These guidelines are intended for marketing authorisation holders who intend to apply for a new marketing authorisation for a medicinal product not subject to a prescription or who intend to apply for a variation to the marketing authorisation for a medicinal product currently subject to a prescription
These guidelines are for medicinal products who receive marketing authorisation via national/MR/DC-procedures. For centrally authorised medicinal products, the European Medicines Agency decides if a product will be subject to prescription or not.
Change in legal status on a national level
Medicinal products are subject to a prescription in Iceland unless an application for a change in legal status is submitted and approved. The decision to grant a change in legal status is evaluated by The Icelandic Medicines Agency on a national level and is only valid for the marketing of the product on the Icelandic market. Granting of a change in legal status in another country does not automatically result in the same decision in Iceland.
Application for an OTC medicine
There are two ways to apply for a change in legal status:
- When applying for a new marketing authorisation. The assessment of the change in legal status will be performed nationally after the conclusion of the MA procedure.
- When applying for a variation to the terms of the marketing authorisation. The Icelandic Medicines Agency requests that applicant categorizes an application for a change in legal status as type II, C.I.z, even if the change does not fall under Commission Regulation (EC) 1234/2008 concerning the examination of variations to the terms of the marketing authorisations for medicinal products for human use
- Other variations can be submitted at the same time, as a grouped variation, e.g. changes to the Risk management plan, C.I.4 or C.I.11. New indications (both in SmPC and PIL) must always be categorized as a type II. C.I.6. Marketing authorisation holders can also apply for a change in legal status for a medicinal product that is already not subject to a prescription, e.g. for a line extension or a new pack size.
Applications for a change in legal status are generally processed within 60 days. If, during the assessment, additional information is required, the time will be extended corresponding to the time taken by the applicant to provide the additional information.
Supporting documents
The following documents should be provided when applying for a change in legal status:
- Cover letter
- Filled out Application form – the form must clearly state the relevant pack size/strength
- Justification for a change in legal status
- Icelandic PI, leaflet and labelling that fulfil the requirements for labelling on medicinal products not subject to prescription
- Updated Clinical Overview (preferred)
- Current or updated RMP
Medicinal products for human use
When assessing applications for a change in legal status for medicinal products for human use, the Icelandic Medicines Agency uses guidelines from the European Commission: A Guideline on changing the classification for the supply of a medicinal product for human use.
Veterinary medicinal products
When assessing applications for a change in legal status for veterinary medicinal products, the Icelandic Medicines Agency bases the assessment on Article 34 in Regulation (EU)2019/6 on Veterinary Medicinal Products and guidelines prepared by the Committee for Veterinary Medicinal Products: Guidline on the application of Article 34 of Regulation (EU) 2019/6.
Justification
The applicant shall discuss the criteria in these guidelines as applicable and provide justification on how the medicinal product meets these criteria. Detailed justification is a prerequisite for a change in legal status.
If the active ingredient is already available OTC in Iceland
If the application for a change in legal status concerns a medicinal product containing an active ingredient that is already marketed in Iceland without a prescription in the same strength, form and pack size, the leaflet and labelling should be harmonized with the currently marketed product whenever possible. This is to prevent the users from receiving different information when purchasing different brand names. If the medicinal product in the application is fully comparable (strength, form, pack size, leaflet and labelling) with a medicinal product already marketed in Iceland without a prescription, a reference to the currently marketed product can be made in the justification for a change in legal status.
If the application for a change in legal status is approved, specific packs of the medicinal products will be available without a prescription. If the applicant later wishes to have other pack sizes, pharmaceutical forms or strengths available without prescription, a new application for those pack sizes/forms/strengths must be submitted.