MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
therein are identified. If the results of a clinical trial are presented without providing information or images that could lead to the identification of the patients, such results would not be consid- ered personal data. 2.5 Use of Data Resulting From Clinical Trials It is permissible to transfer the data resulting from a clinical trial to a third party or an affili- ate, if the privacy notice states that a transfer will occur and identifies a justifiable purpose for that transfer. When sensitive personal data is involved, the data controller must obtain express written consent for its processing through a sig- nature, an electronic signature or any authenti- cation mechanism established for that purpose. 2.6 Databases Containing Personal or Sensitive Data The creation of databases that contain sensitive personal data must be justified, and must fol- low legitimate and concrete purposes that cor- respond to the activities and explicit objectives of the data controller. These kinds of databases are not subject to authorisation before opera- tions commence. 3. Marketing Authorisations for Pharmaceuticals or Medical Devices 3.1 Product Classification: Pharmaceuticals or Medical Devices The GHL provides a general definition for phar- maceuticals, and any product that falls under such definition should be considered a phar- maceutical. According to the GHL, a medicine is any substance or mixture of substances of natural or synthetic origin that has any thera- peutic, preventative or rehabilitative properties,
is presented in any pharmaceutical form and is identified as such for its pharmacological activity and physical, chemical and biological charac- teristics. On the other hand, the new definition of medi- cal device contained in Section 3.41 of Standard NOM-241-SSA1-2021 (NOM-241) is broader: “Medical device, instrument, apparatus, uten- sil, machine, software, implantable product or material, diagnostic agent, material, substance or similar product, to be used, alone or in com- bination, directly or indirectly in human beings; with any of the following purposes of use: • diagnosis, prevention, surveillance or monitor- ing, and/or aid in the treatment of diseases; • diagnosis, surveillance or monitoring, treat- ment, protection, absorption, drainage, or aid in the healing of an injury; • substitution, modification or support of the anatomy or of a physiological process; • life support; • control of conception; • disinfection of medical devices; • disinfectant substances; • provision of information through an in vitro examination of samples taken from the human body, for diagnostic purposes; • devices incorporating tissues of animal and/or human origin; and/or • devices used in in vitro fertilisation and assisted reproductive technologies, as well as those whose main purpose of use is not through pharmacological, immunological or metabolic mechanisms; however, they can be assisted by these means to achieve their func- tion. Medical devices include supplies for health in the following categories: medical equipment, prostheses, orthoses, functional aids, diagnos-
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