Products with PDO and GS legal status of supply

In special cases, both the PDO and GS legal status of supply can be granted to OTC-medicinal products, namely in those cases where differing package sizes require different categorisation.

An example of this is the 500 mg paracetamol tablet, which may have a GS legal status of supply at a maximum of 20 tablets per package. In case of a higher amount of tablets per package, the PDO or PH legal status of supply is granted.

The differing package sizes (with similar strengths) reside under the same marketing authorisation (same RVG number). This is why a single marketing authorisation for differing package sizes may have been granted different legal statuses of supply. The text of the package leaflet must be identical.

Identical information on package and package leaflet

As the chemist has no legal obligation to provide information - he only needs to provide information when a patient asks - this means that a patient can purchase a medicinal product with PDO legal status of supply. Therefore, warnings need to be listed for both GS and PDO medicinal products. The package and the package leaflet in the PDO category and especially the GS category need to contain warnings for specific risk situations. That is why the MEB since the entry into force of the Medicines Act has the policy that the information on package and package leaflet must not differ between a PDO and a GS medicinal product with the same active substance. If the MEB is of the opinion that special warnings need to be placed on the package and package leaflet in case a product is granted the GS legal status of supply, then those warnings need to be stated on all similar products that fall into the PDO category. An example where this was the case are the loperamide containing products.