ETCO Informs

Libbs already has Unique Drug Identifier

1413296248_libbsPharmaceutical Libbs is the first company in the segment in the country to implement its medication monitoring platform with the printing of the Unique Medicines Identifier.

The Unique Medicines Identifier (IUM) will store information such as batch, validity, serial number and registration number with the National Health Surveillance Agency (Anvisa).

By December of next year, all pharmaceutical laboratories should place at least three traceable lots on the market. As of December 2016, the entire market should have tracking mechanisms.

This ensures the authenticity and legal provenance of the medication, avoiding deviations in the production chain and allowing for faster health surveillance action.

According to the government, traceability brings benefits to the industry with more effective management of risks in the production chain, avoiding errors and losses due to maturities and preventing theft of cargo.

Until September 30, Anvisa was notified of more than 1,2 cargoes of stolen or lost medicines. That number last year reached 1.964 and, in 2012, exceeded 3 thousand.

Source: Baguete RS  13/10/2014

 

 

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Federal Highway Police intensifies work on the country's north to south borders

The Federal Highway Police (PRF), in partnership with the Federal Revenue Service and the National Health Surveillance Agency, launched, throughout the month of September, numerous actions on the Brazilian borders.

In addition to the permanent presence that already existed on the southern limits of the country, inspections at the northern and western borders of Brazil were reinforced. With these new barriers intensified, the actions of Operation Sentinel, a strategic project of the Federal Government to fight transnational crimes, gains a new security belt that has already been working.

From Amapá to Rio Grande do Sul, the number of PRF operational units, located at points close to the borders, received reinforcement from agents from other states and groups specialized in fighting crime.
Trafficking in drugs, medicines and weapons, illegal entry of foreigners, evasion of foreign exchange, contraband and embezzlement, theft and theft of vehicles, environmental crimes were some of the illicit combated during the actions. The result is impressive: approximately 13 million reais were seized in smuggled goods - among which 57236 units of medication; 500 liters of fuel; 4529 liters of drinks and 11427 electronics units. In addition, 60 wild animals were also apprehended; thousand cubic meters of wood; 161
firearms among other materials.

Source: Social Communication Office of the Federal Highway Police

Network to track medicine starts operating in Brazil

Last October 08, the pharmaceutical Libbs, presented the first platform to track medicines. The goal is that by December 2016, the National Drug Control System (SNCM), will be operating and all industries will have similar mechanisms.

"The system will guarantee not only patient safety, but also facilitate health surveillance and the control of medication production in Brazil," said Health Minister Arthur Chioro.

With the new system, drug packaging should contain a two-dimensional bar code, a kind of RG. The mechanism will allow the identification of the place and date of production, form of distribution and point of sale. The minister is convinced that the system will allow control of the entire chain, making it easier to recognize possible cases of fraud, smuggling, cargo theft.

The schedule predicts that, by December 2015, all industries will place on the market at least three batches already produced with packaging that allows tracking. As of December 2016, the entire pharmaceutical market will have to have the mechanisms to do the tracking.

The National Health Surveillance Agency (Anvisa) commands a management committee formed by 25 public, private and third sector entities in charge of discussing the implementation of the system.

Source: O Estado de S.Paulo

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Against piracy, drugs will earn their own 'RG'

Source: Veja.com - July 21, 2012

Link to article: http://veja.abril.com.br/noticia/saude/remedios-que-podem-matar

The World Health Organization estimates that 10% of the medicines consumed in the world are counterfeit. In developing countries, such as Brazil, the rate rises up to 30%. To contain piracy and stem an estimated loss of 13 billion reais to the country per year, a 2009 law should finally come off the record in the second half of this year. The text creates the National Medicines Control System and should allow medicines to be tracked from manufacture to the pharmacy counter. The norm of the National Health Surveillance Agency (Anvisa) gives each drug a unique identifier - a kind of RG of the drug.

The trade in counterfeit drugs is considered a heinous crime, with a penalty of 10 to 15 years in prison. To deceive the consumer, pirates copy the boxes, packaging and even the colors and shapes of the pills. At best, the victims will be consuming a pill of flour and will run, without knowing it, all the risks of those who interrupt or even start medical treatment. At worst, they will be consuming any other substance, potentially harmful, sometimes lethal.

