05.12.2006 Representative officials of ministries discussed joint activities, carried out to ensure introduction of new technology of customs clearance of imported medicaments

Beginning from January 1, 2007, pursuant to the Decree of the Government of the Russian Federation, № 72, dated 10.02.2006, imported medicaments will have to be transferred from mandatory certification treatment into the treatment of mandatory declaring of their conformity to safety requirements, and customs authorities, therefore, will be obligated to demand to deliver the declaration of medicaments quality conformity concurrently with delivery of customs declaration.

 On January 4, 2007 the Federal Customs Service held a working session with representative officials of Minekonomrazvitie, Minpromenergo, Rostekhregulirivanie, Rospotrebnadzor and Roszdravnadzor, dedicated to ensuring of implementation of this decree.

The representative officials of ministries and agencies were offered to discuss the problems, which solution is their exclusive competence, however, directly influencing customs clearance of imported medicaments.

Specifically, its management is impossible without the list of those medicaments, which conformity must be evidenced by the declaration of conformity, at what connection this list must be coordinated with the Federal Customs Service of the Russian Federation in terms of identification of codes of medicaments in accordance with commodity nomenclature of foreign economic activity.

In order to establish authenticity of documents and credibility of information hereof, customs authorities must have the list of agencies with the authority of registration of declaration of conformity as well as seal impression samples, unified register of filed declarations of conformity.

The conference discussions addressed the time scales and the procedure of information distribution to customs authorities in respect of the issues in question and other problems, technology of sample taking for carrying out expert examination, upon which results the declaration of conformity is issued, declaration execution terms as well as effect of these factors upon the procedure of customs clearance of medicaments.

At the same time, special attention was drawn to the situation, when in the time of every delivery of medicaments and every delivery lot entering circulation within the territory of the Russian Federation, every participant of foreign economic activity must execute and submit new declaration of conformity to customs authorities.

How to ensure government control over quality of imported medicaments, if the medicaments import license is issued to one legal entity, the declaration of conformity – to another, customs applicant – third, while the consignee is fourth; what standards must be met by imported medicaments; methods of controlling importation of medicaments in the likeness of non-medicaments and keeping record of all parties accessorial to appearance in the Russian market of defective medicine, - these and other problems, disturbing customs authorities, were discussed by the participants, who scheduled the target dates and joint actions for solution of these problems. In the course of the meeting it was recommended to inform public, participants of foreign economic activity and other interested parties, each agency within limits of its competency: Minpromenergo – on regulatory and legal control, Rostekhregulirovanie – on the procedure of declaration execution; Riszdravnadzor – on the list of medicaments to be subject to mandatory quality declaring and so on.