The meeting of regulatory agencies of human and veterinary medicinal products of the Baltic States took place on 10 May 2018 in Tartu, Estonia. The aim of the meeting was to exchange information, to find new areas where the agencies could promote Baltic strength based on long term 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 40 specialists participated in the meeting. The organisations participating were Estonian State Agency of Medicines, Latvian State Agency of Medicines, Latvian Food and Veterinary Service, Lithuanian State Medicines Control Agency, Lithuanian National Food and Veterinary Risk Assessment Institute and Lithuanian State Food and Veterinary Service.
The update on the actions under the Agreement on the co-operation in the area of GMP, GDP, GCP, PhV inspections and laboratory testing between Estonia, Latvia and Lithuania and on the Common Baltic Labelling Procedure was given. The co-operation in these fields continues. In regards to the common labelling procedure for human medicines small amendments were proposed to the template (related to safety features). Regarding the common labelling procedure for veterinary medicines some practical aspects were also discussed in parallel session. It was agreed that the management of the applications for the Baltic packages shall be considered as a priority in all the agencies.
Overview of the Baltic Agencies 2018 was given. Participants discussed the trends in pharmaceutical market, including parallel import, unauthorised medicinal products, shortages and the contribution of Baltic agencies to the European network.
Agencies gave an overview about the situation concerning current and upcoming regulations of pharmacies in the Baltic countries and innovation of the pharmacy services.
The agencies responsible for human medicinal products discussed the implementation of the new clinical trial regulation. There was a discussion about the fees of clinical trial and about sharing the information of the choices the Baltic States have made regards to the implementation of the new regulation.
Lithuania gave an overview about the situation related to the BREXIT. Participants noted that availability issues shall be a challenge for all Baltic countries and everybody agreed to exchange information on any issues foreseen in the nearest future. Agencies have informed the marketing authorisation holders about the possible impacts and needs for action.
Estonia gave an overview on implementation of safety features regulation in the Baltic countries. Participants discussed the supervision of future repository systems and the different levels of NMVS financial model.
The project of publishing the Baltic Statistics on Medicines continues. Participants discussed about the possibilities to include the statistics on veterinary medicines consumption into the Baltic Statistics on Medicines.
Estonia gave an overview on the current situation of publishing additional risk minimisation measures (aRMM) on their website and future plans on integrating them into doctors’ prescribing software. Participants further discussed the possibilities of analysis on aRMM efficacy in Baltic countries based on prescriptions/health services. Agencies agreed that the data should be classified similarly in all Baltic countries in order to analyse it on the same basis.
Cooperation between the laboratories goes on. Agencies looked at the possibilities and discussed the new versions of ISO 17025:2017 and OMCL guidelines.
Agencies discussed the supervision practices in regard to tissues, cells and organs of human or animal origin used for medical purposes, including possible actions and number of children born from one gamete donor. Joint inspections will be planned.
Agencies had detailed discussions about the co-operation in veterinary area, specifically veterinary Baltic package and experiences since the procedure was agreed. Main problems related to the topic were different national requirements for the package, SPC/PIL harmonisation and also additional workload caused by insufficient pre-assessment by marketing authorization holders. Some changes into the procedure are planned.
The common visual reminder (boxed warning and pictogram) to warn patients about teratogenic or foetotoxic effect on Baltic package was discussed. The use, location and layout of the pictogram, also boxed warning issues were agreed. Information about these amendments and agreements have been published on the agencies’ websites.
The next Baltic meeting will take place in spring 2019 in Lithuania.
