Allergen-Based Medicines in Spain – AEMPS Regulatory Framework

Definition and Scope

Allergen-based medicines (medicamentos a base de alérgenos) are defined as preparations containing allergens or allergen extracts intended for:

• Diagnosis of IgE-mediated allergic diseases (e.g., skin prick tests, provocation tests).
• Specific allergen immunotherapy (SIT) to induce tolerance in allergic patients.

They include both standardised and non-standardised extracts from natural sources (pollens, mites, animal dander, moulds, foods, venoms, etc.). These products are classified as medicinal products for human use and fall under the scope of Royal Decree 1345/2007 and EU Directive 2001/83/EC (as amended). Medicamentos a base de alérgenos - AEMPS

Authorisation and Production Requirements

• Marketing Authorisation: Required for industrially manufactured allergens; named patient preparations (preparados para uso individualizado) may follow a simplified authorisation pathway if produced under strict conditions.
• Individualised Production: Many allergen products are prepared specifically for each patient based on allergy test results. Manufacturing must occur in authorised facilities with validated processes.
• Quality Standards: Compliance with European Pharmacopoeia monographs (e.g., allergen products monograph), Good Manufacturing Practice (GMP), and specific AEMPS guidelines on characterisation, potency, and stability.
• Batch Release: Each batch requires official control and release by AEMPS or an Official Medicines Control Laboratory (OMCL).

Safety and Efficacy Considerations

• Risk Management: High potential for anaphylactic reactions requires careful dosing schedules, administration by trained personnel, and availability of emergency treatment.
• Clinical Data: Efficacy must be supported by clinical studies or bibliographic data demonstrating disease modification or symptom reduction.
• Pharmacovigilance: Enhanced monitoring due to risk profile; marketing authorisation holders must submit periodic safety update reports and manage risk minimisation measures.

Labelling and Information Requirements

• Labelling must include the specific allergen(s), concentration/potency unit, administration route, and warnings (e.g., risk of severe allergic reactions).
• Package insert (prospecto) and summary of product characteristics (Ficha Técnica) must detail composition, indications, posology, contraindications, and special precautions.
• Patient information cards are often provided for immunotherapy patients.

Practical Implications for Stakeholders

Manufacturers must maintain detailed documentation of allergen source, extraction methods, standardisation (when applicable), and batch-to-batch consistency. Healthcare professionals administering these products require specific training. AEMPS provides guidance on authorisation dossiers, quality controls, and post-marketing obligations to ensure safe use of these specialised immunological medicines.

This framework balances innovation in allergy treatment with rigorous safety oversight, supporting both diagnostic precision and long-term disease management in allergic patients. Complete requirements, technical guides, and authorised product lists are published on the AEMPS allergens medicines page. Medicamentos a base de alérgenos - AEMPS