International Cooperation

Successful Visit to Russia of ALIMS Delegation Led by Director Sasa Jacovic

A delegation of the Medicines and Medical Devices Agency of Serbia (ALIMS), led by Director Dr. Sasa Jacovic visited Moscow on October 30 – 31, 2013 at the invitation of the Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (Roszdravnadzor). The occasion was the 15th Annual All-Russian Conference “State Regulations in the Area of Drugs and Medical Devices Circulation” (FarmMedObrashenie – 2013) where the ALIMS delegation held a presentation on the national aspects of regulating the pharmaceutical market.

More importantly, the Roszdravnadzor management led by Acting Director Dr. Mikhail A. Murashko and the ALIMS delegation had a bilateral meeting at which the possibilities of cooperation between these two reference regulatory bodies in the field of medicines and medical devices in their respective regions and beyond were discussed. Since this ALIMS visit took place at the same time as the visit to the Russian Federation by the high state Serbian delegation led by Serbian President Mr Tomislav Nikolic and consisted of a number of businessmen from Serbia, Dr. Jacovic commented on this fact in his speech at the negotiations, and as a guest at a reception at the Serbian embassy in Moscow, he was also able to convey the message of the Serbian state officials on providing support to the initiative for cooperation between these two institutions.

The exceptionally successful negotiations between Director Jacovic and Acting Director Murashko, among other things, resulted in establishing cooperation in the fields of competence of both institutions. The willingness of both parties to sign the Memorandum of Understanding on exchange of information, education and technical and analytical support, with emphasis on quality control of medicines and medical devices, monitoring and responding to cases of adverse reactions to medicines and medical devices and fight against counterfeit medicines and medical devices. This Memorandum is expected to be signed as soon as possible, and taking into account the scope of trade in pharmaceutical products between the Russian Federation and the Republic of Serbia, as well as existing and potential investments and, above all, importance for the public health in both countries, there is no doubt that this Memorandum of Understanding will be extremely useful for ensuring greater safety and availability of medicines and medical devices in Serbia and Russia.

Letter of Intent Signed with Health Canada

On November 14, 2013, in an official letter signed by Catherine Parker, senior executive director, Health Canada expressed their desire to continue cooperation with the Medicines and Medical Devices Agency of Serbia as part of the Canadian HIV Vaccine Initiative’s (CHVI) regulatory capacity building program.

Established in 2007 and renewed in 2010, CHVI was established as collaboration between the Government of Canada and the Bill and Melinda Gates Foundation. CHVI represents a significant Canadian contribution to global efforts in the development of a safe, effective, affordable and globally accessible HIV vaccine. One of CHVI’s key goals is to enable emerging National Regulatory Agencies (NRAs) to enhance their regulatory frameworks and improve their capacity with respect to the regulation of HIV/AIDS vaccine clinical trials with the long term goal of facilitating the issuance of marketing authorization for these products.

The Biologics and Genetic Therapies Directorate (BGTD) is responsible for CHVI’s regulatory capacity building activities within Health Canada. Under CHVI, BGTD mentors and provides training to NRAs to help improve their preparedness to evaluate these products; work with partners to promote the global harmonization of regulatory pathways; and work with relevant international stakeholders to address HIV/AIDS vaccines regulatory policy issues.

BGTD intends to continue to work with the Medicines and Medical Devices Agency of Serbia under the CHVI to help strengthen this institution’s capacity in the area of the regulation of vaccines including various forms of assistance as outlined in the Letter of Intent.

ALIMS Director Dr. Sasa Jacovic signed the Letter of Intent in behalf of Medicines and Medical Devices Agency of Serbia.

Cooperation Between Medicines and Medical Devices Agency of Serbia (ALIMS) and Italian Medicines Agency (AIFA)

The Italian Medicines Agency – AIFA (Agenzia Italiana del Farmaco) has in previous years proven to be one of the leaders in the fight against counterfeit medicines and medical devices in Europe, as well as worldwide, and the support of this institution would mean ALIMS’s progress in several key points, which would be verified by the signing of a Memorandum of Understanding agreed between these two institutions.

