Medicinal Products Act

No 93, 20 May 1994

NB. references to Acts in effect link to original Icelandic versions on Alþingi's website

Revised English translation 28.9.09
by Anna Yates, certified translator

Medicinal Products Act

1994 no. 93, 20 May

Took effect 1 July 1994. Amended by Act No. 122/1994 (took effect 1. July 1994), Act No. 131/1994 (took effect 23 Dec. 1994), Act No. 55/1995 (took effect 9 March 1995; EEA Agreement Annex II, Directive 92/109/EC), Act No. 118/1995 (took effect 31 Oct. 1995), Act No. 153/1996 (took effect 1 Jan. 1997), Act No. 10/1997 (took effect 26 March 1997), Act No. 82/1998 (took effect 1 Oct. 1998), Act No. 77/2000 (took effect 1 Jan. 2001), Act No. 108/2000 (took effect 6 June 2000; but requirement as provided in art. 22 was implemented as provided in art. 33.; EEA Agreement Annex II, Directive 65/65/EC, 75/319/EC and 89/105/EC, Annexes I and II. Directive 92/25/EC, Annex II Directive 92/28/EC and Annex I Directive 93/41/EC), Act No. 173/2000 (took effect 1 Jan. 2001), Act No. 16/2001 (took effect 16 May 2001), Act No. 63/2002 (took effect 17 May 2002), Act No. 76/2002 (took effect 17 May 2002), Act No. 93/2002 (took effect 31 May 2002), Act No. 164/2002 (took effect 1 Jan. 2003), Act No. 89/2003 (took effect 10 April 2003), Act No. 83/2004 (took effect 18 June 2004), Act No. 58/2005 (took effect 30 May 2005; implemented as provided in art. 12.; EEA Agreement Annex II, Directive 2002/98/EU, 2004/27/EU, 2004/28/EU and 2004/33/EU), Act No. 76/2005 (took effect 1 Jan. 2006), Act No. 40/2007 (took effect 1 Sept. 2007), Act No. 57/2007 (took effect 3 April 2007), Act No. 167/2007 (took effect 1 Jan. 2008), Act No. 88/2008 (took effect 1 Jan. 2009 except temporary provisions VII which took effect 21 June 2008), Act No. 97/2008 (took effect 1 Oct. 2008 except provisions of art. 10 re. retailers, which take effect 1 Jan. 2010), Act No. 112/2008 (took effect 1 Oct. 2008 except item 12 art. 59 which took effect 25 Sept. 2008; to be implemented as provided in para. 2 art. 56), Act No. 120/2008 (took effect 1 Oct 2008), Act No. 146/2008 (took effect 20 Dec. 2008) and Act No. 28/2009 (took effect 2 April 2009).

SECTION I

Objectives and administrative structure

Article 1

The objective of this Act is to ensure that the people of Iceland have a sufficient supply of necessary medicinal products, as efficiently distributed as possible on the basis of fair and equitable competition, and in accordance with the rules which apply in the European Economic Area [or under the European Free Trade Association (EFTA) Treaty].¹⁾ Where trade in medicinal products is concerned, it must always be borne in mind that the distribution of medicinal products is an integral part of health services and those employed in the distribution of medicinal products are to work with other professions of the health services towards fulfilling current health service objectives. It is, furthermore, the objective of this Act to ensure as far as possible the quality and safety of medicinal products and services, increase public information on the use of medicinal products, counter their excessive use and keep costs to a minimum.

The Minister of Health and Social Security shall supervise the implementation of this Act. At the Ministry of Health and Social Security, the Director of Medicinal Affairs is responsible for administering medicinal product matters on behalf of the Minister. The Director shall be a qualified pharmacist and may not have personal interests at stake in the manufacturing, importation or distribution of medicinal products. The Director of Medicinal Affairs, [the Environmental and Food Agency of Iceland],²⁾ the Medical Director of Health, [the Icelandic Medicines Control Agency],³⁾ [the Medicinal Products Pricing Committee] ⁴⁾ and [the Icelandic Food and Veterinary Authority]⁵⁾ shall advise the Minister on the implementation of this Act.
¹⁾ Act No. 76/2002, Article 24, ²⁾ Act No. 164/2002, Article 18. ³⁾ Act No. 108/2000, Article 1. ⁴⁾ Act No. 83/2004, Article 1. ⁵⁾Act No. 167/2007, Article 74

Article 2

[The Icelandic Medicines Control Agency is under the aegis of the Minister of Health and Social Security.

The Minister shall appoint the Director of the Icelandic Medicines Control Agency for a five-year term. The Director shall have a university degree and knowledge of the Agency's field of operation. The Director shall be responsible for administering the Agency, be responsible for day-to-day operations and ensure that it operates in accordance with all currently applicable laws and regulations.

Neither the Director nor any other staff of the Agency may have any personal interests at stake in the production, importation or distribution of medicinal products.

Independent laboratories in Iceland or abroad may be entrusted with research on behalf of the Agency.]¹⁾
¹⁾ Act No. 108/2000, Article 2.

Article 3

[The role of the Icelandic Medicines Control Agency shall be as follows:

To evaluate medicinal products and other products covered by this Act in accordance with applicable rules in the European Economic Area [and under the European Free Trade Association (EFTA) Treaty].¹⁾
To issue, amend, cancel or revoke marketing authorisations for medicinal products in accordance with rules applicable in the European Economic Area.
To process applications for authorisation to import and sell by prescription medicinal products that do not have marketing authorisation in Iceland.
To issue authorisations for research on medicinal products (clinical trials of medicinal products and research on the bioavailability of pharmaceuticals) [and to monitor the implementation of such trials].²⁾
To handle recording of adverse reactions to medicinal products and the provision of information on medicinal products in collaboration with the Medical Director of Health.
To provide professional inspection of the import of medicinal products, pharmaceutical substances and raw materials for the manufacture of medicinal products, or any other products subject to the authority of the Agency.
To carry out professional inspection of activities of pharmacies, wholesalers of medicinal products and manufacturers of medicinal products, and inspect holders of marketing authorisations for medicinal products and their agents and other enterprises, institutions and individuals who sell, manufacture, import or package medicinal products and related products. The Minister may, in regulations, appoint the Icelandic Medicines Control Agency to inspect other enterprises or other products than medicinal products and related products, if special circumstances call for such action and such inspection is connected with the function of the Agency under this Act.
To monitor advertising of medicinal products and ensure that the promotion and distribution of medicinal products complies with current laws and regulations.

   [9.   To provide special monitoring of medicinal products containing narcotic drugs or psychotropic substances in connection with the delivery, preparation and signing of prescriptions and the dispensing of medicinal products containing narcotic drugs or psychotropic substances by pharmacies. Regulations on narcotic drugs or psychotropic substances and other substances subject to monitoring shall provide in detail for the implementation of such monitoring.]³⁾
   [10.   To carry out surveillance of the activities of blood banks with respect inter alia to the handling, storage and processing of blood and blood products. [Surveillance of the activities of blood banks by the Medical Director of Health is subject to Section VI of the Health Service Act and to the Medical Director of Health Act] ⁴⁾ The Minister may make further provision in Regulations⁵⁾ for the activities of blood banks, recording of adverse reactions, the practice of surveillance, etc.]²⁾
   [11.   Consideration of applications and issue of pharmacy licences under section VII, import and wholesale licences under Section XII, and manufacturing licences under Section XIII.] ⁶⁾
   [12.] ⁶⁾  Other matters concerning the implementation of this Act, including collaboration with bodies abroad in the field of medicinal products, [such as the European Medicines Agency (EMEA)] ²⁾

In accordance with the rules of the European Economic Area [and in accordance with the European Free Trade Association (EFTA) Treaty], ¹⁾ manufacturers of medicinal products or their agents shall provide the Icelandic Medicines Control Agency with all new information on medicinal products under consideration by the Agency as it becomes available. The same shall apply to medicinal products for which marketing authorisations have been granted.

An applicant for a marketing authorisation shall pay the Icelandic Medicines Control Agency a fee for the marketing authorisation which shall cover the cost of evaluation as provided for in item 1 para. 1 and costs incurred under item 2 para. 1 in the case of changes to a marketing authorisation. The fee shall also cover the cost of issuing a marketing authorisation.

Holders of marketing authorisations shall pay an annual fee to the Icelandic Medicines Control Agency which shall cover the costs of maintaining medicinal product registers, recording adverse reactions to medicinal products, and dissemination of information on medicinal products with marketing authorisation in Iceland, as well as costs resulting from necessary co-operation with foreign agencies concerning medicinal products for which marketing authorisation has been granted in Iceland.

[An applicant for professional evaluation of the harmful characteristics (harmlessness) of food supplements and natural products under para. 1, for their intended distribution and resale, shall pay the Medicines Control Agency a fee to cover the costs of such evaluation.]³⁾

[Pharmaceutical companies shall pay the Icelandic Medicines Control Agency a fee for the issue of certificates of a marketing authorisation (Certificate of Pharmaceutical Product) for a medicinal product for which they intend to apply for market authorisation in other countries, also Certificates of Authorisation for Manufactures of Medicinal Products regarding good practice, and Statements of Licensing Status of Pharmaceutical Products. The fee shall take account of the work contributed by experts in issuing them.

