Signing of an agreement with the National Agency for Medicines and Medical Devices of Romania
On 19th August, 2015, Managing Director of the Medicines and Medical Devices Agency of Serbia (ALIMS) Sasa Jacovic, M.D.sp., together with the President of the National Agency for Medicines and Medical Devices of Romania (NAMMD) Dr. Marius Savu, signed a cooperation agreement. This agreement was signed during the official visit of the high level delegation of NAMMD which also included Vice-President Dr. Marius Tanasa. During the visit, NAMMD management was introduced to the responsibilities, organization and, above all, successful results of ALIMS in the previous period.
In the discussions, it was concluded that the ALIMS largely achieved the standards and level of development of agencies for medicines and medical devices of EU Member States, but the readiness of Romania and NAMMD to further support ALIMS was confirmed, particularly regarding in its inclusion into the European regulatory network before the accession of the Republic of Serbia EU, and providing of specific information and advice on technical issues.
This agreement signifies a completion of a two-year initiative by ALIMS regarding the formalization of regional cooperation with regulatory bodies of the neighboring countries, which included the signing of the Memorandum of Understanding and Cooperation with the agencies for medicines and medical devices of Croatia, Bosnia and Herzegovina, Macedonia and Montenegro in 2014, and Bulgaria and now Romania 2015.
The ultimate goal of these efforts is certainly continuous availability of high-quality, efficient and safe medicines and medical devices to our citizens and healthcare professionals, as well as their protection from defective or counterfeit products but also further progress in European integrations of the Republic of Serbia and ALIMS capacity building through training and exchange of information with colleagues from the region.
Signing of a Memorandum of Understanding with the Bulgarian Drug Agency
On Wednesday, July 22nd, 2015 in Sofia, Bulgaria, a Memorandum of Understanding between the Medicines and Medical Devices Agency of Serbia (ALIMS) and the Bulgarian Drug Agency (BDA) was signed. On behalf of ALIMS, the agreement was signed by Sasa Jacovic, M.D.,sp., the managing director of ALIMS, and on behalf of the BDA its Executive Director Assoc.Prof. Assena Stoimenova, PhD, MScPharm, MPH.
This memorandum is the result of negotiations between the two institutions, and the exchange of information and cooperation in the context of European integration of the Republic of Serbia and EU projects ALIMS implements. The ceremony of signing of the memorandum was carried out during a two-day mission of ALIMS delegation in BDA, during which discussions were held for the purpose of concretization of further plans. These plans are primarily related to the mutual notifications and consultations on issues of common interest and specific objectives are more efficient performance of the delegated affairs, matters of organization, fees, harmonization of legislation with the EU acquis, clinical trials, medical devices, quality control, inspection activities, e-business and so on. ALIMS and BDA also plan joint projects and will provide support to each other in the international arena. Interaction among employees will be based primarily on the knowledge sharing and inter-institutional training in all these matters.
Bearing in mind the geographical closeness of the Republic of Serbia and the Republic of Bulgaria, the similarities in population, area, public health and other challenges, as well as experience in the not too distant accession of Bulgaria to the EU, this cooperation will be highly beneficial for both ALIMS but also for our healthcare system and our country in general.
Italy and Serbia have signed an agreement for the exchange of information and cooperation on medicines
Yesterday, the Italian Medicines Agency (AIFA) and the Serbian Medicines and Medical Devices Agency (ALIMS) signed a Memorandum of Understanding at AIFA’s headquarters.
The agreement is expected to strengthen the exchange of information between Italy and Serbia in relation to the pharmaceutical sector as well as to expand the scope of the previous agreement, signed on 19 June 2014, aimed at combating falsified drugs.
The possibility of further collaboration on issues related to pharmacovigilance, testing, quality and efficacy of medicines is outlined in the new protocol.
The signers of such agreement were Prof. Luca Pani, Director General of the Italian Medicines Agency (AIFA) and Sasa Jacovic M.D.,sp., Managing Director of the Serbian Medicines and Medical Devices Agency (ALIMS).
During the meeting, information about the organization, the mission and the activities of both agencies was exchanged. Furthermore, aspects related to sites inspections in accordance with GMP, as well as aspects related to the European legislation in the field of clinical trials and pharmacovigilance, were also discussed.
In addition, cooperation will be developed through training activities of Serbian colleagues; such activities, run by the Italian Medicines Agency (AIFA), will be carried out with study visits, expert missions and workshops within the framework of the dedicated European projects.
This bilateral meeting relates to the cooperation activities and the international exchange that the Italian Medicines Agency (AIFA) runs through its participation in specific working groups and through direct interaction with other countries.
To this aim, the promotion of international and intercultural dialogue is essential in order to consolidate the exchange of expertise.
Information on AIFA website
Conference “Reinforcing Communication to Patients and Healthcare Professionals”
A conference organized by European Medicines Agency (EMA) and Medicines and Medical Devices Agency of Serbia (ALIMS) entitled: “Reinforcing Communication to Patients and Healthcare Professionals” was held in Belgrade, on 23rd June 2014 as part of the project in the scope of Instrument for Pre-accession Assistance (IPA) of the European Union.
