National Drug Control System NDS 8 th NDS Users Group Meeting 7-9th October 2013 Mexico City, Mexico Dr. Katja Pihlainen, Finnish Medicines Agency 6.-8.10.2013 Inspectorate/Katja Pihlainen 2 1
Fimea is the Competent Authority For regulating the: Narcotic and psychotropic substances listed in 1961 and 1971 UN Conventions Drug Precursors (PEN online) Nationally listed subtances controlled as required in the Conventions 6.-8.10.2013 Inspectorate/Katja Pihlainen 3 Volume Manufacturing and handling licences and other decisions 2008 (24) 2009 (54) 2010 (42) 2011 (33) 2012 (43) Import and export certificates 2008 (966) 2009 (949) 2010 (1 085) 2011 (1 096) 2012 (1 252) Licences and certificates for precursors 2008 (36) 2009 (24) 2010 (18) 2011 (15) 2012 (20) 6.-8.10.2013 Inspectorate/Katja Pihlainen 4 2
NDS deployment in 2011 February March April May June July August w5 w6 w7 w8 w9 w10 w11 w12 w13 w14 w15 w16 w17 w18 w19 w20 w21 w18 w19 w20 w21 w18 w19 w20 w21 w18 w19 w20 w21 Master Data Quarterly statistics with NDS Granting import/export authorizations with NDS Prepare Training material Training Piloting NDS Web Identify Pilot users NDS-web security audit Plan & book Training sessions Roll-Out of NDS Web Security audit by external consult to assess Web Application and platform security before opening service for stakeholders Inserting and/or correcting master data within NDS establishments business licenses substances etc. Internal use of NDS begins manual entry of requests authorization print-outs from NDS Identify Pilot users and communicate Piloting web-requests with limited number of actors Registry to be included into the process flow. training sessions for Pilot users (create materials) Roll-out to stakeholders training and comms. sessions to be held materials to be update based on Pilot feed-back Target: all sessions held by end of August 6.-8.10.2013 Inspectorate/Katja Pihlainen 5 NDS deployment in 2011-2012 November December January February March April May w45 w46 w47 w48 w49 w50 w51 w52 w1 w2 w3 w4 w5 w6 w7 w8 w9 w10 w11 w12 w13 w14 w15 w16 w17 w18 w19 w20 w21 Translation of the SPA reporting forms Hands-on teletraining sessions Prepare Training material Training Receiving Annual statistics Receiving corrected annual statistics All users are informed of the changed reporting Roll-Out of NDS SPA Security checks with various instruments Inserting and/or correcting information within forms Preparation of instructions to be sent to the establishment responsible persons by email Identify possible problem points and communicate them Receiving reports from the establishments either via ExtWeb or by CD individual training via phone if needed DL by law 31 st January Roll-out to stakeholders training via instructions sent and personal communication with responsible persons Instructions and forms sent Target: all forms are back and correctly filled by end of June 6.-8.10.2013 Inspectorate/Katja Pihlainen 6 3
Current status NDS 6.169.0.0 is used NDS NDS Web NDS SPA The work-flow is faster and more reliable The web interface was warmly welcomed by users - only a few applications are still received on paper The second round in reporting (in 2013) showed that the routines had adapted to this 6.-8.10.2013 Inspectorate/Katja Pihlainen 7 and Experiences NDS Reliablility - relatively robust to work around The templates make work easy Minor difficulties have occurred but most are resolvable with online help from the UNODC, and trial and error Still many features to be explored oarchiving issue might be a thing to be thought over at some point 6.-8.10.2013 Inspectorate/Katja Pihlainen 8 4
6.-8.10.2013 Inspectorate/Katja Pihlainen 9 NDS Web NDS Web Easy to use Less paper, faster, more efficient and the companies welcomed electronic environment Some panes contain information we do not have any use odoes not support the most recent browsers oendorsing and applying for new preparations still needs further support 6.-8.10.2013 Inspectorate/Katja Pihlainen 10 5
and Experiences NDS SPA ofirst round required more work and close cooperation The companies are already used to work in electronic environment and therefore they were quick to adjust their processes 6.-8.10.2013 Inspectorate/Katja Pihlainen 11 Conclusion Finland came along in a good phase the product was relatively mature The process was fast - which was possible because: volumes are limited There was a need and motivation for such a tool both with authorities and the companies The technical environment was there Now we need to continue in improving and facing future challenges! 6.-8.10.2013 Inspectorate/Katja Pihlainen 12 6
Gracias por su atención 6.-8.10.2013 Inspectorate/Katja Pihlainen 13 7