Registrations & Approvals: Over-the-Counter Medicine
Over-the-counter medicine, also known as OTC or nonprescription drugs, refers to medicine that consumers can buy without a prescription. They are considered safe and effective when following the directions on the label and as directed by a health care professional.
OTC drugs may be sold to the public without a
prescription if they meet the requirements for ingredients, dosage and
label
claims outlined in the appropriate monograph.
Products must be determined to
be safe and effective, and capable of being used without the involvement of
health care practitioners. Each monograph sets out the allowed ingredients,
dosage and labeling claims that are supported.
TSG’s regulatory and scientific experts help determine whether a product meets
the necessary requirements of the monograph. If it does not, we will assist with
an application for approval of a company’s ingredients, doses or label claims.
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