The aim of this conference was to bring together in one place representatives of regulatory authorities in Serbia and region, but above all, patients organizations and associations of health care professionals. Almost 150 delegates from over 50 different organizations participated, and there were also eminent speakers and guests from over 20 EU member states and countries in pre-accession status.
INSTRUCTION FOR IMPORTERS FOR SUBMITTING REQUEST FOR PERMITTING IMPORT OF NON-REGISTERED MEDICINES OR MEDICAL DEVICES AS DONATION OR HUMANITARIAN AID IN CIRCUMSTANCES INDUCED BY NATURAL DISASTERS
In respect of the state of emergency caused by natural disasters, Ministry of Health of the Republic of Serbia on 23rd May 2014 issued instructions for potential donors of medicines and medical devices, on how to carry out the donations.
Medicines and Medical Devices Agency of Serbia shall act upon these instructions, and it specifies the following documents that the importer should submit to the Agency in order of issuing a permit for the imports of an unregistered medicinal product as donation or humanitarian aid DetailsView
All additional information on this topic can be obtained via e-mail address firstname.lastname@example.org
FLOOD relief / payment to flood victims in Serbia by PayPal
Since 18th May 2014, it is possible to make humanitarian aid payment to flood victims in Serbia by PayPal from 193 countries and regions.
Account belongs to the Mission of the Republic of Serbia to the European Union in Brussels from where the money is directly transferred to the special account of the Government of the Republic of Serbia for the aid to flood victims.
Humanitarian help can be performed by PayPal service at floodrelief.gov.rs
Medicines and Medical Devices Agency of Serbia
458, Vojvode Stepe Street
Republic of Serbia
Faxes: (+381 11) 3951 131, (+381 11) 3951 147
Web site: www.alims.gov.rs
NOTE: All the regulation documents in English are UNREVISED VERSIONS
Davenport: National Medicines Agency of Serbia sets the right cooperation example in country’s EU integration process
National Medicines Agency of Serbia “sets the right example in country’s EU integration process, especially since Serbia entered the new phase of relationship with EU and launched accession negotiations,” said the Head of the EU Delegation Michael Davenport during his visit to the organisation.
European Union has invested significant resources in education of the employees, and provision of IT equipment, as well as in equipping the National Control Laboratory. By receiving this kind of support, Agency can now provide citizens of Serbia with quality, efficient and safe medicines, said the Agency’s Director Saša Jaćović.
Since the year 2001, EU has invested around €4 million in drafting the legal framework for pharmaceutic industry, equipment and software purchase.
Jaćović announced further talks with EU experts in order to fully harmonise Serbian legislation on medicines and medical devices with the European ones.
This report was taken from official website of the Delegation of the European Union to the Republic of Serbia: Delegation of the European Union
More on this story: Delegation of the European Union
Visit of H.E. Ambassador Michael Davenport, Head of the European Union Delegation to the Republic of Serbia to ALIMS
On 20th March 2014, H.E. Ambassador Michael Davenport, Head of the European Union Delegation to
the Republic of Serbia, will visit the Medicines and Medical Devices Agency (ALIMS) of Serbia.
The purpose of the visit is to get an insight into the results of previous EU projects for supporting
the Agency and the pharmaceutical market in Serbia.
In the period 2006-2009, the most important such project was a Twinning with French counterpart
Agencies for human and veterinary medicines.
Since 2009 the ALIMS has been co-operating with the European Medicines Agency (EMA) under
a project supported by the EU instrument for Pre-Accession Assistance (IPA).
The Ambassador will also discuss with representatives of the Agency further harmonization with
EU legislation in the field of medicines, as well as options for more intensified colaboration between
the Serbian Agency and EU regulatory bodies, in specific areas like safety of medicines, fight against
counterfeit medicines, clinical trials, medical devices, etc.
The Ambassador will be hosted by Dr. Saša Jaćović, managing director of the Agency, who will arrange
a tour of the National Control Laboratory of the Agency.
BACKGROUND ON EU ASSISTANCE
In early 2002, along with a period of emergency assistance to Serbia, the EU financed assistance to
the drafting of the legal framework for the pharmaceutical sector. Keen to regulate the sector,
the National authorities used this technical assistance to set the grounds for the establishment
of a National Medicines Agency, in line with current EU practices, and upgrade its quality control
laboratory capacities. The EU funded the construction of a pre-constructed building for the Agency,
its sophisticated equipment to test medicines, along with servers and other IT equipment.
Finally, the EU provided the support of the French National Medicines Agency by means of
a twinning project where French experts provided on-the-job training and worked together
with the staff of this Agency to develop procedures, standards and other regulations
for everyday work of the now well-known ‘ALIMS’.
The EU’s investment of more than almost 4 million Euros starting from
January 2002 until July 2008 scores highly on the list of such efforts in Serbia.
ALIMS work today is proof of this.