This quarter has been the age of cosmetics as the upcoming new EU Cosmetics Regulation gets its grip on manufacturers and importers wanting to market their products in the EU. Various meetings currently deal with these issues and we were invited to two of those meetings to present our knowledge of and views on this new regulation. Members of the Dutch Cosmetics Association (www.ncv-cosmetica.nl) were familiarized with borderline issues between cosmetics, medicinal products, medical devices and biocides while for the Product IP Documentation Platform (www.productip.com) we presented the basics of this new regulation. Inevitably, these cosmetics regulations get slowly harmonized with those of medicinal products and medical devices, leading to near-equivalent requirements with respect to the quality, safety and efficacy of cosmetics.
Also, in this quarter we welcomed the return of a former client of ours which needed support for the split of its European operations. Such a split involves quite a restructuring of pharmaceutical licenses, new quality technical agreements with various subcontractors as well as remodelling of various supply chains including formal responsibilities for the EU – Release of products. Such (re)structuring holds no particular secrets to us as we have been involved in similar projects with other multi-nationals. But representatives of American companies who are new to European pharmaceutical regulations sometimes feel like a blind in the dark, in particular when it comes to the roles and responsibilities of the EU – Qualified Person, an entity currently totally unknown in the USA.
At the product regulatory frontier quite some interesting projects came in including the creation and hosting of duplicate marketing authorizations, a pricing & reimbursement project for a new orphan drug as well as developmental support to a company who will shortly launch a new medical device to facilitate the oral intake of tablets and capsules. Talking of medical devices, this quarter a draft version of the new Medical Device Regulation (indeed, not a Directive anymore…..) was published. Quite an effort to digest these 194 pages, but luckily the Explanatory Memorandum, already 12-pages long, serves as an excellent summary. Don’t miss this one to get a quick oversight of the changes to come.