Bradgate Health is a formulator company, producing a large range of generic medicinal products (medicines) sold under various brand names by high street pharmacy chains. It buys in raw materials from a range of mainly EU-based suppliers and a few from non-EU-based companies.
Tim works for Bradgate Health as its regulatory manager. He has recently read an article in his trade association magazine about a new piece of EU legislation called REACH. He decided that he needed to look at this more closely as it may impact on Bradgate’s business and consulted his trade association for more information. On doing so, Tim now understands that substances manufactured or imported at 1 tonne per year or more need to be registered by whoever makes or imports them. Therefore, Tim made a list of all the substances that Bradgate use, including those not directly used to make the final products. He established where Bradgate sits in the supply chain for these and worked out how much of each one they use on average during the year.
Most of the substances that Bradgate uses are bought from suppliers within the EU and therefore should be registered further up the supply chain. For the substances it buys from outside the EU, Tim realised that Bradgate are the importers and therefore will have the responsibility to register these under REACH where the import is greater than 1 tonne per year.
However, Tim also read about the exemption from registration under REACH for medicinal products. Tim was unsure whether this applies only to the active ingredients in the products or all other non-active ingredients (excipients). On looking at the European Chemical Agency website for more information, Tim decided to use the REACH ‘Navigator’ tool. Tim established that the exemption does not distinguish between active and non-active ingredients as it applies to any substance ‘used in medicinal products’. He concluded, therefore, that excipients used in medicinal products are also exempt from registration.
Tim then looked at the substances they buy from within the EU which are not used as ingredients in their medicinal products. For these Bradgate is a downstream user. As some are critical to the business, Tim decided to contact the suppliers to make sure that these substances were at least likely to be pre-registered and in due course registered. He asked these suppliers if they need any further information on how Bradgate use them and established that these uses would be included in any potential registration.