Labeling update process

Which of the following is not a locally driven update?

• MAH address change

• GDS updates

• Template change

• Local regulatory requirements

HTG for country labeling support for local submissions

• VQD-REF-013248

• VQD-REF-013244

• VQD-REF-019698

• VQD-REF-019699

We are not providing country label outputs in this language

• Arabic

• French

• German

• Spanish

KPIs are calculated on the basis of

• Right first time

• Delivery on time

• Both

• None of these

Which of the following is not categorized as a major error?

• Under section 4.4 the revised statement did not fully follow the text in the reference PI as required

• License number incorrect in CL

• Provided details of EU approval letter when this information was not required.

• The wrong reference PI was provided

For ectd markets who assigns the task to SPOCs in country labeling

• Assembly

• LOC

• Self assign

• None of these

Which of the following is not a global PI

• Global Datasheet

• Partner Datasheet

• USPI

• Non-Central Datasheet

Who is responsible to create SCP for HAQs received for EE markets (national procedure)

• CLT

• PT

• Assembly

• Central team

Which of the following is in scope of our work

• Products with a Consumer Health Global PI

• ViiV products

• Single Market Products

• New Chemical Entity (NCE) submissions

Standard delivery time (Total working days for GRPD) for a TSC 3 request

• 17 days

• 19 days

• 23 days

• 33 days