Cooperation with AIFA is also specified in the ALIMS activity plan for 2014, but cooperation with this institution in the context of counterfeit medicines was developed before the initiative to sign the Memorandum.

Specifically: in 2012 and 2013, ALIMS and AIFA jointly organized online seminars and twice this new kind of education had participants from a number of state institutions and the pharmaceutical industry in Serbia and Italy, as well as other European countries (Switzerland, Portugal, the UK, etc.).

At AIFA’s invitation in late 2013, ALIMS also became an associate member of the FakeShare Project, which in addition to the initiator and promoter of the Project – AIFA, gathers a large number of institutions in Europe, North and South America with a goal to exchange information and form databases and cases in order to successfully fight against counterfeit medicines and their trade and advertising through the Internet.

Finally, AIFA representatives have repeatedly been lecturers at professional conferences on the topic of counterfeit medicines in Serbia, including an expert meeting organized by ALIMS.

The Memorandum and the further development of cooperation with AIFA are of great importance, considering the increasingly frequent cases of counterfeit medicines and medical devices in the territory of Serbia, and will enable ALIMS and other institutions, engaged in these activities, to successfully act against this phenomenon in Serbia.

Certified Experts from World Organisation for Animal Health Visit ALIMS

On March 21, 2013, certified experts from the World Organisation for Animal Health – OIE visited ALIMS as part of a mission for the evaluation of veterinary services in the Republic of Serbia. On this occasion, ALIMS representatives held presentations on the subject of ALIMS authority and roles, procedures, operations and results of the veterinary sector, laboratory quality control of medicines and medical devices, as well as advertising and marketing and consumption of veterinary medicines, and answered questions from the OIE representatives. During their stay, they also visited the ALIMS National Control Laboratory.

Poseta sertifikovanih eksperata Svetske organizacije za zdravlje životinja

OIE

ALIMS Starts New Project with Montenegrin Agency for Medicines and Medical Devices

Along with the project “Capacity Building of the Agency for Medicines and Medical Devices of Montenegro (CALIMS)” launched in May 2011, ALIMS has started a new, six-month project of the same type, also funded by the World Bank, but which pertains to the study visits of CALIMS experts to the Serbian Agency for educational purposes and qualitative improvement of the work processes in CALIMS.

Continuation of Project with European Medicines Agency

After the successful completion of the IPA (Instrument for Pre-accession Assistance) project of the European Union, implemented from December 2009 to September 2011, a new, same type of project was initiated in October 2011.

This is a project sponsored by the European Medicines Agency – EMA and funded by the European Commission. The project is intended for the regulatory institutions in the field of medicines for human and veterinary use of the candidate countries (Turkey, Croatia, Macedonia) i.e. potential candidate countries for EU membership (Serbia, Bosnia and Herzegovina, Montenegro, Albania), and in the end, Kosovo in accordance with UN SC Resolution 1244/99. As for our country, the project involves the Ministry of Health, Ministry of Agriculture, Forestry and Water Management, Veterinary Directorate and Medicines and Medical Devices Agency of Serbia (ALIMS).

The main objectives of the IPA project are to develop contacts between the EMA, which is responsible for the implementation of IPA projects, and relevant national regulatory authorities in the field of medicines for human and veterinary use of the above mentioned countries, as well as improving their capacity in preparation for future equal participation and membership in the EU regulatory network.

ALIMS Starts World Bank Project with Montenegrin Agency for Medicines and Medical Devices

Having won a tender called by the World Bank, Medicines and Medical Devices Agency of Serbia in May 2011 started a one-year project entitled “Capacity Building of the Agency for Medicines and Medical Devices of Montenegro (CALIMS).”
This project, funded by the World Bank, aims to increase the competence and raise the operational level of CALIMS through ALIMS expert missions.

ALIMS Takes Part in First Pharmacy Congress of Montenegro

Delegation of the Medicines and Medical Devices Agency of Serbia attended the international “First Pharmacy Congress of Montenegro” held in Becici on May 12 – 15, 2011. ALIMS also participated with three poster presentations prepared by its employees regarding the activities of the Agency. In addition, the ALIMS representatives gave a lecture “Access to Independent Information on Medicines – the Role of the Medicines and Medical Devices Agency of Serbia” at the symposium of the Agency for Medicines and Medical Devices of Montenegro on the topic of regulation of medicines and medical devices.

