Thursday, December 12, 2013

Anvisa (Brazil) Approves Track & Trace System

The board of Brazil’s National Health Surveillance Agency, Anvisa, has approved a system that will be used to track drugs from manufacture to the time of sale.
Within three years, drug packaging will have a two-dimensional code, and the industry will need to have in place an electronic system to monitor each step of the package, from the factory to the pharmacy. In the case of prescription drugs, the monitoring will go further, with the ability to know who purchased a particular drug, explains Anvisa Director Dirceu Barbano.

The agency established an intermediate period of two years from the time of approval of the system to allow every drug company to submit a comprehensive report of traceability of at least three product lots that they have manufactured.
“The report will serve to demonstrate that the company has the system in place, and that it’s working. And the company would have an additional year to buy more equipment," Barbano said.

Another rule, yet to be issued, will define the process for communicating tracking information to Anvisa. The tracking data, says Barbano, should be created by the industry, possibly in partnership with pharmacies and distributors.
Nelson Mussolini, chief executive of Sindusfarma (Association of the Pharmaceutical Industry in the State of São Paulo), says the move brings certainty to the industry and the consumer. Mussolini said he believes it is possible to meet the deadline established by Anvisa, although there is some concern amongst manufacturers about the cost of the change and the availability of equipment necessary to establish traceability. There is no mention of passing costs to consumers, he said, since drug prices are controlled by the government.

The call for traceability was established by law in Brazil in 2009. In 2011, the agency gave up a proposal for traceability which involved the use of a stamp of the Mint, as it would have made products more expensive.

Friday, November 29, 2013

US Track and trace plans signed into law w.e.f. 27.11.2013

The US FDA has started work on a national track and trace system for pharmaceuticals after President Barack Obama signed the Drug Quality and Safety Act into law on 27/11/2013. The Drug quality and security Act of USA is available at the following link which enable  USFDA to formulate the track and trace system .

Friday, October 18, 2013

Monocarton is declared as primary pack by DGFT dt. 17.10.2013

PUBLIC NOTICE NO.31(RE-2013)/2009-2014  Dated 17th October, 2013

Mono cartons to be treated as primary level packaging of export consignment of pharmaceuticals and drugs.

In exercise of the powers conferred under Paragraph 2.4 of the Foreign Trade Policy,
2009-14, Director General of Foreign Trade amends the Public Notice No.21 dated 10.01.2011 as

2. Sub-para (a) of Para 3 of Public Notice No.21 dated 10.01.2011 is amended by adding a new
sentence at the end of the existing para. The amended para would read as under:

“3a. Incorporation of 2D (GS 1 Data Matrix) barcodes on medicines at strip/vials/bottle level
encoding unique product identification code (GTIN), Batch Number, Expiry Date and
Serial Number of the Primary pack. Mono cartons containing stripes/vials/bottle shall be
treated as part of primary level packaging”

3. Effect of this Public Notice:
Mono cartons containing strips/vials/bottles shall be treated as Primary level packaging.

(Anup K. Pujari)
Director General of Foreign Trade

F.No.01/91/180/648/AM09/Export Cell
Issued by:
Ministry of Commerce and Industry
Department of Commerce
Directorate G

Tuesday, September 17, 2013

P.Notice No.54 dt. 5.4.2013 extending the date of implementation to 1.7.14

Public Notice No. 54 (RE-2012)/2009-2014
New Delhi, Dated the 5th April, 2013
Sub: Deferment in the date of effect for implementation of bar-coding on Primary level
packaging on export consignment of pharmaceuticals and drugs for tracing and
tracking purpose.
In exercise of the powers conferred under Paragraph 2.4 of the Foreign Trade Policy,
2009-14, as amended from time to time, Director General of Foreign Trade hereby makes
following amendments in Public Notice No. 59(RE-2010)/2009-14 dated 30.06.2011 read
with Public Notice No. 10 (RE-2010)/2009-2014 dated 11.07.2012:
2. The date of effect for implementation of bar coding on Primary Level packaging as
mentioned at serial number 2(i) a of Public Notice No. 59(RE-2010)/2009-14 dated
30.06.2011 will now come into effect from 1st July, 2014.
3. Effect of this Public Notice:
Earlier the requirement of affixing barcodes on Primary Level packaging was to take
effect from 01.07.2013. Now this date has been deferred to 01.07.2014.
(Anup K.Pujari)
Director General of Foreign Trade
E-mail: dgft[at]nic[dot]in
(Issued from F.No. 01/91/180/648/AM 09/Export Cell)

Friday, February 8, 2013

list of importing countries wherein bar coding is already mandated

Importing Country Requirement - Pre-Printed Bar Code


Linear Bar Code

2D Bar code
Linear Bar Code
Linear Bar Code
Czech Republic
Linear Bar Code
Linear Bar Code
Linear Bar Code
Linear Bar Code
Linear Bar Code