In 2011, the European Parliament passed the directive preventing counterfeit drugs. It aims to prevent the sales of counterfeit medication. In 2011, an estimated 1 percent of the drugs on the European market were counterfeits.

The directive introduces safety measures for the entire European Union to have only high-quality drugs sold within legal distribution. There is ongoing work on the implementation of this directive into Polish legislation.

Safety online as well

The directive also covers Internet drug sale – the main source of entry of counterfeit medication to the market.

It states that online pharmacies must seek permits for drug sales in the countries in which such pharmacies are allowed to cooperate. This is why the websites of online pharmacies must contain a special logo which makes it easier for the buyers to establish whether it belongs to a pharmacy holding a special permit.

The logo leads to a website created by Member States which allows the checking of their authenticity. Furthermore, the portal informs of the risk associated with buying medicinal products online.

The directive also introduced package labelling which aims to facilitate the establishment of the drug’s authenticity and see if the packaging has been previously opened. These security measures are applicable to prescription medication; in the case of over-the-counter drugs, they are not required, unless there is high risk of them being counterfeit.

A counterfeit drug has to be taken off the market

The Member States are obliged to implement the measures preventing the distribution of counterfeit drugs and allowing them to be taken off the market even after they are purchased by the patients.

All suppliers, distributors, and purchasers must be informed of medicinal products which can cause a potential health risk.

If the product is already commercially available, such notification must be released within 24 hours in order to take it off the market as quickly as possible.

In November of the previous year, the European Commission called Poland to fully implement the regulations of this directive. The spokesperson of the Ministry of Health Krzysztof Bąk announced in November of last year in a conversation with the Polish Press Agency that the act implementing the directive into Polish legislation would amend the Pharmaceutical Law and the Act on drug addiction prevention. The work on the said regulations is ongoing.

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