Updated on 29 April 2015
South Korea has manadated serialization on the folding package
Singapore: As the number of counterfeit drugs continues to grow, regulatory authorities around the world are increasingly relying on clear identification of products through serialization.
In accordance with the requirements of the South Korean Ministry of Food and Drug Safety (MFDS), German firm Vetter, provider of serialiazation services to avoid counterfeit products, has started manufacturing its first commercial batches with single-use identification numbers in Korea. Its solution identifies the drugs on the folding boxes via a 2-D data matrix code with a serial number, expiry date, and batch number.
"Together with our customers, we prepared for these requirements very early on," said Mr Thomas Otto, managing director, Vetter. "We have been active in filling and final packaging for the company for years. Thanks to our serialization service, our partner can now meet the regulatory requirements for South Korea. We are, however, also aware of the fact that regulatory requirements differ from one country to the next. Therefore, we offer pharma and biotech companies a wide range of options that will give them flexibility when reacting to different regulatory standards."
Presently, South Korea has only asked for serialization on the folding package. China, however, has legislated use of 1-D linear codes including aggregation with the shipping box.
Vetter's serialization service includes a range of formats for serial numbers, different code systems; such as a 2-D data matrix codes, interfaces and reports, as well as various aggregation depths.