organization further emphasized the importance of such events for the improvement of regulations in the field of medicines and medical devices in Montenegro. 

Posted by Aleksandra

November 28th, 2023.

The participation of our company at the education „System of vigilance of medical devices in the Republic of Serbia“


On November 23, 2023, Chamber of Commerce and Industry of Serbia organized an education on the topic "System of vigilance of medical devices in the Republic of Serbia".

Representatives of our company participated in this training and they had the opportunity to learn about the obligations of health workers, manufacturers and authorized representatives in the vigilance system, as well as to hear examples of practical cases from the lecturers from the Medicines and Medical Devices Agency.

Posted by Aleksandra

November 17th, 2023.

The participation of the team of KK Pharma Leader d.o.o. at the workshop "Registration/extension of registration of medical devices"


In the light of the harmonization with Regulatons (EU) 2017/745 and 2017/746, our company team attendend the second workshop with the topic "Registration/extension of registration of medical devices" that was held by Medicines and Medical Devices Agency of Serbia on November 15th, 2023.

Extremely informative lectures, followed with discussion and concrete examples, provided clarification of current regulatory requirements, but also resolved doubts from practice, which will be of great benefit to all participants in their further work. 

Posted by Stefanija

October 16th, 2023.

Participation of KK Pharma Leader d.o.o. at the 17th ALIMS Symposium with active participation of our CEO Katarina Kovačević as panelist


A huge thanks to the Medicines and Medical Devices Agency of Serbia (ALIMS) for giving our CEO Katarina Kovačević a chance to participate as a panelist on the 18th ALIMS symposium "Healthy Unity With Deep Roots".

Our CEO presented KKPL standard procedure for preparing documentation for submitting an application for registration of medical device, on the Panel discussion - Registration, extension of registration, changes and additions to the registration of medical devices, with special emphasis on challenges arising from the application of new EU regulations. We strongly believe that good preparation of documents is essential for successful and faster registration process, therefore this presentation was held in order to help other pharmaceutical companies reach this common goal.

Kudos to the organization team of Simpozijum Alims, as well as moderators and lecturers on another successful symposium!

Posted by Stefanija

May 24th, 2023.

The participation of our team at the conference “Fighting the organized theft of medicines in the Balkans and in the European Union through the MEDI-THEFT project”


The KK Pharma Leader company team attended the conference “Fighting the organized theft of medicines in the Balkans and in the European Union through the MEDI-THEFT project”, which was held on May 23, 2023, at the Chamber of Commerce and Industry of Serbia. At the held conference, the MEDI-THEFT project, co-financed by the European Union, which the Medicines and Medical Devices Agency of Serbia implements with partners, and which aims to prevent the theft of medicines that are in the legal chain (most often from pharmacies, hospitals, etc.) as well as their re-entry into the distribution chain, was presented. The conference enabled companies and all other relevant actors to network at the local and international level and thus contribute to the prevention of pharmaceutical crime, counterfeiting and theft of the medicines.

Posted by Marijana

May 16th, 2023.

The participation of the team of KK Pharma Leader d.o.o. at the workshop "Applied pharmacoeconomics - analysis of the impact on the budget"


In recent years, pharmacoeconomics has gained more and more importance, as health care costs are constantly increasing, and more budget funds are spent on pharmacotherapy. On April 5, 2023, the KK Pharma Leader company team participated in a workshop organized by the Association for Continuing Education "EduExpert Center". The lecturer at the workshop called "Applied pharmacoeconomics - analysis of the impact on the budget" was Prof. Dr. Slobodan Janković, full professor of pharmacology with toxicology and clinical pharmacy at the Faculty of Medicine of the University of Kragujevac, also an expert in the field of pharmacoeconomics, with many years of experience in the education of representatives of the pharmaceutical industry and the employees of competent institutions that evaluate submitted applications.

Posted by Stefanija

May 15th, 2023.

Participation of representative of the company KK Pharma Leader d.o.o. at the 44th DermoFASUS pharmaceutical meetings


The 44th Pharmaceutical Meeting (DermoFASUS) was held on May 12, 2023, in the Crystal Hall of the Hyatt Regency Hotel in Belgrade. These meetings enriched the offer of the FASUS expert meeting, with a meeting in the field of skin care and health, as well as cosmetics. Lectures dedicated to the latest knowledge in the field of cosmetics were held, and the attending pharmacists, pharmaceutical technicians, doctors and professionals in the field of cosmetology had the opportunity to enrich their knowledge and exchange experiences. A representative of our team followed the event live.