The Icelandic Medicines Control Agency may collect a special fee with respect to scientific advice regarding marketing authorisation requested by a manufacturer of a medicinal product.]²⁾

[The Icelandic Medicines Control Agency shall be paid a fee for granting exemptions under para. 7 art. 7 for medicinal products which do not have marketing authorisations in Iceland, for granting authorisations for carrying out clinical trials of medicinal products under Article 9 and for evaluation of officinal formulae under Article 5.]⁷⁾

The Minister shall, after receiving the proposals of the Icelandic Medicines Control Agency, set a tariff⁸⁾ for activities referred to in [paragraphs 3 to 8.]²⁾ It shall take into consideration the costs of services and implementation of individual projects. The tariff shall be based on the Agency's operating budget, giving grounds for the figures upon which the determination of fees are based.

The Icelandic Medicines Control Agency shall levy an annual inspection fee on the parties subject to its regular inspection, which shall cover the cost of inspection by the Agency. Parties subject to inspection are as follows:

holders of pharmacy licences,
physicians' dispensaries,
local authorities' dispensaries,
manufacturers of medicinal products, [including activities of blood banks],²⁾
wholesalers of medicinal products,
enterprises representing manufacturers of medicinal products,
veterinarians,
health institutions, hospitals and primary health care centres,
medical centres.

The inspection fee shall be determined in the following manner:

concerning the activities of holders of pharmacy licences, physicians’ dispensaries, and dispensaries of local authorities, 0.3 % of the total amount of payments from the [Health Insurance Administration]⁹⁾ to such parties for sales of medicinal products during the year preceding the year of assessment, but of the total amount of purchases of medicinal products by these parties (wholesale price excluding value-added tax), if that amount exceeds the payments from the [Health Insurance Administration]⁹⁾. The amount of the inspection fee shall, however, never be lower than ISK 75,000 per year;
concerning the activities of manufacturers of medicinal products [including the activities of blood banks],²⁾ medicinal product wholesalers, and representatives of manufacturers of medicinal products, 0.3% of the total sales of medicinal products [in Iceland]²⁾ (wholesale price excluding value-added tax) during the year preceding the year of assessment. The amount of the inspection fee shall, however, never be lower than ISK 35,000 per year;
concerning the activities of veterinarians, health institutions, hospitals, primary health care centres and medical centres, 0.3 % of the total amount of purchases of medicinal products (wholesale price excluding value-added tax) during the year preceding the year of assessment. The amount of the inspection fee shall, however, never be lower than ISK 7,500 per year.

The amounts provided for in [items 1-3 [para. 11]²⁾]³⁾ are based on price levels as of January 1999. The amount of the minimum inspection fee for medicinal products shall be adjusted once each year, on 15 January, with 70% of the fee reflecting the wage index and 30% the consumer price index.

The [Health Insurance Administration]⁹⁾ and parties subject to inspection must provide the Icelandic Medicines Control Agency with all the information necessary for assessing the inspection fee for medicinal products.

If the parties subject to inspection fail to provide the necessary information the Icelandic Medicines Control Agency may estimate their inspection fees. The base of the fee shall be estimated so liberally as to preclude any risk of underestimating the actual amounts, and the inspection fee then determined on the basis of that estimate. The levy may be reviewed if the base for assessment changes.

The Minister may make, in regulations, further provision for the implementation of collection of monitoring fees.

The inspection fee shall be levied each year in arrears. The due date for payment shall be 30 days from the date of the invoice, with penalty interest calculated after the due date.

The Icelandic Medicines Control Agency shall collect the fees under this Article. The fees are enforceable by execution.]⁵⁾
¹⁾Act No. 76/2002, Article 25. ²⁾ Act No. 58/2005, Article 1. ³⁾ Act No. 89/2003, Article 1 ⁴⁾Act No. 40/2007, Article 39. ⁵⁾Regs. 441/2006, cp. 1024/2007. ⁶⁾Act No. 97/2008, article 1. ⁷⁾Act No. 83/2004, Article 2. ⁸⁾Tariff 203/2004. ⁹⁾Act No. 112/2008, Article 62. ¹⁰⁾Act No. 108/2000, Article 3.

Article 4

[The Medicinal Products Committee of the Icelandic Medicines Control Agency shall be the advisory committee of the Agency on issues concerning medicinal products.

The Committee shall comprise five persons with the broadest possible expertise in medicine and pharmacology. The Minister shall appoint its chair. The Minister shall appoint other members of the Committee, as well as five alternates, in consultation with the chair. When veterinary medicinal products are dealt with, the Committee shall be joined by the Chief Veterinary Officer, and a veterinarian appointed by the Minister in consultation with the chair of the Committee. Alternates shall be appointed in the same manner. The Committee shall be appointed for a four-year term.

The Director of the Icelandic Medicines Control Agency may request the services of experts and representatives of professional associations as consultants to the Agency when necessary.]¹⁾
¹⁾Act No. 108/2000, Article 4.

SECTION II

[Definitions]¹⁾
¹⁾Act No. 58/2005, Article 3.

Article 5

[For the purposes of this Act the following meanings shall apply:

Proprietary medicinal products: all medicinal products, ready for use or nearly so, for which a marketing authorisation has been granted, under a special name and in the special packaging of the manufacturer (holder of the marketing authorisation).
[Medicinal products: any substance or combination of substances said to have properties which are useful in the treatment of diseases in humans or animals, or for prevention of disease, or any substance or combination of substances that may be used for human beings or animals or administered to them, either with the objective of restoring, correcting or modifying physiological functions by means of medical pharmacological effects or metabolic effects, or in order to confirm a medical diagnosis.] ¹⁾
Substance: Any matter irrespective of origin, from:
- humans, e.g. blood and human blood products;
- animals, e.g. micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products, etc.;
- plants, e.g. micro-organisms, plants, parts of plants, plant secretions, extracts, etc.;
- other chemicals, e.g. elements, naturally occurring chemical materials and chemical products obtained by chemical reaction or synthesis.
Magistral formula: all medicinal products prepared in a pharmacy in accordance with a prescription by a physician for an individual patient.
[Officinal formula: all medicinal products prepared in a pharmacy or medicinal product manufacturing facility in accordance with a formula approved by the Icelandic Medicines Control Agency, and dispensed in pharmacies. A medicinal product manufacturing facility is a location where medicinal products are manufactured in accordance with Good Manufacturing Practice and which has been granted a licence under the provisions of Section XIII of this Act.]²⁾

If there is doubt as to whether individual substances or compounds are medicinal products the Icelandic Medicines Control Agency shall decide the matter. [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 this Act shall apply.]¹⁾

The Minister shall issue regulations on further definitions of medicinal products and the concept of a medicinal product in accordance with the rules of the European Economic Area [and in accordance with the European Free Trade Association (EFTA) Treaty].³⁾

[The Minister shall issue regulations which shall stipulate when substances which may originate in nature are deemed to be medicinal products. They shall also stipulate the daily doses of vitamins and/or minerals, intended for consumption by human beings or animals, which are deemed to be medicinal products.]²⁾
...⁴⁾]⁵⁾
¹⁾Act No. 58/2005, Article 2.²⁾Act No. 83/2004, Article 3. ³⁾ Act No. 76/2002, Article 26. ⁴⁾ Act No. 16/2001, Article 15. ⁵⁾ Act No. 108/2000, Article 5.

SECTION III

Pharmacopoeia

Article 6

Iceland is a signatory to the European Pharmacopoeia (Ph. Eur.), including annexes. The English edition of the pharmacopoeia is valid for Iceland.

Other requirements regarding the form, quality and purity of medicinal product substances and excipients in the manufacturing of medicinal products, as well as the methods of analysis and determination of these substances shall be in accordance with legal advertisements regarding the validity of Nordic and other European standards in Iceland.

Iceland is a signatory to the Pharmaceutical Inspection Convention (PIC). Guidelines regarding good manufacturing practice in the medicinal product industry, the GMP rules, cf. European Commission Directives [and the European Free Trade Association Treaty], ¹⁾ as well as other guidelines issued by these parties, shall apply in Iceland.
¹⁾Act No. 76/2002, Article 27.

SECTION IV

[Marketing authorisation for medicinal products. Evaluation of medicinal products. Clinical trials of medicinal products] ¹⁾
¹⁾Act No. 108/2000, Article 10.

Article 7

[Fully prepared medicinal products (medicinal products, ready for use or nearly so) may only be imported to Iceland, sold or dispensed, following the issue of marketing authorisation by the Icelandic Medicines Control Agency.

An application for a marketing authorisation, together with the necessary documentation, shall be submitted to the Icelandic Medicines Control Agency. [The period of validity of a marketing authorisation is five years, with the exceptions stated in this paragraph. A marketing authorisation for a medicinal product may be renewed after that time, on the basis of the Medicines Control Agency’s reassessment of risk-benefit balance. Before the reassessment the holder of the marketing authorisation shall, at least six months before the expiry of the marketing authorisation, have submitted to the Medicines Control Agency sufficient and updated data on the quality, safety and effect of the medicinal product. When the marketing authorisation of a medicinal product has been renewed once, it shall be valid indefinitely, unless the Medicines Control Agency determines, on valid grounds, with respect to pharmacovigilance, that it should be renewed only for five years. The marketing authorisation is invalidated if the medicinal product for which the marketing authorisation is granted has not been placed on the market within three years of the granting of the authorisation, or if a medicinal product for which authorisation has been granted, and which has been placed on the market, has not in fact been on the market for a continuous period of three years. The Medicines Control Agency may grant exemptions from this provision in special circumstances, and for reasons relating to public health. Such exemptions shall be supported by valid reasons.] ¹⁾

The Icelandic Medicines Control Agency may use a marketing authorisation granted in another member state of the EEA as the basis for recognition of a medicinal product for which marketing authorisation is sought.

