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