Non-food legislation - November 2018

05 December 2018

Industry finds fault with UK vision for drug regulation after Brexit
According an article from the Regulatory Affairs Professionals Society, British biopharma trade groups have spoken out against changes to drug regulation that could be enacted in the event of a no-deal Brexit. The trade groups found fault with proposals for how the Medicines and Healthcare products Regulatory Agency (MHRA) will handle orphan drugs, regulatory fees, the Falsified Medicines Directive and other issues if Britain crashes out of the European Union. The foundation for this article is the joint submission by ABPI and BIA to the MHRA consultation.

More Pharma
An article about Reducing levels of medical device contamination through package redesign and opening technique was published in PLOS ONE. The goal of this research was to evaluate how material curl, package structure and handling of pouches containing medical devices affect rates of contact between non-sterile surfaces and sterile devices during aseptic transfer.
From 27 November 2018, the Drug Supply Chain Security Act (DSCSA) will be actively enforced by regulators in the US. Packaging News has published an article in which leaders from across the pharmaceutical sector discuss the industry’s readiness and what companies should be thinking about in the final month before and beyond deadline.
Serialization Countdown published an overview article about three DSCSA-related Guidances that have been published by the FDA. These draft and finalised guidance docs were recently released regarding product identifiers and grandfathering.

ECHA updates information for companies on UK withdrawal from EU
ECHA has created new web pages to prepare companies for UK’s withdrawal from EU. The UK’s withdrawal from the EU will affect companies including those that manufacture or use chemicals in the UK as well as in the EU-27. ECHA’s updated web section aims to help affected companies who have registered substances or use authorised chemicals in supply chains. For example, under CLP, a company in the EU-27 that purchases a mixture from a UK-based company will become the importer and thus will have the obligation to ensure that the imported mixture is correctly classified, labelled and packaged.

Endocrine disrupters require amendment of the Cosmetics Regulation
Newsletter Waar&Wet states that the requirements for cosmetic products, which are laid down in Regulation (EC) 1223/2009 (consolidated version of 1 August 2018), should be adapted as soon as communitary or international criteria are available for the identification of substances with endocrine disrupting properties. As criteria have been established for biocidal products and plant protection products, this should be taken into account in the revision of the Cosmetics Regulation. The European Commission has identified the consequences and follow-up steps to be taken in this report in preparation for the amendment of the Regulation.

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