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INFARMED – National Authority of Medicines and Health Products, IP is a Government agency accountable to the Health Ministry. The objective is to monitor, assess and regulate all activities relating to human medicines and health products for the protection of Public Health.

The English web pages of the National Authority of Medicines and Health Products (INFARMED, I.P.) contain selected items from its Portuguese language site and will be continuously expanded.
About Infarmed


Medicinal products
InfoMed - Medicinal products database
Marketing authorisation
Portugal as Reference Member State
Paediatric Regulation
Notice on implementation of the Paediatric Regulation Submission of information on existing paediatric studies and paediatric use in accordance with Regulation 1901/2006, from 12 December 2006 (paediatric regulation)
Paediatric Submission Tool
Users manual
Homeopathic products
Points to Consider on non-clinical safety of homeopathic Medicinal Products of botanical, mineral and chemical origin for human use
Points to consider on safety of Homeopathic medicinal products of biological origin
Application form
Clinical Trials
Qualified person declaration concerning investigational medicinal products manufactured in third countries
Statistics of Assessment of Clinical Trials
Pharmacovigilance
Training Course in EudraVigilance
Update of the Instructions to Applicants - Submission of Educational Materials and Direct Healthcare Professional Communication (DHPC)
Instructions to Applicants - Submission of Educational Materials
Instructions to Applicants - Submission of Direct Healthcare Professional Communication (DHPC)
Pharmacovigilance Bulletin
Unavailability of the EudraVigilance Production Environment
Electronic Transmission of ICSR - Test Procedure
Reporting Test Procedure
Reporting Test Form
Company Details Form
Waiver Program
Reporting of Non-Portuguese Adverse Drug Reactions
Statement
Electronic transmission of ICSR - system failure
Inspections - Good Manufacturing Practices (GMP)
Portuguese Manufacturers in compliance with GMP (for Medicinal Products, Investigational Medicinal Products, Active Pharmaceutical Ingredients and Quality Control Laboratories)
GMP Guidelines - EudraLex Volume 4
Inspections - Good Laboratory Practices (GLP)
Note to Applicants for GLP Conformity Assessment
National GLP Compliance Monitoring Program
Portuguese Test Facilities in compliance with GLP
Reimbursement
Guidelines for Economic Drug Evaluation Studies
Hospital Use Medicines - prior assessment report
Observatory of Medicinal and Health Products
PPRI - Pharmaceutical Pricing & Reimbursement Information
ESAC - European Surveillance of Antimicrobial Consumption


Cosmetics
FAQ about cosmetics
Online Registration of Cosmetic Products - User's Manual


Medical Devices
On-line Registration for MD/IVD by its Manufacturers/Authorized Representatives (FABDM)
FAQ about Medical Devices
FAQ about in vitro Medical Devices
Clinical investigation
Statement of clinical investigation with medical devices
Statement of clinical investigation with active implantable medical devices
Form for medical devices and active implantable medical devices in clinical investigation
Manufacturers' registration
Guidances for the on-line registration of class IIA, IIB and III medical devices and implantable active medical devices by the manufacturers putting into service these devices in Portugal
On-line registration of classes IIa, IIb and III medical devices and implantable active medical devices by Manufacturers
Medical Devices Vigilance
FAQ about vigilance system of medical devices
Report form for notification of incidents with medical devices
FSCA report form
Reconciliation report form
Check-List for validation of field safety notice
Minimal contents for receipt confirmation


Other information
Fees
(updated 2008-02-28)
Regulatory and Scientific Advice (RSA)