Rwanda: Labelling and marking of pharmaceutical products — Specification

 

Rwanda has published a new standard DRS 91: 2020 Labelling and marking of pharmaceutical products — Specification.

This Draft Rwanda Standard specifies requirements of a label for pharmaceutical products. It also gives special labelling and marking requirements for some preparations such as biological, sterile products and aerosols.

In accordance with the standard, the label should meet the following requirements:

5.1 A label shall be legible, neat and well balanced. The style of the label shall be appropriate to the preparation, and the size of the label shall match the container.

5.2 The label shall remain permanently attached to the containers under all storage conditions and an area of the container shall be left uncovered to allow inspection of the contents. If the final container is not suitable for labeling (e.g.: capillary tube), it shall be in a labelled package.

5.3 The label for internal medicines shall be in black or blue print and those for external use, shall be in red print or against a red background.

Moreover, the standard contains detailed requirements for the content of the label.

The full document is available HERE.