The Health Ministry insists there is no “red tape” preventing the approval of “Ozempic” or any other drug.
A statement was issued today in response to a newspaper editorial which claimed bureaucratic delays in approving the drug, which was developed by the company Novo Nordisk for diabetes.
The Ministry says the registration of pharmaceutical products in T&T is governed by the Food and Drugs Act and includes the submission of an application form, along with technical drug documentation.
It adds that submissions undergo a rigorous screening process to ensure compliance with safety, quality and efficacy standards before any drug is approved for public use.
The Ministry notes that the onus for submission of an application lies with the Importer/Distributor and not the MoH.
With regard to “Ozempic”, it says there is no application at this time from the local registered distributor for Novo Nordisk for registration of the drug.
However, it says an application for a generic version has been received.
As part of its standard operating procedure when questions of patents arise, the Ministry says it has been communicating with the local Intellectual Property Office, as well as Novo Nordisk and its local distributor, to determine if a patent exists at this time in T&T for “Ozempic”.
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