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    Baltic meeting in Estonia

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    The meeting of drug regulatory agencies of Baltic States took place on 11th of September 2014 in Tartu, Estonia. The aim of the meeting was to exchange information, to find new areas where we could promote Baltic strength based on our long cooperation and to harmonize the positions for different procedures in the area of regulation of medicinal products. Heads of Estonian, Latvian and Lithuanian agencies together with 35 specialists participated in the meeting.

    The update on the actions under the Agreement on the cooperation in the area of GMP, GDP, GCP, PhV inspections and Laboratory testing between Estonia, Latvia and Lithuania (signed in 2012) was given. The co-operation in these fields will continue as it is a good example of avoiding duplication, offering services for each other and strengthening the region.

    The participants discussed the potential risks in increasing distribution of parallel imported and parallel distributed medicines.

    The practicalities and experience about the Common Baltic Labelling Procedure were discussed in the panel and also within the smaller workshop of specialists. Using the QR codes and safety features on Baltic packages was discussed. Different approval times should be avoided. Expanding the procedure to Poland was discussed. It was stressed among the heads of the agencies that priority will be given to the Baltic packages procedures and all the questions/delays will be solved quickly and efficiently keeping in mind that the availability of the products should be the priority.

    An experience was shared about being RMS in DC/MR procedures. Lithuania and Latvia shared experience about pharmacovigilance inspections. Plans and possibilities for the future collaboration were discussed, the first common pharmacovigilance inspection will take place in the end 2014 with inspectors from Lithuania and Estonia.

    Experience about first common publication “Baltic Statistics on Medicines 2010-2012” and plans for the future were made. Reflections on the current publication were given. The general idea was to promote the project and repeat the publication in 2016 (starting in autumn 2015). It was decided to start cooperation in the field of supervision over advertising of medicinal products. Latvia gave an overview about the EU Presidency period in 2015.

    Estonian State Agency shared its experience with advanced therapies, by giving an overview of current status of manufacture and use of ATMPs under hospital exemption, and introduced their experience in granting activity licenses for companies producing these products.

    The colleagues from other Baltic states were asked for their experience in the field. Different aspects like availability, legislation/regulations, requirements of manufacture and use, meaning of ‘hospital exemption’ etc. were discussed.

    Consensus opinion was expressed that in all three Baltic States, the manufacture and therapeutic use of custom-made ATMPs is still in the rudimentary stage of development. Participants stressed that knowledge sharing and harmonization of rules would facilitate further development of oversight and regulatory capability of Agencies.

    With the co-operation between Baltic agencies we aim the trust and cooperation instead of double-checking what other agency has done. All these initiatives must ensure the quality, efficacy and safety of medicinal products for Baltic patients.

    The next Baltic meeting is planned to take place in Lithuania.


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