Israel: Procedure for Packaging Labeling of Medical Preparations

 

Israel has published Procedure for Packaging Labeling of Medical Preparations (PRA-043/03)

The procedure replaces a previous procedure from July 2007 (amended in July 2012) and is based on Regulation 20 of the “Pharmacists Regulations (Preparations) 5746-1986” and regulation 13 of the “Pharmacists Regulations (Sale of an over-the-counter preparation not in a pharmacy or not by a pharmacist) 5765-2004”.

The purpose of the procedure is to clarify the requirements of Regulation 20 and Regulation 13 and to ensure that all packaging requirements shall appear on the preparation packaging, listed in the Preparations Register, in order to provide patients with the essential information regarding the preparation and assist in providing safe and effective drug treatment. It collects all existing requirements into a unified list that contains also references to similar international requirements.

The original text of the procedure is available HERE