On August 21, 2020, Decrees No. 54 and No. 65 of the Ministry of Health were published in the Official Gazette, introducing amendments to Decree No. 3/2010, of the same portfolio, which approves the Regulations of the National System of Control of Pharmaceutical Products for Human Use, regarding health registrations and therapeutic equivalence, respectively.
In relation to Decree No. 54, in order to reduce the processing time of health registrations, mainly, in the case of medicines registered in International Regulatory Agencies, the following amendments are determined:
A. During the processing of a health registration, if the evaluation carried out by the Institute of Public Health (ISP) is unfavorable, it may grant a period of time for the applicant to correct accessory issues or submit sufficient information. If the period of time elapses and these objections have not been corrected, the PSI will proceed with the rejection of the registration application, without a favorable pronouncement from the Ministry of Health being necessary.
Nevertheless, the applicant may initiate a new registration procedure within 6 months from the date of notification of the rejection of the registration, and the PSI will have a period of 3 months to verify the background of the new application.
B. The abbreviated registration procedure may be initiated ex officio by the PSI or at the request of the interested party, and no longer requires a substantiated resolution from the Ministry of Health.
C. It is established that the total period to resolve the application for the simplified registration procedure will be a maximum of 5 months, counting from the entry of the application.
D. The accelerated registration procedure is created, which will be available to those medicines registered with Highly Supervised Drug Regulatory Agencies, whose processing may not exceed 3 months from the receipt of the application. Along with the recognition of the registration of the pharmaceutical product, the authorizations and certifications granted by the Agencies, such as the Good Manufacturing Practices, will also be recognized.
Biological products are exempted from the abbreviated procedure, unless there is a well-founded resolution by the Ministry of Health; and when there are public health reasons that prevent it, which will be qualified by a well-founded resolution by the Ministry of Health.
E. A new cause is incorporated to request the modification of the registration of pharmaceutical products, namely, the change of manufacturer, of active ingredients and modifications of the production process.
F. The possibility of requesting the authorization of a new drug manufacturer is incorporated, keeping the already authorized one. In this case, a new health registration number will be assigned, maintaining the other authorized aspects.
With respect to Decree No. 65, in order to facilitate and make more flexible the registration of bioequivalent medicines, a new article 221 bis is incorporated, providing that therapeutic equivalence will be understood to be demonstrated with respect to those pharmaceutical products that have obtained certification of this quality before any of the Highly Supervised Medicine Regulatory Agencies; as well as those that have been prequalified by the World Health Organization.