Peru: Regulation for the conditional sanitary registration of medicines and biological products

 

Peru has published a Regulation for the conditional sanitary registration of medicines and biological products (es. Reglamento para el Registro Sanitario Condicional de Medicamentos y Productos Biológicos).  The notified Regulation establishes the regulatory provisions of Article 8 of Law No. 29459 – Law on pharmaceutical products, medical devices and sanitary products, amended by Law No. 31091, to regulate the conditional sanitary registration of medicines and biological products with phase III clinical studies.

In accordance with article 6 of the Regulation, the conditional health registration is granted to drugs and biological products with phase III clinical studies with preliminary results, in the prevention and treatment of seriously debilitating or life-threatening diseases, which give rise to an emergency declared due to risks or damage to public health, recognized by the Executive Power or by the WHO.

The conditional health registration of a drug or biological product empowers its manufacture, import, storage, distribution, marketing, dispensing, sale or use.  The conditions under which the conditional sanitary registration is authorized must be maintained during its validity.

Conditional health registration is granted to medicines and biological products, when the following is fulfilled:

1. a) The benefit-risk ratio is positive;
2. b) The applicant undertakes to provide all the data from the clinical studies, within the terms established when the conditional health registration is authorized;
3. c) Unmet medical needs are met;
4. d) The advantages for public health derived from the immediate availability of the drug or biological product in question must outweigh the inherent risk that more data is still needed.

The full text of the regulation is available HERE.

To find out more about the Peruvian regulation, do not hesitate to contact the Product Compliance Institute.