Authorization Procedure for Pharmaceutical Manufacturing Laboratories by AEMPS in Spain

1. Overview and Purpose

Pharmaceutical laboratories in Spain that manufacture medicines or investigational medicines, or perform related processes such as fractionation, packaging, and presentation for sale, must obtain prior authorization from the Spanish Agency for Medicines and Medical Devices (AEMPS). This requirement extends to laboratories manufacturing exclusively for export and to importing laboratories that conduct mandatory control analyses for medicines or investigational medicines imported from third countries. The authorization ensures compliance with quality, safety, and efficacy standards before operations begin.

AEMPS Procedimiento de autorización de laboratorios farmacéuticos

2. Legal Basis and Scope

The procedure is governed by Spanish pharmaceutical legislation. Authorization is mandatory for manufacturing activities (including partial processes) and for importers performing required analyses on products from non-EU/EEA countries. The process includes an evaluation with an AEMPS inspection.

AEMPS Procedimiento de autorización de laboratorios farmacéuticos

Fees are established under Real Decreto Legislativo 1/2015, of July 24.

3. Key Requirements

Applicants must demonstrate:

• Suitable and sufficient premises, installations, technical equipment, and control facilities compliant with legal requirements for manufacturing, quality control, and medicine storage (aligned with Good Manufacturing Practices - GMP).
• Appointment of qualified personnel: a technical director (with proposed alternates), a manufacturing manager, and a quality control manager. In small-scale operations or for simple products, the technical director may assume quality control duties provided manufacturing responsibility is assigned to another person.

AEMPS Procedimiento de autorización de laboratorios farmacéuticos

4. Application Procedure

Applications are submitted exclusively electronically through the LABOFAR platform at the AEMPS Electronic Headquarters (https://sede.aemps.gob.es/).

Required documentation includes:

• Applicant details (name, address, tax ID, and for legal entities, proof of commercial registry including the activity in corporate purpose).
• Legal representative details and proof of representation.
• Technical memorandum justifying compliance with requirements.
• Proposals for technical director and alternates, signed by the legal representative and the proposed director, accompanied by academic qualifications, experience documentation, declaration of no incompatibilities, and proof of employment relationship.
• Proof of payment of applicable fees.

AEMPS Procedimiento de autorización de laboratorios farmacéuticos

5. Evaluation and Decision

The authorization process involves an evaluation, including an on-site inspection by AEMPS. A motivated resolution is issued and notified within a maximum of 90 days from application receipt.

AEMPS Procedimiento de autorización de laboratorios farmacéuticos

6. Practical Considerations

Authorization must specify the medicines, pharmaceutical forms, manufacturing/import activities, and facility locations. For importers, authorization is specifically required when performing control analyses for third-country imports.

AEMPS Procedimiento de autorización de laboratorios farmacéuticos