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.