Issuing of Order no. 985 of August 6th 2018 amending and bringing additional information to the Norms on the authorization of wholesale distribution units of medicinal products for human use, certification of good distribution practice and registration of brokers of medicinal products for human use, approved by the Order of the Minister of Health no. 131/2016.

Issuing of Order no. 985 of August 6th 2018 amending and bringing additional information to the Norms on the authorization of wholesale distribution units of medicinal products for human use, certification of good distribution practice and registration of brokers of medicinal products for human use, approved by the Order of the Minister of Health no. 131/2016.

By accessing this link: Legislative Portal, you can find the Order according to which, wholesale distributors will be able to distribute medicines also to the following categories of legal entities:
– Public health units of the Ministry of Health (only for national public health programs);
– Ambulance services and mobile emergency, reanimation and authorized extrication services (SMURD);
– Dialysis centers;
– Dental offices;
– Clinical units in which ANMDM approved the undertaking of a clinical trial (medicines for clinical investigation, support medication);
– Any entity which ensures and is able to build up stocks for the medicinal products’ reserve according to the provisions of Law no. 477/2003 on the setting-up of the national economy and the defense territory, reissued.

At the same time, you will find information on the reference intervals for verifying and decommissioning the medicines by wholesale distributors before they are delivered to certain categories of legal entities.