Updates to prescribing information for centrally approved products in the event of the UK leaving the EU with no deal

A number of companies have contacted the PMCPA about the possible changes to marketing authorisation (MA) numbers and possible changes to the marketing authorisation holder’s (MAH) name and address and the requirement in the ABPI Code of Practice for the Pharmaceutical Industry to ensure prescribing information in advertising is up-to-date.  

The MHRA has issued guidance regarding the process for the conversion of centrally approved products (CAPs) to UK marketing authorizations in relation to preparation in the event of the UK leaving the EU with no deal.  The MHRA refers to proposals to automatically convert centrally approved product marketing authorizations into UK marketing authorizations on exit day.  This is referred to as ‘Grandfathering’.  

The MHRA is allowing companies a period of 12 months after exit day to submit to the MHRA information on their CAPs and 33 months after exit day to implement changes to the MA numbers and MAH name and address in packs in order that these changes do not have to be made in isolation but can be made when other changes become necessary. 

Clause 4.1 of the ABPI Code requires that prescribing information be provided and this includes the number of the relevant marketing authorization and the name and address of the holder of the authorization, or the name and address of the part of the business responsible for the sale or supply of the medicine.  Clause 7.2 of the ABPI Code requires that materials are up-to-date. 

Pharmaceutical companies with centrally approved medicines should update the marketing authorization numbers and any new marketing authorization holder name in promotional material as soon as possible after exit day and must do so when other changes are needed. 

In the event of the UK leaving the EU with no deal, for the period from exit day until the end of 2021 a complaint that the prescribing information for a previously centrally approved medicine does not have the new UK marketing authorization number or any new marketing authorization holder’s name and address as required by Clause 4.2 (vii) will not be considered to be in breach of that clause, or of Clause 7.2, if the prescribing information includes the previous information and that any new marketing authorization holder can be contacted via the address given in the prescribing information.  This will also apply to other medicines where the marketing authorization number or the marketing authorization holder name and address needs to be changed as a consequence of the UK leaving the EU with no deal. 

In the event that the UK leaves the EU with no deal and where companies have opted out of the process to obtain a UK marketing authorisation under the grandfathering process, the medicine in question will no longer be licensed in the UK as from exit day.  Products that do not have a marketing authorisation valid in the UK may not be advertised (Clause 3 of the ABPI Code).  

The PMCPA position as outlined above has been discussed with the Advertising Standards Unit, Vigilance and Risk Management of Medicines, MHRA. 

10 April 2019