As it was commented in a previous article[i], following the wave of strengthening and control of the community and national legislations initiated in the European Union in relation to the acquisition, use and management of personal data, many Latin American countries began to adapt their corresponding regulations to be in tune with this international practice. But not only at a normative level this phenomenon is occurring, but also the Public Administration began to take some measures following this protection line.
In this regard, in Colombia, the Government made a “preventive nature call to the virtual platform ¨Facebook¨, in which an important amount of user data is stored and processed. According to this order, Mark Zuckerberg’s company must implement “useful and effective security measures” in this country, within 4 months, in order to increase the protection of personal data of Colombian users. But not only must implement the aforementioned measures, but also must demonstrate compliance through a certification issued by an independent, impartial, professional and specialized in information security issues, which may be chosen by the famous social network whenever it is alien to any subordination of it.
Through this “tatequieto” –Colombian slang to refer to “put an end to a conduct”-, the Superintendence of Industry and Commerce (SIC) aims to ensure the security of personal data of more than 31 million Colombians using the network Social. Therefore, the measures taken by Facebook must be “appropriate, useful, effective and demonstrable” to comply with all the requirements of the principle and duty of security in Colombian regulation, avoiding unauthorized or fraudulent access, unauthorized use or fraudulent, unauthorized or fraudulent consultation, unauthorized or fraudulent adulteration or unauthorized or fraudulent loss to the data of its users.
As mentioned in the beginning, this order is not alien to the changes that are taking place at the international level about this matter, but it is related to the facts, investigations and actions of data protection authorities that took place in the United States, Ireland, Great Britain, France, among others, and is based on the protection of personal data is a constitutional and fundamental right in the Republic of Colombia. Therefore, it would not be a surprise if similar measures are taken in the future in other countries of the region.
[i] ¨Wave of Personal Data Updates in Latam¨, by Maria Sol Porro, 29 January, 2019 (lINK: https://www.moellerip.com/wave-of-personal-data-updates-in-latam/).Read More
The Directorate of Drugs and Biological Products of the Colombian Ministry of Health (MoH)– now requires the pharmaceutical drug industry to submit the corresponding Unique Drug Identifier (IUM, according to its Spanish acronym) for all pharmaceuticals for human use. The change is a result of Resolution No. 3166 in force since 2015, which defined and implemented the data standard for pharmaceuticals for human use in Colombia.
Interested parties should request the IUM for the MoH, as it will be mandatory for issuing new sanitary registrations and for the approval of non-available life-saving medications. According to the provisions of the aforementioned resolution, the IUM shall be filed as follows:
1) The IUM previously granted shall be presented to the MoH for each commercial presentation of the dossier requested within.
2) To file the application before the National Food and Drug Surveillance Institute (INVIMA) under the Colombian MoH, it is required to submit the IUM in hard copy for the corresponding record.
3) Once the application is filed, the procedure will continue according to current practice; and, at the time of the examination, the correlation between the information provided to obtain the IUM and the information filed by the interested party before the INVIMA will be verified.
4) According to MoH’s guidelines, lack of conformity will consequently imply requiring a new IUM filing; this shall resolve the inconsistency as well as other technical and legal aspects required.
5) If such sanitary registration is approved, the IUM will be included in the resolution of this new sanitary registration.
For further information, visit the ministry website at www.minsalud.gov.co and click on the IUM button.
On April 12, 2016, the Colombian National Institute for Drug and Food Surveillance (INVIMA) reported that the time to assess clinical trial research protocols will be reduced from 4.5 to 2 months. The reduction will be achieved through the improvement of the processes, without compromising the quality of the evaluation.
Every clinical research project begins with the development of a clinical research protocol, which is a document that describes how the clinical trial will be conducted and ensures the safety of the trial subjects and integrity of the data collected. The protocol includes information regarding the background, goals, design, methodology, statistical considerations and organization of the clinical trial.
The two main changes that will allow to improve the efficiency of the assessment process are: a) the performance of the technical assessment of the research protocol and the quality of the drug simultaneously, and b) the transfer of the technical assessment of the research protocol from the Specialized Board for Drugs and Biological Products to the Clinical Research Group of the Directorate for Drugs and Biological products.
Source: https://www.invima.gov.coRead More
In May 2015, staff of the Colombian Institute of Food and Drugs Surveillance (INVIMA) and the Spanish Agency of Medicines and Medical Devices (AEMPS) attended a conference in Cartagena de Indias (Colombia) focused on the fight against counterfeit drugs.
The event also aimed at the implementation of the FALFRA System, an online system for the fast exchange of information and alerts on counterfeit drugs in Ibero America (Latin America, Portugal and Spain). This online tool was developed by the Ibero American Health Authorities Network (EAMI Network) and currently is managed by the AEMPS. This system contributes to the international cooperation in the prevention and fight against fraudulent and illegal drugs by the competent health authorities.
Additionally, the Colombian and Spanish health authorities consolidated their relationship in order to implement the collaboration agreement signed by both entities in December 2014. With this permanent cooperation, Colombia seeks to strengthen the processes for the evaluation of biosimilarity and bioavailability studies, to support the regulation of biological and biotechnological drugs, as well as the pharmacovigilance.
In order to facilitate trade with the countries to which Colombia exports goods, the National Health Authority(INVIMA) recently initiated the digital issuance of required Health Inspection Certificates for food, raw materials and alcoholic beverages.
The requirement should be considered by health authorities in countries importing goods from Colombia. As of now, the certificates will be issued in digital form, except when failures in the system occur, in which case paper certificates will be issued.
The launch will cut time and operating costs for exporters. Before the digital implementation, the document issuance often took hours, whereas currently it is done quickly and sent directly by email to the interested party.
Source: https://www.invima.gov.coRead More
According to a new resolution, fees have been modified from August 26th, 2014.
Resolution 2014026516 published on August 19, 2014, establishes that as from August 26, 2014, fees for sanitary registrations and related procedures were modified.
For specific information regarding the current fee chart, please click here
Source: https://www.invima.gov.co/Read More
On April 30, 2014, the Colombian Health Authority (INVIMA) informed that there was a change in the means of communicating the evaluations of advertising authorizations. The same will be issued through resolutions and subscribed by digital signature.
The three-month period granted by INVIMA to those companies interested in getting their resolutions with digital signature for previously approved advertisements has ended on July 2014.
Source: https://www.invima.gov.coRead More
Last April 30th 2014, INVIMA (National Food and Drug Monitoring Institute) announced that the requests on authorizations of advertising have to be filed online and with digital signature.
Source: www.invima.gov.coRead More
Resolution Nr. 31958 from local FDA, issued last October 25th, establishes a suspension period as from December 23rd until January 6th for all proceedings related to issuance, modification and renewal of sanitary records.
The goal is to assess the work of some specific areas at INVIMA in order to improve the quality of the services to be rendered during the next year.
The first business day will be January 7th 2014.
As of August 9th, 2013, new regulation for alcoholic beverages in force
The technical regulation for alcohol beverages established by Decree 1686 of 2012 entered into force on August 9, 2013. The purpose of such regulation is to establish the sanitary requirements for alcoholic beverages for human use manufactured, developed, packaged and distributed in, transported into, exported from and imported to the Colombian territory.
The abovementioned Decree sets definitions, sanitary requirements, allowed and forbidden practices for the elaboration of alcoholic beverages and requirements to obtain GMP certificates, and also addresses topics such as labeling, advertising, sanitary registration, etc.
Considering these new requirements, it is crucial to adjust importation processes and products in order to avoid problems or delays.
If you have questions or comments, please feel free to contact us.
Sources: Colombian Decree 1686 of 2012Read More