Glossary

Retail supply of medicinal products

The supply of medicinal products to the final consumer/patient. This is regulated by § 59 AMG.

counterfeit drugs

A counterfeit medicinal product is any medicinal product in which the following has been counterfeited (see § 1 para. 26 AMG):

  • the identity of the medicinal product; this includes its packaging, labelling, name or composition in relation to any constituent of the medicinal product (including excipients and the content of constituents)
  • the origin of the medicinal product; this includes the manufacturer, the country of manufacture, the country of origin, the marketing authorisation holder and the registration holder
  • the records and documents relating to the distribution channels of the respective product

Arzneispezialität ("medical speciality")

This refers to medicinal products that are manufactured in advance in the same composition and marketed under the same name in a certain form. Examples include Aspirin, Parkemed and Voltaren. Definition see also § 1 para. 5 AMG.

Auslobung ("product presentation")

The term "Auslobung" can be translated as "product presentation"refers to the statements made about the properties or mode of action of a certain product. In pharmaceutical law, the claim to be a medicinal product is of particular importance: If for example curative properties are ascribed to a product, it formally becomes a medicinal product, although it may not contain any active ingredient at all. Subsequently, all provisions of the Austrian Medicines Act apply to this product.

Import / Shipment

If a medicinal product is brought into Austria from a country outside the European Economic Area (EEA), this is referred to as importation of medicinal products. If, on the other hand, the medicinal product originates from a Member State of the EEA, this is referred to as a shipment.

distance selling

Distance selling refers to the dispatch of pharmaceutical goods, as carried out by some registered distance selling or mail-orderpharmacies. For example, the drugs are ordered online and then sent to the consumer. According to Austrian law, distance selling is only permitted for non-prescription drugs. Prescription medicines can only be obtained from a public pharmacy or from a doctor with a medicine cabinet.

Funktionsarzneimittel ("drugs by function")

These are drugs which have a positive therapeutic effect on physiological functions (e.g. heartbeat, respiration, growth, digestion, etc.). According to the definition, these are "substances or preparations of substances which [...] restore, correct or influence physiological functions by a pharmacological, immunological or metabolic action [...]". (see § 1 para. 1 no. 2a AMG)

Clinical trial

This is a specific form of medical research. With the help of voluntary patients and/or healthy volunteers, data on new active substances or therapies are collected. A new medicinal product must undergo several clinical trials before it can be placed on the market. See also § 2a para. 1 AMG.

Magistral Preparation

This refers to the individual manufacture of a drug in a pharmacy on the basis of a doctor's prescription. An example for this are e.g. skin creams which are produced according to a dermatological prescription.

Medical Device

Medical device means any instrument, apparatus, appliance, software, substance or other object, whether alone or in combination, whose principal action is not achieved pharmacologically, immunologically or metabolically in or on the human body as compared with a medicinal product. Some examples of medical devices are plasters, prostheses, pacemakers, cardiac catheters, contact lenses and pessaries. See also § 2 para. 1 of the Austrian Medical Devices Act.

Novel, alternative therapies

Alternative or complementary therapies include naturopathic or body therapy, homeopathy, osteopathy or acupuncture. The effect of many alternative medical procedures, if at all demonstrable, is based on placebo effects. A health risk is posed by so-called "new, alternative" procedures, in which unauthorised blood, tissue or cell preparations, such as stem cells, are administered. The manufacturing quality of these preparations is mostly insufficient, a positive, healing effect is not proven. Such treatments are often offered for enormous sums in the case of serious, incurable diseases such as Multiple Sclerosis, Amyotrophic Lateral Sclreosis or cancer.

Officinal preparation

This refers to the manufacture of a medicinal product according to a monograph of the pharmacopoeia for direct administration to the patient.

Austrian Medicines Control Laboratory (OMCL)

The tasks of the Official Medicines Control Laboratory (OMCL) division for analytical chemistry and pharmaceuticals include the investigation and assessment of illegal or unknown drugs in accordance with the Austrian Medicines Act (AMG) for enforcement purposes.

Präsentationsarzneimittel ("drugs by presentation")

This refers to products which, by their description or presentation (advertising), give the impression to a reasonably well-informed consumer that they are intended to cure or prevent human illness. Whether the respective product is effeictive or not is not important for this classification. Within the scope of preventive consumer protection, however, these products also fall under the ambit of the Austrian Medicines Act. This ensures that manufacturers of all kinds of medical products must comply with the requirements of pharmaceutical legislation and can also be held liable under it.

Primary packaging

The term "primary packaging" refers to the container or any other form of pharmaceutical packaging which comes into direct contact with the medicinal product (§ 1 para. 17 AMG). See in comparison "Secondary packaging". An example would be the blister for tablets or capsules.

Secondary packaging

The secondary or outer packaging is that part of the pharmaceutical packaging which does not come into direct contact with the drug (e.g. folding carton).

Stem cells

A stem cell is a "non-specialized" cell that can multiply and renew itself by cell division if necessary. Through this multiplication with subsequent specialization (=differentiation) of the cell, e.g. dying cells of the body can be replaced. A distinction is made between adult and embryonic stem cells; while adult stem cells, i.e. those found in the adult body, are already somewhat restricted in their potential, embryonic stem cells can differentiate into any type of body cell within the framework of the development of the unborn child.

Cell therapy

Prevention, treatment, cure or alleviation of disease, medical condition or injury through the use of autologous (own) or allogeneic (foreign) cells previously removed and possibly processed or altered.

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