Medicine shortages

Medicine shortages can occur for many reasons, such as manufacturing difficulties, problems affecting the quality of medicines or increased demand that can impact on patient care.

The marketing authorisation holder of a medicine included in the list of categorized medicines is obliged to ensure that the medicine is available on the market in sufficient quantity. Stocks of the medicine sufficient to cover the estimated monthly consumption of the medicine in the Slovak Republic are considered to be a sufficient quantity. The obligation of the marketing authorisation holder to ensure the availability of the medicine does not apply to a medicine for a rare disease or to a medicine for innovative treatment. (§ 9 of the Law no. 363/2011 Coll. on the scope and conditions of reimbursement of medicines, medical devices and dietetic foods on the basis of public health insurance)

The State Institute for Drug Control does not have legal mechanisms that would enable it to ensure the availability of medicinal products on the Slovak market.

If you can not find your prescription or over-the-counter medication at your local pharmacy, it may be due to a temporary, localized supply issue. Check multiple stores or pharmacies, or ask your doctor or pharmacist if there is an alternative to the medicine you are looking for.

There are several options aimed at ensuring the availability of medicines for patients, for example:

• generic substitution – substitution of a prescribed medicine for another medicine with the same active ingredient when dispensed at a pharmacy in accordance with the relevant regulations. For many drugs, especially for chronic diseases, several drug alternatives are available from different manufacturers.
• therapeutic use of an unauthorised medicine, called extraordinary import, that is granted by the Ministry of Health based on the request of a healthcare professionals or on one's own initiative, for a specific patient or for a group of patients in the case that a comparable authorised human medicine is not available.
• import of foreign-language medicine packages – exemptions granted by the State Institute, which allow the marketing authorisation holder to place medicine packages of a foreign language on the Slovak market. This option is used not only to bridge the unavailability of medicines in Slovak packaging, but also for new medicines that have not yet been produced in Slovak packaging, so that the availability of such new medicines for Slovak patients is accelerated.

The State Institute for Drug Control publishes and daily updates information on interruptions, cancellations and resumptions of supplies on its website: https://portal.sukl.sk/PreruseniePublic/?act=PrerusenieOznList&mId=2

This is information that marketing authorisation holders are obliged to report (§ 60 of the Law no. 362/2011 Coll. on medicines and medical devices).