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Quality and Regulations > Authorisation Routes > Flashcards

Authorisation Routes Flashcards

1
Q

Under what legislation are medicinal products (medicines) must be authorised before being marketed to ensure safety, quality and efficac

A

European and Irish legislation

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2
Q

Under what legislation are medicinal products (medicines) must be authorised before being marketed to ensure safety, quality and efficac

A

European and Irish legislation

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3
Q

Routes for acquiring market authorisation (4)

A

National Procedure

Mutual recognition procedure

Decentralised procedure

Centralised procedure

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4
Q

EU marketing authorisation procedure….

A

…

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5
Q

Marketing authorisation procedures in Europe

National Procedure assessment time

A

210 days

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6
Q

Marketing authorisation procedures in Europe

MRP (Mutual recognition procedure) assessment time

A

90 days + 30 days (national phase)

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7
Q

Advantages of National Procedure (3)

A

1
2
3

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8
Q

What are the most generic medicines approved through?

A

DCP

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Quality and Regulations (5 decks)

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