To the attention of all wholesale distributors of medicinal products
Please be advised on provisions of:
– Order no. 502/2013 on approval of mandatory monthly reporting of placement on the market in Romania and of sales of medicinal products for human use, respectively, by authorised wholesale distributors/importers/manufacturers;
– Order no. 456 /2013 on approval of the List of International Non-proprietary Names of medicinal products at high unavailability risk, as provided to insurants in the health insurance system and agreement on a measure to secure their market availability in Romania, as amended.
Non-compliance with legal provisions above shall be sanctioned in accordance with Law 95/2006, republished – Title XVIII, The medicinal product, as follows:
– Civil penalty, in accordance with provisions of Article 875 (m);
– Civil penalty and suspension of wholesale distribution authorisation, in line with provisions of Article 875 (n).
The NAMMD has monitored distribution activities and taken immediate action for penalty of respective breaches (e.g. in 2015, penalties applied to Expert Med Import Export SRL, Pharma Storage SRL, Health Care Store SRL, Perfect Farma Distributie SRL, Biolife Pharmamed SRL, Triumph Pharma SRL).