Changes in classification of acetylsalicylic acid-containing medicines with dispensation status without prescription
Under Article 110 of the Medicinal Products Act (Official Gazette, No 76/13, 90/14), the Agency for Medicinal Products and Medical Devices (HALMED) upon being aware of new findings, is reviewing the existing classification of the medicine, by applying measures under Art. 109 of the Act and Ordinance on measures of medicines classification and prescription and dispensing of prescription only medicines (Official Gazette, No 86/13).
Also, under Article 35 of the Ordinance on granting marketing authorisation for medicines (Official Gazette, No 83/13), HALMED is publishing on its webpages the conditions for authorisation of change in place and/or dispensation manner of the medicine, taking account the safety profile of the active substance, route of administration, pharmaceutical form, packaging size, highest single daily dose, indication and other conditions for use.
According to the above, HALMED has reviewed the existing classification of acetylsalicylic acid-containing medicinal products (ATC code: B01AC06) and adopted conditions for authorisation of dispensation "without prescription” for these medicines.
In addition, marketing authorisation holders for acetylsalicylic acid-containing medicinal products (ATC code: B01AC06) with the approved dispensation status "without prescription” are called under Article 50, paragraph 2 of the Act to submit an application for variation to the documentation for medicine to comply with conditions indicated in this notice, within 30 days from the publishing of this notice.
These conditions, detailed instructions for application of variations in the documentation and the key data that should be included in the documentation are accessible on the HALMED webpages in the OTC medicines/conditions for dispensation without prescription section, or here.