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Parliamentary questions
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13 August 2018
Answer given by Mr Andriukaitis on behalf of the European Commission
Question reference: E-003852/2018

1. As the Honourable Member stated, the Commission adopted in 2017 an assessment report(1) on the current shortcomings in the summary of product characteristics (SmPC) and the package leaflet (PL) with recommendations on how these leaflets could be improved to better meet the needs of patients and healthcare professionals.

Regarding readability of the product information, the Commission’s report recommended to consider revising the existing guidelines including the Commission's guideline(2) on the readability of the labelling and package leaflet of medicinal products for human use.

The Commission is working with the European Medicines Agency (EMA), the network of national competent authorities and in close collaboration with other relevant stakeholders towards the implementation of the recommendations of the report. As a follow-up, the EMA published an action plan(3) with identified deliverables and timelines to implement the recommendations of the Commission’s report.

However, the completion of the work is currently impacted by the forthcoming move of the EMA from London to Amsterdam and the need for EMA to focus on core business priorities for the time being.

2. The current guideline of readability includes indeed a reference to the type size of 9 points, but as a minimum. It does not prevent a bigger size. When the guideline was last updated in 2009, the minimum size was increased from 8 points up to 9 points following a public consultation and a discussion with the competent authorities in Member States.

(1)Report from the Commission to the European Parliament and the Council in accordance with Article 59(4) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use https://ec.europa.eu/health/sites/health/files/files/documents/2017_03_report_smpc-pl_en.pdf
(2)Guideline on the readability of the labelling and package leaflet of medicinal products for human use https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-/c/2009_01_12_readability_guideline_final_en.pdf
(3)EMA's action plan https://ec.europa.eu/health/sites/health/files/files/committee/pharm740_3ii_report-on-pil-and-ema-action-plan_0.pdf

Last updated: 14 August 2018Legal notice