Get to know the legal situation around product liability in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 75.
1. What types of liability are recognized in your jurisdiction?
Regarding the quality of the pharmaceutical products and medical devices the responsibility will lie with the manufacturing company when these are made in the country, with the importer holding the Sanitary Registration when manufactured abroad. In the case of establishments in charge of preparing, storage or distributing products on behalf of third parties the responsibility is assumed both by the company owner and the holder of the Sanitary Registration.
Furthermore, the technical director is responsible for the compliance of quality requirements of the pharmaceutical products and medical devices, having joint liability with the legal representative of the establishment.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
As stated in the previous question, they lie with the manufacturing company when made in the country, with the importer holding the Sanitary Registration when manufacturing abroad. The responsibility is joint and shared with the technical director and the legal representative of the establishment.
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
Liability extends to the technical director and legal representative.
4. How can a liability claim be brought?
A liability claim can be brought by the sanitary authority ex officio following the quality control to which every batch of products is subject or the seizing of a product in a regular inspection or bonded warehouses.
Furthermore, an affected third party may alert the sanitary authority of a potential infraction. However the part alerting the authority is not a part of the process.
5. What defenses are available?
The available defenses will change depending on the procedure; however the main defense mechanisms available are the immediate correction of the infringing conduct and to credit that the procedure consigned in the enabling title has been followed.