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Medicines safety

Medicines

The Federal Ministry of Health is responsible for drawing up legislation and for strategic matters in the field of medicines. Important advisory councils and commissions in the pharmaceutical sector are based in the Ministry.

The authority responsible for operative issues in the pharmaceutical sector (licensing, pharmacovigilance, clinical tests, market supervision and inspections) is the Federal Office for Safety in Health Care (BASG Bundesamt für Sicherheit im Gesundheitswesen), which uses the Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH (Division for the Supervision of the Medicines Market) to fulfil its tasks. On this website you can find a great deal of useful background information and forms.

European-wide specifications in this field are drawn up by the Directorate General for Health and Food Safety and the European Medicines Agency. These institutions offer a wealth of information on their websites. Another important institution is the European Directorate for the Quality of Medicines and Health Care (EDQM) of the European Council.

Coordination work of the BASG
Newly-licensed medicines and changes are published in batches several times a month by the Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG).

Register of medicines
A detailed search for medicines (also for the contents of patient information leaflets) can be carried out in the Register of medicines.

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Buying medicines safely on the internet

Since 25 June 2015, Austrian pharmacies can sell prescription-free medicines via the internet. In order to ensure that purchasing medicines on the internet is safe, Austria has, in accordance with EU Directive 2011/62/EU, created strict regulations in the Medicines Act (Federal Law Gazette I No. 48/2013). In addition, the Distance Selling Regulation (Federal Law Gazette II No. 105/2015) has been adopted. Both of these came into effect on 25 June 2015. These regulations are primarily intended to protect the population from the many counterfeit medicines which are offered on the internet and which constitute a considerable health risk for patients.

Only prescription-free medicines are allowed
Distance selling is only permitted for registered public pharmacies which fulfil strict quality standards. This is intended to protect consumers from counterfeit medicines and to increase the safety of medicines. In addition, only prescription-free or registered human medicines which are licensed in Austria can be sold online. The sale of prescription medicines via the internet remains forbidden.

Logo and list: recognising legal pharmacies quickly Another goal is to create conditions which enable customers to identify legal pharmacies easily and quickly.
A standard obligatory logo therefore identifies all legal online pharmacies in the EU. In this way, consumers can recognise at a glance whether they are buying from a certified and monitored seller. In addition, a click on the logo leads to an official list on which you can check quickly and easily whether the pharmacy is registered and legal.

Sales only via public pharmacies
Within Austria, internet and mail order sales may only be carried out by pharmacies which have a real shop which is open to customers, and stock rooms, and which fulfils the strict regulations of the Pharmacies Act and the regulations on operating pharmacies. In addition, internet pharmacies located in Austria have to register with the Federal Office for Safety in Health Care (BASG). The registration list can be viewed from every website of a legal internet pharmacy by clicking on the security logo. The BASG carries out the central monitoring of all online pharmacies.

Orders from abroad
Orders from abroad may only be accepted if they are made via pharmacies in EEA countries. Here again, only prescription-free and registered medicines which are licensed in Austria can be sold online. In turn, Austrian pharmacies may also not send prescription medicines abroad - even if the receipt of prescription medicines in this way is permitted in another Member State.

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More on the issue of counterfeit and illegal medicines

Links:

auf-der-sicheren-seite.at (on the safe side)
campaign against counterfeit medicines

BASG (Austrian Federal Office for Safety in Health Care)
current warnings on counterfeit medicines

AGES (Austrian Agency for Health and Food Safety Ltd.)
monitoring laboratory for the analysis of illegal medicines

Leaflet:
Together against counterfeit medicines (PDF 301 KB)
(in German language)

 

 

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