Important Update from AEMPS | Authorization and Simplified Registration for Allergen-Based Medications

July 12, 2024
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The official Calendar for the Regularization of allergen-based medicines and medicines list is out!!

The Spanish Agency of Medicines and Medical Devices (AEMPS) has just issued a binding resolution listing industrially produced allergen-based medications and allergen-based bulk medications for human and veterinary use that have been communicated.

The AEMPS has published an official schedule detailing the deadlines for submitting marketing authorization applications or simplified registration for these allergen-based medications.
Key Points to Note:

• Only medications listed in the binding resolution, and those for which marketing authorization is applied for within the specified timeframe, can continue to be marketed.
• Medications not included in the resolution or those that do not meet the application deadlines will no longer be authorized for sale.

Access the detailed list of medicinal products for human use and laboratories here: List of Allergen-Based Medications for Human Use | AEMPS

Access the detailed list of veterinary medicinal products and laboratories here: List of Allergen-Based Veterinary Medicinal Products | AEMPS

Stay informed and ensure compliance! Contact us if you need help updating your allergen-based medicines! [email protected]

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