12月20 New Regulations On Anti – Counterfeiting of Drug Packaging in EU
It is reported that in order to curb counterfeit drugs (fake) into the EU market, the EU countries to protect the quality and safety of drug sales, the EU will be in addition to three countries (Belgium, Greece and Italy, the three countries have long been strict drug labeling ) In the EU-listed drug companies to implement more stringent new anti-counterfeiting regulations for pharmaceutical packaging.
According to the latest issue of the European Union (2016/161), the European Union (EU) will report to the European Union (EU) that on February 9, 2019, three countries (Belgium, Greece and Italy, which have already implemented stringent anti-counterfeiting laws) All the companies outside the EU-listed drugs to implement more stringent new anti-counterfeiting regulations for pharmaceutical packaging. This is to curb the increasingly rampant counterfeit drugs (fake) into the EU market momentum, in order to protect the quality and safety of drugs sold in the EU countries.
The new provisions are as follows: the purpose is to prevent the counterfeit drugs (fake) into the EU market; drug manufacturers must be added to its drug packaging on the recognition of a unique identification symbols and anti-cheating devices, the so-called identification symbol means The 20-letter serial number contains the product code, production approval, time of expiry of the drug, the country of manufacture, etc., and, if necessary, additional (European Union) medical insurance compensation code and other related symbols. In addition, the new provisions also provides that, in order for patients to intuitively understand whether the use of drugs for authentic products, manufacturers need to print a barcode on the drug packaging, patients with a portable scanner scan can be read out The above text information. If the product does not have a hard pack, such as an outer box, the manufacturer should print the barcode directly on the product packaging (such as a vial). But the following products may not implement the new requirements, including: medical gas products, medical wipe paper or cell culture liquid products. Some non-prescription drugs also need to meet the new requirements (such as omeprazole, etc.). To help drug manufacturers and exporters to learn more about and master the new anti-counterfeit packaging drugs on the content of the new regulations, the European Union Drug Administration will organize a number of long-day selection of companies selling medicines in the EU countries by the European Medicines Agency (EMA) Technical experts, the new regulation of the seminar. The new anti-counterfeit drugs have been included as an annex to the EU Drug Administration Act.