FMD

Question 1

Can you talk me through the FMD and the requirements for safety features?

Answer 1

4 pillars:
API controls - written confirmation from competent authorities, API declaration of equivalent GMPs
Excipient controls - risk assessment for applicable level of GMP
Safety features - GTIN, serialisation and tampers
Data repository systems

Question 2

What products is the FMD applicable to?

Answer 2

Licensed products (not IMPs)
POM and with Brexit PLNI, PLUK (note there are some non-POM into the FMD – omeprazole and POM products that fall outside the FMD, e.g. radionuclide generators/precursors)

Question 3

Is the FMD applicable for Vet products?

Answer 3

No

Question 4

What are the FMD safety features?

Answer 4

2011/62 and 2016/161 and SI 2012:1916 and amendments SI 2019:775
Anti-tampering device
Unique identifier (authenticity and identification of an individual pack) (product code, serial no., (reimbursement code), batch no., expiry date)
Serialisation and aggregation
Data repository systems to confirm true product

Question 5

What are the pillars of FMD and what do they cover?

Answer 5

1. safety features
   - A unique identifier (2D barcode)
   - Anti tampering device
2. Supply chain and good distribution practice
   - Responsibilities for wholesalers and brokers
3. Active substances and excipients
   - Control for active substances imported into the EU
4. Internet sales
   - Obligatory logo for websites of legally operating online pharmacies