Modification Procedure for Pharmaceutical Laboratory Authorizations by AEMPS in Spain

1. Overview and Requirement for Prior Authorization

Any modification to the conditions established in the authorization of a pharmaceutical laboratory (as manufacturer and/or importer) requires prior authorization from the Spanish Agency for Medicines and Medical Devices (AEMPS). This ensures continued compliance with quality and safety standards.

AEMPS Modificación de la autorización de un laboratorio farmacéutico

2. Application Submission

Applications for modification must be submitted exclusively electronically through the LABOFAR platform at the AEMPS Electronic Headquarters.

Platform: LABOFAR

AEMPS Modificación de la autorización de un laboratorio farmacéuticos

3. Evaluation Process

AEMPS evaluates the application, which may include an on-site inspection to verify that the laboratory maintains adequate personnel and material resources to guarantee pharmaceutical quality for the requested operations.

Timelines may be suspended if additional information or clarifications are requested (with a one-month response deadline). Incomplete applications allow ten days for rectification, or the request is considered withdrawn.

AEMPS Modificación de la autorización de un laboratorio farmacéutico

4. Resolution and Notification

The standard resolution notification period is 30 days from receipt of the application, exceptionally extendable to 90 days.

If the evaluation is unfavorable, AEMPS notifies the reasons, granting 15 days for allegations and additional documentation.

Upon favorable resolution, the modified authorization is issued and immediately communicated to the applicant and relevant autonomous communities.

AEMPS Modificación de la autorización de un laboratorio farmacéutico

5. Additional Notes

No specific classification of modifications (e.g., major/minor) or associated fees are detailed. For cases involving suspension or revocation (not modifications), separate procedures apply with a maximum 6-month resolution period.

AEMPS Modificación de la autorización de un laboratorio farmacéutico