Frequently Asked Questions
“Any substance or combination of substances shown to have therapeutic or prophylactic properties for human diseases’ or ‘any substance or combination of substances that can be used or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or making a medical diagnosis.”
“Any substance or mixture of substances intended to be used in the production of a medicine and which, when used in its production, becomes an active ingredient of the said product which is intended to have a pharmacological, immunological or metabolic active for the purpose of restoring, correcting or modifying physiological functions or making a medical diagnosis.”
“A response to a medicine which is untoward and unintended”
Adverse events are classed according to the risks they pose to the health of patients taking the medicine. They are thus divided into ‘expected adverse events’, ‘serious adverse events’ and ‘unexpected adverse events’.
All adverse events that are known from the use of a particular active substance and are referred to in the Patient Information Leaflet, which is enclosed in the packaging of all pharmaceutical preparations, are characterised as ‘expected adverse events’.
An adverse event that brings about death, places the patient’s life at risk, requires hospital inpatient treatment or prolongs hospital inpatient treatment, leads to permanent or significant disability or incapacity or results in a congenital anomaly / birth defect is classified as a ‘serious adverse event’. An ‘unexpected adverse event’ means an adverse event the nature, severity or result of which is not in accordance with the Summary of Product Characteristics or Patient Information Leaflet.
The basic division between medicines lies with whether or not a medical prescription is required before they may be dispensed. In other words, they are divided into prescription and non-prescription medicines.
Medicines may only be dispensed on medical prescription when:
- they may, directly or indirectly, pose a risk to health, even when used correctly, if used without medical supervision
- very frequent or widespread incorrect use is made of them resulting in human health being, directly or indirectly, put at risk, or
- they contain substances (or are preparations based on such substances) the effects and/or side effects of which need to be studied more extensively or which are usually prescribed for parenteral use.
World Health Organization (WHO): http://www.who.int/en/
Ministry Of Health: http://www.moh.gov.gr/
European Medicines Agency (ΕΜΑ): http://www.ema.europa.eu/ema/
Hospitals Call: http://www.moh.gov.gr/articles/citizen/efhmeries-nosokomeiwn
Pharmacy Call: http://www.moh.gov.gr/articles/citizen/efhmeries-farmakeiwn
Pharmaceutical Association of Attica: http://www.fsa.gr/
Piraeus Pharmaceutical Association: http://www.fsp.gr/
Pharmaceutical Association of Thessaloniki: http://www.fsth.gr/
Greek Heart Association: http://www.hcs.gr/
Greek Association for Hypertension: http://www.hypertasi.gr/
Greek Association for Lipidiology and Atherosclerosis: https://www.eelia.gr/
Greek Paediatric Association: http://www.e-child.gr/
Greek Psychiatric Association: http://www.psych.gr/
Greek Neurological Association: http://www.enee.gr/
Greek Association of Orthopaedic Surgery and Traumatology: http://www.eexot.gr/
Greek Association of Rheumatology: http://www.ere.gr/
Panhellenic ENT Association: http://www.hellasorl.gr/
Greek Diabetes Association: http://www.ede.gr/
Greek Endocrine Association: http://www.endo.gr/