News

The United Kingdom has formally left the European Union on 31 January 2020 and has become a third country to the EU. On 1 February 2020 a transition period has started which will end on 31 December 2020. During the...

As announced previously, Marketing Authorisation Holders (MAH), that still have relevant entities located in the UK, are again reminded to make the necessary changes until 31 December 2020 to ensure that their authorised...

Dear marketing authorisation holders, Thank you for your comments and active participation in the harmonisation process. Baltic agencies greatly appreciate it. Most of the comments were related to Type IA variations as...

In order to harmonize the approval of variations of medicinal products authorised via mutual recognition or decentralised procedures and to ensure the smooth supply of medicinal products, experts from the Baltic agencies...

The transition period in the relationship between the European Union (EU) and the United Kingdom is due to end on 31 December 2020. Henceforth, EU legal acts prohibiting or restricting import and export of active...

In order to facilitate productive cooperation and shorten the harmonization process, pharmacovigilance experts from the State Agency of Medicines have prepared updated information to marketing authorization holders on...

The State Agency of Medicines (hereinafter – Agency) has published its Annual Report of the year 2019 which summarizes information regarding the operation of the Agency during the previous year. Some of the numbers that...