Online medicines – between legality and illegality

Staying safe when buying medicines online

1Figure 1 EU countries

 Patients in the European Union (EU) will now be able to easily identify legally operating online medicine retailers. To help them identify trustworthy sites, an EU-wide logo will appear on the websites of online retailers that are registered in an EU Member State.

The logo looks like the one in Figure 2 and is personalised for each country, having the image of the national flag, while the message is written using the official language of the country.

2

When clicking on the logo, patients will be taken to the online register of the national competent authority that lists all legally operating online retailers in that country. This system is currently being implemented across the EU Member States.

The European Medicines Agency (EMA) has published a webpage with links to the national registers.

“When buying medicines online, consumers must be aware that unless they buy from legally-operating online medicine suppliers, they run the risk of buying falsified medicines, which are usually ineffective, substandard and dangerous. The Commission has established a common logo for online medicines retailers so consumers can stay safe,” explained Vytenis Andriukaitis, European Commissioner for Health and Food Safety.

Patients can follow these easy steps to make sure they buy from legitimate sources:

  • check whether the EU logo appears on the homepage of the website that they are considering buying medicines on;
  • click on the logo. This takes them to the national competent authoritywebsite, which lists all legally operating online pharmacies and other legally authorised retailers of medicines that are established and registered in the country;
  • check that the online retailer is listed;
  • if the retailer is not listed, patients should not buy from that website. They should only use one of the legitimate medicine retailers listed.

Protecting patients from growing threat of falsified medicines

Although the EU has a strong regulatory system, there is still a threat that falsified medicines can come into circulation in the EU. These are fake medicines that pass themselves off as real, authorised medicines.

Fake medicines may be faulty in different ways. For example, they may contain the wrong ingredients, ingredients of low quality or wrong doses, they can be deliberately mislabelled with respect to their identity or source or they can have fake packaging.

Falsified medicines are a threat to public health as they can be ineffective, leaving patients untreated, or they can be harmful.

A medicine must be authorised before it can be placed on the market. In the EU regulatory system, there are several routes for obtaining marketing authorisation:

  • either at European level (the centralised procedure) or
  • at national level (the decentralised and mutual-recognition procedures).

Under the centralised procedure, EU authorisation is granted by the European Commission via an application to the EMA. The EMA coordinates the assessment of the quality, safety and efficacy of medicinal products. The EMA also coordinates Member States’ activities in connection with the monitoring of medicines for safety once they have been placed on the market (pharmacovigilance), and manages the internet-based information system created to this effect. In addition, the EMA coordinates Member States’ supervision and inspection of manufacturers.

This Directive aims to prevent falsified medicines from entering the legal supply chain and reaching patients, by strengthening existing controls and introducing new measures. The implementation of the logo for online retailers and the establishment of registers of legitimate online retailers is a new milestone in the implementation of the Directive. However, selling medicines online in Romania is illegal. If Romanians want to buy medicines online from another EU country, they need to check if the pharmacy providing the needed medicine is authorised.


References:

EMA 1, 2

AMF.MS

European Parlimentary Research Service

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