www.vda.pt

SAÚDE

REGULAÇÃO

Resolução do Conselho de Ministros n.º 84/2015 - Diário da República n.º 193/2015, Série I de 2015-10-02

Presidência do Conselho de Ministros

Extingue a Comissão Interministerial de Coordenação da Resposta ao Ébola, criada pela Resolução do Conselho de Ministros n.º 60/2014, de 31 de outubro

GOVERNO

Despacho n.º 10715-B/2015 - Diário da República n.º 188/2015, 1º Suplemento, Série

II de 2015-09-25

Ministério da Saúde - Gabinete do Ministro

Aprova o Regulamento da Atividade Inspetiva da Inspeção-Geral das Atividades em

Saúde

Portaria n.º 324-A/2015 - Diário da República n.º 192/2015, 2º Suplemento, Série I de

2015-10-01

Ministérios das Finanças e da Saúde

Fixa os valores das taxas moderadoras na concretização da interrupção voluntária

da gravidez

MINISTÉRIO DA

SAÚDE

Publicação para efeitos do artigo 15º-A do Decreto -Lei n.º 176/2006, de 30 de

Agosto - pedidos de autorização de introdução no mercado de medicamentos

genéricos

INFARMED

Detalhe do Concurso 2015 / 24 - Material disposable de bloco operatório - Parte I-A

- Programa de Concurso

- Caderno de Encargos

Detalhe do Concurso 2015 / 76 - Equipamentos e dispositivos médicos de uso

comum em internamento e ambulatório - parte I

SPMS

saude@vda.pt 28 de setembro a 1 de outubro de 2015

www.vda.pt

- Programa de Concurso

- Caderno de Encargos

JOUE | Não oposição a uma concentração notificada (Processo M.7559 —

Pfizer/Hospira) ( 1 )

Italy joins the unitary patent

Today, Italy has joined the unitary patent and become the 26th member of the

enhanced cooperation on unitary patent protection. This is a major breakthrough as

Italy is the fourth biggest market in Europe in terms of patent validation.

Resumo das decisões da União Europeia relativas às autorizações de introdução no

mercado dos medicamentos de 1 de agosto de 2015 a 31 de agosto

de 2015[Publicado nos termos do artigo 13.o ou do artigo 38.o do Regulamento (CE)

n.o 726/2004 do Parlamento Europeu e do Conselho]

Resumo das decisões da União Europeia relativas às autorizações de introdução no

mercado dos medicamentos de 1 de agosto de 2015 a 31 de agosto

de 2015[Decisões adotadas nos termos do artigo 34.o da Diretiva 2001/83/CE ou do

artigo 38.o da Diretiva 2001/82/CE]

COMISSÃO

EUROPEIA

Press Release: MEDICRIME Convention, Landmark Tool to Curb Global Medicines

Counterfeiting

The global innovative and generic/biosimilar pharmaceutical industries welcome the

entry into force of the Medicrime Convention and encourage countries worldwide to

sign and ratify it.

The Medicrime Convention will ensure international cooperation between the

competent health, police and customs authorities and will help to make real strides

globally in fighting counterfeit medicines.

This marks the beginning of a new era in our collective efforts to criminalize the

production and distribution of counterfeit medicines and to shine a light on a

dangerous business that puts patients at risk.

Position Paper - EFPIA Policy Principles for Off-patent Biologic Medicines in Europe

Over the coming years an increasing number of biologic medicines will lose patent

protection creating both competition and headroom for governments and payers to

further invest in innovation. Biologic medicines have, and continue to play a key role

in disease treatment and EFPIA fully supports the creation of competitive, efficient

and sustainable off-patent biologic markets as a means to help achieve these goals.

However, due to their unique characteristics, it needs to be recognised that policies

must be designed specifically for biological medicines.

EFPIA has developed a set of principles to help healthcare systems design and

implement policies that can successfully create competitive off-patent biologic

markets.

Press Release - EFPIA Launches Robust Principles to Secure a Competitive

EFPIA

www.vda.pt

European Off-Patent Biologic Medicines Market

Comprehensive EFPIA principles launched 30th September 2015, are designed to

create and secure a sustainable and competitive off-patent biologic medicines

market that balances efficient patient access to the most appropriate medicine for an

individual patient and effective cost management across Europe.

With an increasing number of biologic medicines set to lose patent protection in the

coming years, the EFPIA policy principles have been devised to encourage

competition, while establishing essential headroom for governments and payers to

further invest in innovation.

Health & Growth – 10 Facts for European Health Policy Makers (Infographics)

Human Medicines | Scientific guideline: VICH GL53: Electronic exchange of

documents: electronic file format

This Guideline has been developed by the appropriate VICH Expert Working Group

and has been subject to consultation by the parties, in accordance with the VICH

Process. At Step 7 of the Process the final draft is recommended for adoption to the

regulatory bodies of the European Union, Japan and the USA.

Human Medicines | Scientific guideline: Draft guideline on immunogenicity

assessment of biotechnology-derived therapeutic proteins

The number of biological/biotechnology-derived proteins used as therapeutic agents

is steadily increasing. These products may induce unwanted immune responses,

which can be influenced by various factors, including patient- and disease-related

factors as well as product-related factors.

Human Medicines | List of medicinal products under additional monitoring (updated)

Human Medicines | Plasma-master-file certifications (updated)

Human Medicines | Scientific guideline: Draft guideline on the use of

pharmacokinetics and pharmacodynamics in the development of antibacterial

medicinal products

This guideline replaces the 'Points to consider' on pharmacokinetics and

pharmacodynamics in the development of antibacterial medicinal products

(CHMP/EWP/2655/99). The Guideline has been developed to outline the regulatory

expectations for application dossiers and reflects both the scientific advances in the

field of pharmacometrics that have implications for antimicrobial agent development

programmes and the regulatory experience since the adoption of the 'Points to

consider'

EMA

CMDh Best Practice Guide on the compilation of the dossier for New Applications

submitted in Mutual Recognition and Decentralised Procedures

The objective of this Best Practice Guide (BPG) is to emphasise the importance of taking

care in the compilation of the dossier for a Marketing Authorisation Application (MAA), to

minimise delays in validation, to avoid invalidation of submissions, to forestall questions

from Member States (both RMS and CMS), and to enhance the efficiency of the regulatory

process.

Additional Data requested for New Applications in the Mutual Recognition and

Decentralised Procedures

List of active substances for which data has been submitted in accordance with Article

45 of the Paediatric Regulation

Report from the meeting held on 21-23 September 2015

CMDh - Meeting 21-23 September: Agenda

HMA