Over-The-Counter (OTC) Drugs come with their own unique set of requirements. dicentra’s expertise is by no means confined to natural health products, cosmetics and foods. We also assist companies in obtaining licences to sell their OTC drug products.
Our services in Over-The-Counter (OTC) Drugs Regulatory Consulting include:
- Drug classification (labelling standard vs new drug; prescription vs non-prescription)
- Preparation of Drug Identification Number (DIN) applications
- Responding to Clarifaxes
- Preparation of compliant draft labels
- Filing notifications and amendments
- Filing Annual Drug Notifications
- Adverse reaction reporting (See also Adverse reaction reporting)
- Pre submission meetings with the Therapeutic Products Directorate (TPD)
Government cost recovery fees for drug applications can be expensive. You can ensure your application is right the first time with help from dicentra.