Excerpt from the Ministry of Health' Approval (Departmental) Order of the Guide Regarding the "Umbrella" Type of Commercial Names

January 17, 2006

On 28th of December 2005 the Ministry of Health issued the (departmental) order no. 1453 which has entered into force on 11th of January 2006, pursuant to its publication in the Official Gazette of Romania, Part I, No.26/January 11, 2006.

The most significant provisions of the order are enumerated further on:

• An "umbrella" type of commercial name is a unique commercial name for a group of drugs.
• Drugs, which have an "umbrella" type of commercial name, distinguish themselves as to their active substances and/or their therapeutic instructions.
• The cases in which the proposal of an "umbrella" type of commercial names is possible, are:
  1. The proposed drug, in whose name will be used an "umbrella" type segment, contains additional active substances and is destined to the same therapeutic areas as the already existing drug which uses the same "umbrella" type segment in its commercial name;
  2. The proposed drug in whose name will be used an "umbrella" type segment, contains the same active substance or additional active substances and is destined to a different therapeutic area as to already existing drug which uses the same "umbrella" type segment in its commercial name
  3. The proposed drug in whose name will be used an "umbrella" type segment, contains different active substances and is destined to the same therapeutic areas or different therapeutic areas from the already existing drug which uses the same "umbrella" type segment in its commercial name.