Answers to frequently asked questions
The Icelandic Medicines Agency (IMA) issues a letter of approval in regards to new marketing authorisations, renewals, line extensions, withdrawals, suspensions and lifting of suspensions. In general, variations are considered automatically approved in Iceland at the same time as in the EU Member States. Consequently IMA does not issue letters of approval regarding for example for new indications and new presentations. However, IMA issues a letter of approval when a variation leads to new conditions or restrictions with regard to the safe and effective use of the medicinal product to be fulfilled before marketing in a Member State or when those conditions are changed from the ones previously fulfilled by the marketing authorisation holder. IMA also issues a letter informing the marketing authorisation holder if a variation effects the prescription status of the medicinal product in Iceland. (21.9.2015)
Human: No, IMA checks acceptability of the name of medicinal product during the application procedure.
Veterinary: Yes, change in the name of the medicinal product is considered to be a variation not requiring assessment in accordance with the new veterinary regulation (2019/6). Therefore, check for acceptability of the proposed veterinary medicinal product name has to be finalised before the variation is submitted via Union Product Database.
For assessment of product names, IMA refers to published guideline from EMA, “Guideline on the acceptability of names for human medicinal products processed through the centralised procedure”
IMA emphasizes the following:
Human and veterinary products: IMA has not published specific guidelines for acceptability of names for medicinal products but refers to published guideline from EMA “Guideline on the acceptability of names for human medicinal products processed through the centralised procedure”
Veterinary only: A filled out Request form for Proposed (invented) product name(s) should be submitted to the Icelandic Medicines Agency before the variation application is submitted via Union Product Database, as a change in product name is considered to be a variation not requiring assessment. Up to 3 product names can be suggested for each check. If the product is to be marketed in a Nordic-language packaging this should be stated.
To facilitate manufacturing of multilingual packages and marketing in small, IMA refers inter alia to what the other Nordic countries can accept. Additionally, IMA refers to published guideline from EMA, “Guideline on the acceptability of names for human medicinal products processed through the centralised procedure”.
IMA always requests an Icelandic translation of the whole English product information as approved in the procedure. The marketing authorization is granted including the Icelandic translation of the whole English product information approved in the registration procedure. If the applicant wishes to carve out patented indications, he should apply for a national variation with the following grouping: C.I.6 Change(s) to therapeutic indication(s), Procedure type IB, Deletion of a therapeutic indication. It is the responsibility of the applicant to carve out all information in the product information (SmPC, Package leaflet and labelling) that relates to the patented indication. When the applicant wishes to add the carved-out indication(s) after patent expiry, he should do so with a national application with the following grouping: C.I.z, Change(s) to therapeutic indication(s), Procedure type IA, Addition of carved indications. Then it is only allowed to change back to the originally approved product information.
The Sunset Clause in Directive 2001/83/EC was implemented in Article 15 of the Pharmaceutical Act No 100/2020: “Marketing authorisation shall lapse if the medicinal product for which it was granted has not in fact been placed on the market within three years of the granting of the authorisation or if the medicinal product for which it was granted has not in fact been on the market for an unbroken period of three years. The Icelandic Medicines Agency may grant exemptions from this provision under special circumstances or for reasons concerning public health. Reasons for such exemptions shall be stated.”
The Icelandic Medicines Agency, IMA, is of the opinion that applying the sunset clause could counteract the necessary increase of marketed medicinal products in Iceland. Hence IMA has decided not to enforce the sunset clause for the time being. Marketing authorisation holders will be informed should this decision be amended.
The Icelandic Medicines Agency follows EMA‘s linguistic review process of product information in the centralised procedure. However, from 10 November 2018, the Icelandic Medicines Agency postpones the review of changes for medicinal products not marketed in Iceland until released. The Icelandic product information for new products will still undergo a linguistic review, and therefore the postponement only applies to changes to the product information for products not marketed in Iceland. Product information for products sold on special licence undergoes linguistic review, as applicable. Product information for centrally authorised originator products, not on the Icelandic market, will undergo a linguistic review if a centrally authorised generic product is on the Icelandic market. When a product is marketed in Iceland, the Icelandic Medicines Agency will use the first opportunity to review the changes made from the last review of the Icelandic product information.
No, IMA will not issue approval letters for national authorisations in these cases. Changes, not affecting the product information, can be considered approved by IMA, at time of opinion from EMA (CHMP Opinion). When worksharing procedures affect the product information, applicants should submit updated texts to IMA at [email protected] at end of procedure.
