Signing of Cooperation agreement between FSI “SID&GP” and Agency for medicinal products and medical devices of Bosnia and Herzegovina
On the 11th of December a singing of a Cooperation agreement between FSI “State Institute of Drugs and Good Practices” of the Russian Ministry of Industry and Trade and the Agency for medicinal products and medical devices of Bosnia and Herzegovina (ALMBiH) took place. Year 2020 has been a test for the world’s pharmaceutical market and the signing of a bilateral agreement in this challenging period – yet another evidence of the countries’ readiness for cooperating and fostering effective relationships.
Director of FSI “GILS & GP” Vladislav Shestakov and Director of the Agency for medicinal products and medical devices of Bosnia and Herzegovina Aleksandar Zolak participated in the signing of the Agreement. The ceremony was held in an online format, a mode that has already become a common form for interaction for the entire international community. An exchange of the original documents will be done through a courier service.
“I am sure that the signing of this Agreement establishes a solid foundation for our further cooperation, – said in his address to the foreign colleagues Director of FSI “GILS & GP» Vladislav Shestakov. – In such a difficult year as 2020, it has become evident that in the fight against the consequences of the coronavirus infection it is imperative to unite efforts and build capacity for bilateral and multilateral cooperation. I am glad that at the end of this year, despite all the challenges, we are open and ready for partnership. Notwithstanding the lack of an opportunity to meet in person and shake each other’s hands as a gesture of mutual collaboration, we are finding ways to develop bilateral cooperation”
Under this Agreement on long-term cooperation, it is supposed to conduct joint information and training activities, information exchange in order to ensure the quality of medicines, participation in GMP-inspections of each party as observers.
Representatives of the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina already know SID&GP. Russian GMP-Inspectorate conducted inspections of Bosnian pharmaceutical companies in 2016 and 2019 years. Therefore, the Agency’s inspectors took part in the IV All-Russian GMP Conference as participants in 2019, and this year the Head of the Bosnian Inspectorate, Indira Fazlagić, gave a presentation as an expert of the event during the workshop dedicated to GMP inspections
The share of medicines from Bosnia and Herzegovina for the period of 1-3 quarters in 2020 is 0.27% of the total pharmaceutical market of the Russian Federation in value terms and 0.25% in volume terms.
“Now the share of medicines supplied by Bosnia and Herzegovina to Russia is insignificant, but I am sure that cooperation between our countries has great potential. I hope that the signing of the Cooperation Agreement will be another step in strengthening bilateral relations between Inspectorates of our countries, improve the quality of inspections, accelerate the implementation of future projects, including in the field of professional development and exchange of experience,” – summed up the online meeting Vladislav Shestakov.
Since 2017, SID&GP has signed 11 agreements on bilateral cooperation with foreign Inspectorates.
- The Cooperation Agreement was signed between State Institute of Drugs and Good Practices and National agency of pharmaceutical products of Algeria
- SID&GP passed the recertification audit of the Quality Management System according to ISO 9001:2015
- Russian Federation has submitted an application for the Pharmaceutical Inspection Co-operation Scheme PIC/S accession
- SID&GP experts participated in the ISPE Eurasian Affiliate pre-conference
- Director of “SID&GP” has introduced the statistics of identified non-conformities in the registration dossier