" The fees, currently applied in Portugal, set by Governmental Decree No. 377/2005, April 4th [Portaria n.º 377/2005, de 4 de Abril], are as follows: Values updated 2006 1 – For each..."
"On-line Registration for MD/IVD by its manufacturers/authorized representatives (SIDM) Vigilance See FAQ Regulatory and scientific advice (RSA) Request for regulatory and scientific advice of medical devices Guide for regulatory and scientific advice (RSA)"
"Acessibilidade What is the Regulatory and Scientific Advice Office (GARC)? The Regulatory and Scientific Advice Office (GARC) aims to advise on requests to INFARMED, I.P. or to other entities with similar competences in accordance with current regulatory, legislative and scientific requirements, allowing their validation and evaluation to be carried out in an expeditious manner. Which is the mandate of GARC? GARC is responsible for clarifying issues arising from the preparation of documents relating to: Clinical Trials, Marketing Authorization (AIM), changes to AIM’s terms, Renewals of AIM for Medicines for Human Use or any other subjects related to them; CE marking, or procedures complementary to the CE marking; Notification and registration of Medical Devices and Cosmetic Products; Licensing of entities and good practices. What is the scope of the advice to be provided by GARC? Advice can be sought during initial development stages of medicinal products, medical devices and cosmetic ..."
"Pre-submission of Marketing Authorisation applications SMUH-AIM (Login) SMUH-AIM external user's manual (version september 2023) Template - Declaration form for the use of e-mail communications with Infarmed - E-mail address identification form Summary of Actions - Manual SMUH-AIM (EN) Guidance to applicants - Submission of Marketing Authorisation Applications approved by Executive Board of INFARMED, I.P. Deliberation nr 186/CD/2013 (dated 24/10/2013) Credit card payment - Online portals for submission of marketing authorization and variation applications (SMUH-AIM e SMUH-ALTER) SMUH-AIM - Payments by credit card Eletronic pre-submission of MAA A new version of INFARMED's electronic portal for management of medicinal products for human use for pre-submission of MAA (SMUH-AIM) will be made available on October, 21st 2013. The new version of the electronic portal will allow pre-submission of marketing authorisation applications to INFARMED, I.P. by national and mutual recognition/decentr..."
"Marketing authorisation Portugal as Reference Member State Submission of Marketing Authorisation Applications Submission of translations (Marketing Authorisation, Renewal and Variation procedures) Publication of SmPCs and PLs in Infomed from clinical variations and renewals with Portugal as Concerned Member State Publication of SmPCs and PLs in Infomed from clinical variations and renewals with Portugal as Concerned Member State - Correction Template for revocation/withdrawal of marketing authorisation MA revocation/ withdrawal request Variations Contact person for pharmacovigilance issues at national level Homeopathic medicinal 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 countrie..."
"Infarmed was the 3rd Member State to start procedures as Reference Member State in 2018 Strengthening Portugal's position in the regulatory system is one of the strategic objectives of Infarmed and includes the active participation in the European medicines evaluation network through Mutual Recognition and Decentralised procedures, in particular through the number of marketing authorisation applications initiated by Portugal as Reference Member State. In 2018, Infarmed reached the top 3 of the Member States that most contribute to the European evaluation system. The work carried out by Infarmed in the last 10 years, along with Brexit, has made it possible for Infarmed to integrate the European group of agencies with a greater active role in the evaluation of medicines. The technical and scientific capacities in different therapeutic areas, recognised experience in the authorisation assessment and the availability are some of the aspects that are recognized and valued. Portugal as Ref..."