Nastupanje ALIMS-a na I kongresu farmaceuta Crne Gore 1 Nastupanje ALIMS-a na I kongresu farmaceuta Crne Gore 2

ALIMS/HALMED Info Days

The first part of the conference “ALIMS/HALMED Info Days” took place on Thursday November 11, 2010 at Galenika a.d.’s Blue Hall. The meeting, with over 70 participants, was mostly attended by representatives from the Agency for Medicinal Products and Medical Devices of Croatia (HALMED), Medicines and Medical Devices Agency of Serbia (ALIMS) and Agency for Medicines and Medical Devices of Montenegro (CALIMS), as well as representatives of the company Galenika a.d., Association of Local Manufacturers of Medicinal Products and representatives of the Croatian pharmaceutical manufacturers.

The meeting was first addressed by Galenika a.d. Managing Director Nenad Ognjanovic, Pharm. B. sp., followed by the lectures “Experiences in evaluating documentation on the quality of medicines” held by Katica Milcic, Pharm. B., senior expert adviser to HALMED, “Assessing the API quality in the licensing process of the drug: API manufacturers and their GMP, 2. API quality: ASMF/Module 3 : 3.2.S, 3. API Variations” by Svetlana Mihaljica, Pharm. B. sp., Head of the ALIMS Pharmaceutical Department, and finally “Comparative review of regulatory requirements in Croatia and Serbia, with special reference to the Law on Medicines” by Jelena Ognjenovic, Pharm. B., Head of the International Registration Department, Galenka a.d.

On the second day of the HALMED representatives’ visit, November 12, 2010, a tour of the ALIMS National Control Laboratory was organized, along with a presentation on ALIMS’s achievements in ensuring quality, efficacy and safety of medicines. Colleagues from HALMED and ALIMS all considered this meeting very useful for the exchange of experiences and the development of mutual dialogue, but also for providing advice on how to overcome challenges faced by both national regulatory bodies, and the overall conclusion was that these positive initiatives should continue through mutual cooperation between these two institutions and their cooperation with the pharmaceutical industry in Serbia and Croatia.

Pharmacy and Healthcare in Southeast Europe Conference

The fourth annual conference “Pharmacy and healthcare in Southeast Europe” was organized by EMG on Wednesday, November 10, 2010 at the Hyatt Regency Hotel, Belgrade. The conference brought together a number of representatives of the pharmaceutical industry from this region and representatives of national regulatory authorities from Serbia, Croatia, Montenegro and Macedonia, as well as representatives from the Ministry of Health of the Republic of Serbia and the national health insurance funds from neighbouring countries. During Panel 2 – Marketing and Quality Control of Medicines, ALIMS Director Tatjana Sipetic, Pharm. B. sp., held a lecture titled “The role of the Medicines and Medical Devices Agency of Serbia (ALIMS) in determining the quality, efficiency and safety of medicines.”

The event was covered by the media, and after completion, the participants concluded that gathering so many high officials and directors of state institutions, competent in the field of medicines, is very useful for cross-border exchange of experience at the level of regulatory bodies, as well as constructive discussions with industry representatives.

Stavljanje u promet i kontrola kvaliteta lekova 1 Stavljanje u promet i kontrola kvaliteta lekova 2

Introducing ALIMS Activities to Students from Diaspora

Over 40 Serbian students from abroad will meet and voluntarily participate in the work of state institutions of the Republic Serbia as part of the pilot project “Meet the State of Serbia” organized by the Ministry of Diaspora and Organization of Serbian Students Abroad (OSSI) from 26 July – 20 August.
Within this project, Jelena Radenkovic, chemistry graduate with a Masters Degree in biotechnology from the US and Denis Jusovic, a pharmacy student in Vienna, visited the Medicines and Medical Devices Agency of Serbia, on August 3 – 5. During the intensive program, they were acquainted with all the work processes of the Agency, and a very positive highly-graded report on the Agency’s work resulted from their stay, which became part of the project documentation.

