Renseignements non divulgués
5. Please explain in detail if your legislation ensures that undisclosed and confidential test data or other data submitted by an applicant to the responsible State agency in the procedure for market authorisation of a pharmaceutical or of an agricultural chemical product is protected against disclosure and against unfair commercial use by a competitor, for example by prohibiting a second applicant from relying on, or from referring to the original data of the first applicant, when applying subsequently for market authorisation for his own product. Does your legislation provide for exceptions to this? If yes, under what conditions would such exceptions apply? Does your legislation provide for a defined period of protection for undisclosed information / for such test data of the first applicant?
The Grenada Pharmacy Council, operating under Cap 241, recognizes marketing approval from the regulatory authorities in the United States and the United Kingdom and does not itself require test data submission for marketing approval for pharmaceuticals or chemical entities. There is therefore no provision in the current law pertaining specifically to the protection of test data for pharmaceuticals or chemical entities. There is no general protetction for undisclosed information in the draft acts mentioned above.