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EMA Shortage Prevention and Mitigation Plan Templates

Date
June 20, 2024
Category

EU Regulations

Description

On 18 June 2024 the EMA published two new documents: one on Shortage Prevention Plans (SPPs) and one on Shortage Mitigation Plans (SMPs). Both documents include templates for documenting and communicating the plans.

When issuing these two new plans the EMA said that they encourage marketing authorisation holders (MAHs) to draft a shortage prevention plan (SPP) to help reduce the likelihood of shortages for their marketed medicines. This plan should identify potential risks in the supply chain and set out the measures to manage those risks.

EMA say it is highly recommended that the high-level hierarchy of the company is involved in the development of the SPP. It is key that the company considers the SPPs not as an administrative document but as a useful tool that is beneficial, first and foremost for them to identify any potential risk and be prepared if shortages occur. The SPP should be part of the company’s pharmaceutical quality system and be “subject to continuous evaluation.” The document should be written in English and translated into the language of the Member State when requested by the NCA.

SPPs should be readily available for submission to the Competent Authority who issued the product’s Marketing Authorisation, upon request. SPPs can be subject to inspection during GMP and/or GDP inspections or inspections of MAHs, in accordance with national regulations.

MAHs should also set up shortage mitigation plans to address potential or actual shortages for their marketed medicines. These plans should contain proposals on how to mitigate the impact that a medicine shortage can have on patients. The degree of effort, formalisation and documentation for each SMP should be proportionate to the identified level of risk for each medicine.

SMPs will be submitted to the Competent Authorities concerned upon request according to timelines laid down in the pharmaceutical legislation and national regulations. SMPs may also be submitted directly to Competent Authorities when MAHs become aware of a shortage, in such case the shortage report and SMP might be merged in a single document.

These two new templates can be found at https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/medicine-shortages-availability-issues-guidance-companies.