``Information of a serious nature has been presented, and following a thorough and rigorous assessment, I have formed a preliminary view that the club is in breach of the rules and that action needs to be taken with respect to the registrations of two individuals,'' Smith said.
Smith said ASADA's investigation is still ongoing and as such, no infraction notices have been handed down to players.
He stressed the NRL's findings were provisional, and the Sharks as well as Flanagan and Elkin would have a chance to respond before punishments are confirmed.
The provisional view of the NRL is that Flanagan and Elkin failed in their duty of care to players, putting the athletes at risk and exposing them to possible violations of the game's anti-doping code.
Smith said no other Cronulla officials or training staff had a case to answer.
The major players will now have a chance to reply, and an appeal process is in place.
"This has been a very, very thorough process,'' Smith said.
"All parties now have the chance to put their case forward.
"We've worked through this over a number of months and I spoke to Cronulla this morning and to Shane.
"It's a difficult situation and I encouraged him to put his submission forward and we would make sure any support we can give him and his family we would be right there with him. But quite clearly it's a very difficult set of circumstances. If provisional findings are upheld - player welfare and wellbeing is front and centre of considerations we make.''
Cronulla have been in the sights of ASADA for the alleged use of illegal peptides, since the drugs in sport investigation was announced by the Australian Crime Commission on February 7.
In March, the Sharks launched an investigation into happenings at the club in the 2011 season, which was overseen by sports scientist Stephen Dank.
Flanagan was stood down by the Sharks, along with four other staff members, however he was reinstated on March 22 following a second review by a different consultancy group.
However, Flanagan is set to have no involvement with the Sharks' 2014 season, with Brett Kimmorley in line to take over the reins as coach.
The NRL's actions against Cronulla aren't dissimilar to punishments handed down from the AFL to Essendon for their supplement program.
Coach James Hird was ousted for a year and the club hit with a $2 million sanction.
"It's a very complex set of circumstances for both codes,'' said Smith.
"We have followed a fair process, didn't overreact in any shape or form, and taken everything into consideration.
"Any comparison with AFL is inevitable but it's not a route we've followed.
"We owe our fans and players that we follow a transparent process whereby we act when we have the facts and make sure people have the opportunity to present their side as well.''