FAS will give approvals for regional mark-ups for life-saving and essential medicines
On 1 March 2016 the Federal Antimonopoly Service (FAS Russia) shall be assigned the powers to approve regional maximum wholesale and retail mark-ups to ex-works prices for life-saving and essential medicines. The Prime Minister Dmitry Medvedev signed a relevant Decree (1) on 3 February 2016.
In accord with the new procedure, regional executive bodies must submit draft decisions on fixing and (or) changing maximum wholesale and retail mark-ups to the actual ex-works manufacturer prices for medicines to the antimonopoly body for approval.
Within 30 working days after the date of registering a draft decision, FAS must approve or refuse to approve the draft.
The grounds for refusing a draft can be:
– Mismatching between estimates of the maximum wholesale mark-ups and maximum retail mark-ups to the actual ex-works manufacturer prices for medicines and estimates specified by the technique
– Submitting documents and materials to FAS that contain incorrect data
– Submitting an incomplete package of documents and materials or absence of data in the submitted documents and materials that are required in accord with the technique
– Submitting documents and materials that are not compiled to fit the forms specified by the technique.
The Decree also adopted a new form of protocols approving prices on life-saving and essential medicines.
Reference:
- 1. No. 58 Decree of the Government of the Russian Federation “On Introducing Changes to No. 865 Decree of the Government of the Russian Federation of 29 October 2010 and Invalidating Some Provisions of Acts Passed by the Government of the Russian Federation” of 03.02.2016.