Application for classification

/ Send application to:
Icelandic Medicines Agency
Vínlandsleið 14
113 Reykjavík

According to paragraph 2 in Article 5 of the Medicinal Products Act No. 93/1994 with updates the Icelandic Medicines Agency (IMA) shall decide the matter if there is doubt as to whether individual substances or compounds are medicinal products.
Fee for assessment of a product is in accordance with IMA´s fees list.
The IMA reserves up to 90 days for the assessment from the payment day.
Product name
Dosage form / Manufacturer

Description of product (please fill in the form as appropriate):

1.  Do any of the ingredients of the product have a B-classification according to the following lists on the IMA homepage?

http://www.lyfjastofnun.is/media/voruflokkun/Listi_til_birtingar_a_vef_jurtir_nov13.pdf or http://www.lyfjastofnun.is/media/voruflokkun/Listi_til_birtingar_a_vef_algeng_innihaldsefni_b.pdf

£ Yes
£ No

If yes, state the ingredient, the recommended daily dose and the purpose of the ingredient in the product (if known) in the table below:

Ingredient / Recommended daily dose / Purpose

2.  Are there herbal extracts in the product?

£ Yes
£ No

If yes, state which herb, what type of extract (type of solvent), what substances are extracted, the recommended daily dose and what is the purpose of the extract (if known) in the table below:

Herb / Type of solvent / Substance(s) extracted / Recommended daily dose / Purpose

3.  Has a product with the same ingredient(s) previously been classified at the IMA according to list on the IMA homepage? (http://www.lyfjastofnun.is/media/voruflokkun/Listi_til_birtingar_a-_vef_vorur.pdf)

£ Yes
£ No

If yes, state the product that has previously been classified and the ingredient that is common in the table below:

Name of the classified product that has the same ingredient / Ingredient

4.  Does the product contain an ingredient that has been on the Icelandic market as Herbal Medicine, i.e. Valeriana officinalis (Valerian), Hypericum perforatum (St. John´s wort) or Passiflora incarnata (Passion flower))?

£ Yes
£ No

If yes, state the Herbal Medicine and recommended daily dose in the table below:

Herb / Recommended daily dose

5.  Does the product label list claims that indicate a pharmacological effect according to the definition of a medicinal product in Article No. 5 in the Medicinal Product Act No. 93/1994? A list of claims that IMA has evaluated can be found on IMAs homepage, http://www.lyfjastofnun.is/media/voruflokkun/Aletranalisti.pdf. If a claim is not on the list the claim must be evaluated by the IMA. The IMA evaluates if the claim is according to the definition of a medicinal product.

£ Yes
£ No

If yes, state the claims on the product that indicate pharmacological effect of the product in the table below:

Claim / Definition from IMAs list (A or B)

6.  Does the product contain an ingredient that is the active ingredient in a medicinal product that is on the Icelandic market according to the Icelandic medicinal product registration (http://www.serlyfjaskra.is)?

£ Yes
£ No

If yes, state active ingredient and recommended daily dose in the table below:

Substance / Recommended daily dose

7.  Is the product intended for use in: 1 humans 1 animals

Applicant (Company)
Address / Postcode
ID number / Telephone / E-mail
Company's responsible person

The following should be enclosed with the application:

·  A sample of the product.

·  List of all the ingredients of the product and the amount.

·  Other data that the applicant wishes IMA to consider.

Date / Signature

Icelandic Medicines Agency Reviewed 15.09.2015