The Icelandic Medicines Control Agency may approve an application from the holder of a marketing authorisation for a major or minor amendment to the terms of a marketing authorisation.

The Icelandic Medicines Control Agency may revoke, [invalidate, cancel temporarily or amend]¹⁾ a marketing authorisation if:

it transpires that a medicinal product on the market in Iceland does not conform to current law or rules on medicinal products or does not meet requirements for marketing authorisation;
the medicinal product is no longer considered to fulfil requirements for quality, safety and efficacy;
information which was provided in connection with an application is incorrect;
quality control in accordance with the requirements of a currently applicable quality description is not carried out as prescribed by the rules;
the obligations to make necessary changes to production or supervision or to the summary of product characteristics (SPC), are not fulfilled;
the time which must elapse until the utilisation of animal products may begin once more after administration of a medicinal product is no longer considered long enough to ensure that the animal products contain no residues harmful to consumers;
new representation has not been notified within the specified time limits, provided the parties have been warned that exceeding such time limits would result in revocation of the marketing authorisation. Rules on the revocation of market authorisation shall also apply to special marketing authorisations, as applicable.

The holder of a marketing authorisation may request that the Icelandic Medicines Control Agency cancel the marketing authorisation.

The Icelandic Medicines Control Agency may, under exceptional circumstances, grant a physician, upon his/her personal responsibility, an exemption from para. 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.

The Icelandic Medicines Control Agency may refuse an application for a marketing authorisation [or marketing]¹⁾ for a vaccine, serum or other immunological veterinary medicinal product if its registration is contrary to law or if it is intended for use against a disease which is unknown in animals in Iceland.

The Minister shall, in regulations,²⁾ make provision for the granting of marketing authorisations for proprietary medicinal products, [parallel imports of medicinal products],³⁾ homeopathic medicines and natural medicinal products, vitamins and minerals. Provision shall also be made for the processing of applications, [recognition of central marketing authorisations from the European Medicines Agency (EMEA), duration of protection of data from preclinical and clinical trials],¹⁾ recognition based on marketing authorisations granted in other member states of the EEA, amendment to the terms of marketing authorisations, revocation and cancellation of marketing authorisations and exemptions for medicinal products which do not have marketing authorisation in Iceland.]⁴⁾
¹⁾Act no. 58/2005, Article 4.²⁾Reg. 462/2000, cf. 766/2001, 443/2005, 581/2006. ³⁾ Act No. 83/2004, Article 4. ⁴⁾ Act No. 108/2000, Article 6.

Article 8

The [granting of marketing authorisation for a medicinal product]¹⁾ may be limited to use in hospitals, specified wards, and/or for prescription by specialists in specific branches of medicine.

[The Icelandic Medicines Control Agency may, on the basis of a marketing authorisation in another member state of the EEA and upon the fulfilment of the requirements of this Act concerning the granting of a marketing authorisation, issue a marketing authorisation for a medicinal product which has been removed from the registry or for which a marketing authorisation has not been sought if the Agency deems justifiable, due to considerations of public health or public interests, to have the medicinal product in question on the market. [If the Icelandic Medicines Control Agency intends to exercise this right, it must notify the holder of the marketing authorisation in the country in which the medicinal product is registered of its intent, requesting a copy of the evaluation report and the valid marketing authorisation for the medicinal product from the authorities in that country. The Minister shall provide in detail for the implementation of this provision in regulations.]²⁾]³⁾]⁴⁾

[The Icelandic Medicines Control Agency may authorise temporary distribution of a medicinal product which has not been granted a marketing authorisation, if it is for protection against pathogens, toxic substances, chemical agents or nuclear radiation which are believed or known to have spread, or to be likely to do so.

The Icelandic Medicines Control Agency may grant a veterinarian, having received his/her reasoned application, and on his/her own responsibility, permission to use out-of-label a medicinal product, with or without marketing authorisation in Iceland, or use it for another animal species than that for which the medicinal product is intended. Further provision shall be made for such cases in regulations on veterinarians’ authority to prescribe medicinal products.]³⁾
¹⁾Act No. 108/2000, Article 7. ²⁾Regs. 462/2000, cp. 1251/2008. ³⁾ Act No. 58/2005, Article 5. ⁴⁾Act No. 83/2004, Article 5.

Article 9

[A clinical trial of a medicinal product is a systematic testing of a medicinal product intended to discover or confirm its effect and/or to discover any adverse reactions to the medicinal product and/or to investigate the absorption, distribution, metabolism and excretion of the medicinal product for the purposes of evaluating its safety and effectiveness.
The Minister shall issue regulations¹⁾ with further provisions on the definition of clinical trials of medicinal products, the granting of permits for such, and for their monitoring and implementation in accordance with rules on Good Clinical Practice (GCP), the Helsinki Convention, codes of ethics and the Patients' Rights Act.]²⁾
¹⁾Regs. 443/2004. ²⁾ Act No. 108/2000, Article 8.

Article 10

[The Icelandic Medicines Control Agency supervises publication of a registry of proprietary medicinal products, listing the proprietary medicinal products with marketing authorisation in Iceland by medicinal product categories or in a similar manner. The registry shall include, for instance, clinical indications, contra-indications, dosages, the main adverse reactions and the maximum price of medicinal products, cf. [Article 43.]¹⁾]²⁾
¹⁾Act No. 89/2003, Article 4. ²⁾ Act No. 108/2000, Article 9.

SECTION V

Prescription of medicinal products. Prescription forms and dispensing of prescriptions. Labelling of medicinal products

Article 11

[The Icelandic Medicines Control Agency shall decide whether a medicinal product shall be subject to prescription, what quantity of a medicinal product may be dispensed on the basis of a prescription, and how often on the same prescription. The Agency shall also decide when exemptions from prescription status may be granted.]¹⁾

A prescription form is a prescription for a medicinal product issued by a physician, dentist or veterinarian holding a valid licence to practice medicine in Iceland. In emergency cases, pharmacists are authorised to dispense a medicinal product in the smallest available packaging without a prescription.

The person issuing a prescription shall sign it in his/her own hand and indicate his/her professional status (physician, dentist, veterinarian) or communicate by telephone in such a manner as to make his/her identity clear. A prescription may be sent by fax or by computer file transmission in any standardised format which enables the receiver to verify the identity of the sender. The person issuing the prescription thus verifies having him/herself prescribed for the specified individual or his/her guardian the stated medicinal product in the stated quantity, specifying dosage or use.

The Medical Director of Health monitors physicians’ prescriptions and the dispensing of medicinal products by pharmacists in emergency cases. [[The Icelandic Food and Veterinary Authority]²⁾ monitors the prescribing of veterinary medicinal products.] ³⁾
¹⁾Act No. 108/2000, Article 11. ²⁾ Act No. 167/2007, Article 74. ³⁾Act No. 131/1994, Article 1.

Article 12

The Minister shall issue regulations¹⁾ concerning prescription forms and the prescribing of medicinal products, their dispensing and labelling. These regulations shall provide, for instance, for the following matters:

prescription forms,
the prescription of medicinal products,
...²⁾
how containers (dispensing containers) of ready-to-use medicinal products shall be labelled,
prescription of medicinal products by telephone, fax or via computer,
prescription of medicinal products containing narcotic drugs or psychotropic substances,
prescription of medicinal products for use aboard ship or in aircraft,
the right of medical students and physicians without a licence to practice to prescribe medicinal products,
term of validity of prescriptions,
labelling of medicinal products.

¹⁾Regs. 539/2000, cf. 912/2000, 14/2008 and 1069/2008; Regs. 91/2001, cf. 844/2002, 801/2007, 894/2008 and 219/2009; Regs. 111/2001, cf. 485/2001 843/2002, 382/2006, 802/2007 and 893/2008;; Regs. 233/2001, cf. 490/2001, 248/2002, 848/2002, 480/2005 and 516/2006; Regs. 1077/2006 ²⁾Act No. 108/2000, Article 12.

SECTION VI

[Advertising and promotion of medicinal products. Registration of Adverse reactions and Reporting Requirements (Pharmacovigilance)]¹⁾
¹⁾ Act No. 108/2000, Article 18.

Article 13

Advertising of medicinal products of any kind is prohibited, with the exceptions provided in this Section.

[[Advertising, by means of text or illustrations, directly or indirectly, that a product which has not been approved as a medicinal product has preventive effects, cures or alleviates diseases, disease symptoms or pain, or has effects on physiological functions, is also prohibited.]¹⁾ Under exceptional circumstances, the Icelandic Medicines Control Agency may grant exemptions from this paragraph.]²⁾
¹⁾Act No. 63/2002, Article 1. ²⁾ Act No. 108/2000. Article 13.

Article 14

[Medicinal products which have marketing authorisations in Iceland]¹⁾ may be advertised and promoted in Icelandic in journals and newsletters of health professions which prescribe or distribute medicinal products.

