For the distribution of medicines and healthcare products, a licence, authorisation or registration is required depending on the type of activity. These licences, authorisations or registrations can be terminated by the holder at their request. Furthermore, it can also be cancelled by the MHRA (Medicines and Healthcare product Regulatory Agency). If it is terminated or cancelled, the distribution of any medicines or healthcare products that require a licence, authorisation or registration by that distributor is henceforth illegal.
Once the termination has been requested, it takes approximately 28 days to be processed. However, this can be shortened at the request of the holder with the Inspector’s agreement. Additionally, this can also be extended if required for the Inspector.
The holder may have additional duties in reference to the licence, authorisation or registration even after termination. This includes, but is not limited to, the retention of records which must be maintained by the holder for 5 years, in a safe and secure location.
Regarding termination, the request must be made before or on December 31st of that year or the holder is obliged to pay the annual service fee. If at any point a new licence, authorisation or registration is submitted after a previous termination, no fee reduction is applicable owing to the one previously held.
The Inspector responsible for the site(s) correlating with the licence, registration or authorisation must be informed of the request for termination. If the holder has any doubts about the termination process, they must contact the Inspector before the termination date. After the termination, the details will be recorded on the MHRA website.
For further information, please refer to the links below:
Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients
Medicines: terminated and cancelled manufacturing and wholesale dealer licences