Enforcement

What is "Enforcement"?

"Enforcement" is the term used to describe the unit of an authority that deals with intentional and unintentional violations of the relevant legislation. On behalf of the Federal Office for Safety in Health Care (BASG), the Enforcement Team handles all suspected cases of illegalities in the areas of the Medicines Act, the Blood and Tissue Safety Act, the Act on the Import of Pharmaceuticals and Medical Devices Law.

Initiation of the investigation procedure

A well-founded suspicion is either the result of investigations or it originates in informations obtained from third parties. After an initial assessment of the risk to human and animal health posed by the case, all relevant facts are collected for the purpose of a detailed risk assessment. Subsequently, a decision is taken in cooperation with a management committee as to whether further investigations should be carried out on the basis of the identified risk potential. In many cases, an unannounced inspection is part of the investigation. As soon as the facts of the case are clear, a report is made to the police, the responsible district administrative authorities and/or the responsible public prosecutor's offices.

Inspections

In most suspected cases, an on-site inspection, including sampling if required, is necessary to establish the exact facts of the case. If serious infringements of relevant laws are found to have occurred, the necessary measures, such as confiscation of the goods or closure of the manufacturing site, must be initiated immediately. In order to carry out inspections quickly and safely, the enforcement team cooperates with the police, the district medical officer and/or the trade office.

Reporting legal violations

If a suspected legal violation could be proven with the help of surveys and inspections, a report is made to the responsible penal authority. A health hazard, fraud or falsification of documents that has been identified will lead to complaints to the police or the public prosecutor's office. Administrative offences are reported to the responsible district administrative authority or the magistrate. The Enforcement group shall remain in contact with the competent criminal authorities after the report has been transmitted. This may help them to clarify the facts of the case.

Monitoring of drug advertising

The design, content, scope and target groups of pharmaceutical advertising are precisely defined in Section 5 of the Austrian Medicines Act. Thus, it is prohibited to direct advertising of prescription drugs at laypersons, or to promise unrealistic treatment success, etc. If these requirements are exceeded, the BASG Medical Market Surveillance initiates detailed surveys.

Execution and Prevention

The primary objective of the Enforcement group is to eliminate health hazards for the Austrian population by detecting and ending illegal activities on the basis of suspicious activity reports. However, particular attention is also paid to preventing illegal activities. Preventive measures are taken, for example, in the form of information brochures, media articles or information events.

Here you will find information and warnings resulting from current cases of the Enforcement Division. The use of the products listed here is not recommended. If you are offered one of the listed or similar products, please report this immediately to the Enforcement Group!

Recognising suspicious circumstances

If you have a well-founded suspicion that a medicine bought from a legal source could be a counterfeit or illegal, this should be reported to BASG. A suspicion could, for example, be based on an unusual colour of the tablets, a different efficacy or a different taste than usual as well as conspicuous features in the packaging.

First, please check the package leaflet (instructions for use) , section 6. for information on the appearance of the medicinal product and the contents of the package. The currently valid version of the Instructions for Use can be found in the Register of Medicinal Specialities on the BASG website.

In order to clarify the suspected case, information on the product, knowledge of the source from which you obtained it and notification of the anomalies observed are required.

If you have a suspicion of an illegal medicine or a counterfeit in the case of a medicine or other product (e.g. a food supplement) which you have neither received from a doctor nor obtained from a public pharmacy or hospital, i.e. which comes from a possibly illegal source, then you can contact the BASG.

However, the prerequisite for processing your case is the disclosure of all data and facts relating to the drug.

Furthermore, your doctor or pharmacist can provide information in case of suspicious circumstances.

Buying medicines on the Internet

The Internet offers many opportunities to make everyday life easier, such as online shopping for various goods. However, this comfortable service also harbours dangers: Orders for medicines from the Internet can have unpleasant and sometimes serious consequences, namely if the ordered medicines do not deliver what they promise or even contain harmful ingredients.

Please also note the relevant notifications and information on registered Austrian distance selling pharmacies (or mail-order pharmacies) on our homepage.

Report well-founded suspicion

If you suspect that a drug, a blood, tissue or cell product or medical device or a novel alternative form of therapy does not comply with the respective Austrian law, you can refer it to the Enforcement group of BASG (report here). The more information you can provide about the source of supply, manufacturer, etc., the better. Samples of the drug in question will be forwarded to the Austrian Official Medicines Control Laboratory (OMCL) for analysis.

Please understand that the employees of the BASG are bound by official secrecy. Therefore, no information can be provided on the status and outcome of an investigation or administrative criminal proceeding. However, you can be sure that every suspicious case will be investigated conscientiously.

Help us to identify and eliminate health hazards!

Report possible illegal activities related to drugs, blood and tissue products, medical devices or novel alternative therapies, either:

Federal Office for Safety in Health Care

Institute Monitoring - Enforcement

Traisengasse 5, 1200 Vienna

 

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