PDO legal status of supply

Section 58, third subsection of the Medicines Act states: "The MEB decides to classify a medicinal product as PDO medicinal product if it does not qualify for classification of PH or GS medicinal product."

The key distinction between PH and PDO is the requirement for a pharmacist in the delivery of PH medicinal products. The reason for this is that PH medicinal products require a form of care that the chemist cannot and is not required to provide. This relates in particular to Pharmacovigilance and associated education and supervision.

The second difference between PH and PDO relates to the care (in the form of education or supervision) that must be provided upon delivery. This involves education or supervision that cannot be provided by the pack leaflet alone (e.g. choosing between various types of medicinal products, or if use is very complex). For PH medicinal products, education or supervision is necessary (Section 4.1 of the Medicines Act Regulation) and the pharmacists must provide this, regardless of whether the patient requests it or not. This contrasts with the situation for PDO medicinal products.

For a medicinal product with PDO legal status of supply, the chemists must provide adequate care and inform the patient that he or an assistant chemist clerk can provide the information required. It is up to the patient to indicate whether or not he wants the information. However, the patient cannot be expected to know in advance whether education or supervision are necessary. Therefore, medicinal products for which education or supervision upon delivery is required to guarantee good and safe use, and that cannot be provided by the pack leaflet alone, are classified as PH rather than PDO medicinal products.