BREXIT
procedures in progress immediately before exit day. These procedures currently already result in a national MA. The government will complete the assessment (the transitional process for this will depend on how far the procedure has got immediately before exit day) but if successful, they will be approved as a national (UK) MA.
Data and market exclusivity for marketing authorisations
The government is not proposing any changes to the data and market exclusivity periods for UK MAs. After the UK’s exit from the EU, the start of data or market exclusivity will be the date of authorisation in the EU or UK, whichever is earlier.
The MHRA will not have access to the data provided in support of EU approved products. Therefore, new generic applications would need to be based on reference products that have been authorised in the UK.
Existing MAs for generic products which are based on a reference product authorised in the EU would remain valid.
Legal presence requirements
At present, the MHRA requires a named individual who can be contacted in the event of a safety issue, and has the ability to require independent re-testing of medicines and also the ability to withdraw a product from the market. This will continue if there’s no deal.
The requirement for this would include:
l A MAH should be established in the UK by the end of 2020. Until then, the MHRA will require a contact in the UK. A Change of Ownership will need to be submitted to MHRA to change from an EU MAH to a UK MAH for UK MAs
l The Qualified Person for Pharmacovigilance (QPPV) should be established in the UK on day one, although those without a current UK presence will have until the end of 2020 at the latest to do so, but would nevertheless be required to make arrangements for providing the MHRA with access to the relevant safety data related to
UK MAs at any time. Companies may choose to have the EU QPPV take on responsibility for UK MAs until the UK QPPV can be established. A variation should be submitted to the MHRA to change QPPV. Exact details of this will be consulted upon
l A Qualified Person (QP) for products manufactured in the UK or directly imported into the UK from outside a country on a designated country list (whitelist) must reside and operate in the UK. A QP for products manufactured in a country on a whitelist or manufactured in a third country and imported into the UK from a country on a whitelist can reside in a country on the whitelist.
Paediatric medicines
In the event of no deal, there will be a UK system for regulation of paediatric medicines in which the UK will ensure incentives remain to encourage such medicines onto the UK market. The government will make provisions for a UK Paediatric Investigation Plan (PIP), including the deferral and/or waiver of the requirement for studies where appropriate as currently provided for in EU legislation. Details of this will be subject to consultation.
The government will be consulting on the
proposed UK approach to the regulation of orphan medicines (medicines that have been developed to treat rare diseases) post exit, including incentives to encourage such medicines into the UK market.
Packaging and leaflets
The MHRA would continue to accept proposals for packaging and leaflets in the English language that include information from other jurisdictions (such as Ireland), as long as information complies with UK requirements. The MHRA would be pragmatic in changing UK requirements and would provide time for companies to comply with any changed requirements, including updates to packaging and leaflets. Once again, any changes will be subject to consultation.
An advanced therapy medicinal products
(ATMP) is a medicinal product which is either: a gene therapy medicinal product, a somatic cell therapy medicinal product or a tissue engineered product. MA applications for ATMPs to be marketed in the UK, whether for an initial, variation or in progress application, or a conversion from a CAP, would be treated as set out above.
Pharmacovigilance
Currently, pharmacovigilance, which is the monitoring of the safety of medicines on the market, is co-ordinated at EU level. If there’s no deal, the MHRA will have primary responsibility for the conduct and oversight of all pharmacovigilance activities in relation to UK MAs, certificates of registration and traditional herbal registrations. The details of this approach will be subject to consultation. Sharing of common systems, and formal exchange and recognition of data submitted for regulatory activities between the UK and EU countries would cease. The MHRA already holds its own database of Individual Case Safety Reports (ICSRs), so will not require historical information from MAHs. In future, for medicines sold in the UK, MAHs will be required to submit pharmacovigilance data (UK and non-UK ICSRs and PSURs (Periodic Safety Update Report) directly to the MHRA. An Individual
18 I
WWW.CLINICALSERVICESJOURNAL.COM SEPTEMBER 2019
©Alexander Sánchez -
stock.adobe.com
©2014
t
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92
