The Spanish Agency of Medicines and Medical Devices (AEMPS) is at a crucial juncture in the regulation of allergens with the receipt of a total of 14,464 notifications for products regularizations. The AEMPS will publish a list of the notified medicinal products by July 14, 2024, the latest. Products not included on this list may not be marketed unless explicit consent is obtained from the AEMPS.
The submission schedule has been stablished:
| GROUP NAME | ALLERGENS | Timeline |
| Priority Group 1 | Hymenoptera, Positive and negative controls for diagnosis, albumin, “Provocation Diagnosis,” Peach
| 1-Jan-2025 to 31-Dec-2025 |
| Priority Group 2 | Acarus | 1-Jan-2026 to 30-Jun-2026 |
| Priority Group 3 | Grasses (excluding Acarus) | 1-Jul-2026 to 31-Dec-2027 |
| Priority Group 4 | Olive (excluding Acarus and Grasses)
| 1-Jan-2028 to 30-Jun-2029 |
| Other allergens | Other allergens for diagnosis, bulk and immunotherapy
| 1-Jul-2029 to 31-Dec-2030 |
| Veterinary allergens (dogs, cats, horses) | Schedule to be determined |
The above calendar outlines the submission deadlines for the industry, however, the assessment period by the AEMPS is not defined. During the assessment period, the products may continue to be marketed.
Contact Asphalion now for transversal personalized support for AEMPS meeting requirements! [email protected]
