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International support to the development of the Agency
Annual Meeting of Secretaries of National Bodies for the Questions of Pharmacopoeia
Medicines and Medical Devices Agency of Serbia (ALIMS) was the host of the National Pharmacopoeia Authorities (NPA) Annual Meeting held in Belgrade, Serbia, on 11th – 12th May 2009, in organisation of the European Directorate for the Quality of Medicines and HealthCare (EDQM & HealthCare, Strasbourg, France). Twenty-six secretaries of national authorities from all over Europe participated in the Meeting which was chaired by Dr. Susanne Keitel, the EDQM & HealthCare director, and co-chaired by the three eminent EDQM experts: Mr Hendrik De Jong, Mr Claude Coune and Ms Emmanuelle Charton. Besides this, there was also held the Meeting of Praesidium of the Pheur. Commission.
Twinning Project
Agreement on Business Collaboration between ALIMS and AFSSAPS
On 5th March 2009, there was signed the Agreement on a three-year Business Collaboration between the Medicines and Medical Devices Agency of Serbia and the French Health Products Safety Agency (Agence française de securité sanitare des produits de santé - AFSSAPS) presented by Mr Jean Marimbert, director general.
On the same occassion, there was signed a Letter of Intention by Mr Patric Dehaumont, director of the French Agency for Veterinary Medicinal Products (Agence française de securité sanitaire des alments – AFSSA - ANMV) as a guarantee of future agreement on collaboration which is to be signed with this institution as well.
After the Twinning Project, where during these two and half years there has been accomplished a close cooperation between ALIMS and AFSSAPS and AFSSA – ANMV, through this agreement there will be continued and realised further joint performance in certain fields of work and activities.
EU Aid in Enhancing the Quality of Medicinal Products in Serbia
The Final Meeting of the Twinning Project was held at the Sava Center on 5th March 2009. The Meeting was attended by over one hundred and eighty participants among who there were experts in the field of health products regulatory affairs from the country and the region, representatives of pharmaceutical industry, patients′ associations and media. The Meeting included the presentation of Project results and panel discussions of the EU, French and Serbian representatives.
National Control Laboratory
Representatives of the Agency participate on a regular basis in the work of the Pheur. Commission of the European Directorate for the Quality of Medicines and HealthCare (EDQM & HealthCare). As a valid member of the Official Medicines Control Laboratory Network (OMCL), the Agency, i.e. the National Control Laboratory has established exceptional cooperation with the other European laboratories, which contributes to the improvement of quality of work and provision of services to the Agency clients. Membership in this Network imposes the obligation all the requirements of the strict international standards in the field of medicinal products and medical devices quality control, to be met. Thus, the National Control Laboratory has successfully implemented all the requirements of the ISO/IEC 17025:2005 standard, as well as all the additional OMCL Network requirements defined in the OMCL guidelines.
Nationalni Pharmacovigilance Centre
Medicines and Medical Devices Agency closely cooperates with the Uppsala Monitoring Centre (UMC), World Health Organisation (WHO), through the active participation of the National Pharmacovigilance Centre (NCF) in the system of spontaneous reporting, collecting and monitoring of adverse drug reactions.
National Pharmacovigilance Centre forwards to the Uppsala Monitoring Centre (UMC) the estimated reports of adverse drug reactions (ADR) occurred on the territory of our country. On the other hand, in order to maintain a good practice in pharmacovigilance, UMC communicates with national centres and informs them on generated signals (new suspected reactions to medicinal products), as well as on other safety information significant for rational use of medicinal products. The National Pharmacovigilance Centre also has en insight into the UMC data base, which contains over 3 million reports on suspected ADRs from a large number of countries all over the world, which represents a significant source of information in the total assessment of medicinal product safety profile.