Advertisements for medicinal products shall include the name of the manufacturer, name of the medicinal product, its active ingredients, the principal indications and contraindications for the use of the medicinal product in question, package sizes and price. Also dosages and other significant factors concerning administration and adverse reactions. The afore-mentioned information must always be indicated clearly and legibly and be in accordance with that contained in pharmacopoeia.

[An advertisement may include only the name of a medicinal product if the intent of the advertisement is solely to draw attention to the name. This provision applies only to the advertisement of non-prescription medicinal products.]¹⁾
¹⁾Act No. 108/2000, Article 14.

Article 15

Prescription medicinal products may be promoted among the health professions prescribing or distributing medicinal products, by such means as will make it unlikely that such advertisements will reach the general public.

Article 16

Non-prescription medicinal products, i.e. medicinal products for which a prescription is not required, may be promoted and advertised to the general public. [Non-prescription medicinal products may not, however, be advertised on television.]¹⁾ Advertisements of non-prescription medicinal products shall be in accordance with the rules applying in the European Economic Area, as prescribed in more detail in regulations.

Pharmacies may advertise and promote their services, such as home delivery service, the price of non-prescription medicinal products and general discounts.

Information given in advertisements must always be clear and legible and be in accordance with that contained in pharmacopoeia, with regulations concerning prescription forms and the prescribing of medicinal products, their dispensing and labelling, and any other instructions in this regard.

[Holders of marketing authorisations, or their agents, may convey general information on diseases and the use of specific medicinal products to patients by means of brochures. All information included in such brochures shall be in accordance with an approved Summary of Product Characteristics (SPC) and the Icelandic Medicines Control Agency shall be sent copies of the brochures.]²⁾
¹⁾Act No. 55/1995, Article 1. ²⁾ Act No. 108/2000, Article 15.

Article 17

It is permissible to deliver personally to a physician, dentist or veterinarian a medicinal product sample in the smallest package size without charge, provided that it is a newly registered medicinal product, not deemed narcotic drug or psychotropic substance, being introduced on the market in Iceland. Such supply is only authorised if the physician has signed and dated a request to this effect.

Any other delivery or mailing of medicinal product samples for advertising purposes is unauthorised.

Article 18

[The Icelandic Medicines Control Agency monitors advertisements of medicinal products. The Agency may prohibit and/or order the withdrawal of specific advertisements that provide false or inadequate information on medicinal products. The Agency may also require that the advertiser publish corrections or additional information in a comparable manner. This also applies to substances which have not been approved as medicinal products, cf. para. 2 art. 13. The Icelandic Medicines Control Agency shall refer decisions on advertisements of medicinal products to the Competition and Fair Trade Authority in cases were there are reasons to suspect that an advertisement of a medicinal product violates provisions of the Competition Act. Advertisers shall keep records of all advertisements, indicating where and when they were published. The records are to be preserved for two years and be accessible to the Icelandic Medicines Control Agency.]¹⁾

[The Icelandic Medicines Control Agency can require individuals and legal entities to provide written information with respect to suspected violation of the provisions of articles 13-17, and this shall be provided within a reasonable period allowed by the Agency. The Icelandic Medicines Control Agency can, in investigation of suspected violations of the provisions of articles 13-17, make necessary inspections of the working premises or the location where data are stored, provided that there is probable cause to believe that the provisions have been violated. In the implementation of measures, the provisions of legislation on [criminal]²⁾ procedure shall be followed with respect to search and seizure of objects.

The Icelandic Medicines Control Agency may pass to authorities of other members of the European Economic Area information and data deemed necessary in the implementation of the provisions of articles 13-17 in accord with Iceland’s obligations under the European Economic Area Agreement.

In handing over information and data, the conditions shall be required that:

the information and data be treated as confidential by the recipient,
the information and data will only be used for the purpose stated in the European Economic Area Agreement and in accord with a request for information,
the information and data will only be passed to other parties with the consent of the Icelandic Medicines Control Agency, and for the purpose specified in the statement of consent.]³⁾

¹⁾Act No. 108/2000, Article 16.²⁾ Act No. 88/2008, Article 234³⁾Act no. 57/2007, Article 9.

Article 19

[Recording of adverse reactions and reporting obligations is the responsibility of the Icelandic Medicines Control Agency in collaboration with the Medical Director of Health and as provided in regulations issued by the Minister.

A marketing authorisation holder must have in its service an appropriately qualified person responsible for pharmacovigilance in the enterprise. He/she shall record all suspected adverse reactions of a medicinal product which are notified. He/she must also notify the competent authorities of such adverse reactions in accordance with the provisions of regulations issued by the Minster.]¹⁾
¹⁾Act No. 108/2000, Article 17.

SECTION VII

The establishment of pharmacies and pharmacy licences

Article 20

Only those parties who have received a licence for such from the [Medicines Control Agency]¹⁾ are authorised to sell medicinal products. [But it is permissible to sell outside pharmacies fluoride medicines and the smallest packages and lowest doses of nicotine medicines which are not prescription-only. Sale of nicotine and fluoride medicines is subject to the provisions of paras. 1 and 7, article 8 of the Tobacco Control Act and para. 2 article 62 of Regulations on pharmacy licences and pharmacies. Monitoring, coercive measures and penalties are subject to the provisions of the Health and Safety and Pollution Control Act.]¹⁾

[The Medicines Control Agency]¹⁾ shall issue a pharmacy licence to a party fulfilling the following conditions who applies for such licence:

Is a pharmacist licensed to practice in Iceland, cf. the Pharmacists Act.
Has worked as a pharmacist for three years. Exceptions may be made from this requirement under special circumstances.
...²⁾

Applications for new pharmacy licences shall be referred by the [Medicines Control Agency]¹⁾ to the local authority concerned for an opinion. Consideration of the application shall, among other things, take into account the number of inhabitants to be served by the pharmacy and its distance from the next pharmacy. If the party giving the opinion opposes the granting of a new licence, the [Medicines Control Agency]¹⁾may refuse the application. [Applications for pharmacy branches shall be sent to the local authorities for their opinion in the same manner.]²⁾

[Before the pharmacy may commence activities, it must be confirmed that the premises, facilities and staff meet the Medicine Control Agency's criteria.]²⁾

The [Medicines Control Agency]¹⁾ may provide for an obligation for holders of pharmacy licences to provide after-hours services.

[The Medicines Control Agency may assign responsibility for the operation of a pharmacy to the director of a primary health care centre if no pharmacy operates in the health care district.]¹⁾

[The director of a primary health care centre]³⁾ which has been assigned responsibility for the operation of a pharmacy may make a contract with an external holder of a pharmacy licence regarding its services, including the operation of a pharmacy, cf. [Article 38].⁴⁾

The fee for a pharmacy licence shall be determined by the Minister of Finance.
¹⁾Act No. 97/2008. article 2 ²⁾108/2000, Article 19.³⁾ Act No. 83/2004, Article 6. ⁴⁾ Act No. 89/2003, Article 4.

Article 21

[Each pharmacy licence shall be restricted to the operation of one pharmacy and the licence-holder him/herself shall be professionally responsible for the pharmacy's operation. A pharmacist may only be issued one pharmacy licence at any time, but the licence-holder may apply for a licence to operate a branch of the pharmacy in a community where no pharmacy is operated. In the absence of the licence-holder a pharmacist shall be entrusted with the daily operation of the pharmacy in consultation with the Icelandic Medicines Control Agency. Pharmacy branches shall be classified in accordance with the nature and the scope of the services they are authorised to provide. The Minister shall, in regulations, make detailed provision for the classification of pharmacy branches. If a pharmacy branch is operating in a community where no pharmacy exists, authorisation to operate another branch with a lower level of service shall not be granted. ...¹⁾ [The Minister may make further provisions on conditions and implementation of mail order of medicines and postal deliveries of medicines in regulations²⁾ on pharmacy licences and pharmacies.] ¹⁾

[Should a pharmacy be operated by a person other than the holder of a pharmacy licence, this licence holder must obtain authorisation from the [Medicines Control Agency]¹⁾ for the operation. The holder of an operating licence shall be responsible, together with the holder of the pharmacy licence, for ensuring compliance with this Act. The [Medicines Control Agency]¹⁾ may revoke the operating licence of the holder if he/she violates the provisions of this Act.]³⁾

Practising physicians, dentists, and veterinarians may not own such extensive holdings in pharmacies, medicinal product manufacturers or wholesalers of medicinal products that this has a significant impact on their personal finances. The same shall apply to their spouses and children under 18 years of age. Sale of medicinal products by veterinarians is subject to [para. 6 Article 33.] ⁴⁾ The Minister may make further provision in regulations regarding this paragraph, including for instance exceptions from this prohibition in the case of spouses where no alternative is available.]⁵⁾
¹⁾Act No. 97/2008, article 3.²⁾Regs. 1065/2008.³⁾ Act No. 63/2002, Article 2. ⁴⁾ Act No. 89/2003, Article 4. ⁵⁾ Act No. 108/2000, Article 20.

