Non-food legislation - February 2019

06 March 2019

Pharmaceutical packaging legislation
The European Commission has issued a press release about the completion of the implementation of the Falsified Medicines Directive. From now on, the industry will have to affix a 2-D barcode and an anti-tampering device on the box of prescription medicines. The pharmacies – including on-line pharmacies – and hospitals will have to check the authenticity of medicines before dispensing to patients. This is the final step in the implementation of the Falsified Medicines Directive, adopted in 2011, aiming at guaranteeing the safety and quality of medicines sold in the EU.
New EU rules for Veterinary Medicines have been published in the Official Journal of the EU. The new legislation will help provide for a modern, innovative and fit for purpose legal framework on veterinary medicinal products and strengthen the EU action to fight antimicrobial resistance. The rules will apply from 2022 onwards.
U.S. FDA is taking new steps to adopt more modern technologies for improving the security of the drug supply chain. Packaging Digest has published an interview about how the FDA looks to these pilot projects to enhance pharma track-and-trace. The FDA initiative, which is part of the Drug Supply Chain Security Act (DSCSA), supports development of an improved electronic track-and-trace system for prescription drugs. Until March 11, 2019, FDA will be accepting requests from entities within the pharma distribution supply chain to participate in the DSCSA pilot-project program.
Meanwhile, the U.S. FDA has published a statement on ongoing efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and forcefully confront opioid epidemic.  Serialization Countdown reports about the first warning letter under the DSCSA that is mentioned in the statement.

Labelling with CE or UKCA marking after Brexit
The UK Government has published guidance for using the UKCA marking if the UK leaves the EU without a deal. If the UK leaves the EU without a deal you will still, in the majority of cases, be able to use the CE marking to demonstrate compliance with the legal requirements and to sell products on the UK market after 29 March 2019. However, in some cases you will need to apply the new UKCA marking to products being sold in the UK. The guidance explains when you should use the UKCA marking and in which cases you can continue the CE marking. Hogan Lovells has also published an article about how things will change after 29 March 2019 in case of a “No-deal” scenario.

ECHA urges all companies placing chemical substances onto the markets of the European Union and European Economic Area to prepare for the United Kingdom’s withdrawal from the EU. New instructions are now available on ECHA’s website.
The European Cefic and British CIA have published a joint briefing note – preparing for UK out of REACH scenario (926 kB).
CLP: The leaflet on classifying and labelling chemicals in the EU has been translated and is now available in 23 languages.

Results of the Plastic additives initiative
ECHA and industry sector organisations have mapped a range of plastic additives used in Europe. This information will provide a better basis for ensuring the safe use of these substances. Read more about it in the ECHA Newsletter of February.

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