MD regulation News

Order No. 403n of the Ministry of Health of Russia dated 11 July 2017

On 22 September 2017 Order No. 403n of the Ministry of Health of Russia dated 11 July 2017 came into effect in the territory of the Russian Federation

Order No. 403n of the Ministry of Health of Russia “On approval of the rules for dispensing medicinal products for medical use, including immunobiological medicinal products by pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities” came into effect.

On 22 September 2017 Order No. 403n of the Ministry of Health of Russia dated 11 July 2017 “On approval of the rules for dispensing medicinal products for medical use, including immunobiological medicinal products by pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities” came into effect on the territory of the Russian Federation.

The rules determine a procedure for dispensing medicinal products for medical use, including immunobiological medicinal products by pharmacy organizations and individual entrepreneurs licensed for pharmaceutical activities, without a prescription and/or by a prescription for a medicinal product prescribed in accordance with the established procedure by medical professionals, and on requisition notes of an organization that provides medical care, or of an individual entrepreneur who holds a license for providing medical care.

The Order No. 403n of the Ministry of Health regulates:

– types of medicinal products that can be dispensed by pharmacies, pharmacies, pharmacy branches, individual entrepreneurs that hold a license for pharmaceutical business;

– special considerations of dispensing narcotic drugs, psychotropic medicinal products, immunobiological medicinal products;

– period of time during which medicinal products are dispensed, including those marked in the prescription as “statim” (immediately) and “cito” (urgently);

– shelf life of prescriptions for the medicinal products dispensed in a pharmacy organization;

– requirements for primary and secondary packaging of the medicinal product dispensed at the pharmacy;

– duties of a pharmacy organization employee when identifying the prescriptions issued in violation of the registration rules;

– special considerations of dispensing the medicinal products subject to strict record keeping and storage;

– special considerations of dispensing the medicinal products on requisition notes of medical organizations, individual entrepreneurs that hold a license of providing medical care.