Article 22

A pharmacy licence shall be cancelled:

if the licence-holder has his/her pharmacist's licence revoked ...,¹⁾
at the end of the year the licence-holder reaches the age of 70; after that time the licence may be extended for a one-year period at a time ...,²⁾
if a licence-holder ceases work,
4. upon the death of a licence-holder. The estate of a deceased licence-holder may, however, operate the pharmacy for six months under the professional administration of a pharmacist, after receiving the agreement of the [Medicines Control Agency]. ¹⁾

The [Icelandic Medicines Control Agency]²⁾ may withdraw pharmacy licence if the pharmacy licence-holder violates the provisions of this Act or others and the violation is of such nature that the licence-holder must be deemed unfit to sell medicinal products. The provisions of Section V of the Pharmacists Act , No. 35/1978, shall apply to the loss of professional licence.

A retiring licence-holder, or the estate of a deceased licence-holder, may sell the operations to a pharmacist who has acquired a pharmacy licence under the provisions of this Act.
¹⁾Act No. 108/2000, Article 21.²⁾ Act No. 97/2008, Article 4

SECTION VIII

Operation of pharmacies

Article 23

A pharmacy shall be clearly designated as such. Holders of pharmacy licences are permitted to call their pharmacies, and them alone, lyfjabúðir or apótek.

Article 24

Pharmacy licence holders must offer for sale those medicinal products which may be sold in the country, keep sufficient stocks of medicinal products to meet foreseeable prescription needs from the doctors, dentists and veterinarians practising in the area and obtain medicinal products which they do not have in stock as quickly as possible. Pharmacies shall, furthermore, have for sale as far as possible essential medicinal product supplies and equipment for nursing and medical treatment.

Pharmacy licence holder must provide the [Medicines Control Agency]¹⁾ with information on their activities and keep records thereof, provided that such actions are not in violation of other laws. [Pharmacy licence holders are furthermore obliged to deliver to the [Health Insurance Administration]²⁾ in electronic format all information indicated on prescription forms on the dispensing of medicinal products with personal information encrypted, fulfilling the requirements of the Act on the Protection of Privacy as regards the Processing of Personal Data. The Medical Director of Health is responsible for the encryption and decryption of these data.]³⁾

Pharmacy licence holders must provide consumers and health care professionals with information on medicinal products, their use and proper storage. They must furthermore provide information on the utilisation of medicinal products and medicinal product care in co-operation with other health professions with the objective of reducing the risk of diseases and promoting general health.

Pharmacy licence holders shall keep computerised records of all information regarding their prescriptions in a format which has been approved by the Medical Director of Health and the [Personal Data Protection Authority, cf. the Act on the Protection of Privacy as regards the Processing of Personal Data.]⁴⁾ The Medical Director of Health can require such information to be produced for a period of up to one year retroactively.
¹⁾Act No. 97/2008, Article 5 ²⁾ Act No. 112/2008, Article 62 ³⁾ Act No. 89/2003, Article 2. ⁴⁾ Act No. 77/2000, Article 46.

[SECTION IX

Databases]¹⁾
¹⁾Act No. 89/2003, Article 3.

[Art. 25

Two databases shall be operated, a statistical database and a medicinal products database, containing information which the [Health Insurance Administration]¹⁾collects from pharmacies, cf. para. 2 Article 24. The objective of operating the databases is to enable the [Health Insurance Administration]¹⁾, the Medical Director of Health and the Medicines Control Agency to carry out their mandated monitoring of the prescribing of medicinal products containing narcotic drugs or psychotropic substances and of prescriptions in general, as well as to monitor the cost of medicinal products and process statistical data on national consumption of medicinal products.

The Data Protection Authority shall, in accordance with its role under the Act on the Protection of Privacy as regards the Processing of Personal Data, monitor the security of personal information in the statistical database and the medicinal products database and their operation in other respects.]²⁾
¹⁾Act No. 112/2008, Article 62 ²⁾Act No. 89/2003, Article 3.

[Article 26

For the purposes of monitoring the cost of medicinal products and to process statistical data on national consumption of medicinal products, the [Health Insurance Administration]¹⁾ shall operate a database on dispensing of medicinal products to patients, cf. para. 2 Article 24, to collect statistical information on medicinal products, prescribing and use of medicinal products, and their cost.

Personal identification of patients and physicians shall be removed before encrypted data from pharmacies are entered into the statistical database. The [Health Insurance Administration]¹⁾ shall ensure that this is done within one month of receipt of data by the Administration.

The [Health Insurance Administration]¹⁾, the Medicines Control Agency and the Directorate of Health may obtain information from the database for purposes of instruction and research. Other parties may obtain information from the database for the same purpose. The Minister shall issue regulations on the use of the information and on access to the database.]²⁾
¹⁾Act No. 112/2008, Article 62 ¹⁾Act No. 89/2003, Article 3

[Article 27

The Medical Director of Health shall operate a medicinal products database on dispensing of medicinal products for the purpose of general monitoring of physicians’ prescriptions for medicinal products and for monitoring of medicinal products containing narcotic drugs or psychotropic substances.

Personal identification of patients and physicians shall be specially encrypted in the medicinal products database. Encrypted personal identifications older than [thirty years]¹⁾ shall be deleted from it. The Medical Director of Health is responsible for encrypting personal identification and alone holds the key to both encryption and decryption.

The Medicines Control Agency and [Health Insurance Administration]²⁾ may apply for access to personal information from the database. The Medical Director of Health may grant such access:

if the [Health Insurance Administration]²⁾ requests access:
1. due to reimbursement of a patient’s costs for medicinal products and the patient’s consent has been given,
2. to examine prescriptions and prescribing practice of physicians for the purpose of monitoring cost of medicinal products, provided no patients’ personal identifications are included in these instances;
if the Medicines Control Agency requests access in accordance with that Agency’s monitoring role under this Act:
1. when there is reason to suspect the forging of a prescription for a medicinal product containing narcotic drugs or psychotropic substances or that it has come into existence by other unlawful means;
2. when there is reason to suspect the incorrect dispensing of a prescription for a medicinal product containing narcotic drugs or psychotropic substances.

The Medical Director of Health shall him/herself have access to the medicinal product database in accordance with the monitoring role of the office under the Health Service Act, Physicians Act and this Act, if any of the following criteria are fulfilled:

when there is reason to believe that a large quantity of medicinal products containing narcotic drugs or psychotropic substances have been prescribed for an individual by many physicians;
when there is reason to believe that a physician has prescribed medicinal products containing narcotic drugs or psychotropic substances for his/her own use;
when there is reason to believe that more medicinal products containing narcotic drugs or psychotropic substances have been prescribed for an individual than can be regarded as normal during a specific period;
for purposes of general monitoring of physicians’ prescriptions of medicinal products and for monitoring developments in medicinal product use, under Article 19 of the Physicians Act.

The Medical Director of Health shall issue rules of procedure for handling applications for access to the medicinal products database. These shall include inter alia provisions on obligations of applicants to explain the purpose of requesting information from the database and how the handling and processing of information will be arranged.]³⁾
¹⁾Act No. 97/2008, Article 6, ²⁾Act No. 112/2008, Article 62³⁾Act No. 89/2003, Article 3.

[Section X]¹⁾

Workplace training of pharmacy students and trainee pharmacy technicians. Obligations of pharmacy employees
¹⁾ Act No. 89/2003, Article 3.

[Article 28]¹⁾

Pharmacies shall provide pharmacy students and trainee pharmacy technicians with practical training in co-operation with the educational institutions concerned.
¹⁾Act No. 89/2003, Article 3.

[Article 29]¹⁾

Pharmacy students, who have completed a four-year programme of studies and two months of workplace training in a pharmacy, may apply to the [Icelandic Medicines Control Agency]²⁾ for permission to serve as assistant pharmacists on a temporary basis. In such cases the pharmacology student shall work with and on the responsibility of a pharmacist.
¹⁾Act No. 89/2003, Article 3. ²⁾Act No. 97/2008, Article 7

[Article 30]¹⁾

Employees of pharmacies are shall treat as confidential all knowledge or suspicions which they acquire in the course of their employment concerning illnesses or other private affairs.

The obligation of the afore-mentioned parties to bear legal witness is covered by the provisions of the Act on Legal Procedure.
¹⁾Act No. 89/2003, Article 3.

[SECTION XI]¹⁾

Dispensing of medicinal products
¹⁾Act No. 89/2003, Article 3.

[Article 31]¹⁾

A pharmacist or assistant pharmacist shall be responsible for dispensing a prescription and carry out the final check that it is correctly dispensed in accord with the prescription or request for toxic substance. [During regular business hours and during peak hours outside regular business hours, a pharmacy shall as a rule have no fewer than two dispensing pharmacists at work filling prescriptions and providing guidance and advice on the proper use and handling of medicinal products. The [Icelandic Medicines Control Agency]²⁾ may, on receiving an application to such effect, grant permission for only one pharmacist to be employed in a pharmacy, provided that the extent of its activities is limited and that the pharmacist is assisted by pharmacy technicians or other trained staff.]³⁾ [Furthermore, the [Icelandic Medicines Control Agency]²⁾ may, after receiving an application for such, grant temporary permission for only one pharmacist to work in a pharmacy, if there is a risk that the operation of a pharmacy in the area would otherwise cease. The Minister may, in regulations, provide for more than two pharmacists to work as a rule in pharmacies with a high level of activity.]⁴⁾

The [Icelandic Medicines Control Agency]²⁾ may grant a pharmacy technician limited authority, restricted to a specific location, to dispense from a pharmacy branch, provided this involves only standardised packages on a list approved by the [Medicines Control Agency]²⁾ acting on a proposal from [a director of a primary health care centre]⁵⁾ and a pharmacy licence-holder. If a pharmacy technician is not available to fulfil such a position in a pharmacy branch the same permission may be granted to another responsible representative whom the pharmacy licence-holder employs for the purpose, subject to the approval of the [Icelandic Medicines Control Agency.]³⁾
¹⁾Act No. 89/2003, Article 3. ²⁾Act No. 97/2008, Article 8. ³⁾ Act No. 108/2000, Article 23. ⁴⁾Act No. 63/2002, Article 3. ⁵⁾Act No. 93/2002, Article 14.

