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Parliamentary questions
8 August 2017
E-003872/2017
Answer given by Mr Andriukaitis on behalf of the Commission

The final report on the off-label use of medicinal products published on 28 February 2017(1) provides a description of practices across Member States, of the positions of all parties, and it investigates the balance between benefits and risks of off-label use for patients.

The report was discussed at the Commission Expert Group on Safe and Timely Access to Medicines for patients (STAMP) on 14 March 2017. Given that off-label prescribing of authorised medicinal products is not regulated by EC law and remains in most Member States the responsibility of the prescribing physician, the Expert Group considered that the options identified in the report relevant to collaborative action could be directly led by Member States.

The Expert Group will continue exploring with relevant stakeholders the possibilities for repurposing, one of the options identified in the report to move from the ‘off’ to ‘on’ label of medicinal products.

The Commission has no information on investigations by Member States on possible malpractice involved in the refurbishment and re-use of medical devices originally designed and labelled for single use. Nevertheless, Regulation 2017/745(2) on Medical Devices sets up strict conditions under which reprocessing of single use devices can take place.

As of 1 July 2015, in line with Directive 2001/83/EC(3) and Implementing Regulation (EU) 699/2014(4), any legally operating online retailer, authorised in a Member State of its establishment to sell medicinal products on the Internet, should display the logo on every webpage offering medicinal products to sell.

The Commission is gathering information on the progress of implementation of these requirements and on the national information campaigns on the logo and danger of falsified medicines.

(1)https://ec.europa.eu/health/sites/health/files/files/documents/2017_02_28_final_study_report_on_off-label_use_.pdf
(2)Article 17 of Regulation (EU) 2017/745 relating to single-use devices and their reprocessing.
(3)Article 85 c of Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended, by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011(OJ of01.07.2011 L174/74).
(4)Commission Implementing Regulation (EU) No 699/2014 of 24 June 2014 on the design of the common logo to identify persons offering medicinal products for sale at a distance to the public and the technical, electronic and cryptographic requirements for verification of its authenticity, OJ of 25.06.2014 L184/5.

Last updated: 10 August 2017Legal notice