The last couple of months have seen some catastrophic weather conditions across the globe. These can have a significant impact upon the pharmaceutical supply chain.
We have already received reports of some manufacturing sites being affected and possible shortages occurring as a result. Therefore, we request those companies that have sites within their supply chain that could be at risk due to recent weather events (such as those in Puerto Rico, Southern USA, India and Bangladesh) take steps to identify any potential supply issues.
We are also liaising with our international regulatory partners in order to gain additional information on potential supply issues and support plans to ensure continued supply of products to patients.
You can play a big part by providing relevant information to help with this process.
There is an obligation for licence holders to notify the MHRA of any interruption in supply, for GMP matters this can be done via the Interim Compliance report which should be submitted to email@example.com
Assurances that there are no issues would also be welcomed via the same email address.
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Access our guidance on good practice for information on the inspection process and staying compliant.