[SECTION XII ]¹⁾

[Importation and wholesale of medicinal products. Parallel importation of medicinal products]²⁾
¹⁾Act 89/2003, Article 3. ²⁾Act 83/2004, Article 8.

[Article 32]¹⁾

Only those parties which have received a licence thereto from the [Icelandic Medicines Control Agency]²⁾ are authorised to import ready-to-use medicinal products and medicinal product substances for wholesale distribution.

A fee shall be paid for a wholesale licence to sell medicinal products, to be determined by the Minister of Finance.
¹⁾Act No. 89/2003, Article 3. ²⁾Act No. 97/2008, Article 7.

[Article 33]¹⁾

[To obtain a wholesale licence for medicinal products in Iceland a wholesaler must fulfil the following conditions:

It shall be under the professional direction of a pharmacist licensed to practice in Iceland, who does not hold a pharmacy licence, or an individual who, in the view of the Icelandic Medicines Control Agency, meets at least the equivalent educational requirements. He/she shall be professionally responsible for the wholesale enterprise.
It must have at its disposal premises, equipment and staff which, in the view of the Icelandic Medicines Control Agency, enable it to fulfil the requirements for storage and handling of medicinal products.

If the licence-holder does not fulfil the requirements made regarding equipment, staff or other factors relating to the handling of medicinal products or if the licence-holder violates the provisions of this Act, it shall be given written warning and allowed a reasonable period to rectify the situation. If the licence-holder fails to heed such warning, the [Icelandic Medicines Control Agency]²⁾ may withdraw the licence. If the violation is serious, the [Icelandic Medicines Control Agency]²⁾ may withdraw the licence without giving prior warning or a time limit within which to rectify the situation.

Wholesalers of medicinal products must keep adequate supplies of specific medicinal products regarded as essential by the health authorities (Essential Drug List), for which marketing authorisation has been granted in Iceland and which are distributed by the medicinal products wholesaler.

A medicinal products wholesaler may not break the seals of packaging of medicinal products or alter their appearance unless it also holds a licence to manufacture medicinal products. Alterations to the packaging of a medicinal product must be in accordance with the conditions of its marketing authorisation. With the consent of the marketing authorisation holder, the Icelandic Medicines Control Agency may authorise other alterations to packaging of a medicinal product if special circumstances make this advisable.

Medicinal product wholesalers may sell medicinal products to holders of pharmacy licences, [other medicinal product wholesalers,] ³⁾ [those who have been granted a licence for dose dispensing of medicinal products,]⁴⁾ institutions with pharmacists on their staff which are operated on the basis of the Health Service Act or other special Acts, physicians and dentists for use in their own offices or on house calls, and laboratories conducting research on medicinal products. Costs incurred by physicians and dentists due to such purchases of medicinal products shall be considered as operational costs.

Furthermore, medicinal products wholesalers may sell veterinary medicinal products to veterinarians for use in their own offices or for house calls, and for sale from their offices. The Minister shall, in consultation with the [the Icelandic Food and Veterinary Authority]⁵⁾ issue regulations providing for licences to sell veterinary medicinal products, which medicinal products veterinarians are authorised to sell, and which of them they themselves alone may administer to animals. Provision shall also be made for the information which accompany medicinal products administered to animals whose products are intended for human consumption, and for the records which must be kept of sales of veterinary medicinal products, cf. Article 24.

[[Medicinal products wholesalers may also carry out parallel importation of a medicinal product with the permission of the Medicines Control Agency.]⁶⁾ [All intended parallel importation of a medicinal product shall be notified to the holder of the marketing authorisation of the product and to the Medicines Control Agency. Further provision shall be made for the conditions for parallel imported medicinal products and Medicines Control Agency procedures in regulations on parallel importation of medicinal products, cp. para. 9 Article 7.]⁶⁾ A parallel imported medicinal product shall mean a proprietary medicinal product for which a marketing authorisation has been granted in a country which is a member state of the European Economic Area, and which is imported from that country to Iceland, while the medicinal product in question has already been registered and a marketing authorisation issued in Iceland.]³⁾

Medicinal product wholesalers must maintain computerised records of sales in a form approved by the Medicines Control Agency and, furthermore, provide the Agency with information on their activities and maintain records thereof.]⁷⁾
¹⁾Act 89/2003, Article 3. ²⁾Act 97/2008 Article 7. ³⁾Act 83/2004, Article 7. ⁴⁾ Act 63/2002, Article 4. ⁵⁾Act 167/2007, Article 74 ⁶⁾Act 58/2005, Article 6 ⁷⁾Act 108/2000, Article 24.

[SECTION XIII]¹⁾

Manufacture of medicinal products
¹⁾Act 89/2003, Article 3.

[Article 34]¹⁾

Only those parties which have received a licence for such from the [Medicines Control Agency]²⁾ are authorised to manufacture medicinal products. [Manufacturing refers to all operations in purchase of materials and products, and also production processes, such as weighing, mixing, filling, packing, labelling, quality control, approval and storage, together with the appropriate monitoring. [The Icelandic Medicines Control Agency]²⁾ may issue temporary manufacturing licences, and restricted manufacturing licences, for specified categories of production, e.g. dose dispensing of medicinal products. Further provision shall be made for the conditions of such licences in regulations on manufacture of medicinal products.]³⁾

A fee shall be paid for a licence to manufacture medicinal products, to be determined by the Minister of Finance.
¹⁾Act 89/2003, Article 3. ²⁾Act 97/2008, Article 7 ³⁾Act 58/2005, Article 7

[Article 35]¹⁾

To obtain a licence to manufacture medicinal products, an enterprise must fulfil the following conditions:

It shall be under the professional direction of a pharmacist licensed to practice in Iceland, [who does not hold a pharmacy licence,]²⁾ or an individual who, in the view of the Medicines Control Agency, meets at least equivalent educational requirements; [that person shall be professionally responsible for the production.]²⁾
It must have at its disposal premises, equipment and staff which enable it, in the view of the [Icelandic Medicines Control Agency,]²⁾ to fulfil the requirements for storage and handling of medicinal products. If the licence-holder does not fulfil the requirements made regarding equipment, staff or other factors relating to the handling of medicinal products or if the licence-holder violates the provisions of this Act in one way or another, the licence may be withdrawn. A manufacturer of medicinal products must provide the [Medicines Control Agency]²⁾ with information on its activities and keep records thereof.

¹⁾Act No. 89/2003, Article 3. ²⁾ Act No. 108/2000, Article 25.

[Article 36]¹⁾

¹⁾Act No. 89/2003, Article 3.

Pharmacies shall produce magistral formulae or obtain them as quickly as possible. Standardised formulae may be produced by pharmacies [and pharmaceutical manufacturing facilities]²⁾ if the specified requirements are fulfilled. Licence for their production may be restricted to certain pharmaceutical forms.
¹⁾Act No. 89/2003, Article 3. ²⁾ Act No. 83/2004, Article 9.

[SECTION XIV]¹⁾

Medicinal product services in hospitals and other health care institutions
¹⁾Act No. 89/2003, Article 3.

[Article 37]¹⁾

Hospitals may operate special hospital pharmacies, which supervise and are responsible for procurement and storage of medicinal products and monitoring of their administration in individual wards. The operation of a hospital pharmacy shall be kept financially separate from other hospital operations.

The chief pharmacist shall be the director of the hospital pharmacy and shall be engaged by the Board of Directors of the hospital concerned.

The hospital directors may seek tenders for the operation of a hospital pharmacy to provide the services specified in this Section, provided such operations fulfil all other requirements of the Act on the Activities and Operations of Pharmacies.
¹⁾Act No. 89/2003, Article 3.

[Article 38]¹⁾

In hospitals and other institutions operated under the Health Service Act or other special Acts, where no pharmacy is operated, a pharmacist shall supervise and be responsible for procurement of medicinal products and monitoring of their administration.

If the institution does not have a pharmacist in its employ under para. 1, the directors of the institution shall reach an agreement with an external holder of a pharmacy licence [or hospital pharmacy]²⁾ for medicinal product services, such as supervision of medicinal product procurement and monitoring of their administration. The agreement is subject to the approval of the [Medicines Control Agency.]²⁾
¹⁾ Act No. 89/2003, Article 3. ²⁾ Act No. 108/2000, Article 26.

[Article 39]¹⁾

A hospital pharmacy may dispense medicinal products to patients who are discharged from hospital and to outpatients. A hospital pharmacy may only dispense prescriptions bearing the hospital’s name and issued by its physicians.

