Scientific Advice Procedure at the AEMPS

Scientific Advice Procedure at the AEMPS
Legal Basis
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Real Decreto 520/1999, de 26 de marzo, por el que se aprueba el Estatuto de la
Agencia Española del Medicamento
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Circular 12/2002 de la Agencia Española del Medicamento, Instrucciones para la
solicitud de asesoramiento científico sobre la calidad, seguridad y eficacia de un
medicamento de uso humano o de uso veterinario, durante las etapas de investigación
y desarrollo del mismo, para iniciar un procedimiento de reconocimiento mutuo y otro
tipo de asesoramientos
Aims
Scientific advice is not to be considered as a pre-assessment of a product. The aim is to give
the Agency’s opinion on specific questions about what could be done regarding a particular
situation or problem, concerning 3 main areas of product development (in addition to Regulatory
Affairs and Pharmacovigilance):
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Clinical
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Preclinical - Toxicology
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Quality - Biotechnology
Procedures & timeline
There are three different kinds of advice procedures:
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Initial scientific advice
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Follow-up scientific advice
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Pre-submission meeting
Depending on the posed questions, the AEMPS will decide on the convenience of a Written
Scientific Advice Report or a Scientific Advice Meeting, being the latter the most frequent
choice. The meeting usually takes place at least one month after validation, usually on
Thursdays, depending on the assessors’ and applicant’s availability (please limit the number of
company staff attending the meeting to 8). The minutes of the meeting are to be prepared by
the applicant within the following 15 days and sent to the AEMPS for their revision. The
reviewed document will be considered as the Final Scientific Advice Report, which finalizes the
procedure, not allowing for any further inquiries.
Regarding the timeline of the procedure, the Circular considers a maximum of three months
(90 days) after validation of the complete set of documents.
CORREO ELECTRÓNICO
smhaem@aemps.es
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C/ CAMPEZO, 1 – EDIFICIO 8
28022 MADRID
TEL: 91 822 50 73
FAX: 91 822 51 61
Documentation
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Application form (updated Annex IA), EN)
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Letter of intent
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Questions and applicant’s position (Q&As format)
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Relevant information about the product concerning the posed questions
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Previous Scientific (Advice/Assessment) Reports from other HAs
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Relevant guidelines - UE, ICH, FDA, etc.
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Bibliographical references
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Proof of fee payment*
http://www.aemps.gob.es/en/industria/tasas/home.htm
The request (4 paper copies + 1 CD, Briefing Book in ES or EN) can be sent directly to the
following address:
Unidad de Registro y Tasas – AEMPS
Att: Asesorías Científicas Nacionales
Parque Empresarial Las Mercedes, Edificio 8
C/ Campezo 1
E-28022 Madrid / Spain
For further inquiries regarding the Scientific Advice procedure at the AEMPS, please do no
hesitate to contact us under: ascina@aemps.es
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MINISTERIO DE SANIDAD,
POLÍTICA SOCIAL
E IGUALDAD
Agencia Española de
Medicamentos y
Productos Sanitarios