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Parliamentary questions
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24 October 2019
Answer given by Mr Andriukaitis on behalf of the European Commission
Question reference: E-002597/2019

The Commission is aware of the study referred to by the Honourable Member.

Public scrutiny of decisions taken by regulatory authorities to authorise medicinal products is an important element to create and maintain trust in the system of authorising medicines in the EU.

The Commission as the authority responsible for the authorisation of centrally authorised medicines is in contact with the European Medicines Agency and the Member States for the centralised authorisation procedures as well as policy and implementation issues related to the authorisation of medicines.

The authorisation of a new medicine is based on an assessment of its quality, safety and efficacy. Only when the benefit/risk balance of the product is positive, the product will be authorised.

The Commission relies on the scientific expertise of the European Medicines Agency and its committees for the evaluation of medicines on the basis of the evidence submitted by the applicant. EU legislation however does not require that new medicines be superior to medicines already on the market.

Once a medicine is authorised, the decision as regards to its use is taken by healthcare professionals in Member States who take into account national guidelines and conclusions of health technology assessment bodies.

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