Posted by Ljiljana

April 7th, 2023.

Participation of our company at the expert meeting "The problem of the illegal market of dietary supplements in Serbia"


An expert meeting on the problem of the illegal market of dietary supplements in Serbia was held at the Chamber of Commerce of Serbia on April 4th, 2023. Lecturers from numerous state institutions pointed out that this problem requires special attention and constant education of the general public.
In order for the use of dietary supplements to be safe, controlled and rational, the involvement of all relevant institutions is necessary. 

Posted by Katarina

March 20th, 2023.

Participation of the company team in continuous education "Pharmacovigilance and vigilance of medical devices"


The team of KK Pharma Leader participated in continuous education "Pharmacovigilance and vigilance of medical devices", within the framework of the 43rd Pharmaceutical Meetings (FASUS) held on March 17, 2023 in the Crystal Hall of the Hyatt Regency Hotel in Belgrade. Prominent experts from the Agency for Medicines and Medical Devices of Serbia as lecturers, showed with great effort concrete examples how to effectively monitor the safety of medicinal products and medical devices on the market, and they invited health professionals to continue to participate actively in that process, in order to contribute to the most effective system of pharmacovigilance and vigilance in our country.

Posted by Marijana

March 8th, 2023.

Participation of our team in the workshop "Registration/extension of registration of medical devices"


The medical devices sector of the Medicines and Medical Devices Agency of Serbia continues with innovations in the way of doing business and digitalization of business processes. On 07.03.2023. the first workshop was held in the independent organization of ALIMS with an overview of the daily challenges during the procedures of registration and extension of the registration of medical devices. This interactive workshop enabled the exchange of experiences between assessors and applicants, as well as the resolution of perplexities from practice and the presentation of further steps in order to comply with EU regulations.

Posted by Stefanija

March 6th, 2022.

Participation of our company in the Cosmetics Europe seminar


The Serbian Chamber of Commerce hosted an important event, not only for Serbia, but also for the region. The seminar of the European trade association for the cosmetics and personal care industry, Cosmetics Europe, was organized in cooperation with the Association of manufacturers, importers and distributors of detergents and cosmetic products in Serbia (KOZMODET). This seminar was dedicated to important topics, major changes in Europe, and therefore in Serbia, among which are the Green Deal, the European chemical strategy for sustainability and microplastics.

Posted by Marijana

December 8th, 2022.

Participation of our company's representatives on the education "Fundamentals of pharmacovigilance for marketing authorization holders"


Representatives of the KK Pharma Leader attended the education "Fundamentals of pharmacovigilance for marketing authorization holders" organized for Qualified Persons for Pharmacovigilance and Deputies in the Serbian Chamber of Commerce, in cooperation with the National Center for Pharmacovigilance. Annual trainings in this area enable continuous training for responsible persons and their deputies, which is also their legal obligation. All participants of the training received a certificate, which provides proof that they have adequate knowledge in this area.

Posted by Katarina

December 5th, 2022.

Participation of our company at the training intended for responsible persons in the vigilance system of medical devices


The team of KK Pharma Leader attended a training intended for responsible persons in the vigilance system of medical devices. At the training held by experts from the medical devices sector of the Medicines and Medical Devices Agency of Serbia, the vigilance system for manufacturers and authorized representatives was presented, through current regulations and a practical demonstration of work in the ALIMS electronic system.

Posted by Stefanija

November 17th, 2022.

Participation of our company on expert meeting "Dietary supplements in the Republic of Serbia"


An expert meeting "Dietary supplements in the Republic of Serbia" was held at the Serbian Chamber of Commerce. The Association of Pharmaceutical and Medical Economy and IQVIA presented an overview of the market of dietary supplements registered in the register of the Ministry of Health of the Republic of Serbia and trends in sales from the beginning of 2019 to September 2022.

Posted by Jelena

October 31st, 2022.

