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Christian Alejandro Lopez-Silva

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Dr. Lopez Silva is the head of Healthcare & Life Sciences Industry Group in Mexico, as well as a member of the Steering Committee of the North American and Latin America Healthcare Group. He has more than 17 years of experience in regulation of life sciences, pharmaceutical law and biotechnology matters, having worked in the private and public sectors and at the national and international level. For several consecutive years, Dr. Lopez Silva has led the rankings for Life Sciences both nationally (Chambers Latin America) and internationally (Chambers Global).

On 31 May 2021, the Mexican President published on the Federal Official Gazette a major amendment to the Secondary Regulations for Health Supplies (Reglamento de Insumos para la Salud, “RIS”) (“Decree”). The Decree is effective as of 1 June 2021, affecting both medicines and medical devices. It improves the regulatory environment.

The Health Pod, Baker McKenzie’s industry podcast series, highlights sector-specific issues and trends that affect healthcare and life sciences companies. Episode 5: Japan Pharmaceuticals Market – Distinguishing Features and Industry Practice Japan accounts for approximately 7% of the global pharmaceuticals market and is the third-largest market in the world following…

The Health Pod, Baker McKenzie’s industry podcast series, highlights sector-specific issues and trends that affect healthcare and life sciences companies. Episode 5: Japan Pharmaceuticals Market – Distinguishing Features and Industry Practice Japan accounts for approximately 7% of the global pharmaceuticals market and is the third-largest market in the world following…

After having rejected initially any possibility in this regard, the Federal Ministry of Health (“MoH”) issued a Decree, published in the Official Gazette on 25 January 20211 establishing the conditions under which the local (State) governments and the private sector, can participate in the National Vaccination Program for COVID-19. Although it does not eliminate many uncertainties, it opens certain possibilities of action.

There is a clear increase of enforcement actions taken by health authorities, both at the Federal and State level, where authorities are verifying if both physician and dining rooms at manufacturing plants, from all industries, have been properly supported by the applicable Notices of Operation. At the same time, many local health authorities are unduly requesting companies to have a Notice of Operation for their manufacturing operations. Companies shall comply the former and be prepared to reject the latter in order to prevent disruptions of operations and future sanctions.