Manufacturing of Medicines in Spain – AEMPS Regulatory Oversight

Legal and Regulatory Framework

The manufacturing of medicinal products in Spain is governed by EU Directive 2001/83/EC (as amended), Regulation (EU) 2017/745 for certain borderline products, and national legislation including Royal Decree 1345/2007 and Royal Decree 824/2005 on radiopharmaceuticals. AEMPS, as the national competent authority, is responsible for authorising manufacturing and import activities, inspecting facilities, issuing GMP certificates, and ensuring compliance with EU GMP guidelines (EudraLex Volume 4). This framework applies to all human and veterinary medicines, including investigational medicinal products and advanced therapy medicinal products. Fabricación de medicamentos - AEMPS

Authorisation Requirements

• Manufacturing Authorisation: Required for any entity involved in manufacturing, packaging, labelling, or importing medicinal products. Applications are submitted to AEMPS with detailed information on premises, equipment, personnel, processes, and quality systems.
• Qualified Person (QP): Each authorised site must have a nominated QP responsible for certifying batches before release.
• Import Authorisation: Separate authorisation for importing from third countries, including verification of equivalent GMP standards in the exporting country.
• Special Categories: Additional requirements apply to biologicals, sterile products, radiopharmaceuticals, and ATMPs.

Good Manufacturing Practice (GMP) Compliance

Manufacturers must implement a pharmaceutical quality system in line with EU GMP principles, covering:

• Quality management
• Personnel and training
• Premises and equipment
• Documentation
• Production and process controls
• Quality control and validation
• Outsourced activities
• Complaints, recalls, and self-inspection

AEMPS conducts routine and for-cause GMP inspections to verify compliance. Non-compliance may lead to warning letters, suspension, variation of authorisation, or withdrawal.

GMP Certification and Mutual Recognition

• GMP Certificates: Issued by AEMPS following satisfactory inspection; valid for 3 years and recognised across the EU/EEA under the mutual recognition system.
• Third-Country Inspections: AEMPS participates in joint EU inspections and relies on MRA/Mutual Recognition Agreements with certain countries (e.g., Japan, Australia) for GMP equivalence.
• API Manufacturing: Active substance manufacturers are inspected under EU GMP for APIs (Part II); written confirmation of GMP compliance may be required for imports.

Practical Implications and Resources

Manufacturers must notify AEMPS of significant changes (e.g., site transfers, new dosage forms) via variation procedures. AEMPS maintains a public register of authorised manufacturers and GMP certificates. Guidance documents, application forms, inspection procedures, and contact points are available to support compliance.

This rigorous oversight ensures that medicines manufactured or imported into Spain meet high standards of quality, contributing to patient safety and public health across the EU market. Detailed requirements, forms, guidance, and authorised entity lists are published on the AEMPS manufacturing medicines section. Fabricación de medicamentos - AEMPS