Generic Labeling of Medicines - Amended Ministerial Decision

The Minister of Health (MoH) in an attempt to facilitate compliance with Ministerial Decision No. 068/Menkes/SK/II/2006 has amended the provisions to allow pharmaceutical companies until 31 December 2006 to ensure that medicine and drug labels are in compliance with the Decision. The Decision does not amend the requirement that the generic name of all branded medicines and drugs must appear on the label at a size of 80% of the branded name (see ILB 28/2/2006).

Despite the increased amount of time for compliance, the earlier concerns of the additional costs that will have to be borne by pharmaceutical companies remain. The International Pharmaceutical Manufacturers Group (IPMG) has stated in the press their continued objection to the Decision and to this amendment as creating an investment environment that is increasingly less conducive for foreign pharmaceutical manufacturers.