The texts/translations should be submitted in Word format (highlighted and clean versions).
If the answer is yes to any of the four questions above, your trials falls under the definition of a clinical trial. Therefore, a clinical trial application must be submitted to the Icelandic Medicines Agency – unless your trial is a non-interventional study.
If the answer is yes to all of the 7 questions above, your trial falls under the definition of a non-interventional study. Terefore, a clinical trial application does not need to be submitted to the Icelandic Medicines Agency.
If you are not sure whether or not your clinical trial needs to be notified to the Icelandic Medicines Agency, please send us an email with the protocol or protocol synopsis along with detalis about the products expected to be used in the trial. Please send us email to [email protected]
Further information is available in Volume 10 - Guidance documents applying to clinical trials.
A EudraCT number can be created on EMA's webpage.
The Voluntary Harmonisation Procedure (VHP) is a procedure which makes it possible to obtain coordinated assessment of an application for a clinical trial that is to be conducted in several European countries.
Further information in available on our VHP site.
Import of all medicinal products, including investigational medicinal products (IMP), must be carried out by a licensed wholesaler of medicinal products, according to Article 28 of the Medicinal Products Act No. 100/2020 and Article 4 (1) of Regulation No. 699/1996 on import and wholesale distribution of medicinal products. Regulation No. 699/1996 on import and wholesale distribution of medicinal products details the requirements for import and distribution of medicinal products.
All imports of investigational medicinal products must therefore be carried out by a licensed wholesaler. A list of companies licensed to import medicinal products can be found in the European database EudraGMDP.
IMA would like to emphasize that according to Article 9 of Regulation No. 699/1996 licensed manufacturers of medicinal products are authorised to distribute through wholesale channels the medicinal products that their manufacturing license pertains to, including IMPs.
In the case of a multi-centre investigation one application is sufficient.
No, the adverse reaction is only reported once into the European database EudraVigilance.
The EU Clinical Trials Register contains information on interventional clinical trials on medicines conducted in the European Union (EU), or the European Economic Area (EEA) which started after 1 May 2004.
The information contained in the EU Clinical Trials Register is extracted from EudraCT, the EU clinical trials database. The information for studies applied for in Iceland, provided by the sponsor, is loaded into the EudraCT database by the Icelandic Medicines Agency (IMA). Upon approval/rejection from the National Bioethics committee, IMA adds the relevant information.
More information can be found at EU Clinical Trial Register site.
The same application form shall be used when applying for a transfer of a marketing authorisation to a third party as for changes to the terms of a marketing authorisation. General provisions apply when filling out the form, except that stating the type of application or submitting a checklist is not required.
In order to support an application for an approval of a new marketing authorisation holder (MAH) a signed statement shall be submitted from competent representatives of the current as well as the prospective MAH (the same form may be used), as well as an updated SmPC and PIL, in accordance with general rules. Mock-up of an updated PIL, as well as updated packages shall be sent to the IMA, when available, but still within the time-limit set out in a formal letter from the Agency.
The statement shall include the date from which the new MAH takes over all duties related to the medicinal product, i.e. from the date the transfer of the marketing authorisation comes into effect.
If the prospective MAH does not have a medicinal product with a marketing authorisation in Iceland, a description of the MAH´s pharmacovigilance system shall also be supplied. The statement should also contain the name of an Icelandic representative of the new MAH as well as of a wholesale distributor for the Icelandic market (if applicable).
It is up to the current and proposed Marketing Authorisation Holders to decide which one of them submits the application provided the application contains all the required documentation (see question 1).
IMA‘s goal is to handle the application as soon as possible and in most cases within one month from receiving the application provided it contains all the required documentation.
Generally if the medicinal product has been released for sale on the Icelandic market, it is permitted to stay there for up to 12 months. IMA requests updated mock-ups and PILs within a year from the time the MA transfer has been granted. IMA expects updated packages to be available on the market within 12 months. If a situation arises where it is foreseen that one year will not be sufficient to sell old supplies the MA holder can apply to IMA for an extension which will then be assessed on a case-by-case basis.
The same application form shall be used when notifying a new representative as for changes to the terms of a marketing authorisation. General provisions apply when filling out the form, except that stating the type of application or submitting a checklist is not required.
