Peru's Regulations for Medicines and Biologicals
Peru’s Ministry of Health approved the Regulations for the Conditional Sanitary Registration of Medicines and Biological Products
Peru’s Ministry of Health approved the Regulations for the Conditional Sanitary Registration of Medicines and Biological Products (the “Regulations”). This regulation allows a special sanitary registration to be granted by the Peruvian Healthcare Regulator, DIGEMID, to medicines, vaccines and biological products linked to emergency situations, such as the current COVID-19 pandemic. The regulation does not apply to medical equipment.
The registration will be granted within a period of no more than 90 calendar days and, in the case of products approved by High Sanitary Surveillance Countries, such as the United States, no more than 30 calendar days. Prior to this regulation, the process for DIGIMED to grant a Sanitary Registration could take over six months.
- A Conditional Sanitary Registry (the “Registry”), which will be valid for one year and renewable a maximum of four times, may be granted to products that have phase III clinical studies with preliminary results.
- For products with a Registry that successfully conclude their studies, a full Sanitary Registration may be requested with a validity of five years.
- Only laboratories and drugstores established in Peru may request the Registry from DIGEMID and, likewise, these establishments may import and commercialize the Products. U.S. companies must have a Peruvian partner to obtain the Conditional Sanitary Registration.
- These establishments must comply with the Manual of Good Pharmacovigilance Practices, published by the Ministry of Health at the end of 2020.
- The Products may be stored in places other than the legal address of laboratories and drugstores. These places will be determined by DIGEMID, who will also verify the cold chain of the Products.
- The Regulation provides that the Ministry of Health may import medicines and biological products directly from the manufacturing laboratory, if it has the acceptance of the holder of the conditional sanitary registration in the country, for each import of the referred products.
If you need additional information on this subject or require assistance to further understand this regulation, please contact the CS Peru Medical Industry Specialist: Gustavo.firstname.lastname@example.org