1. Anne Hayes, Inspection Manager
Brexit
Compliance Issues
Anne Hayes, Inspection Manager
HPRA Veterinary Medicines Information Day
Wednesday 13 June 2018, Dublin

2. Continuity of supply of medicines
Priorities
Continuity of supply of medicines
Increased engagement to facilitate trade
Assist companies by reviewing plans for changes
Participation in EU Brexit working groups
Patients & animals - committed to ensuring continuity of supply of medicines
Increased engagement with industry, associations, Government departments, customs & IDA to facilitate trade
Participation in EU Brexit working groups to collaborate on guidance, Q&As etc.
Work with individual companies, as requested, to discuss their plans for changes
07/04/2019

3. Requirements For Products Coming From the UK After Brexit
Usual 3rd country requirements in EEA
Importation by authorised manufacturer
Testing in EEA
QP certification in EEA
Wholesalers are not authorised to import from 3rd countries
07/04/2019

4. Requirements For Products Coming From UK After Brexit
Transport through the UK using the ‘transit protocol’ does not invoke export / import requirements
Negotiations on an MRA/ACAA will not start before Brexit
Continuity of supply strategies should be implemented
07/04/2019

5. Relocation of batch certification activities to Ireland
Significant no. transferring
New companies establishing
New Manufacturer’s Authorisation
Variation to add importation
Inclusion of products and 3rd country sites on the annexes
Added to existing authorisation
07/04/2019

6. Relocation of batch certification activities to Ireland
Contact us
Intending applicants
At least 6 months before authorisation is required
Timeline
07/04/2019

7. Frequently Asked Questions regarding new QPs
Will a QP named on a UK licence be accepted in IE?
Does the QP need to be resident in Ireland?
Can the QP work from another jurisdiction?
Yes No No
07/04/2019

8. Marketing Authorisation Transfer Due to Brexit
Day Zero
When an MA is transferred QP certification of product in old livery should cease
Companies can request a date when transfers are processed
Complex
Complex supply chain with typical forecasts in 18 month cycles
Difficulty planning for zero day implementation highlighted by various companies
Impacts significant proportion of the industry with stock outs resulting
Flexibility
MAHs preparing for Brexit allowed up to 6 months to make packaging changes
Removal of reference to stock rundown or recall of product bearing previous details
Currently following transfer of an MA from one MAH to another, the HPRA requires immediate cessation of QP certification of medicinal products bearing the current MA number once the transferred authorisation has been granted
Difficulties highlighted by MAH’s include:
The supply chain is complex and global.
With forecasts in a typical 18 month planning cycle, and the complexity of multiple stock keeping units with variable forecasts, supply chain experts advise that it is impossible to plan with a fixed zero day implementation date without incurring periods of stock-out.
The issue impacts a significant proportion of the industry and stock-outs across multiple products around the uncertain period of ‘Brexit’ in 2019/2020 are likely.
Even with careful forecasting, demand by customers has the potential to skew forecast product availability in the marketplace, as uncertainty around Brexit may lead to customers ordering extra stock.
07/04/2019

9. Points for QPs to Consider in Managing Transition
Pack changes
Plan to manage the transitions at site level are strongly recommended
New Products
Request data e.g. report quality defects, PQRs
Contracts
Covering onward reporting of complaints and adverse drug reactions
07/04/2019

10. Thank You