Information of interest to sponsors
To the attention of persons concerned – useful links
To the attention of persons concerned – with respect to VHP (Voluntary Harmonised Procedure) procedure
Given Romanias agreement to take part in the VHP procedure as Concerned Member State since 2008 and as Reference Member State as of 2015, please be advised on the following:
– Detailed information on the VHP procedure for harmonised assessment by Concerned Member States of clinical trial applications and important amendment applications, respectively, is available in the CTFG/VHP/2016/Rev6 Guidelines of June 2016: (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2016_06_CTFG_VHPguidance_for_sponsor_v4.pdf)
– Fees for NAMMD operations are paid in accordance with national legislation (Order of the Minister of Health no. 888/2014), by national submission to the NAMMD of a formal application for approval of a clinical trial/important amendment, for response, regardless of the outcome of scientific assessment by the VHP procedure (approval/rejection/withdrawal by the applicant during or after the VHP assessment).
– In case fee payment is declined, the risk for the sponsor is permanent exclusion from future VHP procedures. Details on procedure fee management may also be found in the VHP guideline CTFG/VHP/2016/Rev6 of June 2016.
To the attention of parties concerned – with respect to submission of the ANNUAL SAFETY REPORT (DSUR-Development Safety Update Report)
– the Annual Safety Report (in the format provided in the ICH E2F/ EMA/CHMP/ICH/309348/2008 Guideline) is submitted to the NAMMD electronically (as a CD, DVD or memory stick), accompanied by a cover letter, preferably in Romanian, indicating the name of the investigational medicinal product tested and the list of clinical trials on the respective product conducted in Romania.
To the attention of stakeholders
Please be advised on approval of Scientific Council Decision no. 2/2014 on Regulations for authorisation of units able to perform clinical trials in the field of the medicinal product for human use on 22 April 2014.
Therefore, the applications for authorisation of units able to perform clinical trials on medicinal products for human use shall be submitted to the NAMMD at least 3 months prior to expiry of the previous authorisation validity.
Schedule for submission of applications: Friday, 9:45-13:45.