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The new Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDMD)

September 3, 2020September 4, 2020 crofar

The new Regulation (EU) 2017/746 will significantly change the regulatory requirements on IVDMD (mainly represented by the European Directive 98/79/EC dating back from 1998) for manufacturers and other stakeholders. It’s time to get ready! The new Regulation will have to… Read More

Normas para Atribuição do Título de Especialista em Farmácia Comunitária

July 15, 2020July 15, 2020 crofar

Regulamento n.º 567/2020 Publicação: Diário da República n.º 134/2020, Série II de 2020-07-13 Emissor: Ordem dos Farmacêuticos Disponível em: https://dre.pt/web/guest/pesquisa/-/search/137615373/details/maximized

EMA finalises opinion on presence of nitrosamines in medicines

July 15, 2020July 15, 2020 crofar

EMA’s human medicines committee (CHMP) has issued an opinion requiring companies to take measures to limit the presence of nitrosamines in human medicines as far as possible and to ensure levels of these impurities do not exceed set limits. The… Read More

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