Pharmacy Guidelines for Investigational Medical Products.

These Guidelines apply to clinical trials in human participants in Zimbabwe in terms of the Medicines and Allied Substances Control Act (Chapter 15:03) and regulations thereunder. They provide guidance to investigators on establishing and maintaining adequate records of study product and disposition of study products to comply with statutory requirements and policies of the Medicines Control Authority of Zimbabwe. The Guidelines lay down the responsibilities of the Pharmacist of Record, contents of a Pharmacy Plan and the study product accountability record to be created. Further, guidance in respect of dispensing of study products, import and management of investigational products and disposal of study medical products is provided.