The mantra over the past two years when it comes to Brexit has been ‘prepare for the worst and hope for the best’. As March 29th closes in, this appears like the best advice possible. Preparations in the Pharmaceutical and Biopharmaceutical industry are in reasonably good shape, and certainly better than other industry sectors, if the mood of last Friday’s HPRA Brexit Stakeholder Meeting on 01 Feb 2019 is reflective of the reality in the industry.
With over 400 participants, 200 of whom signed up within three hours, this was a meeting which captured the industry’s attention. The panel of experts, which consisted of government bodies (Health Products Regulatory Authority, Revenue, Health Service Executive and the Department of Health) and industry representatives (Irish Pharmaceutical Healthcare Association and Medicines for Ireland ) provided short, sharp and clear information on what preparation has been done and what is in progress in relation to a ‘no-deal’ or disorderly Brexit. The participants, who clearly believed by a show of hands that a disorderly Brexit is likely, were highly interested in the latest information from the HPRA on Brexit planning. The advice can be summarised as follows:
- Know your supply chain and how it ‘touches’ the UK.
- Be familiar with the regulatory requirements with the UK as third country.
- Be familiar with the future customs requirements for import and export to the UK.
- Seek assurances from your suppliers, particularly if UK based.
From a regulatory standpoint, the audience were informed that the EU commission have informally indicated that in cases of non-compliance, Marketing Authorisations (MAs) will not become automatically invalid. The HPRA indicated that quite limited information had been fed back to the HPRA from MA Holder’s. Engagement with the HPRA is strongly advised where risks of non-compliance exist, e.g. where testing and release of medicines will be required from the meeting. The principle reason for this advice is so that the agency can gauge (a) how many products are affected and (b) how regulatory solutions could be prepared and attained.
The key advice for MAH’s who have not yet engaged with the agency was to:
- Avoid unilateral withdrawals of medicine packs
- Consider multilingual packs where there are commercial challenges in having a dedicated Irish pack
- Be aware that Joint UK-Ireland packaging is acceptable after 29 March 2019 (once compliant with Title V of Directive 2004/83/EC and reflects the Summary of Product Characteristics (SMPC) of the product authorised on the Irish market.)
Further specific areas of information from the meeting included:
- Removal of the requirement for a Manufacturing Importation Authorisation (MIA) when importing exempt (unauthorised) medicines from a third country. There is an amendment to current legislation being progressed and the HPRA have no objection to a Wholesale Distribution Authorisation (WDA) being used for exempt medicine importation from now.
- An MIA is required for physical importation of authorised medicinal products from a third country, but a WDA is sufficient for financial (or fiscal) importation – which is no change from the existing situation.
- Wholesalers currently receiving authorised medicinal products from UK distributors must have an MIA in order to act as a site of physical importation after Brexit
- That where there are clinical trials on-going in Ireland, it was recommended that the Irish entities involved in the trial contact the HPRA for clarification on the sponsor of the trial if they are currently UK based.
- For medicinal products ‘mid-application’ where the UK is the Reference Member State (RMS), there is a consultation happening with MHRA for critical medicines to determine whether the HPRA or other EU National Competent Authorities (NCAs) would take on the application for assessment.
- There will be a commission led expert technical seminar for EU27 NCAs on February 18, 2019 to review the ‘no-deal’ Brexit scenario. HPRA are preparing for the potential to issue more detailed guidance in the event of a ‘no-deal Brexit’.
Brexit planning in the pharma sector appears well developed but there are no absolutes in terms of preparation for the unknown. ‘Preparing for the worst and hoping for the best’ will continue until further notice!
We, at PharmaLex, can support your organisation in many ways including the provision of regulatory support for MAH’s, performance of Brexit readiness assessments or provision of a collaborative responses to any technical queries that you may have in relation to Brexit. Please connect with us to discuss +353 1 846 4742 or email us at email@example.com.