reform of pharmaceutical legislation Archives - European Industrial Pharmacists Group (EIPG)

ICMRA published a Reflection paper on remote inspections


by Giuliana Miglierini Remote inspections have become a widely used approach since the last two years to ensure the oversight of the compliance of pharmaceutical productions to regulatory requirements, as the prolonged lockdown periods determined by the pandemic made very Read more

EMA’s Q&A on the integration of EudraGMDP and OMS


by Giuliana Miglierini A new step in the integration at the central level of data needed to manage regulatory procedures is going to be activated on 28 January 2022: starting from this date, member states’ national competent authorities (NCAs) shall Read more

Draft Guideline on the acceptability of names for human medicinal products


The scope of this guideline is to provide information on the overall procedure for submitting and reviewing the acceptability of proposed (invented) names for human medicinal products processed through the centralised procedure, as well as detailed guidance on the Read more

Consultation on the reform of the European pharmaceutical legislation

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In November 2020, the Commission published a Communication on a Pharmaceutical Strategy for Europe. The Pharmaceutical Strategy identifies flagship initiatives and other actions to ensure the delivery of tangible results: https://ec.europa.eu/health/sites/default/files/human-use/docs/pharma-strategy_report_en.pdf As part of the implementation of the strategy, the Commission is evaluating the general pharmaceutical legislation and assessing the impacts of possible changes in the legislation as described in the relevant inception impact assessment.

This consultation aims to collect views of stakeholders in order to support the evaluation of the existing general pharmaceutical legislation and the impact assessment of its revision. A summary on the outcome of the public consultation will be published by the Commission services on the ‘Have your say’ portal. The Commission’s questionnaire is under consideration by our Bureau members and the link is as follows: https://forms.office.com/r/EUHkxBN3Sk. The deadline to participate in this consultation call is the 10th December. 

We thank you for your participation.