Stofna umsókn - Lyfjastofnun

Application for Certificate of a Pharmaceutical Product (CPP Type A)

Please fill in one application for each product and each strength, one application per certificate.
The turnaround time for processing applications is 4 weeks from the filing date.
If expedited processing is requested the turnaround time is 5 working days.
The price for regular turnaround time and expedited processing is according to the price list.
Expedited shipping can be requested, for which a flat fee of 11.600 ISK is charged.

Date of application: 27.04.2024

Applicant

Company name

Address

Contact

Name

e-mail address

Phone

Product

Name of product, with Marketing Authorisation in Iceland:

Name of product in importing country:

Pharmaceutical form:

Ingredients

Active ingredient(s)

Amount(s) pr. unit dose

Marketing authorization

Number of marketing authorization

Date of issue

Marketing authorization holder

Name

Address

Importing country:

Producer(s) of dosage form:

Other information relevant to application:

Invoice details

Company name

Address

Is a copy of the SmPC needed?:

Delivery details

Company name

Address

Expedited processing requested:

Expedited shipping requested, extra fee of 11.600 ISK:

Latest approved version of composition (32p1): (Needed to submit application)