… although “compassionate use” programmes are in practice implemented in Lithuania, Lithuanian law does not offer a satisfactory legal basis for them but leaves many questions open, such as (i) what procedure should be followed for obtaining unlicensed medicines, or (ii) at what phase should a medicinal product be in order to be used for healthcare purposes, or (iii) what criteria should be applied to establish the severity of a disease, or (iv) to what extent is the responsibility of the HCP limited?
… Latvian law allows unlicensed medicines to be ordered by post from non-EU countries if (i) a prescription or an assignment of a healthcare institution’s is presented and (ii) the SmPC and PIL have been translated into Latvian and (iii) the order does not exceed the amount of medicines necessary for 12 months‘ consumption?
… due to the small market in Estonia quite often products that are unauthorised and thus unlicensed in Estonia may be widely used in the rest of the world but unlicensed medicinal products may be distributed and used in Estonia only if the State Medicines Agency has granted an import authorization and distribution permit?
These and more legal-insider facts are presented in the study “Access to Unlicensed Medicines” published by the conference bleue network (http://conference-bleue.com/). The study aims to provide a concise and practical comparative guide on access to unlicensed medicinal products for human use in almost all EU countries as well as in the Ukraine, Switzerland and Turkey. The study fills over 200 pages.
bnt attorneys in CEE offices in Vilnius, Ryga and Tallin are proud to have contributed to the reports for the Baltic States.
We will be glad to share the survey upon request.