Pepeliaev Group advises that the Federal Service for Surveillance in Healthcare (Roszdravnadzor) has issued Letter No. 16I-1595/13 “On informing Roszdravnadzor about holding scientific or other events” (the “Letter”).
The Letter can be found on the official website of Roszdravnadzor (http://www.roszdravnadzor.ru/main/oficial/27439).
The document in question contains recommendations regarding the form and procedure for informing Roszdravnadzor about any scientific or other events organised (sponsored) by pharmaceutical companies (“Companies”) as provided for by article 67.2 of Federal Law “On the circulation of medicines”.
The above article places an obligation on companies to inform Roszdravnadzor about any scientific or other events organised (sponsored) by companies or their representatives which aims to increase the professional skills of medical staff or provide information connected with monitoring the safety of medicines. The information concerning such events should be submitted to Roszdravsadzor no later than two months prior to any such event so that it can later be published on the site of the relevant state authority.
It is proposed that companies fill in the form enclosed with the Letter and send it by e-mail. Based on the information provided, Roszdravnadzor intends to set up a database of scientific and other events which will be used in scheduled and unscheduled monitoring and control.
Please note that the above document is not a regulatory act and that it merely recommends that the approved form be used. However, if a company fails to meet its obligation to inform Roszdravnadzor (or submits to Roszdravnadzor inaccurate data), then such company may be held administratively liable under article 19.7.8 of the Russian Code of Administrative Offences in the form of a fine ranging from RUB 30,000 to RUB 70,000.
To think about, to do
In connection with the above developments, we recommend that companies arrange for Roszdravnadzor to be informed, using the form suggested by the Service and in a timely manner, about events such companies and their representatives organise (sponsor).
Advice from our lawyers
Pepeliaev Group's specialists will readily provide legal assistance in matters connected with new regulations being implemented in respect of scientific or other events which involve medical staff and are organised (sponsored) by companies and their representatives, including: analysing the current policies or other internal regulations of a company relating to the organisation and financing of the events; preparing standard provisions for the contracts of a company aimed at organising and holding such events; developing legal instruments for controlling the activities of contractors engaged by the company to organise such events.