• English
  • Eesti
    NewsNews

    Baltic meeting in Estonia

    31.05.2010
    Printer-friendly version

     

    The meeting of drug regulatory agencies of Baltic States took place on 11th of May 2010 in Tartu, Estonia. The aim of the meeting was to exchange information, to find further possibilities for efficient co-operation and to harmonize the positions for different procedures in the area of regulation of medicinal products. Heads of Estonian, Latvian and Lithuanian agencies participated in the meeting.

    An experience of the work done under the agreements between Baltic agencies was discussed. Experience about common GMP inspections shows positive sides of the effort and the general idea is that relatively small local industries and small inspectorates call for continuation of practical joint inspections. Agencies were positive also about the cooperation of OMCLs in testing of medicinal products. The possibility of sharing the workload and saving resources concerning the analysis of medicinal products with national marketing authorisation was considered.

    It was decided that the procedure described in the Common Baltic Package Guidance (signed renewed version in 2009) should be the priority for all three agencies. A special working group was established to elaborate further the procedure of Baltic package.

    Other themes discussed were the problem of availability of medicinal products, the obligations of the agency in the area of pharmacovigilance, the role for the agencies in the Health Technology Assessment and reimbursement decisions, the technical solutions in use and in preparation by the agencies to be able for e-submission and the environmental aspects of pharmaceuticals.

    Previous Baltic meetings have taken place in 2004 in Tartu and in 2006 in Riga. The next Baltic meeting is planned to take place in 2011 in Lithuania.