"Acessibilidade What is the regulatory framework for cosmetic products in Portugal? In Portugal cosmetic products are legislated by Regulation (EC) No 1223/2009, Deliberação n.º 15/CD/2013, Decree-Law n.º 189/2008, September 24th, as it stands, namely articles 10, 20, 22, 23, 24, 25, 29 as well as penalties applicable. What do I have to do to place a cosmetic product on the Portuguese market? Some elements of the cosmetic¿s labelling should be written in Portuguese, namely the nominal content, date of minimum durability, particular precautions to be observed in use and the function of the cosmetic product. In case your products are manufactured in Portugal you should also keep the following data: Name, qualifications, address and contacts of the qualified technician, established in the European Union, who is responsible for the products in terms of manufacturing, quality control, composition and packaging/labelling, according to the Articles 24 and 25 of the Decree-Law No. 189/2008,..."
"Acessibilidade Marketing authorisation Variations Electronic submission MA Holder Transfer The medicinal products are subject to changes throughout their regulatory lifetime in order to be kept always up-to-date. Those changes must be authorised by INFARMED, I.P. and follow standard procedures designated by variations to the terms of marketing authorisation. The Commission Regulation (EC) No. 1234/2008 of 24 November 2008, concerning the examination of variations to the terms of marketing authorisations, amended by the Commission Regulation (EU) No. 712/2012 of 3 August 2012, intended to establish a simpler, clearer and more flexible legal framework, while guaranteeing the same level of public health protection.This regulation is applicable to variation applications submitted by centralised procedure and mutual recognition/decentralised procedure since January, 1st 2010. It is not applicable to the transfers of a marketing authorisation. The Commission Regulation (EC) No. 1234/2008, am..."
"�� SMUH-AIM Payments by credit card SMUH-AIM electronic portal manages the payment of fees regarding pre-submission of marketing authorization applications to INFARMED,I.P. A new functionality..."
"�� SMUH-ALTER Payments by Credit Card SMUH-ALTER portal is an online platform for submission of variation applications allowing applicants to submit applications and view information..."
" Instructions to applicants for submitting variations to the terms of Marketing Authorisations Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation ..."
" M -A T E N D -0 0 8 /0 0 1 1/1 INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. Parque de Saúde de Lisboa - Av. do Brasil, 53 1749-004 Lisboa Tel.:..."
" 1 ELECTRONIC PRE-SUBMISSION OF MARKETING AUTHORISATION APPLICATIONS USING THE PORTAL SMUH-AIM INFARMED Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. 2 • Required for MAA..."
" 1/8 Guidance to applicants Submission of Marketing Authorisation Applications The purpose of this notice to applicants is to clarify aspects related with the submission to..."
" Guide for Regulatory and Scientific Advice 1/7 Version January, 2022 GUIDE FOR REGULATORY AND SCIENTIFIC ADVICE (RSA) 1. INTRODUCTION The purpose of this guide is to give..."
" OVERVIEW EudraVigilance is the European data-processing network and management system, established at the European Medicines Agency (EMA) to support the electronic exchange, management and..."
" External User Manual Page 1 of 62 Version 2, August 2013 INFARMED’S Electronic System for the Management of Medicinal Products of Human Use (SMUH‐ALTER) ‐ ..."
"Regulation for INFARMED, I.P.’s auditorium and meeting room use. Article 1 (Object) This regulation establishes the conditions for use of the auditorium, meeting rooms and support spaces of the..."
" EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals NOTICE TO APPLICANTS Medicinal Products for Human Use VOLUME 2B ..."
" Versão 2, fevereiro 2014 1 ELECTRONIC PRE-SUBMISSION OF MAA (SMUH-AIM) INSTRUCTIONS MANUAL Versão 2, fevereiro 2014 2 1. INTRODUCTION..."
" ELECTRONIC PRE-SUBMISSION OF MAA (SMUH-AIM) INSTRUCTIONS MANUAL � 51. INTRODUCTION � 51.1. Objective � 52. REQUIREMENTS FOR USE OF THE PLATFORM � 52.1. Login Screen � 63. Initial..."
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Press release - More than 2600 generics with proven quality
Infarmed Newsletter - Edition n.º 57
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