Participation of Serbia and ALIMS in IPA (Instrument for Pre-accession Assistance) project

In the period 2009 – 2011, Serbia is participating in the European Union’s IPA (Instrument for Pre-accession Assistance) project. This is a project sponsored by the European Medicines Agency – EMA and funded by the European Commission. The project is intended for the regulatory institutions in the field of medicines for human and veterinary use of the candidate countries (Turkey, Croatia, Macedonia) i.e. potential candidate countries for EU membership (Serbia, Bosnia and Herzegovina, Montenegro, Albania), and, finally, Kosovo in accordance with UN SC Resolution 1244/99. As for our country, the project involves the Ministry of Health, Ministry of Agriculture, Forestry and Water Management, Veterinary Directorate and Medicines and Medical Devices Agency of Serbia (ALIMS).
The main objectives of the IPA project are to develop contacts between the EMA, which is responsible for the implementation of IPA projects, and relevant national regulatory authorities in the field of medicines for human and veterinary use of the above mentioned countries, as well as improving their capacity in preparation for future equal participation and membership in the EU regulatory network.

More specific objectives are, as follows:

  • Establishing strong communication, open dialogue and mechanisms that will facilitate the adoption of common technical requirements among the participating countries, assist in identifying areas of expertise which are expected to receive the greatest assistance from EMA regarding the project, in order to enable the successful transposition of the EU acquis communautaire in national regulations of the countries participating in the project and to prepare them, and their experts, to participate in EMA committees.
  • Inclusion in the EU Telematics programs in order to enable the countries participating in the IPA project to become compatible members of the EMA electronic regulatory networks, after their EU accession.

The first in a series of meetings within the IPA project was held on February 1 – 2, 2010 on the premises of the European Medicines Agency in London and thereby also launched the IPA project.
The IPA project follows previous similar programs, and its implementation involves participation of representatives from the above mentioned institutions in numerous professional meetings held at EMA, expert trainings and organizing conferences during 2010 and 2011. This would assist the regulatory authorities in these countries to prepare for their future involvement in the activities of EMA, when their countries become full EU member states. Also, this training is useful for the general improvement of work processes and competencies of the ALIMS experts and relevant departments of the competent ministries in their day-to-day work.
It is important to note that Serbia has been given the honour of being the only among the potential candidate states to organize an international conference, within the project, to be held in Belgrade in November 2010.

More information about this IPA project can be found via the following link:

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/12/WC500017877.pdf

Arab Republic of Egypt High Delegation Visits ALIMS

On May 10, 2012, Medicines and Medical Devices Agency of Serbia was visited by the high delegation from the Arab Republic of Egypt, led by the Minister of Health and Population of this state H.E. Dr. Fouad Elnawawy accompanied by Egypt Ambassador in Serbia H.E. Mr Aly Galal Mohamed Abdelaziz Bassiouny.
In addition to these officials, the delegation consisted of a significant number of representatives of state institutions, associations and pharmaceutical industry of the Arab Republic of Egypt. After the presentation of the results and responsibilities of ALIMS, Agency Director Tatjana Sipetic and her colleagues discussed the issues raised by the delegation, which was followed by a tour of the ALIMS National Control Laboratory. Representatives of the Arab Republic of Egypt expressed their satisfaction with the level of knowledge about the regulation of medicines and medical devices in Serbia and expressed interest in deepening cooperation in this field at the interstate level.

Poseta visoke delegacije Arapske republike Egipat ALIMS-u 2 Poseta visoke delegacije Arapske republike Egipat ALIMS-u 3

