PERU

On August 24, the Ministry of Health (Minsa in Spanish) launched a public consultation on the draft regulation for the Conditional Sanitary Registration of Medicines and Biological Products. The regulation seeks to regulate the granting of the sanitary registration for one year with phase III clinical studies with preliminary results. The objective of the studies in this phase is to demonstrate or confirm a therapeutic benefit and that the drugs are designed to be safe and effective according to their use. Interested parties may submit comments by Nov. 23 to [email protected].

The draft states that the conditional sanitary registration of a drug or biological product will authorize its manufacture, importation, storage, distribution, sale, dispensation, commercialization or use. It may be requested by pharmaceutical product laboratories that have sanitary authorization. In order to obtain the registration, the drugs must comply with certain qualities such as a positive benefit-risk ratio and the applicant’s commitment to provide all the data from the clinical studies, among others.

On the other hand, the draft proposes that the labeling must be expressed in Spanish, with indelible, legible and visible printings. Additionally, they can be presented in other languages, as long as such information corresponds to that found in the conditional sanitary registration. Labels may not include labels to correct or add information, except in the immediate packaging, which are intended to indicate the name, address and unique registration of the importer’s taxpayer.