47
Edition nº
Meeting of the Heads of the
European Medicines Agencies
At the meeting of the Heads of European Medicines Agencies held on 10-12 May in Malta, where Infarmed Executive Board was present, the main impacts of the UK's exit from the European system activities were discussed, both in the scientific area and in the operation of the network's functional structure.
Guidelines for dealing with the Brexit have been agreed, regarding the challenges that national Agencies will face after 29 March 2019. It was decided that National Agencies should strengthen their collaboration and also cooperate with the European Medicines Agency, planning the response to the needs arising from the exit of the United Kingdom from the EU and also, maintain open channels of communication and cooperation with the experts and colleagues in the UK, ensuring a favourable environment for all parties during the transitional period.
Hepatitis C - One more medicine reimbursed
Published in Diário da República, the Portuguese Official Journal, Portaria 111/2017 of May 15, which adds an annex to Portaria no. 158/2014, of February 21, which reviews the special regime of reimbursement for medicines destined to the treatment of the disease of hepatitis C, adding the drug containing the substances Sofosbuvir + Velpatasvir. The application for reimbursement of this medicinal product has been evaluated in the following therapeutic indication: for the treatment of chronic hepatitis C virus (HCV) infection in adult patients with genotype 3 infection.
With the medicines available, almost eleven thousand treatments have been started, and approximately six thousand patients have been cured, according to data from the Hepatitis C Platform - Monitoring of treatments, managed by INFARMED.
The Ministry of Health has guaranteed the best contractual conditions and thus ensured the sustainability of the Portuguese Health System by making these medicines available to all patients who need them.
Thematic Dossier - Biosimilar Medicines
INFARMED published on its website, an update of information for patients about biosimilar medicines. This information provides access to information in easy-to-understand language, despite the complexity of the concept.
This information is the result of a consensus between the European Commission, the European Medicines Agency (EMA) and the partners involved: European Patients Forum (EPF), The European Federation of Crohn's Disease & Ulcerative Colitis Associations (EFCCA), Standing Committee of European Doctors (CPME), European Federation of Pharmaceutical Industries and Associations (EFPIA), The European Associations for Bioindustries (EuropaBio) and Medicines for Europe.
Addition of new homogeneous groups
INFARMED makes available on its website the list of Homogenous Groups and unit reference prices, regarding the second quarter of 2017. This list is updated with the inclusion of 3 new homogeneous groups, for which the respective reference price were approved (GH1098, GH1099 and GH1100) - Amlodipine + Valsartan, film-coated tablet, 5 mg + 160 mg and 5 mg + 80 mg.
According to what is established in line b) of paragraph 1, of article 3 of the Portuguese legal document Portaria no. 195-B/2015, of June 30, Infarmed publishes until the 20th of the month, the new Homogenous groups created as a result of the introduction of new generic medicinal products (…). Thus, Infarmed announces the Deliberation of the Board of Directors that approves the Homogeneous Group that will come into effect on June 1, 2017.
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.
Parque de Saúde de Lisboa - Avenida do Brasil, 53, 1749-004 Lisboa - Portugal
Telef: +351 217 987 100 | Fax: +351 217 987 316 | E-mail: Infarmed@Infarmed.pt