Norkem Limited have obtained a licence to import and distribute Zinc Oxide as an active substance to be used as a starting material in medicinal products for human use.

 

Issued by the Medicines and Healthcare products Regulatory Agency (MHRA), Norkem Limited have joined a small number of UK companies that are registered to distribute Zinc Oxide as an active substance.  They are also currently the only UK company registered to import from a third country (these are countries that have a regulatory system for active substances which corresponds to EU standards).  In order to import or distribute an active substance from a third country they are required to comply with the guidelines for Good Distribution Practice (GDP) in relation to the active substance.

 

Active substances are used to give medicinal products their therapeutic effects and are often referred to as Active Pharmaceutical Ingredients (API’s).  Falsified active substances pose a serious risk to public health and the Falsified Medicines Directive 2011/62/EU tightens up the control of active substances for use in the manufacture of medicinal products for human use.

 

The Directive introduces a key change in order to provide a greater level of control and transparency in the supply chain.  There is a need for UK manufacturers, importers or distributors of active substances to be registered with the MHRA.  Norkem have completed their registration and now welcome enquiries from customers working with Zinc Oxide as an API in medicinal products for human use.