On September 29, the Secretariat of Health opened three public consultations. The first one digitizes and simplifies procedures that private companies will be able to carry out before COFEPRIS, including permits for the exportation of any type of medicine. Interested parties may send comments through the following link. The second extends the validity of emergency provisions on drug interchangeability. Interested parties may send their comments through this link. Finally, the third one extends the validity of emergency regulations on the production of drug mixtures. Those interested in this consultation may send their comments through the following link. The first text will be open for consultation until October 27, while the other two are open for comments but will be issued, as a matter of urgency, as soon as possible.
Regarding the first consultation, it proposes modifications to an agreement with the procedures and services applied by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS in Spanish). Among its most important modifications, it enables this entity to use electronic tools on drug procedures, legally protected by Article 84 of the General Law of Regulatory Improvement. Among them, it includes the Request for sanitary verification visit for exportation and the Request for extension of the sanitary registration of herbal, vitamin and homeopathic medicines.
The second one, on the other hand, proposes to extend the validity of the emergency modification on drug interchangeability tests. The text, which modifies the original one that established provisions on national recognition of interchangeability tests performed abroad, would extend the validity of the original version for 6 months as from November 3, 2021. Finally, the third consultation seeks to extend the validity for 6 months of the emergency amendment on facilities for the preparation of sterile medicinal and nutritional mixtures.