The general rules which apply to prescription forms and dispensing of medicinal products shall apply to dispensing of medicinal products as authorised under this Article.
¹⁾Act No. 89/2003, Article 3

[Article 40]¹⁾

[The medicinal products committee of a healthcare institution shall issue a list of the medicines to be used in the institution in question. Such a committee shall include at least one physician practising at the institution and one practising pharmacist serving the institution. Care shall be taken, when a choice exists between two or more medicinal products, that the less expensive be selected for use at the institution, taking into account effectiveness, quality and safety.]²⁾
¹⁾Act No. 89/2003, Article 3. ²⁾ Act No. 97/2008, Article 9

[Article 41]¹⁾

The hospital Board of Directors must ensure that the premises and facilities of the hospital pharmacy or its medicinal product storage are fit for purpose and shall abide by the ruling of the [Medicines Control Agency]²⁾ in this respect.
¹⁾Act No. 89/2003, Article 3. ²⁾ Act No. 108/2000, Article 27.

[SECTION XV]¹⁾

Prices of medicinal products
¹⁾ Act No. 89/2003, Article 3.

[Article 42]¹⁾

The pricing of all non-prescription medicinal products shall be without restriction.

[[The Medicinal Product Pricing Committee]²⁾ shall determine the pricing of non-prescription veterinary medicinal products, cf. [Article 43.]³⁾]⁴⁾ [Vendors, i.e. medicinal product wholesalers and manufacturers and their agents or retailers, which wish to sell prescription-only medicines at a lower price than the stated maximum price, shall notify the lower price to the Medicinal Products Pricing Committee, which publishes the price in the next issue of the Medicinal Products Price List. The vendor shall sell the medicinal product at the same price at all its sales outlets.]⁵⁾
¹⁾Act No. 89/2003, Article 3. ²⁾ Act No. 83/2004, Article 10. ³⁾ Act No. 89/2003, Article 4. ⁴⁾Act No. 131/1994, Article 4. ⁵⁾Act No. 97/2008, Article 10. The provision takes effect 1 Jan. 2010 with respect to retailers under Act No. 97/2008, Article 13, cp. Act No. 28/2009, Article 1.

[Article 43]¹⁾

[The Minister appoints a five-person committee, the Medicinal Products Pricing Committee, for a four-year term. The committee shall comprise professionals in the fields of medicine, pharmacology and finance. Four of the committee members shall be appointed following nominations from the [Health Insurance Administration]²⁾, the Ministry of Finance, the Medical Director of Health and the Medicines Control Agency respectively. The chair shall be appointed by the Minister without nomination. Alternates shall be appointed in the same manner. In taking decisions, the Medicinal Products Pricing Committee shall bear in mind the objective of this Act to keep the cost of medicinal products to a minimum.

Upon receiving an application, the Medicinal Product Pricing Committee shall decide:

the maximum wholesale and retail price of prescription medicinal products and of all veterinary medicinal products;
whether public health insurance shall contribute under [Section III of the Health Insurance Act]²⁾ to the cost of medicinal products on the market in Iceland;
the contribution reference price, i.e. the price used as a basis for [health insurance]²⁾ contribution,
the contribution towards the price of medicinal products for which exemptions have been granted as provided in para. 7 Article 7.

The committee may refer applications concerning medicinal products for which exemptions have been granted under this provision to the [Health Insurance Administration]²⁾ for consideration.

The Medicinal Products Pricing Committee shall monitor the wholesale and retail pricing, and contribution reference price, of medicinal products in member states of the EEA and take its observations into consideration in its decisions on prices under items 1 and 3, para. 2. The Minister may in regulations decide that the committee’s decisions on prices shall be based on specified states of the EEA. In the case of parallel imported medicinal products, the Medicinal Products Pricing Committee shall, in determining a maximum price, take into consideration, for instance, the price for which an importer has made application, provided this is lower than the price for the same medicinal product in Iceland. In determining the price and contribution reference price of generic medicinal products (medicinal products containing the same active ingredient), the committee shall consider the price of the generic medicinal products in question in the EEA.

The Medicinal Products Pricing Committee shall classify generic medicinal products and medicinal products with comparable therapeutic effects into reference categories to determine the [health insurance]²⁾ contribution. Decisions by the committee under items 2, 3 and 4 para. 2 shall be based, on the one hand, on an assessment of the efficacy of the medicinal product and, on the other hand, on the cost of contribution.

When maximum wholesale prices for medicinal products are on the agenda, a representative of the organisation of medicinal product wholesalers shall take a seat on the committee and when the maximum retail prices for medicinal products are on the agenda a representative of the retail pharmacy organisation shall take a seat on the committee. When the maximum retail price for veterinary medicinal products is on the agenda, a representative of the veterinarians’ organisation shall take a seat on the committee and the views of [the Icelandic Food and Veterinary Authority]³⁾ shall also be elicited. In the case of a tied vote on a decision by the committee, the chair shall cast the deciding vote.

The Medicinal Products Pricing Committee undertakes publication of a medicinal products price list, listing maximum prices and the contribution reference prices for prescription medicinal products and all veterinary medicinal products. The Medicinal Products Pricing Committee may collect a fee for the medicinal products price list as determined by the Minister, acting on a proposal by the Medicinal Products Pricing Committee. The fee shall cover the cost of preparing the list.

Pharmacy licence-holders, veterinarians, medicinal products wholesalers and medicinal product manufacturers must provide the Medicinal Products Pricing Committee with all reports and documentation concerning the pricing of medicinal products, and other information which the Committee deems necessary in order to carry out its tasks.

The cost of the committee’s work, including remuneration to committee members and staff, shall be paid from the National Treasury.

If the committee does not agree to a requested price, price change or contribution, it must give grounds for its decision and inform the applicant of his/her right to refer the committee’s decision to a court, under the general rules. Decisions by the committee are not subject to review by the Minister.

The Minister may in regulations⁴⁾ make further provision for rules on the work of the Medicinal Products Pricing Committee. The Medicinal Products Pricing Committee may adopt its own rules of procedure.]⁵⁾
¹⁾Act No. 89/2003, Article 3. ²⁾Act No. 112/2008, Article 62 ³⁾Act No. 167/2007, Article 74. ⁴⁾Regs. 213/2005, cp. 892/2008 ⁵⁾Act No. 83/2004, Article 11.

[Article 44]¹⁾

[Importers and manufacturers of medicinal products and their representatives must make application to the Medicinal Products Pricing Committee concerning the maximum wholesale price, [health insurance]²⁾ contribution, and for all price changes to prescription medicinal products and veterinary medicinal products; applications must be accompanied by information on the wholesale price of the medicinal product in question in the countries specified in regulations, cf. para. 3 Article 43.

A decision by the Medicinal Products Pricing Committee on the price of a medicinal product shall be available and made known to the applicant no later than 90 days after receipt of an application. If an applicant has not submitted the necessary information with an application, the Medicinal Products Pricing Committee shall notify the applicant without delay as to what information is missing. A reasoned decision by the Medicinal Products Pricing Committee shall be available and made known to the applicant no later than 90 days after receipt of the necessary additional information by the committee. If a decision is not available within this time limit the applicant may market the medicinal product at the price applied for.

If a decision is also requested on the health insurance contribution for those with health insurance, this shall be made known to the applicant no later than 180 days after receipt of an application concerning the price of a medicinal product. If an applicant has not submitted the necessary information with an application, the Medicinal Products Pricing Committee shall notify the applicant as to what information is missing. A decision by the Medicinal Products Pricing Committee shall in such case be available and made known to the applicant no later than 90 days after its receipt of the necessary additional information.

A decision by the Medicinal Products Pricing Committee on an increase in the price of a medicinal product shall be available and made known to the applicant no later than 90 days after receipt of an application. The applicant shall provide the committee with sufficient information, including detailed information on the factors which it considers to justify the increase to the previously determined price. If an applicant has not submitted the necessary information with an application, the Medicinal Products Pricing Committee shall notify the applicant as to what information is missing. A decision by the Medicinal Products Pricing Committee shall in such case be available and made known to the applicant no later than 90 days after its receipt of the necessary additional information. If the Committee has received an unusually large number of applications it may extend the processing period for one additional period of 60 days. The applicant shall be notified of such an extension before the end of the normal time that the Medicinal Products Pricing Committee has to process the application. If no decision has been made available within this time limit the applicant may raise the price in accordance with the application.]³⁾
¹⁾Act No. 89/2003, Article 3. ²⁾Act No. 112/2008, Article 62. ³⁾ Act No. 83/2004, Article 12.

[Article 45

The Medicinal Products Pricing Committee is empowered to impose a price freeze. If a price freeze covers all medicinal products or medicinal products in a specific category the decision shall be reviewed at least once a year. Exemptions may be granted from a price freeze on the basis of an application under exceptional circumstances. Applicants requesting exemption shall provide sufficient information on the reasons for the request. A reasoned decision by the Medicinal Products Pricing Committee shall be made available and made known to the applicant within 90 days. If an applicant has not submitted the necessary information with an application, the Committee shall notify the applicant as to what information is missing. A decision by the Medicinal Products Pricing Committee shall in such a case be made available and made known to the applicant no later than 90 days after its receipt of the necessary additional information. If the committee has received an unusually large number of applications for exemptions it may extend the processing period for one additional period of 60 days. The applicant shall be notified of such an extension before the end of the normal time that the Committee has to process the application.]¹⁾
¹⁾Act No. 83/2004, Article 13.

