Do you “Manufacture, Import or Distribute”, “Active Substances” currently in the UK?
You should have received an mail from the MHRA regarding Falsified Medicines Directive 2011/62/EU. Registration with the MHRA is compulsory and has to be completed before the 2nd of March 2012.
The MHRA will assess the application and they may choose to inspect the applicant and they will publish the successful applicant’s names on a UK register, which can be viewed by other National Competent Authorities in other EEA Member states or legal entities. This will enable companies to check company “Bona fides” and compliance with GDP and DMP. Pharmacy Consulting will help you with your application and help to prepare you for a MHRA inspection. The MHRA will grant or refuse your application within 60 days of receipt and during this period they will notify you if they intend to inspect you.
Wholesalers who source medicinal products from outside the regulated supply chain, including stock from a pharmacy would be in breach of his licence and could face regulatory action against his licence and or criminal prosecution.
Pharmacy Consulting has received several enquiries from pharmacies who have been supplying medicines to wholesalers enquiring about how to apply for a Warehouse licence. If you would like more information or would like WDL SOPs written to suite your business needs please contact [email protected]