30 May 05

Heads of Baltic drug regulatory agencies have signed the new Common Baltic Package Guidance. The aim of the document is to simplify the work of marketing authorisation applicants and holders who would like to use one common package instead of 3 different. It takes into account the regulatory environment of  EU and 3 Baltic countries. In case of legal misunderstanding the local law applies. The previous Common Baltic Package Guidance was developed in the EU pre-accession period.

Common Baltic Package Guidance