CAP Grandfathering

BREXIT will affect the pharmaceutically industry greatly and with an exit date of 31/12/2020 it is important that you are aware of all the changes that will take place.

One of these changes will be that Centrally Authorised Products (CAPs) converted to UK Marketing Authorisations (MAs). However, there are a lot of important dates and pressure points that you need to be aware of.

Regulatory

Conversion to UK MAs automatically happens on 01/01/2020. A Marketing Authorisation Holder (MAH) can opt out, however they must inform the MHRA in writing by 21/01/2021. Although there is no fee for conversion, the annual fee will continue to apply from 01/04/2021.

Sunset clause clock for non-marketed medicines start on 01/01/2021. This means if the product has not been marketed in Great Britain the three-year deadline to launch the product on the UK market will be restarted from the date of conversion to a Great Britain MA.

PLGB number issued. If the CAP MAH does not have a company number allocated by MHRA then an application form for a number will be required.

MAH to register to new MHRA portal and allocate third party consultant to act on their behalf (if required).

Variations can only take place after initiating sequence/base line has been submitted. The MHRA strongly prefers MAHs submit the initiating sequence as a single event. However, it is recognised that some MAHs may need to submit variations, renewals or Article 61(3) notifications to the MA before they can produce the complete initiating sequence. In these circumstances, the MAH can use a two-step process by first submitting a minimal initiating sequence containing at least the mandatory documents.

Non-UK MAH needs to have an MAH established within 24 months, this can be done in two ways:

  • Submit a Change of Ownership application (COA), after the submission of the baseline initiating sequence within 21 months* after the transition period (*to allow time for the processing of the COA).
  • Include the COA in the initiating sequence as if it had already been approved by the MHRA and state in the cover letter that this option had been adopted.

There is then a 12 month period to ensure stock released to the market has compliant artwork.

Regarding renewals, converted EU MAs are treated as if they were granted on the date on which the corresponding EU MA was granted. The converted EU MA will therefore have the same renewal date in the UK as in the EU. Renewal applications will continue to be submitted nine months prior to the expiry date. Documentation requirements remain unchanged. Minimal initiating sequence required.

Further guidance on submissions detailed – https://www.gov.uk/guidance/converting-centrally-authorised-products-caps-to-uk-marketing-authorisations-mas-from-1-january-2021-grandfathering-and-managing-lifecycle-chan

Note EMA CAPs remain valid in Northern Ireland therefore Grandfathered CAPs are specific to Great Britain.

Pharmacovigilance

From 01/01/2021 the MAH will be responsible for submitting the following pharmacovigilance data to the MHRA for medicines authorised in GB:

  1. UK and non-UK Individual Case Safety Reports (ICSRs)
  2. Periodic Safety Update Reports (PSURs)
  3. Risk Management Plans (RMPs)
  4. Post-Authorisation Safety Studies (PASS) protocols and final study reports.

ICSRs will need to be submitted by MAHs via the MHRA Gateway or ICSR Submissions

QPPVs can be located in the UK or the EU. But bear in mind where based in the EU you must nominate a national contact person for pharmacovigilance who resides and operates in the UK and reports to the QPPV. This individual should have access to the reports of suspected adverse reactions referred to in regulation 187 of the HMRs and the PSMF for UK authorised products. The individual should be able to facilitate responses to pharmacovigilance queries raised by the MHRA, including via inspections.  There will be 12 months from the 1/1/2020 to appoint a national contact person.

For MAs that are specific to Great Britain, the PSMF must be accessible electronically at the same point in the UK from which the reports of suspected adverse reactions referred to in regulation 187 of the HMRs are accessible. The PSMF needs to be permanently and immediately available for inspection at the stated location in the UK.

For MAs that are specific to Great Britain, legal requirements concerning the format and content of the PSMF are outlined in Part 1 of Schedule 12A of HMR, which mirrors Chapter I of CIR.

All PSMFs that cover UK authorised products should be registered with the MHRA. You should request a unique UK PSMF number from the MHRA for each pharmacovigilance system that you are operating for UK authorised products. You are encouraged not to request the UK PSMF number until you are notifying the MHRA of a change in the details of the QPPV for UK authorised products from the baseline information held by the MHRA.

Ben Smith