In 2006, more than 100 patients died in Panama from drugs made with counterfeit glycerin. In 2008, contaminated versions of the anticoagulant Heparin, imported from China, killed 62 people in the United States. In 2011, pirated versions of Truvada and Viread, against AIDS, were seized in England. Estimates from the International Policy Network, an organization based in London, show that the consumption of fake drugs against tuberculosis and malaria has been responsible for more than 700.000 deaths to date.

According to diplomat Roberto Abdenur, current president of the Brazilian Institute of Competition Ethics (ETCO), counterfeiting of medicines is the most cruel form of piracy. While most of the time consumers of pirated electronics, CDs and DVDs know they are buying fake products, the one who buys the drugs is often acting in good faith. "And the poorest, in search of affordable prices, are the most affected," he says.

Online Piracy - According to Anvisa, the traditional selling points for pirated medicines are street vendors and open markets. But fake drugs can also be found in pharmacies, mainly outside the country's major centers. “The Brazilian market is very large. We have many municipalities where enforcement is tenuous, and informality is high, ”says Sérgio Mena Barreto, executive president of the Brazilian Association of Pharmacy and Drugstore Networks (Abrafarma).

In the last decade, technological advances have opened yet another route for this illegal trade: the internet. According to a survey commissioned by the Ministry of Health and released by the newspaper The Globe, there are about 1.200 illegal websites selling drugs in the country.

Anvisa informs that online pharmacies can only function if they also exist physically, with a proven address, and with the agency's authorization. According to delegate Paulo Alberto Mendes Pereira, from the 2nd Police Station for Public Health and Crimes Involving Medicines, in São Paulo, combating these pharmacies is not easy. “Many of these sites are registered in other countries, which makes work difficult. However, 40 days ago, we carried out an operation where we apprehended 4 drugs sold illegally over the internet ”, he says.

Weapons and drugs - According to the Center for Medicine of Public Interest, an American research group funded by the pharmaceutical industry, the world market for fake medicines grows 13% annually. Piracy is practiced on a global scale and is thus linked to other mafias, drug and arms trafficking.

"Shipments of pirated drugs have already been seized in the same containers as fake electronics and ammunition," says Edson Vismona, president of the National Forum Against Piracy (FNCP), an entity formed by Brazilian companies with the aim of combating product counterfeiting. In Brazil alone, Vismona calculates that the losses reach 13 billion reais, of which five billion in tax evasion alone.

The RG of the remedy - Currently, drug certification mechanisms in Brazil are fragile. 'There is no way to control the batches of medicine', says Sérgio Mena Barreto, from Abrafarma. The new technology to be implemented by Anvisa will make it possible to monitor all drugs produced and sold in Brazil throughout the entire production chain.

When the law was approved in 2009, it was stipulated that Anvisa would have three years to establish the rules to be used. Finally, the agency decided to adopt a technology known as Datamatrix, similar to the barcode. But, while the latter allows the storage of only a number of several digits, Datamatrix allows the reading of various data, as the information is stored both in rows and in columns. The code must contain the drug registration number, batch, validity and a unique identifier of the drug, which would function as a kind of RG.

According to Anvisa, the details about the identification system are still being closed and should be announced in the second half. The law is expected to finally get off the ground. In these three years of discussions, more than 153.000 counterfeit pills were seized in Brazil. Last year alone, 40 joint operations were carried out, during which 177 establishments and 156 people were arrested.

Learn how to identify counterfeit drugs

According to a survey commissioned by the Association of the Pharmaceutical Research Industry (Interfarma), 6% of Brazilians buy medicines from street vendors, and 1% from unauthorized websites. Interfarma gives some tips for the consumer to recognize pirated products:


  1. • Scratch card - All medicines have a kind of “scratch card” on the packaging. With any metallic object it is possible to scrape and find a product security code.
  2. • Security seal - More expensive drugs also have security seals on the inside. When in doubt, contact the manufacturer's Customer Service Center (SAC).
  3. • Shapes and colors - Pharmaceutical companies invest to vary the shape of their pills. Some are triangular, others balloon-shaped. Another difference is the colors, textures and logos attached to the pill. Paying attention to these details also helps to avoid pirated products.
  4. • Confidence in selling - Finally, another way to avoid counterfeiting is to always use reliable points of sale and demand invoices for the sale.