Regulators in the European Union (EU) have began taking the first steps reduce shortages of medicinal products. The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) recently published two guidance documents. The two guidance documents are said to be used as a foundation.
The first guidance document that has been published surrounds ‘Guidance on detection and notification of shortages of medicinal products for Marketing Authorisation Holders (MAHs) in the Union (EEA)’.
The guidance addresses the following areas:
- What is a shortage?
- What issues should be reported by MAHs?
- Who is responsible for monitoring supply and reporting shortages?
- When should a notification be made?
- Who should be notified?
- What information should be included in notifications?
The second guidance that has been published surrounds ‘Good practice guidance for communication to the public on medicines availability issues’ , while also providing recommendations for EU national competent authorities and the EMA to ensure the public receive adequate information.
The guidance addresses the following areas:
- Who should communicate?
- Who is the target audience?
- Which format or tools?
- What information to be published?
- When to publish?
- How to involve stakeholders in the preparation and dissemination of information?
- Internal collaboration?
- Examples of communication to the public and interaction with stakeholders
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Source: https://www.gmp-compliance.org/gmp-news/ema-publishes-first-two-guidances-on-drug-shortages
