Draft Policy on Remaining Shelf-Life for Medical Products

The World Health Organisation (WHO) was looking for feedback from stakeholders on a draft policy which gives details of how medical devices, diagnostics and other medical products should be managed right through the supply chain while safeguarding their availability within the remaining shelf-life.

The policy should be completed later in the year and is valid for all medical products in the supply chain. Suppliers, donors, procurers and distributors can all put the policy into operation and it can be incorporated by WHO member states within their national policies. 

The policy is intended to tackle several concerns, for example, making sure that there is ample reserve of medical products with adequate remaining shelf-life in a country.

The policy is intended to tackle several concerns, for example, making sure that there is ample reserve of medical products with adequate remaining shelf-life in a country, dealing with access and supply barriers to medical products, putting a stop to dumping and stock-outs, avoiding donations of medical products which are not suitable and averting the build-up of expired stock. Where necessary, it also wants to assist the national authorisation of importation of stock, where necessary. 

The WHO says that the information could differ depending on the category of product, their variety, how they are kept, resources in the country and other influences. It makes a well-defined difference between manufacturing and expiry/install by dates and says that for all products with an expiry date, the customer or recipient should never carry out re-testing in an effort to lengthen the shelf-life. However, the manufacturer or provider can get authorisation for a new or extended shelf-life from the relevant national regulatory authority and this should be applied to batches of the product to be delivered and should have at least a one year shelf-life.

The policy also explains when and how suppliers, recipients and national authorities can reach a deal about deviations from the remaining shelf-life policy. 

Furthermore, the WHO explained that the policy should be read in combination with other documents and guidelines, e.g. the guidelines on good storage, stability testing and distribution procedures, the pharmacopeia etc.

Source: Medtech Insight (an Informa product)