Guidelines for repackaging and labelling of medicines.

These Guidelines focus on establishing standards for the repackaging and labelling of medicines, and for the content and format of the information on the label essential for identifying product, minimising medication errors and enabling customers and health professionals to select the correct medicine and its safe use. The Guidelines apply to all the medicines defined by the Medicines and Related Products Act, 2014, except for radioactive medicines, and apply to persons or entities engaged in repackaging and relabelling of medicines, manufacturers, marketing authorisation holders and importers of medicines. The Guidelines include: prerequisites for repacking and relabelling of medicines; packaging materials; packaging process; establishing expiry date; moisture and temperature sensitive products; specific requirements for veterinary medicines; labelling and relabelling procedures; retention of samples for repackaged medicines.