Regulatory Affairs Articles

Latin America
24 Jun 2013

¿Can this product be considered a Medical Device in Latin America?1

“Doubt, of whatever kind, can be ended by action alone.” (Thomas Carlyle, 1795-1881) Manufacturers of healthcare products, mainly those located outside Latin America often doubt about how their products will be considered in this Region. This question is also frequently asked by manufacturers of medical devices, especially by the time a regional business strategy is […]

Mexico
24 Jun 2013

Simplified steps with COFEPRIS announced by President Felipe Calderon on August 17th 2010

To avoid unnecessary costs and to facilitate the access to cutting-edge products and technology services, Mexican President Mr. Felipe Calderon has announced six measures that will benefit Mexican citizens and foreign pharmaceutical, cosmetic and food industries as well. The six measures announced are: Over the counter drugs marketed in the USA and Canada with demonstrated […]

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24 Jun 2013

Regulation of the term “BIO” as an example of the conjuntion between Regulatory and Trademark issues 1

For a trademark to be successfully used as a distinctive sign of a product that is regulated by sanitary norms such as pharmaceutical or alimentary law, it has to comply with two simultaneous and necessary legal requirements: 1) to be authorized by the sanitary authority (or at least not rejected), as the “commercial name” of […]

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24 Jun 2013

Pharma Trademark: Sanitary Agency Authorization for Its Effective Use 1

Introduction In the marketing strategy of the pharmaceutical industry the trademark has a leading role: as Intellectual Property right, the trademark distinguishes and continuous protecting the pharmaceutical product from the generic versions, even when the patents linked to it have expired. From the process of trademark selection to the consolidation of the right of effective […]

Argentina
24 Jun 2013

New Requirements for Registration of Medical Devices

Comments to ANMAT Provision 727/2013 Introduction On February 4, 2013, the National Drugs, Food and Medical Technology Administration (ANMAT) amended through the issuance of Provision 727, the requirements for the application of medical devices and annulled Provision No. 5267 of 2006. While the new regulation maintains many of the requirements of MERCOSUR Technical Regulation for […]

Argentina
24 Jun 2013

New Regulation for Rare or Infrequent Serious Diseases

ANMAT Provision N°4622/20121 ANMAT 2 understood the need to establish in the country a scientifically supported standard operating procedure for the applications that will be filed for the registration of drug products or medicines for the prevention, diagnosis and treatment of rare or serious diseases. Diseases with a high prevalence within the population have always […]

Argentina
24 Jun 2013

Argentina: News regarding the National Regulation of Clinical Trials

For the last few years, the number of clinical trials performed in Argentina has exponentially increased1; that is why the recent events, which will have consequences in the quality and quantity of the trials to be performed, should not be surprising. Resolution HM 1490/2007 of November 14, 2007. This Resolution of the National Health Ministry […]

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