Regulation for the Protection of Test Data is created in Honduras

As the pharmaceutical industry expands and due to the amount of economic and human resources that are used in the development of a safe and effective pharmaceutical product for direct or indirect consumption by humans, the protection of test data is a tool to counteract the unfair competition that exists at the time of the commercialization of the pharmaceutical product.

The test data refer to the generation of information necessary to accredit, before a health authority of a given country, the safety and efficacy of a product whose commercialization is regulated by the State for reasons of public health.

In Honduras, the Health Authority, the Health Regulation Agency with its initials in Spanish (ARSA) is the entity in charge of granting the Certificate of Protection of Test Data, which may be requested by the owner of the innovative product or by third parties authorized by it or that present their own clinical studies.

The time established for data protection is 5 years against all unfair use, effective from the date of approval for marketing in the country it was requested. Through the granting of the Certificate of Protection of Test Data, the ARSA confers to the holder the essential right of the exclusive protection of the commercialization of the protected product.

The issuance of this Certificate, as well as its transmission, must be registered with the competent Health Authority to have effects before third parties. The concession and transmission thereof will be published in written, digital or electronic media.

The owner of the product can make the request for the Certificate of Protection of Test Data, in conjunction with the request for authorization of sanitary registration, and must submit the following documents additional to those required for the registration:

  1. The test data or other undisclosed data, or a certificate of the authorization obtained in another country where the respective data have already been presented.
  2. Sworn statement before a notary stating that it is a new pharmaceutical product, not patented.
  3. Document indicating all national and foreign patents covering the new pharmaceutical product or its approved use. This list must include information on the health registration number, trade name, expiration date of the same and the identification of the owner.

However, the Health Authority may cancel the Certificate in the following cases:

  1. At the request of the owner or a natural or legal person authorized by it.
  2. For reasons of public interest such as public health, national security, emergency or circumstances of extreme urgency that justify the termination of the exclusivity period;
  3. When the Health Authority determines, as a result of an administrative or judicial procedure, that the holder of the Certificate of Protection has abused their rights, for example, through practices declared anti-competitive;
  4. When the competent Health Authority determines, as a result of an administrative or judicial procedure ordered by the corresponding entity, that the Certificate of Protection has been granted in contradiction with any provision of this regulation and other applicable legal regulations, its revocation corresponds.

It is important to note that the rejection by the ARSA of the data protection request is not decisive to grant the sanitary registration of the product.

Downloade copy of the regulation here.

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