Por: Andrea Castillo
On February 2023, the Department of Regulation and Control of Pharmaceutical and Related Products published an update of Technical Standard 57, corresponding to version 2 – 2023, which will be in force on March 21, 2023.
Some of the new features of this new version are as follows:
– In Article 1, the objective is modified, adding the option of applying the abbreviated procedure to branded products so that they can also be registered as generic, and vice versa.
– Article 2 is added, clarifying that the application scope is for specialty pharmaceutical products.
– Article 3 is added, where several definitions are listed for the correct application and interpretation of the Standard.
– Article 4 contains the general provisions, including the following:
- The pharmaceutical product, whether generic or brand name, must have the same information and characteristics as the drug already registered. No differences will be accepted.
- The requirements are the same as those established in the RTCA of Pharmaceutical Products, Drugs for Human Use, current version. Likewise, renewals and modifications will be governed by said legislation.
- Payment will be made to the National Health Laboratory, which will perform post-marketing analysis for surveillance.
– In Article 5 on the requirements, it is indicated that in addition to what is requested in the RTCA, a Letter of Pronouncement signed by the Holder or Legal Representative must be submitted, stating that the product to be registered has the same information as the product already registered as a reference.
– Article 7 is added, which clarifies that the National Health Laboratory is in charge of performing the post-marketing analysis, for surveillance. In case this result is of non-compliance, the registration will be canceled”.