Importing Pharmaceutical Products from 1st January 2021

by | Oct 21, 2020 | Blog, Brexit

Facts that UK wholesale dealers should not miss!

Read this if you intend to carry on importing pharmaceutical products into United Kingdom from 1st of January 2021:

  • You must notify the MHRA in writing within 6 months (from 31st of Dec 2020) if intending to continue to import pharmaceutical products from MHRA country list.
  • If the medicinal products intended to be imported into UK is licensed products in the UK, then you must name a Responsible Person Import (RPi) on the license within 2 years who will carry out specific functions.
  • If you import a UK or Great Britain (England, Wales and Scotland) authorised medicine from a country on the list, the wholesale dealer’s licence will need to cover the following activities of handling medicinal products:
    • 1.1 With “an authorisation” (a UK or Great Britain Marketing Authorisation, certificate of registration or traditional herbal registration)
  • Your licence must authorise wholesale distribution operations, including:
    • 2.5 Products imported from countries on a list,
    • 2.5a Products certified under Article 51 of Directive 2001/83/EC
  • Get a EU EORI number
  • Get an agent if do not want to do custom declaration by yourself
  • Have an updated Quality System to reflect the changes in your business process

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I attended one of the first virtual GDP Responsible Person Cogent “Gold Standard” training sessions due to the Covid-19 social distancing requirements. regardless of the circumstances the training was well organised and delivered to the required standard. This is why I recommended my associates to utilise PCL. Thank you Ryan, Sally, Adel and Jackie. Goncalo Sousa –  Quality Head UK at the Janssen Pharmaceutical Companies of Johnson & Johnson 05/05/2020
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