Registration

Question 1

What are the MHRA authorisation routes

Answer 1

· Existing, national 210 days
· New, national, Accelerated – new and existing APIs and orphans, 150 days
· New, Rolling review – new APIs and biosimilars (submit in modules)
· Will adopt decisions by EU/NCAs on approval of new MAs (for 2 years from Jan 2021, not for MAs granted via national procedure in a MS) – 67 days
· All CAPs converted to PLGB (in NI CAPs will remain as CAPs)
· NIMAR (GB to NI)
· Unfettered Access (for MAs approved in NI to allow GB approval with existing MA covering NI)
· IRP

Question 2

What happens if you are centrally registered in the EU once Brexit happens

Answer 2

MA is valid until end of January 2023
Expectation is that you apply for a GB licence
Grandfathering - PLGB licences only market product in GB and PLNI licences can only be marketed in Norther Ireland.

Centrally Authorised Products can still be marketed in Northern Ireland

Question 3

Describe the difference in registration requirements for marketed products versus IMPs

Answer 3

MA vs CTA
MAH Holders vs Clinical Trial Sponsors
Ethical Approval – Declaration of Helsinki of Clinical Trials
IMP – Product Specification File, Investigative Medicinal Product Dossier (IMPd)

Question 4

One of your products needs an updated label as a result of a safety update
What process would you use and what controls are needed? What are your concerns from a QP perspective

Answer 4

Raise a Change Control
Variation – urgent safety update
Supplement a caution in use for product on the market
Quarantine any batches within your control to include new leaflet
Potentially might want to perform some level of recall
Pause release activities until update has been completed
Concerns from QP perspective?
Consider availability of medicine to patients – market stock outs
Is it impacting patients currently using it
What has initiated the update

Question 5

General controls around generation of printed components

Answer 5

Artwork updates / Version Control
Waste Disposal of Artwork – Falsified Medicines
Braille requirements
Language
Batch Specific Data
Earliest implementation date and latest implementation date

Question 6

Whats in the quality section of the CTD?

Answer 6

Legal Duties – How would you know you can certify Product – P2 etc Know some key references

Drug Substance
General Information – Description, Structure , General Properties
Manufacture - Flow Chart of Manufacturing Steps – (CPPS and CQAS), Validation
Characterization – Impurities
Control of drug substance – specification, Methods, Method Validation
Reference Standards or Materials
Container Closure
Stability

Drug Product
General Information – Description, Composition,
Pharmaceutical development
Manufacture - Flow Chart of Manufacturing Steps – (CPPS and CQAS), Validation
Control of Excipients – Specs, Methods, Method Validation, Excipients of Human / Animal Origin,
Control of Drug Product - – Specs, Methods, Method Validation
Post Marketing commitments / Stability Info
Reference Standards or Materials
Container Closure
Stability