On May 23, 2023, Supreme Decree No. 012-2023-SA was published in the official gazette "El Peruano," which establishes provisions regarding the Good Manufacturing Practices (GMP) Certificate for the registration, re-registration, and importation of pharmaceutical products.
This regulation states that until May 23, 2028, for the registration, re-registration, and changes in the sanitary registration of pharmaceutical products manufactured abroad, valid GMP certificates issued by the Competent Authority of the country of origin or their equivalents recognized as such by the DIGEMID will be accepted, provided that the applicant has submitted pre-liquidation requests for GMP certification to DIGEMID and the laboratory to be certified is included in the unique list of foreign manufacturing laboratories of pharmaceutical products pending GMP certification, prepared by DIGEMID.
Furthermore, it indicates that until May 23, 2028, for the importation of pharmaceutical products, in cases where the GMP certificate issued by DIGEMID is not available, Customs of the Republic will accept valid GMP certificates issued by the Competent Authority of the country of origin or their equivalents recognized as such by DIGEMID, provided that they are included in the unique list of foreign manufacturing laboratories of pharmaceutical products pending GMP certification, prepared by DIGEMID.
In addition, it is established that GMP certificates of foreign laboratories of pharmaceutical products, issued by DIGEMID, which expire during the period of validity of the Health Emergency due to the existence of COVID-19, will be automatically renewed for a period of one (01) year while the Health Emergency is in effect.
However, DIGEMID may require information related to compliance with GMP from all applicants who have submitted pre-liquidation requests and/or import pharmaceutical products without a GMP certificate issued by DIGEMID.
For more details on the regulation, please visit the following link: https://busquedas.elperuano.pe/normaslegales/dictan-disposiciones-referidas-al-certificado-de-buenas-prac-decreto-supremo-no-012-2023-sa-2180169-2/
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