Canada to change OTC approval rules

Changes to the procedures regarding access to over-the-counter (OTC) drugs in Canada have been unveiled by the government.

Under the existing system, prescription medicines must be formally added to Schedule F of Health Canada's Food and Drug Regulations. A regulatory amendment is required to bring this about, as well as to remove a particular drug from Schedule F and give it OTC status instead.

However, concerns have been raised that the process is too time-consuming, as removing a drug can often take more than a year and sometimes up to 20 months. This means that even if it has been deemed perfectly safe to hand drugs to consumers over the counter, pharmacies are still unable to do so for a long time.

As a result, the Canadian government has confirmed it is removing Schedule F from the Food and Drug Regulations in order to make OTC medicines easier to get hold of.

Health minister Leona Aglukkaq commented: "With this move, consumers will soon benefit from quicker access to safe non-prescription drugs.

"This proposal also means taxpayers will no longer have to cover the costs of outdated regulatory processes."

She described the existing processes as inefficient, but insisted the new procedures would be faster and more transparent, with information on each drug being made available online.

Ms Aglukkaq added that concerns over the current procedures had been raised during meetings of the Red Tape Reduction Commission, a body set up to give businesses the chance to say which rules and regulations they believe need to be reformed or scrapped.

The Canadian government has confirmed that efforts to put the planned reforms in place are now in motion at Health Canada. However, it stressed that safety will not be compromised by this cut in red tape.

Indeed, it said a "rigorous process of scientific review" will be carried out to determine whether a drug can be approved for sale and sold over the counter.

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