30 de novembro a 4 de dezembro de 2015
[email protected]
SAÚDE
LEGISLAÇÃO
Portaria n.º 417/2015 - Diário da República n.º 238/2015, Série I de 2015-12-04
NACIONAL
Ministério da Saúde
Primeira alteração à Portaria n.º 223/2015, de 27 de julho, que regula o procedimento de
pagamento da comparticipação do Estado no preço de venda ao público (PVP) dos
medicamentos dispensados a beneficiários do Serviço Nacional de Saúde (SNS) e à
Portaria n.º 224/2015, de 27 de julho, que estabelece o regime jurídico a que obedecem as
regras de prescrição e dispensa de medicamentos e produtos de saúde e define as
obrigações de informação a prestar aos utentes
REGULAÇÃO
Despacho n.º 14450/2015 - Diário da República n.º 238/2015, Série II de 2015-12-04
Ministério da Saúde - Gabinete do Ministro
MINISTÉRIO DA
SAÚDE
Designa, em regime de substituição, para exercer o cargo de presidente do Conselho
Diretivo do Infarmed - Autoridade Nacional do Medicamento e Produtos de Saúde o
Professor Doutor Hélder Mota-Filipe
Publicação para efeitos do artigo 15º-A do Decreto -Lei n.º 176/2006, de 30 de Agosto -
INFARMED
pedidos de autorização de introdução no mercado de medicamentos genéricos
Documento Orientador CEIC sobre Consentimento Informado (CI) para participação
CEIC
em ensaios clínicos em pediatria - Este documento contém recomendações para o
Consentimento Informado em pediatria.
Sector Inquiry | Sixth Report on the Monitoring of Patent Settlements (period: JanuaryDecember 2014)
Concurso 2015 / 28 - Suturas Cirúrgicas - Parte I
COMISSÃO
EUROPEIA
SPMS
- Programa de Concurso
- Caderno de Encargos
www.vda.pt
Lista de Entrada em Vigor dos CPA (04/12/2015)
EMA
Human Medicines | Regulatory and procedural guideline: Post-orphan medicinal
product designation procedures: guidance for sponsors
Human Medicines | Position paper on the non-acceptability of replacement of pivotal
clinical trials in cases of GCP non-compliance in the context of marketing authorisation
applications
The aim of this position paper is to inform applicants and Marketing Authorisation Holders
(MAH) on the position of the European Medicines Agency (EMA) concerning the nonacceptability of replacement of pivotal clinical trials during the assessment of an
application in the context of a marketing authorisation in cases of GCP non-compliance
Human Medicines | Regulatory and procedural guideline: Scientific guideline:
Guideline on non-clinical local tolerance testing of medicinal products,
This document provides guidance for the development and evaluation of medicinal
products that will, or have the potential to, come into contact with different sites of the
human body following normal clinical use, as well as after unintentional administration
HMA
Validation Procedure| Common Grounds for Invalidation/Delaying Validation
The CMDh has continued the work on validation to streamline the MRP/DCP and an
Agreement has been reached between all MS to divide issues raised as Validation Issues
respectively Non-Validation Issues allowing the RMS to start the procedure when all stated
Validations Issues have been solved cf. CMDh Template for Validation of Application for
marketing authorization(CMDh/181/2010).
Risk Management Plans | Cover Note to the list of safety concerns per approved
RMP
By publishing the safety concerns of agreed RMPs, Members States and companies can
base their assessment/prepare their RMP on safety concerns of already approved RMPs
for the active substance, which will lead to more harmonised outcomes.
In due time the Working Party on Pharmacovigilance Procedures Work Sharing will
discuss based on the information included in the list how full harmonisation (where
applicable) of RMPs for the same active substances may be achieved.
Renewal Procedure | CMDh Best Practice Guide on the processing of renewals in
the
MRP/DCP
This Best Practice Guide is intended to facilitate the processing of renewals in the mutual
recognition and decentralised procedures, with an aim of giving procedural advice to assist
Member States and applicants, in order to ensure a consistent and beneficial approach to
renewal
Unforeseen Variations | CMDh Recommendation for classification of unforeseen
variations according to Article 5 of Commission Regulation (EC) 1234/2008
Variation Procedure | Examples for acceptable and not acceptable groupings for
MRP/DCP products
www.vda.pt
Questions & Answers | Variations
FAQ: foods for special medical purposes
EFSA
EFSA has published scientific and technical guidance that will help the European
Commission to apply new rules on foods for special medical purposes (FSMPs). But what
are these products and how will the new rules work? Our nutrition specialists answer the
key questions
European medical technology industry adopts new Code of Ethical Business
Practice
Members of the European Diagnostics Manufacturers Association (EDMA) and of the
European Medical Technology Industry (Eucomed), have approved a new and common
MedTech Europe Code of Ethical Business Practice at their General Assemblies held on 2
December in Brussels, in a continuous effort to set high ethical standards for the medical
technology industry across Europe.
The Code will replace the EDMA and Eucomed codes of business practice and will
become binding for members of both associations on 1st January 2017. For more
information
Position Paper | Concept of an IVD kit - Definition and labelling
EDMA