The EOF supervises compliance with product adequacy obligations. Inadequate coverage of patients’ needs entails the imposition of the prescribed sanctions.
In a temporary ban on parallel exports for 119 medicines of various categories, the National Medicines Agency (EOF), after evaluating the evidence of the adequacy of the medicines in question on the market. The decision is valid for a period of three months, i.e. until April 19, 2024.
During the validity of this decision, the storage of the specific medicines is prohibited. The EOF reminds that the obligation to make available exclusively on the domestic market applies to all pharmaceutical products that are marketed in Greece after approval of an emergency import or with a decision on the exception of marketing with foreign language labeling.
In any case, states the EOF, the availability of medicines to patients, in Greece as a priority, by all participants in the distribution chain (marketing license holders, drug warehouses, pharmacies) in accordance with their demand and legal prescription, is imperative.
The EOF supervises compliance with product adequacy obligations. Inadequate coverage of patients’ needs entails the imposition of the prescribed sanctions.
Also, the EOF supervises the adequacy of the market for medicines. In the event of a change in the eligibility data, this is subject to total or partial withdrawal, modification or extension of its validity period or its replacement with a newer decision.
Source :Skai
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