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Parliamentary questions
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21 August 2019
Answer given by Mr Andriukaitis on behalf of the European Commission
Question reference: E-002265/2019

As the Honourable Member rightly states, Directive 2001/83/EC(1) obliges that the labelling and the package leaflet of medicinal products placed on the market shall be in an official language (or languages) of the Member State where the medicinal product is placed on the market.

Where the medicinal product is not intended to be delivered directly to the patient, or where there are severe problems in respect of the availability of the medicinal product; or in case of certain medicinal products for rare diseases, the competent authorities may, subject to measures they consider necessary to safeguard human health, grant a full or partial exemption to the abovementioned obligation. This may be the case in Member States with smaller markets where there is an issue of availability of the medicinal product.

The enforcement of the directive is the primary responsibility of the Member States’ competent authorities. These authorities check marketing authorisation holders’ compliance with the terms of the marketing authorisation, for instance by conducting inspections and imposing applicable sanctions. If consumers believe companies do not comply with the terms of a marketing authorisation they can contact their respective national medicine regulator.

The role of the Commission consists of monitoring the Member States’ implementation of EC law and ensuring that national legislations and practices comply with EC law, in line with the communication from the Commission ‘EC law: Better results through better application’(2). In its communication, the Commission explains its strategic approach to enforcement and the important role that the national authorities play in securing the rights of individuals when EC law is breached.

(1)Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, as amended — (Article 63).
(2)OJ C 18, 19.1.2017, p. 10.

Last updated: 28 August 2019Legal notice