Experts of medicines agencies of the Baltic States discuss news in the field and sign an updated agreement on the common Baltic Package procedure

03.09.2015.

On 3rd September 2015 a meeting of the experts of medicines agencies of the Baltic States is taking place in Vilnius, Lithuania, discussing the news and the normative regulation of the field. The meeting agenda contains issues related to the common Baltic Package procedure, strategic development issues of the European Medicines Agency, medicines safety issues and additional safety elements on packages, risks of falsified medicines and other issues.

Guido Rasi, Principal Adviser in Charge of Strategy at the European Medicines Agency, is also participating in the meeting and emphasising the role of national medicines agencies, "Strong national competent authorities are essential in the field of pharmaceutics. They provide their expertise in centralised and national marketing authorisation procedures, they can connect local representatives of the industry with people who carry out scientific expertise on medicines centrally assessed in Europe, they are the national centres for pharmacovigilance and market surveillance issues, they link healthcare systems, healthcare specialists and patients."

The renewed agreement between Latvia, Lithuania and Estonia regarding the common Baltic Package procedure was signed during the meeting. Changes in the agreement were related to new quality requirements for product documentation. The common Baltic Package procedure is the most successful example of the cooperation of three state medicines agencies so far. It was initiated in order to decrease the administrative burden and the resources required from the merchants, as well as to promote the availability of medicines in the market and to make the preparation and approval of medicines packaging easier, faster and more transparent. Since 2010 marketing authorisation holders no longer have to contact each of the medicines agencies of the Baltic States separately in order to receive approval for the common Baltic package. Also patients must have noticed that the packages contain summaries of product characteristics and package leaflets in Latvian, Lithuanian and Estonian.

The agenda of the meeting between colleagues from the Baltic States contained also the exchange of experience relating to marketing authorisation, statistics on consumption of medicines, news in the field of pharmacovigilance (monitoring of adverse reactions), aspects of collaboration between the medicines examination laboratories in Latvia, Lithuania and Estonia and other topics.

Latvia was represented by Sanita Timbare-Zilvestere, the Head of the Legal Department of the State Agency of Medicines, and a group of experts, Estonia was represented by Kristin Raudsepp, the Head of the Estonian State Agency of Medicines, together with colleagues and Lithuania was represented by Gintautas Barcys, Director of the State Medicines Control Agency of the Ministry of Health of Lithuania, with colleagues. Due to urgent issues regarding attempts to reorganize the functions of the State Agency of Medicines of Latvia, Inguna Adoviča, the Director of the State Agency of Medicines, could not be in attendance of the meeting, therefore, the agreement document between the medicines agencies of the Baltic States will be signed on behalf of the Republic of Latvia after it is delivered to Riga.

On 22nd November 2012 the directors of the three medicines agencies of the Baltic States singed a contract in Riga on collaboration in the field of good manufacturing practice, good distribution practice, good pharmacovigilance practice and good clinical practice, as well as on the cooperation of the laboratories of the Baltic States relating to the testing of medicines authorised through the national procedure.