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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.

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

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

Pharmacovigilance Bulletin

Electronic Transmission of ICSR - Test Procedure

Reporting Test Procedure

Reporting Test Form

Company Details Form

Waiver Program

Reporting of Non-Portuguese Adverse Drug Reactions

Outbound Testing

Reimbursement

Guidelines for Economic Drug Evaluation Studies

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

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)

Satisfaçăo do Cliente

Centro de Contacto
Telefone: 217 987 100
E-mail: infarmed@infarmed.pt

Última Actualização:

September 2, 2010

Portal da Saúde - Ministério da Saúde