If the application covers two or more medicinal products only one form needs to be filled out if the application only relates to nationally authorised medicinal products. If the application also covers DCP, MRP and centrally authorised medicinal products a separate form must be completed for each procedure, where one form for two or more medicinal products is also sufficient.
The concerned medicinal products can either be listed in the appropriate places on the form itself or a reference can be made to an annex to the form, in which case the annex must contain all the information stipulated in the application form.
Along with the notification of a new representative there shall be a proposal for an updated PIL for nationally, DCP and MRP authorised medicinal products, in accordance with general rules. A mock-up of an updated PIL, as well as updated packages, if applicable, shall be sent to IMA, when available, but still within the time-limit set out in the formal letter from the Agency.
It is anticipated that PILs for centrally authorised medicinal products will be updated in connection with the EU Commission´s update of the same information and then consequently a mock-up would be sent to the Agency.
The MAH shall send the above-mentioned application to the Agency, but in case somebody else does it a statement from the MAH shall be appended to the application specifying who is authorised to apply for the change and which change it covers. The application must have reached the Agency at least one month prior to the anticipated change to come into effect.
Yes, after the transfer has been approved the new MAH will receive answers for the variation application that were still unfinished at the time the transfer was approved.
Please refer to "Transfer of a marketing authorisation to a new marketing authorisation holder - one fee for each marketing authorisation number" under 'Other changes' in Tariff no 1451/2020.
It is up to the applicant where the invoice will be sent and should be stated in the application form.
Yes, a person is permitted to buy medicinal products from a pharmacy within the EEA that has license to sell medicinal products online. The import has to fulfil all provisions and restrictions in regulation No. 212/1998 on importation by individuals of medicinal products for personal use, stated in the answer to questions No. 2, 3, 5, 6 and 7.
There are a number of licensed Icelandic pharmacies. The list of licensed pharmacies is available on our Icelandic site.
The European Union has introduced a common logo that should appear on the websites of licensed pharmacies in the 28 EU Member States.
Yes, an individual can import medicinal products for his/her personal use through the mail from European Economic Area (EEA) states in a quantity equivalent to no more than 100 days use.
The import must fulfill requirements set out in Regulation No. 212/1998 (see answers to questions No 5-7 below).
An individual may bring medicinal products for his/her personal use in a quantity equivalent to no more than 100 days ‘use when entering Iceland.
The import needs to fulfill requirements in regulation No. 212/1998 (see answers to questions No 5-7 below).
A person that imports a medicinal product to Iceland can be requested to verify that the medicinal product he or she intends to import for personal use has been acquired by legitimate means and that the medicinal product is necessary for the individual in the amount specified.
For information on restrictions of imported amounts of medicinal products (see answers to questions No 3 and 4 above). Restrictions on import of narcotic, psychotropic, anabolic steroids and growth hormones also apply in regulation No. 212/1998 (see answers to questions No 6 and 7 below).
In the case of medicinal products covered by the provisions of the Act and Regulations on Habit Forming and Narcotic Substances No. 65/1974 and No 233/2001, respectively, and which are included on lists N-I, N-II, N-III and N-IV of the International Convention on Narcotic Drugs of 1961 and lists P-I, P-II and P-III of the International Convention on Psychotropic Substances of 1971 to which Iceland is a party, the following shall apply to their importation:
An individual who is resident in a country which is a member of the Schengen Treaty may take along medicinal products, for personal use and which have been prescribed in a legitimate manner, equivalent to up to 30 days use. The same shall apply to individuals resident outside the Schengen area, except that they may only take along medicinal products for 14 days use.
Medicinal products covered by these provisions may not be imported through mail.
The import also needs to fulfill requirements of regulation No. 212/1998 (see answer to question No. 5 above).
Information on which medicinal product are included in the INCB lists can be found in the unofficial English translation of Regulation No. 233/2001 on habit forming and narcotic substances and other controlled substances,
An individual may not import anabolic steroid type (anabolica) and similar substances and growth hormones and comparable substances either in personal luggage or by other means in excess of the quantity required by an individual for a maximum of 30 days.
Customs authorities may request that an individual in possession of anabolic steroid type (anabolica) and similar substances and growth hormones and comparable substances provides satisfactory proof that these medicinal products are necessary to the individual in the quantity specified, e.g. by means of a physician's certificate.
