The controversial question regarding “off-label” use of medicinal products has been recently tackled by the Greek legislator.
Article 47 of Law 4316/2014 entitles the National Organization for Healthcare Services (“EOPII”) to reimburse:
a. medicinal products for indications, dosages and combinations not in accordance with the summary of product characteristics (“off-label” use) subject to the following preconditions.
The “off-label” indications, dosages and combinations should be:
The National Drug Organisation (EOF) has published a new circular amending certain requirements and rules for the organisation and sponsoring of scientific events and congresses. The New Circular no. 106329/15.12.2014 does not present considerable differences from the previous one; nonetheless, it contains changes, which indicate a certain trend of the authority to a somewhat less strict approach on certain issues. The major changes introduced by the new circular are the following: