1. Centrally Authorised Products – Does the Icelandic Medicines Agency issue approval letters?
2. Does the Icelandic Medicines Agency (IMA) assess product names before an application is submitted?
3. What rule/guidlines does the Icelandic Medicines Agency (IMA) use for assessing product names?
IMA emphasizes the following:
- Likeness to approved product names
- Whether the applied name has bad connotation or is misleading in any way
- Whether the applied name conveys a promotional message
4. Has the Icelandic Medicines Agency (IMA) published rules/guidelines for product names?
No. IMA refers to published guideline from EMA, “Guideline on the acceptability of names for human medicinal products processed through the centralised procedure”
5. Does the Icelandic Medicines Agency (IMA) have different requirements from other countries in Europe?
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”
6. When applying for a marketing authorization for a generic product and part of the indications are protected by patent, is it necessary to submit Icelandic translation of the whole English product information as approved in the registration procedure or omit (carve out) the patented indications?
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.
1. Transfer of a marketing authorisation for a medicinal product to a third party – applies to national, as well as DCP and MRP authorisations.
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 Icelandic Medicines Agency (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).
2. Upon transfer of Marketing Authorisation for a medicinal product who shall apply for the transfer: the current or the proposed Marketing Authorisation Holder?
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).
3. What is the estimated IMA´s timeframe for approval of a Marketing Authorisation Holder transfer?
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.
4. Once the MA is transferred to the new owner, for how long can stocks be sold using the details of the previous MA holder?
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.
5. Notification of a new representative – applies to all types of authorisation procedures
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.
Importation by Individuals of Medicinal Products for Personal Use
1. Am I allowed to buy medicinal products on the internet?
Yes, a person is permitted to buy medicinal products from a pharmacy within the EEA that has license to sell medicinal products on-line. The import has to fulfill 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.
Further information on the regulation is on the IMA homepage, http://www.ima.is/inspections/importation_by_individuals/.
2. How do I know which pharmacy within EEA has license to sell medicinal products on the internet?
There is currently no licensed Icelandic pharmacy that operates an internet pharmacy.
The European Union has introduced a common logo that should appear on the websites of licensed pharmacies in the 28 EU Member States. Further information regarding the common logo can be found on the European Commission´s website: http://ec.europa.eu/health/human-use/eu-logo/index_en.htm
3. Am I allowed to have medicinal products sent by mail from a licensed pharmacy and are there any restrictions on quantity?
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).
4. When travelling to Iceland, can I bring medicinal products for personal use in my luggage?
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).
5. What are the requirements I have to fulfill to import medicinal products for personal use to Iceland?
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).
6. What are the restrictions for importing narcotic and psychotropic medicinal products?
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, https://eng.velferdarraduneyti.is/media/Reglugerdir-enska/Regulation-on-habit-forming-and-narcotic-substances-and-other-controlled-substances-No-233-2001.pdf.
7. What are the restrictions for importing anabolic steroid type (anabolica) and similar substances and growth hormones and comparable 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).
1. Should Marketing Authorisation Holders send ICSRs to both EMA and IMA, for cases which occur in Iceland?
Marketing Authorisation Holders are required to send all serious ICSRs which occur in Iceland to EMA via EudraVigilance (ID: EVHUMAN), but not to IMA.
2. What happens to ICSRs received by IMA from healthcare professionals and the public?
ICSRs received by IMA are assessed and then submitted to the European Medicines Agency via EudraVigilance, to the relevant Marketing Authorisation Holder and to the World Health Organization (WHO).
3. How is the process of sending ICSRs from IMA to Marketing Authorisation Holders (MAHs)?
According to GVP VI.C.4.1. and table VI.4 in Appendix 3 to GVP VI., IMA is required to transmit all serious ICSRs, that occur in Iceland and are reported to IMA, electronically in ICH E2B (R2) format as an xml message to the relevant MAHs. All transmissions of ICSRs from IMA to MAHs and EMA are sent in the internationally agreed format via the EudraVigilance-gateway. IMA requests that MAHs submit an Acknowledgement message (ACK) to IMA via EudraVigilance (ID: ADALIMCA01) when they receive ICSRs from IMA, but as long as IMA receives confirmation of a successfully delivered transmission (MDN) and a subsequent ACK from EMA, IMA considers the reporting responsibilities fulfilled. The ability of MAHs to upload ICSRs into their database is outside IMA's responsibility. IMA uses the ACK from EMA to validate the correctness of reports according to EMA´s business rules. If reports are considered valid and correct by EMA, IMA also considers them to be valid towards the MAHs.