[Article 46

The Medicinal Products Pricing Committee shall re-evaluate the pricing basis of medicinal products in Iceland as compared to the same products in the EEA on a regular basis and no less frequently than at two-year intervals, making proposals for changes if such evaluation so warrants.]¹⁾
¹⁾Act No. 83/2004, Article 13.

[SECTION XVI]¹⁾

Surveillance, legal proceedings and penalties
¹⁾Act No. 89/2003, Article 3.

[Article 47]¹⁾

[Surveillance under this Act, regulations or other instructions shall be the responsibility of the Medicines Control Agency. [In order to enforce a rectification or the implementation of a measure, or with respect to a violation of this Act, the Medicines Control Agency may apply the following actions:]²⁾
1. issue a reprimand;
2. issue a reprimand, allowing a suitable time limit for rectification;
[3. impose per diem fines]³⁾
[4.]³⁾ halt or limit the activities or use in question, including seizing products and ordering their destruction.

Halting activities and destruction of products may only be applied if the Icelandic Medicines Control Agency deems the danger of the operation or use in question to be so serious that action must be taken immediately, or if violations are repeated and the parties concerned fail to rectify the situation within the prescribed time limit. In the case of such a violation the Icelandic Medicines Control Agency may propose that the Minister revoke the licence for the operation in question.

In cases where a seal is used to halt activities, a special seal identifying the Icelandic Medicines Control Agency shall be used.] ⁴⁾

[If instructions from the Icelandic Medicines Control Agency are not heeded within the specified time limit, the Agency may levy per diem fines on parties subject to inspection under this Act. Such fines may amount to up to ISK 50,000 per 24-hour period. Their amount shall be determined by the nature of the violation and the financial capacity of the party subject to inspection.

The Minister of Health shall, in regulations, provide for more detailed rules on the determination of per diem fines.

If a decision on a fine is referred to a court the per diem fines shall not commence until final judgement is pronounced. The fines shall accrue to the National Treasury and are enforceable by execution without a prior court judgement.]³⁾
¹⁾Act No. 83/2004, Article 13. ²⁾Act No. 58/2005, Article 8. ³⁾ Act No. 63/2002, Article 5. ⁴⁾ Act No. 108/2000, Article 30.

[Article 48]¹⁾

[...²⁾
Violations against this Act or regulations issued on the basis of the Act shall be punishable by fines, unless more severe penalties are incurred under other legislation. In the case of repeated or major violations, punishment may consist of ...³⁾ imprisonment for up to two years. [The handling of gains resulting from a violation of this Act is punishable under Article 264 of the Criminal Code.]⁴⁾

An attempted violation or complicity in a violation of this Act is under Section III of the Criminal Code.

Medicinal products and substances for medicinal products which are manufactured, imported or sold illegally in Iceland shall be confiscated by court order, together with any profit from illegal sale of medicinal products. The value of the confiscated property shall accrue to the national treasury.]⁵⁾
¹⁾ Act No. 83/2004, Article 13. ²⁾Act No. 88/2008, Article 234 ³⁾Act No. 82/1998, Article 215. ⁴⁾ Act No. 10/1997, Article 13. ⁵⁾Act No. 55/1995, Article 2.

[SECTION XVII]¹⁾

Final provisions
¹⁾Act No. 89/2003, Article 3.

[Article 49]¹⁾

[The Minister may issue regulations²⁾ on the implementation of this Act, e.g. on dispensing of medicinal products in dose packaging and on restrictions on and monitoring of the production and marketing of specific substances which can be used for illegal manufacture of narcotic drugs or psychotropic substances.
The rules of the European Union on the European Medicines Evaluation Agency may be issued as Regulations.³⁾

[The rules of the European Union on Medicinal Products, as adapted for the EEA Agreement and the European Free Trade Association Treaty, may be published as Regulations.⁴⁾]⁵⁾

Decisions by the Icelandic Medicines Control Agency may be referred to the Minister under the provisions of the Public Administration Act.]⁶⁾
¹⁾Act No 83/2004, Article 13. ²⁾Reg. 421/1988, as subsequently amended, cf. 539/2000, 91/2001, 105/2001, 111/2001 and on prescription forms and prescribing of medicinal products, etc.). Reg. 633/1994 (on the entry into force of EEA Acts on medicinal products). Reg. 328/1995, cf. 95/2001 (on advertising of medicinal products). Reg. 582/1995, cf. 584/1995 and 622/1995 (on marketing authorisations for parallel imported medicinal products). Reg. 594/1995 (on colouring agents in medicinal products). Reg. 501/1996 (on the determination of prices of medicinal products). Reg. 650/1996 (on fees for medicinal product licences). Reg. 699/1996, (on the importation and wholesale distribution of medicinal products), cf. 484/2001 and 846/2002. Reg. 700/1996 (on manufacturing of medicinal products). Advertisement No. 226/1997 (on the entry into force of international conventions on pharmaceutical affairs). Reg. 426/1997 (on licences for the sale of medicinal products and pharmacies). Reg. 674/1997 (on marketing authorisation for natural medicinal products). Reg. 212/1998 (on importation by individuals of medicinal products for their own use), cf. 230/2001. Reg. 421/1998 (on practical training of pharmacology students and pharmacy technicians). Reg. 462/2000 (concerning marketing authorisations for proprietary medicinal products, their labelling and package leaflets), cf. 766/2001, 443/2005, 581/2006 and 1251/2008. Reg. 539/2000 (on veterinarians’ authorisations to prescribe medicinal products), cf. 912/2000, 14/2008 and 1069/2008. Reg. 967/2000 (on the importation, sale and distribution of homeopathic medicinal products). Regs. 91/2001 (on issue of prescriptions, signature and delivery of medicinal products), cp. 844/2002, 801/2007, 894/2008 and 219/2009. Regs. 111/2001 (on prescription forms and prescription of medicinal products), cp. 485/2001, 843/2002, 382/2006, 802/2007 and 893/2008. Reg. 850/2002 (on dosages of medicinal products). Reg. 241/2004 (on the selection, storage and handling of medicinal products in hospitals and other health care institutions). Reg. 443/2004 (on clinical trials on humans), cp. 907/2004. Regs. 893/2004 on manufacture of medicinal products). Advertisement. 902/2004 (on adoption of international conventions in the field of medicinal products).Regs. 213/2005 (on the Medicinal Products Pricing Committee) cp. 892/2008. Regs. 441/2006 (on collection, handling, storage and distribution of blood) cp. 1024/2007. Regs. 1077/2006 (on dentists’ prescribing of medicinal products) Regs. 1065/2008 (on sale of medicinal products by mail order. Regs. 1188/2008(on quality and safety in handling of human cells and tissues).³⁾ Reg. 181/2001. ⁴⁾Reg. 652/2001, reg. 402/2002, regs. 834/2004, regs, 386/2006, regs.346/2007, regs. 950/2008. ⁵⁾Act No. 76/2002, Article 28. ⁶⁾ Act No. 108/2000, Article 31.

[Article 50]¹⁾

This Act shall enter into force 1 July 1994.

...
¹⁾Act No. 83/2004, Article 13.

Temporary provisions

Regulations issued on the basis of the Medicinal Products Act No. 108/1984 and the Medicinal Products Distribution Act No. 76/1982, as subsequently amended,¹⁾ shall remain in force until new Regulations have entered into force, provided their content is not contrary to this Act.
Present pharmacy licence-holders shall retain their pharmacy licences following the entry into force of Section VII of the Act. Pharmacies operated by co-operatives in Akureyri and Selfoss, and the Pharmacy of the University of Iceland, shall have until [15 March 1996]²⁾ to fulfil the requirements of this Act. Physicians and local authorities shall retain their pharmacy licences until [15 March 1996]²⁾ and thereafter until a person fulfilling the requirements of this Act applies for a pharmacy licence. Notwithstanding the provisions of para. 2 Article 6 of the Act on the Distribution of Medicinal Products No. 76/1982, the Minister may extend pharmacy licences until the provisions of Section VII enter into force.
The provisions of Sections VII and [XV]³⁾ shall not enter into force, however, until [15 March 1996.]²⁾ The same shall apply to the decision on remuneration for dispensing of medicinal products by veterinarians under [Article 33]³⁾.
[
A Medicinal Products Pricing Committee shall be appointed under para. 1 art. 43 of this Act not later than 1 September 2004. The Medicines Pricing Committee and Medicines Contribution Committee shall retain their authority until the Medicinal Products Pricing Committee has been appointed.]⁴⁾
[
Marketing authorisations issued or renewed before 30 October 2005 shall be renewed once for a period of five years in accord with para. 2 art. 7 of this Act.]⁵⁾
[
Licences to sell or import medicinal products, wholesale licences and manufacturing licences issued by the Minister of Health before 1 October 2008 remain in force, notwithstanding the provisions of arts. 20, 32 and 34 of this Act.]⁶⁾

¹⁾With respect to regulations for which provision was made in previous legislation, see Lagasafn 1990, cols. 11041-1050 and 1054-1062. ²⁾ Act No. 118/1995, Article 4. ³⁾ Act No. 89/2003, Article 4. ⁴⁾ Act No. 83/2004, Article 14.⁵⁾ Act No. 58/2005, Article 9. ⁶⁾ Act No. 97/2008, Article 11

Medicinal Products Act

No 93, 20 May 1994