- The Minister of Health ("Minister") recently issued Regulation No. 28 of 2022 on the Amendment to the Classification, Limitation and Categorization of Drugs ("Regulation 28/2022"). Regulation 28/2022 was issued in order to repeal and replace Regulation of the Minister No. 3 of 2021, which bore the same title.
- Overall, the classifications of 14 drugs have now been changed. One of the most notable is the change in the classification of oxygen from that of a limited, over-the-counter drug to that of a counter drug. Furthermore, a total of 14 drugs have now had their limitations changed. One of the most notable of these is ibuprofen, which will now have to be consumed in 200mg or 100mg/5ml suspension sizes and which should not be packaged in packages that contain more than 10 tablets or capsules and/or 60ml of syrup.
- In terms of changes in categorization, the following active substances have also had their categories changed: 1) Vitamin E (from a limited, over-the-counter drug to a health supplement); 2) Cetrimide (from a limited over-the-counter drug to health equipment); and 3) Chlorhedixin (from a limited over-the-counter drug to health equipment).
- It should be mentioned that by the time Regulation 28/2022 becomes applicable, all drugs for which the relevant registrations have been approved in line with the previously applicable classifications and limitations will still be subject to the previous regulations.
- Regulation 28/2022 has been in force since 30 September 2022.
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