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General & Regulatory Updates
Wholesale Distribution Conference
8th February 2017
Emer O’Neill MPSI
Health Products Distribution Inspections Co-ordinator
General Housekeeping
Format of the day
Presentations
Safety Feature for Wholesale Distributors
Responsible Person
Temperature Management – Cold Chain Medicinal Products
Transportation
Medical Device Distributors – Pilot Inspections
Feedback from Wholesale Distribution Inspection Programme
Common Issues on Wholesale Distribution Applications
Recalls of Medicinal Products – Key Requirements and Pitfalls
General Panel Q&A
One-to-one Inspector Q&A
The Health Products Distribution team
Aoife Farrell Darren Scully Emer O’Neill
HPD Manager HPD Manager HPD
Inspections (Maternity (Acting) Co-ordinator
Leave) (Acting)
Anita Nolan Barbara Henry Joanne Bergin Nora Fitzgerald Deirdre O’Keeffe
HPD Inspector HPD Inspector HPD Inspector S.O. Controlled S.O. Controlled
(Maternity Leave) Drugs Drugs
(Maternity Leave)
The Health Products Distribution team
Aoife Farrell Darren Scully Sinead Hickie
HPD Manager HPD Manager Cosmetic
Products (Maternity (Acting) Co-ordinator
Leave) (Acting)
Patrick Walsh Estefania Perez Ita Quinn
S.O. HPD S.O. Cosmetics S.O. Cosmetics
Introduction to Health Products Distribution (HPD)
HPD
Human
Medicinal
Products
Distributors Brokers
Cosmetics
Manufacturers
Distributors
Medical
DevicesDistributors
Controlled
Drugs &
Precursor
Chemicals
Manufacturers
Distributors
Other entities
Active
SubstancesImporters
Distributors
7
Authorisations
When is a wholesale distribution authorisation (WDA)
required?
WDA
Procure
Hold
Supply
Export
• Medicinal Products
• Transactions within
Europe
• Entities holding
marketing
authorisations
When is a active substance registration (ASR) required for
distributors?
• Manufacturing activities
– Manufacture
– Extraction
– Finishing steps
– QC testing
• Importation activities
– Site of physical importation
Active
substance
Registration
Procure
(distribution)
Procure
(importation)
SupplyHold
Export
When is a controlled drug authorisation required?
• Site of possession
• Licence vs registration
• Import and export
licences
• Annual returns- 31st
January 2017
• Legislative updates
Controlled
Drug
Authorisation
Production
Possession
SupplyImport
Export
When is a precursor chemical authorisation required?
• Scheduled
substances/drug
precursors
• Licence vs registration
• Threshold
• Annual reporting – 31st
January 2017
Precursor
Chemical
Authorisation
Possession
Intermediary
Role
Placing
on the
market
Import
Export
• Safety Features
• Management of Samples
• Guide to Quality System for General Sale Wholesale Distributors
• Guide to Good Distribution Practice of Medicinal Products for Human Use
• Guide for Medical Device Distributors
• HPRA Medicinal Products Newsletter Issue no. 55
– Preventing falsified medicines entering the supply chain: Have you played your part as an authorised wholesaler?
– Misuse of Drugs legislative changes
– Submission of annual returns for Controlled Drugs & Precursor Chemicals
Regulatory Updatesmedicinal products
• Misuse of Drugs (Amendment) Act 2016
– New Substances Added
• Zopiclone
• Zaleplon
• Lisdexamphetamine
• Phenazepam
Regulatory Updatescontrolled drugs
• Misuse of Drugs (Amendment) Act 2016
– Changes to import and export licence
Regulatory Updatescontrolled drugs
Activity Current requirements New requirements
Each import or export of controlled drugs
listed in Schedule 1, 2 or 3
Import or export licence (as
appropriate)
No change
Each import or export of temazepam and
flunitrazepam
Letter of no objection Import or export licence
(as appropriate)
Each import of controlled drugs listed in
Schedule 4 part 1 (e.g. alprazolam, diazepam,
nitrazepam, zolpidem)
Letter of no objection Import or export licence
(as appropriate)
New controlled drugs such as zopiclone and
zaleplon
No requirement Import or export licence
(as appropriate)
• Chloroephedrine and chloropseudoephedrine have
been added to the list of category 1 substances
• EU Guide for Operators
• Annual returns – due 31st January
Regulatory Updatesprecursor chemicals
• Cosmetics inspections
Obligations of a Cosmetics Product Distributor
Act with due care in relation to applicable requirements
Verify that certain labelling information is present
*European Responsible Person Address on the product labelling*
Ensure that the appropriate storage or transport conditions are in place
To take corrective measures to bring a non-compliant product into conformance
To take preventative measures where relevant
To cooperate with the Competent Authority (the HPRA)
Regulatory Updatescosmetics
General & Regulatory Updates
text questions to: 0873769292
