On May 31st, 2021, the Decree (“Decree”) by which different provisions of the Health Supplies Regulation were amended, added, and repealed, was published in the Official Gazette (“Diario Oficial de la Federación”)
The Decree’s main amendments are as follows:
The requirement to renew sanitary registration of medicines after the first renewal is eliminated.
Article 190 Bis 7 was amended setting forth that in order for holders of sanitary registration of medicines to obtain their second and subsequent renewal applications, they must submit every five years and no later than one hundred and fifty calendar days before Registry expiration date. Such renewal will have the effects of extension of the sanitary registry in the understanding that the certificate issued by the Federal Commission for the Protection Against Sanitary Risks (“COFEPRIS”) acts as an acknowledgment of receipt of the renewal application.
Documentation in English to be accepted as part of sanitary Registry applications.
Article 153 was amended to establish documentation gathered as part of the application file may be either in Spanish or English.
Foreign biocompatibility studies become accepted for biocompatible drugs approval.
Article 177 Bis 2 was amended to provide that upon a biocompatible biotechnological medicine demonstrating its biocompatibility will be authorized. This will be as long as the biocompatible biotechnological medicine is presented in the same pharmaceutical form and doses as the reference biotech and such indications share the same action mechanism or the biocompatible biotech drug has the same pharmacodynamic effect.
Implementation of mandatory General Health Act (“LGS”) guidelines as to adding legends to the labelling of products destined to the public sector.
Article 26 states the obligation to include labelling to products destined to the public sector as per the following: i) primary or secondary packaging must be differentiated from that destined to the private sector; ii) contain health information related to the generic name, distinctive name, active ingredients, expiration date, batch number, storage instructions, dose and way of administration, precautionary lable, warning lable, etc.; iii) include the label “Not for Sale” or “Property of the Health Sector”, and iv) contain the key number of the national compendium of health supplies.
Response Times reduction for modification of the sanitary registries.
Article 186 states that requests for modifications to the health registry conditions of any medicine must be issued within a period of forty-five business days for those related totechnical modifications, and twenty business days for administrative modifications. Should such requests not be answered within those terms, the request will be understood as approved.
At González Calvillo we are prepared to provide the advice required in relation to this matter. We remain available for any questions or clarifications regarding the scope of this.
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