Annual Meeting of Secretaries of National Pharmacopoeia Authorities

The annual meeting of National Pharmacopoeia Authorities was held on May 11 – 12, 2009 at the Medicines and Medical Devices Agency of Serbia organized by the European Directorate for the Quality of Medicines and HealthCare – EDQM & HealthCare, Strasbourg, France.
The meeting was attended by 26 representatives of National Pharmacopoeia Authorities from European Pharmacopoeia member states. In addition, meeting of the Presidium of the European Pharmacopoeia Commission was also at ALIMS.
The meeting was chaired by Ms Susanne Keitel, EDQM Director, and three other prominent EDQM experts participated in its proceedings: Mr Hendrick de Jong, Mr Claude Coune and Ms Emmanuelle Charton.
EDQM, as the Council of Europe Directorate, is the leading European organization which performs introduction and harmonization of quality standards and regulations in the field of medicines, blood transfusions and organ transplants. The role of EDQM is gaining in importance, and some the most important activities for the patients are the fight against counterfeit medicines, harmonization of medicine testing, as well as setting the highest standards for human and veterinary medicines. A special and also very important activity is providing information to the public and patients, and above all, answering questions related to medicines and standardization in this area at EU level. Most of these activities are mirrored in the work of the Medicines and Medical Devices Agency of Serbia.
Since 2004, the National Control Laboratory of the Medicines and Medical Devices Agency of Serbia has been a member of the European Official Medicines Control Laboratory Network – OMCL Network, and our role in various EDQM bodies is manifold. Also, there is a steady flow of information and regular cooperation with EDQM experts.
This was a meeting of the highest rank and another proof of the high status the Medicines and Medical Devices Agency of Serbia has in European organizations, as confirmed by the recently successfully completed Twinning Project for harmonization of the ALIMS work process with EU standards.

Godišnji sastanak sekretara Nacionalnih tela za pitanja farmakopeje 2 Godišnji sastanak sekretara Nacionalnih tela za pitanja farmakopeje 3 Godišnji sastanak sekretara Nacionalnih tela za pitanja farmakopeje 1
Twinning Project

ALIMS Signs Cooperation Agreement with AFSSAPS

The Medicines and Medical Devices Agency of Serbia (ALIMS) signed on March 5, 2009 an agreement on three-year cooperation with the French Agency for Health Products Safety (Agence française de securité sanitare des produits de santé – AFSSAPS) which was on this occasion represented by the Managing Director Jean Marimbert.

Subsequently, ALIMS signed the Letter of Intent with Patrick Dehaumont, Director of the French Agency for Veterinary Health Products (Agence française de securité sanitaire des alments – AFSSA – ANMV), as a guarantee of future cooperation agreement to be signed with this institution.

After the Twinning Project, within which close cooperation for over two and a half was achieved between ALIMS and AFSSAPS and AFSSA – ANMV, this agreement will continue and accomplish further joint work in specific areas and activities.