The import also needs to fulfill requirements of regulation No. 212/1998 (see answer to question 5 above).
ICSRs received by IMA are assessed and then submitted to the European Medicines Agency via EudraVigilance and to the World Health Organization (WHO).
IMA does not have a preferred list, but the Icelandic Medical Journal (Læknablaðið) should be monitored as a minimum.
Marketing Authorisation Holders should report literature cases to EMA through EudraVigilance and IMA can access them in the database. Generally, IMA does not require a copy of literature articles, however IMA may request these.
IMA does not require Marketing Authorisation Holders to have a QPPV residing in Iceland, however, the QPPV must be located within the EEA.
No, Marketing Authorisation Holders are not required to have a Local Contact Person for Pharmacovigilance in Iceland.
According to GVP Module VI section VI.C.2.2.8. marketing authorisation holders are encouraged to receive and collect all adverse events/adverse drug reports, irrespective if the license for a medicinal product is withdrawn or not, and report them to EMA.
After a marketing authorisation is withdrawn there is no requirement for submission of a PSUR with the exception of withdrawn products with conditions/restrictions with regard to the safe and effective use of the medicinal product, in such cases the IMA requires submission of a PSUR.
When a product is withdrawn there are no obligations to create or update an RMP in the dossier for the withdrawn product. However, GVP Module V states the following „For an individual marketing authorisation holder and applicant, all products containing the same active substance should be included in one RMP [IR Art 30(2)] unless separate presentations are requested by the competent authority or agreed by the same at the request of the applicant/marketing authorisation holder.“ Therefore, if the relevant RMP covers other products than the withdrawn one, the RMP needs to be updated to reflect that one product was withdrawn. The dossier for each product (apart from the withdrawn product) needs to be updated accordingly at the next regulatory opportunity.
The red warning triangle is a part of additional information on labelling required nationally for Iceland (blue box). Medicinal products which can reduce the ability to drive or operate machines must have a warning triangle. This once harmonised requirement among the Nordic countries has changed in recent years. The red warning triangle is applicable In Denmark, Norway and Finland. Denmark and Norway publish lists of active substances that shall bear the warning triangle on packaging but their contents differ. This symbol is no longer used in Sweden. These different requirements between the Nordic countries have created challenges for Iceland. Being a very small market, products are often in multilingual packaging, most often shared with one of the Nordic countries. The consequence is that products that are on the market in Iceland and can reduce the ability to drive or operate machines are not all bearing the warning triangle, it depends on which of the Nordic countries Iceland shares packaging with. Information on ability to drive or operate machines are always stated in the packaging leaflet of each product. Therefore it is of vital importance to read the packaging leaflet.
The marketing authorisation holder shall, in accordance with Annex I to Tariff no. 1454/2020, pay an annual fee pursuant to Article 89 of the Medicinal Products Act No. 100/2020 for each pharmaceutical form and strength of a proprietary medicinal product, a parallel-imported medicinal product, a herbal medicinal product and a medicinal product pursuant to Article 17 of the Medicinal Products Act, which has a marketing authorisation on 1 January each year.
The annual fees are inter alia intended to cover the maintenance of the drug catalogues, the registration of adverse reactions and the information service in respect of medicinal products which have a marketing authorisation in Iceland, as well as expenses resulting from necessary co-operation with foreign agencies in respect of medicinal products that have already been granted marketing authorisations in Iceland.
If the marketing authorisation holder does not reside in Iceland, his national representative is responsible for paying the annual fee.
You can find information regarding IMA´s annual fees on our website.
Yes, you can but your medicinal product has to meet certain conditions to make it possible:
You can find an application for reduction of annual fees on our website.
A completed application form must be sent together with a cover letter from the applilcant to IMA after 1 January and no later than 20 January each year. No discount will be granted for applications received by IMA after that time. Each cover letter may accompany application forms for medicinal products from the same marketing authorization holder. Each application form can cover all strengths of one pharmaceutical form.
The application form must contain information about the turnover of the produc for the last 2 years. The turnover refers to the aggregate value of all packages of all formulations and the strength of the product concerned, without VAT.
You can find information regarding IMA´s fees on our website.
IMA doesn´t issue a list of fees in EUR. However – when you receive inovoces from IMA the invoice´s amount is stated both in ISK and EUR on the invoice.
After your application/variation has been reviewed and registered into our database, you will receive an invoice. The invoice contains all the information required to make a payment.
