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Parliamentary questions
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9 April 2019
E-001056/2019(ASW)
Answer given by Vice-President Katainen on behalf of the European Commission
Question reference: E-001056/2019

According to EU medicines legislation, a marketing authorisation is required to place a medicine on the market in the EU, including online(1). In 2011, stricter rules for online sales of medicines were introduced in the EU to address increasing concerns with falsified medicines being sold online to citizens(2).

EU legislation requires online pharmacies to obtain an authorisation to supply medicines at a distance and to notify the national authorities where they are established of their intention to sell medicines online(3). Member States are responsible for enforcing the legislation and ensuring that only legal economic operators are offering medicines for sale in the EU.

In addition, Member States cooperate with other jurisdictions around the world to tackle illegal online sales. In 2018, the INTERPOL operation Pangea shut down 3 671 websites with illegal online offerings. The operation led to the seizure of ten million units of medicines and 859 arrests around the world(4).

Since 1 July 2015, a common EU-wide logo is mandatory for all online pharmacies legally operating in the EU(5). The logo makes it easier for EU citizens to identify legal online pharmacies.

(1)Article 6 of Directive 2001/83/EC
(2)Directive 2011/62/EU
(3)Article 85c of Directive 2001/83/EC
(4)https://www.interpol.int/Crimes/Illicit-goods/Pharmaceutical-crime-operations
(5)https://ec.europa.eu/health/human-use/eu-logo_en

Last updated: 10 April 2019Legal notice