We’ve developed the Packaging Code of Practice to help navigate the complexities of medicines labelling regulation and support companies to remain compliant. The MHRA have contributed to this Code of Practice, along with member companies, to capture all the important information you’ll need to be aware of.
In this Code, we cover the statutory and non-statutory information required and allowed on OTC medicines packaging. We also provide guidance on the use of promotional information, including what you cannot say, and on design elements such as typography, layout and graphics.
Supporting you with self-regulation
Complying with the Packaging Code for Medicines is not a legal requirement; however, it is a key element for the self-regulation of OTC medicines and enabling continued access to self-care products without a prescription. This Code sets out legislative requirements and additional guidance that are needed to support pack design applications.
We’ve developed this Code to expand on existing guidance and provide practical advice to manufacturers designing and amending the packaging of OTC medicines. The Code draws from the Best Practice Guidance on the Labelling and Packaging of Medicines developed in the UK and issued by the MHRA. This Code also refers to the Report of the Committee on Safety of Medicines Working Group on Patient Information, ‘Always Read the Leaflet – Getting the best information with every medicine’, and the EMA Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use.
Our members are responsible for ensuring that all applicable legal requirements and all requirements of the relevant self-regulatory Codes of Practice are complied with. We recommend that members share the PAGB Packaging Code for Medicines with all their regulatory, brand and marketing teams, and relevant suppliers, and nominate someone to be responsible for ensuring compliance.
