Is your scope of Wholesale Distribution Authorisation (WDA) out of date?
Is your scope of Wholesale Distribution Authorisation (WDA) out of date? – Are you aware that the Wholesale Distribution Authorisation (WDA) categories have changed?
Separation of the Licence Holder and Responsible Person
Separation of the Licence Holder and Responsible Person – The last paragraph on page 128 of the 2017 Green Guide contained the following sentence:
In the case of small companies, the licensing authority may accept the licence holder as the nominated RP.
Defective Medicinal Products and Recall Management Guidance
The main concerns with regard to possible defects of medicinal products and the substances used in their manufacture or packaging.
Medicinal products seized by MHRA worth just under £1,000,000
Medicinal products seized within the week running from the 23rd-30th June, the Medicines and Healthcare products Regulatory Agency (MHRA) seized 285,000 medicines and medical devices which were valued at almost £1,000,000.
Import Licensed Human Medicine(s) to the United Kingdom (UK) – Guidance
Import Licensed Human Medicine – Prior to importation of a licensed medicine applications for the relevant Licence(s) must be completed and submitted which may include one or more of the following:
Import Unlicensed Human Medicine(s) to the United Kingdom (UK) – guidance
An Introduced Product is an unlicensed medicine which can be imported from a country other than an approved country for import to be exported to a country other than an approved country for import, or if imported from a non-EEA country into Northern Ireland for export back to a country outside the EEA.