4. Is there a list of local literature that the Marketing Authorisation Holders should monitor?
IMA does not have a preferred list, but the Icelandic Medical Journal (Læknablaðið) should be monitored as a minimum.
5. Does IMA require literature reports for Icelandic cases? Should a copy of the literature article be attached?
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.
6. Are Marketing Authorisation Holders required to have a Qualified Person for PharmacoVigilance (QPPV) residing in Iceland?
IMA does not require Marketing Authorisation Holders to have a QPPV residing in Iceland, however, the QPPV must be located within the EEA.
7. Are Marketing Authorisation Holders required to have a Local Contact Person for Pharmacovigilance in Iceland?
No, Marketing Authorisation Holders are not required to have a Local Contact Person for Pharmacovigilance in Iceland.
8. How long is there an obligation to continue collection and submission of spontaneous ADR reports after a marketing authorisation of the suspect product was withdrawn?
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.
9. How long is there an obligation to create and submit PSURs or RMPs after a marketing authorisation was withdrawn?
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.
Compassionate use / exemption to use an unauthorised product
1. How are products prescribed for compassionate use handled in Iceland?
Products prescribed for compassionate use are handled via the same procedure as products granted named-patient basis use exemptions (exemptions granted under exceptional circumstances to physicians to use a product which does not have a marketing authorisation in Iceland).
This is in accordance to Article 7(7) of the Medicinal Product Act No 93/1994: „The Icelandic Medicines Agency may, under exceptional circumstances, grant a physician, upon his/her personal responsibility, an exemption from paragraph 1 for medicinal products which do not have marketing authorisation in Iceland. In granting such exemptions, care shall be taken to ensure that the amount of the medicinal products is limited to the needs of those for whom they are intended.“
Products with Icelandic marketing authorisation but not marketed in Iceland are handled via the same procedure.
2. Are there any restrictions?
The amount of the medicinal products is limited to the needs of those for whom they are intended. In general an exemption would not be granted if an authorised product that can be used is marketed in Iceland.
3. Are there special requirements regarding labelling?
No. When applying for a named-patient basis use or hospital-basis use the physician takes responsibility of the product, including labelling and PIL.
4. Must the product be provided free of charge?
5. Who is responsible for making the request?
A physician applies for the use of a product. It can allow up to one year's use of the product. The approval is sent to the patient or pharmacy (an approved prescription) and to the wholesaler who will import the medicinal product.
6. Can an application be made for a group of patients?
A physician might apply for the use in a hospital or a specific hospital ward. However, this would never be the case for products that do not have marketing authorisation anywhere.
7. How long does it take to get an approval?
Most applications are dealt with immediately and processed within the same workday. However, first instance applications for medicinal products applied can take longer.
8. How long does the approval last and can it be renewed?
The approval can last for up to one year. Then a physician will have to apply again using the same procedure.
9. Does the product need to be licenced somewhere in the EU?
There is be a possibility, in special circumstances, to allow the use of a product with that has not been authorised in the EU and possibly even no license at all.
10. Are pharmacies able to hold stock of these products?
Pharmacies can only buy these products from a wholesaler when they have a valid prescription (an application approved by the Icelandic Medicines Agency).
11. Are there any rules and restrictions for import?
The import is done by a licensed wholesaler.
12. Are there any specific reporting obligations, e.g. pharmacovigilance, adverse event reporting?
There are no specific reporting obligations – general reporting rules are valid.
13. What happens when a product becomes commercially available in Iceland? Does all „compassionate“ supply finish immediately or is there any period to allow a patient to move from a compassionate to a commercial supply of the drug?
Generally, no applications would be approved for the compassionate use supply after the product becomes available. However, in most cases already approved applications would still be valid (for up to a year).