No, do not send a payment for application/variation in advance. If you do so we have no invoice to record the payment on and the payment could get lost in the system. Only pay when you have received an invoice from IMA.
Invoices from IMA are sent by mail. If customers prefer to receive invoices in PDF by email for a faster delivery, please contact: [email protected]
In the application form (in the signature section) is a field for payment information „Billing address (when relevant)“.
IMA´s issues the invoices to the address which is stated in the field „Billing address (when relevant)“. If there is no address stated in the abovementioned field the invoice is sent to the representative or the marketing authorization holder. Therefore, it is important that the information stated in the field „Billing address (when relevant)“ are correct.
IMA´s payment terms are 30 days from the invoice date.
IMA is an Icelandic public institution and therefore we can only issue invoices in local currency.
However for optimization for our customers we have added a recalculation from ISK to EUR to our invoices. So the invoice´s amount is stated both in ISK and EUR on the bottom of our invoices:
Invoice no. 77703
Due ISK: 52.000
Exchange rate: 124,70
Due EUR: 417,00
Please pay in EUR
Payment terms: 30 days
Please note that the above calculation can cause the invoice to be on 2 pages and can be visible on the backside of the invoice.
IMA is using the exchange rate that can be found on the website of The Central Bank of Iceland.
IMA uses the buying rate on the invoice date.
Yes, it is possible, but a double fee for application/variation will be charged.
In Iceland healthcare service is exempt from VAT and therefore IMA doesn´t have a VAT number. IMA has an organization number: 08317 and a social security number: 670900-2740 which can be used as an ID number.
Yes, you can get a refund as long as you have no unpaid, overdue invoices in place. For assistance, please contact: [email protected]
Yes. The medicinal product Sativex (contains THC and CBD) has a marketing authorization in Iceland. Sativex can be bought in a pharmacy with prescription from physicians who are specialists in neurological diseases.
Physicians in Iceland can apply for other medicinal products which contain THC and/or CBD if they have valid marketing authorizations in other countries. The physician needs to justify why the patient cannot use other medicinal products with marketing authorizations in Iceland.
IMA can only grant a marketing authorization for a medicinal product if the marketing authorization holder applies for it in Iceland.
No, in Iceland the main rule is that medicinal products are sold in pharmacies and that medicinal products must have marketing authorizations in Iceland, in accordance with the Medicinal Products Act No. 100/2020. Furthermore, cannabis is prohibited within the Icelandic territorial jurisdiction, except for special exemptions according to the Habit-forming and Narcotic Substances Act No. 65/1974.
If a product is manufactured and marketed as a food supplement and/or imported as such, the product and the import must be according to Icelandic food regulation. The Icelandic Food and Veterinary Authority is the competent authority for food on the Icelandic market.
No, THC is a substance which is prohibited in Icelandic territorial jurisdiction with special exemptions cf. Article 2 of the Act on Habit-forming and Narcotic Substances, No 65/1974
According to paragraph 3 of Article 2 of the Medicinal products Act No. 100/2020 the Icelandic Medicines Agency shall decide if there is a doubt as to whether individual substances or compounds are medicinal products. In case of doubt as to whether a product can, taking into account all its properties, fall within the terms of definition of a medicinal product, and the definition of a product subject to other legislation, the provisions of Medicinal products Act shall apply.
The medicinal product Sativex has a marketing authorization in Iceland and one of the two active ingredients is CBD.
If a product has an ingredient that is an active ingredient in a medicinal product which has a marketing authorization there is the abovementioned doubt and the product has to fulfil same restrictions as other medicinal products to be legal on the Icelandic market.
Yes, an individual can import CBD for his/her personal use through mail or in his/her luggage if the CBD is manufactured as a medicinal product. The import needs to be according to regulation No. 212/1998 on importation by individuals of medicinal products for personal use.
A person that imports a CBD to Iceland can be requested to verify that the medicinal product he or she intends to import for personal use has been acquired by legitimate means and that the CBD is necessary for the individual in the amount specified.
If a product is manufactured and marketed as a food supplement the import must be according to Icelandic food regulation, the Icelandic Food and Veterinary Authority is the competent authority.
Yes. On 13th of June 2016 the PSUR Repository became mandatory. This means that marketing authorisation holders must use the PSUR repository as a single point for all submissions and should no longer submit PSURs to NCAs (national competent authorities) directly.