by Molly Majumder | Apr 16, 2021 | Compliance, Pharmaceutical, Regulations, Serialization, Track and Trace
The recently announced TGO 106 guidance by the Australian government department of Health provides guidance to sponsors and manufacturers supplying medicines in Australia. Even though serialization and use of data matrix codes at this time continues to be optional,...
by Molly Majumder | Apr 2, 2021 | Brexit, Compliance, Pharmaceutical, Regulations, Supply Chain
The United Kingdom voted to leave the European Union in 2016, but it wasn’t until December 24th 2020 that the details of trade between the two countries was solidified. On that date, the two entities signed a 1,250-page Trade and Cooperation Agreement (TCA)...
by Molly Majumder | Mar 26, 2021 | Aggregation, Compliance, Pharmaceutical, Regulations, Serialization, Supply Chain, Track and Trace
The EU Falsified Medicines Directive (FMD) puts in a framework to track any potential falsified medicines that reach the legal supply chain. Individual units are scanned at the dispensary to verify their legitimacy. In case of any verification failures, the...
by saba | Mar 12, 2021 | Compliance, Counterfeit, Pharmaceutical, Regulations, Serialization, Supply Chain, Track and Trace
Brazil’s legislation has had a complex set of requirements for putting into effect their serialization and reporting processes in order to achieve complete compliance. Back in 2016, ANVISA signed the National Medicine Control System SNCM into law (Law No....
by saba | Nov 27, 2020 | Brexit, Compliance, Pharmaceutical, Regulations, Serialization, Track and Trace
Although the Brexit Transition period ends on December 31 2020 at 11 pm in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) believes the exchange and circulation of medical goods may continue till January 1 2021 (as per their update on October 21...
by saba | Nov 20, 2020 | Compliance, Pharmaceutical, Regulations, Serialization, Track and Trace
Regulatory and compliance teams faced immense pressure after Covid-19 spread across the globe. The life sciences industry was trying to inculcate regulatory changes however, the pandemic expedited the need to put these into effect and to address all the new challenges...
Recent Comments