EU Assistance for Improving Quality of Medicines in Serbia

The final meeting of the Twinning Project was held on March 5, 2009 at the Sava Center. The event was attended by over one hundred and eighty accredited participants, among whom were experts in the field of regulation of health products from Serbia and the region, representatives of the pharmaceutical industry, patients and media. The results of the project were presented, and panel discussions were held, with attendance from representatives of the European Union, France and Serbia.
As part of the opening statements, which were intended to provide strategic and policy perspectives in the regulation of medicines and medical devices in Serbia, among others, the audience was addressed by the Minister of Health of the Republic of Serbia Tomica Milosavljevic, leader of the Twinning Project on the Serbian side, representatives of the European Commission Delegation to Serbia, Pierre Dybman, Head of Operation 1, and Maja Vuckovic-Krcmar, Project Manager in the field of Health and Social Affairs, Jean Marimbert, Director of the French Agency for Health Products Safety (Agence française de securité sanitare des produits de santé – AFSSAPS ), and Patrick Dehaumont, Director of the French Agency for Veterinary Health Products (Agence française de securité sanitaire des alments – AFSSA – ANMV), as well as Zoran Micovic, Director of the Veterinary Department of the Ministry of Agriculture, Forestry and Water Management.
This was followed by three panel discussions on safety and availability of medicines and medical devices, and building institutional capacities. Beside the representatives from the Ministry of Health of the Republic of Serbia and Medicines and Medical Devices Agency of Serbia, the discussions were attended by around fifteen eminent experts from France in the field of regulation of medicines.
At the end of the meeting, the conclusion on the project was given by the representative of the Ministry of Foreign Affairs of France Michel Berlot, followed by Ljiljana Stojanovic, Deputy Project Manager on the Serbian side, and Ljiljana Milosevic-Kapetanovic, former Resident Advisor of the Twinning Project.
To provide Serbian citizens with quality, efficient, safe and accessible medicines and medical devices with the best practices of the European Union – the latest in a series of projects to improve the pharmaceutical sector in Serbia was started in December 2006. This is a project that will ensure the harmonization of activities of the pharmaceutical sector in Serbia with European standards.
The project “Capacity Building of Medicines and Medical Devices Agency of Serbia,” i.e. the Twinning project, worth $1.5 million, funded by the European Union through the European Agency for Reconstruction, was launched within the direct cooperation of the French agencies with Serbian partners. Employee training and improvement of the work processes of the Medicines and Medical Devices Agency of Serbia (ALIMS) were realized during the project, as well as of the corresponding departments of the Ministry of Health of the Republic of Serbia and Veterinary Directorate of the Ministry of Agriculture, Forestry and Water Management of the Republic of Serbia. These activities were intended to practically assist the institutional development of ALIMS as a regulatory body and improvement of relevant inspections in the ministries, but more importantly, to enable the evaluation and marketing of new medicines, clinical trials, monitoring of adverse drug reactionse, as well as inspection and control of production and distribution of medicines in accordance with EU standards.
The French Agency for Health Products Safety (AFSSAPS) and French Agency for Veterinary Health Products (AFSSA – ANMV) were responsible for expert training. Both of these agencies have the highest level of development in the implementation of EU standards and extensive experience in the field of developing regulatations for medicines and networking of regulatory authorities in Europe, as well as in cooperation with European and international partners. Crucial training of local experts involved study visits, participation in international conferences, organizing expert training, seminars and workshops, as well as the continuous exchange of experience with colleagues from France.
While addressing the meeting, Minister of Health of the Republic of Serbia Tomica Milosavljevic said that the Medicines and Medical Devices Agency of Serbia largely adopted European standards and is ready for the implementation of new regulations in the pharmaceutical industry, while His Excellency, the French Ambassador to Serbia, Jean-François Terral expressed his admiration for the expertise and knowledge of Serbian healthcare professionals, and that for that very quality they should be provided with better working conditions. He pointed out that the project to improve the quality control of medicines helped Serbia to introduce European standards in the field of pharmacy, which will lead to faster EU accession.

National Control Laboratory

Agency representatives regularly participate in the work of the European Pharmacopoeia Commision of the European Directorate for the Quality of Medicines and Healthcare – EDQM. As a full member of the Official Medicines Control Laboratory (OMCL) Network), the ALIMS National Control Laboratory achieved excellent cooperation with other laboratories of the Council of Europe member states, which contributes to improving the quality of work and services to clients.
Membership in this network imposes an obligation to implement all the requirements of strict international standards for quality control of medicines and medical devices. Thus, the National Control Laboratory successfully implemented all the requirements of ISO/IEC 17025:2005, and any additional requirements of the OMCL network, defined as the OMCL guidelines.
The high quality of work of the National Control Laboratory is confirmed by regular participation in Proficiency Test Studies (PTS), which are a form of comparing the quality of the laboratory test results obtained, conducted in European laboratories. Results of the National Control Laboratory are traditionally at the very top, which is a confirmation of quality of work.
Compliance of the National Control Laboratory management system with requirements of the ISO/IEC 17025:2005 was checked by EDQM experts EDQM in 2007. The positive compliance assessment allows the accreditation of the National Control Laboratory, which is the final step in its recognition in the OMCL network and Europe in general, as a reputable laboratory for quality control of medicines and medical devices.

National Pharmacovigilance Centre

Medicines and Medical Devices Agency of Serbia cooperates closely with the Uppsala Monitoring Centre (UMC), the World Health Organization (WHO), which is reflected in the active participation of the National Pharmacovigilance Centre in the system of spontaneous reporting, collection and monitoring of information on adverse drug reactions.
The National Pharmacovigilance Centre forwards to this center assessed reports on adverse drug reactions, which occured in our country. On the other hand, the UMC, in order to maintain good practice in pharmacovigilance, communicates with the national centers and informs them of the generated signals (new suspected reactions to medicines), and gives them all other security information relevant for the rational use of medicines.
The National Pharmacovigilance Centre also has access to the UMC database that has over 3 million reports of suspected adverse reactions from a number of countries around the world, which is an important source of information in the overall assessment of the medicine safety profile.