Participation of our company on education „Cosmetic products - step towards full aplication of new regulation”


Another education regarding the new regulations in the field of cosmetic products was held at the Chamber of Commerce of Serbia on October 28, 2022. The topic of the education was current challenges in the application of regulations and the possibility of applying IT technologies to overcome them.

Posted by Marijana

October 25th, 2022.

Participation of KK Pharma Leader d.o.o. at the 17th ALIMS Symposium

The team of KK Pharma Leader d.o.o. attended this year's symposium "To new heights of regulatory practice", held on October 21-22, 2022 in the Gorski Hotel on Kopaonik mountain. The record attendance was a confirmation of the excellent organization, the actuality of the topics and the expertise of the lecturers, as well as the importance of such events for the improvement of regulations in the field of medicines and medical devices in the Republic of Serbia.

Posted by Jelena

September 28th, 2022.

KK Pharma Leader d.o.o. has harmonized its business with the requirements of the ISO 9001:2015 standard


KK Pharma Leader d.o.o. has harmonized its business with the requirements of the ISO 9001:2015 standard and received the ISO certificate issued by TÜV AUSTRIA on 27th September 2022, for the following scope: preparation of regulatory documentation for medicinal products, medical devices, dietary products and supplements, cosmetic products, regulatory representation for pharmaceutical products, pharmacovigilance and vigilance, as well as trainings from listed fields.

This certificate is a confirmation of many years of effort to ensure that the services we provide are always at the highest level, and in that spirit we will continue to improve our work.  

Posted by Jelena

June 27th, 2022.

Participation of our company in the education “Presentation of guidances in the area of cosmetic products”


Towards new requirements in the area of cosmetic products, the education “Presentation of guidances in the area of cosmetic products” was held in the Chamber of Commerce of Serbia. This current topic was addressed both from the point of view of manufacturers in the Republic of Serbia, and from the point of view of companies that are representatives of foreign manufacturers of cosmetic products, and thus greatly clarified the new requirements of Serbia and the EU.

Posted by Marijana

May 25th, 2022.

Participation of our company in the education for authorized representatives of foreign manufacturers and manufacturers of medical devices in the Republic of Serbia


In anticipation of the new profile "Suveillance" on the ePortal of ALIMS for medical devices, the education "Introduction of the profile of monitoring medical devices on the market (surveillance)" was held at the Belgrade Chamber of Commerce. The lecturers were the head and experts of the Department for Medical Devices who, through lectures, practical training and discussion, explained the requirements that await us in this area. A representative of our team followed the event live, and the rest of the team followed the training online.

Posted by Stefanija

April 8th, 2022.

Participation of our company's representative in the panel discussion “Digitalization and protection of personal data”


Representatives of KK Pharma Leader attended a panel discussion on April 8, 2022 at the Hilton Hotel on "Digitalization and protection of personal data" organized by the Law Office Stanković and Partners and JBAS - Japanese Business Alliance in Serbia with the support of the Slovenian Business Club and CANSEE Canadian-Serbian Business Association. A very interesting panel discussion, and especially useful for us through the presentation of the current digitization in health care.
We thank the lawyer Nenad Stanković from the Law Office Stanković and partners for the invitation.

Posted by Katarina

November 28th, 2021.

Participation of our company's representatives at the 16th ALIMS 2021 Symposium


After a two-year break, the ALIMS Symposium was held with the topic "Beat COVID-19: experiences, reality, opportunities". Due to the situation with the COVID-19 disease pandemic, the event could only be followed online. As every year, current topics in the field of drugs and medical devices were covered, but also the challenges faced during the pandemic by ALIMS and other regulatory authorities from the countries in the region, responsible for these areas, whose representatives shared their experiences.
Special praises for the organization of the event, which was flawless in such challenging conditions. 

Republic of Serbia:

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11 000 Belgrade, Serbia



Montenegro:
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85310 Budva, Crna Gora

Office Hours:
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  • Office Hours:
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Business Data:
  • Name: KK PHARMA LEADER D.O.O.
  • ID Number: 21417823
  • Tax ID Number: 111043766

  • Business Data:
  • Name: KK PHARMA LEADER D.O.O.
  • ID Number: 51243100
  • Tax ID Number: 03675785

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