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Tag Archives: biological medicinal products

European Commission invites targeted stakeholders for consultation on duplicate marketing authorisations for biological medicinal products and biosimilars

The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorisations from stakeholders. These include entities involved in the development, manufacture and/ or commercialisation of medicinal products for human use, in particular biological medicinal products and biosimilars, patient groups, healthcare professionals as well as insurance and procurement agencies. The objective of this

EMA Adopts new Chapter to its Guidelines on Good Pharmacovigilance Practices concerning Biological Medicinal Products

The European Medicines Agency (“EMA”) has adopted a new chapter to its guidelines on good pharmacovigilance practices (“GVP”). The new chapter addresses the specific challenges of pharmacovigilance relating to biological medicinal products. The chapter entitled “Product- or population-specific considerations II: Biological medicinal products” (“the Chapter”) came into effect on 16 August 2016.

European Commission adopts the black symbol to be placed in the patient information leaflets for medicinal products subject to additional monitoring in the EU

On 7 March 2013, the European Commission adopted a black triangle as the symbol to be placed on the patient information leaflets and the Summary of Product Characteristics (“SmPC”) of medicinal products “subject to additional monitoring” in the European Union (“EU”). The history of the black triangle The requirement to include a black symbol in