International Cooperation in Combating Counterfeit Medicines and Medical Devices

Counterfeit medicines and medical devices are a global problem faced by all countries of the world. This criminal activity contributes to poor health of patients, even causes fatalities, but also has specific negative economic implications. It is therefore essential that all relevant public authorities actively oppose this phenomenon. To this end, international cooperation is very important, since the counterfeiting of medicines is one of the most common cross-border crimes, and it is also important to use the experience of countries and institutions that have achieved concrete results in this fight, such as AIFA.

Since 2010, Serbia has introduced in its regulations, i.e. the Law on Medicines and Medical Devices (“Official Gazette of RS,” No. 30/10 and 107/12) and the Rulebook on the quality control of medicines and medical devices (“Official Gazette of RS,” No. 64/11 and 463/13) the definition and measures regarding counterfeit medicines in accordance with the recommendations of the World Health Organization (WHO).

It is very important to continue to implement into national legislation the new legal solutions in this area, such as the EU Directive 2011/62 – the so-called Falsified Medicines Directive and Medicrime Convention of the Council of Europe, which Serbia is also invited to join and sign.

Medicines and Medical Devices Agency of Serbia is, heretofore, entrusted by law with the quality control of medicines and medical devices, which includes special control, i.e. cases where the inspection of the Ministry of Health, in order to resolve identified problems in the quality of a medicine or medical device, takes samples of suspicious medicines and medical devices and forwards them to the ALIMS National Control Laboratory, for control.

In addition to the reported suspicions of quality or deviations from the quality standard of a medicine or medical device, this control is also performed in case of suspecting a fake medicine or medical device. Based on their findings, the Agency will issue a recommendation to the Ministry of Health regarding the individual medicine or medical device that was controlled.

The Agency cooperates with other state authorities in Serbia, and in addition to continuous contact and coordination with the inspection of the Ministry of Health, ALIMS also communicates with the Ministry of Internal Affairs and Customs Administration, and is a part of the working group for intellectual rights protection coordinated by the Intellectual Property Office, then has a representative in the group of the Single Points of Contact (SPOC) in the context of cooperation with the European Directorate for the Quality of Medicines and HealthCare (EDQM ) of the Council of Europe and participates in all meetings and training courses in this field.

The Agency is also, as part of its activities, conducts trainings for both the general and professional public such was, for example, a conference “Medicines Safety – how to monitor counterfeit medicines and establish a sustainable pharmacovigilance system” that was held in Belgrade, on September 25, 2012. The Agency is also present in the media, and always uses the opportunity to warn the general and professional public on the dangers of using counterfeit medicines and medical devices.

Further institutional development in this area would be beneficial for the Agency, primarily due to the strengthening of internal capacity in order to effectively meet the objective challenges set before it.

Among the current international support and cooperation that the Agency has achieved, emphasis is on cooperation with WHO, from which ALIMS receives international alerts relating to counterfeit medicines. Also, the Agency cooperates with the organization Heads of Medicines Agencies (HMA), which gathers medicines agencies of the European Union, where ALIMS has permanent representatives in the Working Group of Enforcement Officers for Counterfeit Medicines (WGEO) in the area of medicines for human and veterinary use, and also regularly receives warnings through this organization about the emergence of counterfeit medicines in the markets of HMA member states, which can potentially endanger the Serbian market. The Agency is also included in international initiatives to combat counterfeit medicines, such as operation Pangea organized once a year by the Interpol and which in 2013, when it was held for the sixth time, involved 99 countries, including Serbia. Finally, there is cooperation with the European Directorate for the Quality of Medicines and HealthCare where the Agency also has a representative on the Committee of Experts on Minimising Public Health Risks Posed by Counterefiting of Medical Products and Similar Crimes (CD-P-PH/CMED), and is actively involved in numerous projects and initiatives started and implemented by this Committee.