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Parliamentary question - E-000325/2023(ASW)Parliamentary question

Answer given by Ms Kyriakides on behalf of the European Commission

The EU has a strong legal framework for the authorisation, manufacturing and distribution of medicines. Only licensed pharmacies and approved retailers are allowed to offer medicines for sale, including legitimate sale via the Internet.

Asparaginase is under the name Spectrila authorised throughout the EU to treat acute lymphoblastic leukaemia (ALL). It is given by infusion into a vein following a prescription by a healthcare professional.

In July 2011, the EU strengthened the protection of patients from dangerous, substandard products by adopting the Falsified Medicines Directive[1].

The directive is supplemented by Commission Delegated Regulation (EU) 2016/161[2]. As a consequence, safety features guarantee medicine authenticity for the benefit of patients and businesses.

Improving the availability of medicines authorised in the EU is a key priority. The European Medicines Agency together with national regulatory authorities work together in a dedicated Task Force on the Availability of Authorised Medicines for Human and Veterinary Use, to ensure that essential and high-quality medicines remain available and affordable on the EU market[3].

Last updated: 20 March 2023
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