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January 5, 2026
Approximately 5 minutes
Frequently Asked Questions on Pharmaceutical Laboratories Authorization and Operations by AEMPS in Spain
Frequently Asked Questions on Pharmaceutical Laboratories Authorization and Operations by AEMPS in Spain
1. Importation of Medicines
Importation of medicines into the EU must be carried out by an authorized importing pharmaceutical laboratory listed in the medicine's registration. In Spain, such laboratories must comply with Real Decreto 824/2010, including specifications for imported medicines, adequate facilities for manufacturing/control/storage, and qualified personnel (technical director, manufacturing manager, quality control manager). Full qualitative and quantitative analyses are mandatory for each imported batch, even for export-only medicines.
AEMPS FAQ on Pharmaceutical Laboratories
Importation without facilities for qualitative/quantitative analyses is not permitted.
2. Subcontracting of Activities
Subcontracted manufacturing or control activities cannot cover all phases of production or importation, as this would undermine the purpose of the laboratory authorization.
AEMPS FAQ on Pharmaceutical Laboratories
3. Technical Director Requirements
The technical director must be permanently and continuously available at the facility. Appointment is managed by AEMPS as a minor modification. One director can oversee multi-shift operations with appropriate protocols. Multiple plants may share a substitute director if absences are properly managed.
Qualifications include a university degree in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry/technology, or biology, plus specific coursework and at least two years of practical experience in authorized laboratories (reducible for longer university cycles).
Labor contract proof is required; service contracts or subcontracting are not accepted.
For veterinary medicine manufacturers, requirements align with Regulation (EU) 2019/6.
AEMPS FAQ on Pharmaceutical Laboratories
Requirements are identical for manufacturing and importing laboratories.
4. Batch Release and Responsibilities
The manufacturer or importer is responsible for batch release. The technical director's organizational role must enable fulfillment of legal and GMP responsibilities.
AEMPS FAQ on Pharmaceutical Laboratories
5. Contract Warehouses
Contract warehouses are subject to relevant regulations. They cannot invoice in their own name and must notify exports if storing export medicines (even if the holder lacks laboratory authorization).
Certificates may reflect both AEMPS and regional inspections.
The laboratory may appoint the warehouse's responsible technician, who need not belong to the laboratory.
AEMPS FAQ on Pharmaceutical Laboratories
6. Additional Notes
These FAQs were published on 16 October 2023. For customs-related queries, refer to AEMPS external trade section.
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