Iceland Pharmaceutical Licensing

This record concerns retail sale, import/wholesale and manufacture of human medicinal products in Iceland; it is not about financial licensing. IMA regulates manufacture, distribution and sale; company registration or a product marketing authorisation cannot replace the relevant business licence.

Company formation and medicinal product licensing must be treated separately. Wholesale and manufacturing applications require the company name, address and kennitala, and pharmacy applications also require identity information; however, the verified materials do not establish generally applicable company-form, capital, foreign-ownership-ratio or incorporation requirements for all three types of business. The Directorate of Health issues individual pharmacist practice licences, while IMA handles business licences.

— Retail requires a licence for a single pharmacy; import/wholesale licences are valid for up to five years; manufacturing licences are site-specific, while product and controlled-substance requirements must be assessed separately.

IMA is the principal regulator of medicinal product businesses, responsible for medicinal product manufacture, sale and related licences, and supervises pharmacies, manufacturers and businesses licensed for import/wholesale. IMA handles the specific applications, inspections and variations for retail, wholesale and manufacturing.

Pharmacies involve two separate levels: IMA issues pharmacy licences and consults the relevant local government on new pharmacy applications; the Directorate of Health issues individual pharmacist practice licences. Local government input is not a pharmacy licence. Applicable rules include the Medicinal Products Act No. 100/2020, Pharmacy Regulation No. 1340/2022, Import/Wholesale Regulation No. 699/1996 and Manufacturing Regulation No. 893/2004.

— IMA is responsible for business regulation; the Directorate of Health is responsible for pharmacist practice; local government provides input to IMA only in relation to new pharmacies.

For a new pharmacy, IMA issues a pharmacy licence when the requirements are met and, where applicable, an operating licence; each pharmacy licence is limited to one pharmacy, the holder assumes personal professional responsibility, and a pharmacist may hold only one at a time. The application must include a copy of an Icelandic pharmacist practice licence and evidence of at least two years’ work as a pharmacist in Iceland after obtaining that licence; if the operating licence holder is a different person, their details and confirmation of operational cooperation must also be submitted.

Before opening, submit site/equipment plans, a quality manual covering receipt, storage, dispensing and supply, personnel information, and fire safety, hygiene and occupational safety opinions; once the premises are ready, apply to IMA in writing for an inspection. A change of holder at an operating pharmacy requires information about the new applicant and a relinquishment declaration from the former holder; the licence cannot simply be carried over automatically as part of a commercial transaction.

— For new applications, IMA consults local government; the verified page does not specify when an operating licence applies, a standard fee, a general period of validity or renewal rules.

IMA’s official page states that finished medicinal products and active substances may be imported and wholesaled only by a person licensed by IMA; applications must be made using the designated form. IMA supervises businesses licensed for import and wholesale. This also applies to investigational medicinal products: IMA expressly states that all medicinal products, including IMPs, must be imported by a licensed medicinal product wholesaler.

Documents for a new wholesale/import application include basic information about the company and its representative applicant, an outline of the planned activities, site plans, principal equipment, medicinal products and dosage forms intended for import and/or wholesale, the main components of the quality system, the technical manager’s CV and, if different, the QP’s CV. IMA assesses the application documents and conducts an on-site inspection of the applicant company.

A manufacturing licence holder may distribute products covered by its own manufacturing licence through wholesale channels, but this does not mean that general wholesalers may manufacture, nor does it remove separate product marketing authorisation or controlled-substance requirements.

— The scope covers import and wholesale of finished medicinal products/active substances; submit information on the site, equipment, products/dosage forms, quality system and responsible personnel, and undergo IMA document review and an on-site inspection.

Only a holder of an IMA manufacturing licence may manufacture medicinal products. The licence applies only to the site where the applied-for activities are to take place; manufacture of human, veterinary and investigational medicinal products must comply with GMP. The application must list the company and applicant, manufacturing/quality-control addresses, activities, site plans, equipment, products and dosage forms, processes, quality system, technical manager and, where required, QP information.

A manufacturing company must have a technical manager and a QP; the technical manager must be a qualified pharmacologist or hold at least an equivalent qualification, and the QP may also serve as the technical manager. The licence specifies the site, number, authorised operations and period of validity; an MIA in EudraGMDP remains valid only while supported by a valid GMP certificate, and cannot replace a product marketing authorisation or controlled-substance licence.

— A manufacturing licence is site-specific; a GMP certificate, MIA, CPP and laboratory GMP certification each have distinct scopes and cannot substitute for one another.

Individual pharmacist practice is licensed by the Directorate of Health; pharmacy applications additionally require that licence and evidence of at least two years’ work as a pharmacist in Iceland. Pharmacists are responsible for and supervise prescription dispensing; pharmacists, pharmacy graduates or pharmacy technicians may provide information and advice about medicines, but the dispensing pharmacist remains responsible for the consultation.

Wholesale applications must list the technical manager and, where required, the QP, but the page does not publish uniform qualification thresholds for all wholesalers. The Manufacturing Regulation requires a technical manager and a QP and specifies the technical manager’s qualifications; retail pharmacist experience or manufacturing qualifications must not be mechanically applied to wholesale.

— Individual practice, pharmacy licence holding, wholesale management and manufacturing QP requirements are distinct compliance matters and should be verified separately.

Pharmacy premises must comply with Chapter 3 of the Pharmacy Licensing and Pharmacy Regulations No. 1340/2022. IMA requires submission of a plan showing and describing the location of the main equipment, and stipulates that it be received at least eight weeks before the planned opening; the quality manual must be received at least one month before the planned opening. Readiness of the pharmacy includes completion of fit-out, operability of the necessary equipment, and ability to receive supplies from wholesalers.

Wholesale/import premises should undergo an IMA on-site inspection based on the premises plan, main equipment, products/dosage forms intended to be handled, and quality system in the application materials. The official pages do not publish a single set of area or environmental values applicable to every category and every warehouse; this guide must not invent area, temperature/humidity, or storage-location standards.

A manufacturing licence applies only to a specific site. The manufacturing application must specify the addresses for manufacturing and quality control, layout, main equipment, production steps, and quality system; IMA verifies the information by on-site inspection. The Manufacturing Regulations also require all manufacturing processes to comply with GMP principles and guidelines.

— Pharmacy: emphasis on the quality manual and pre-opening inspection; wholesale: premises/equipment/quality system; manufacturing: premises, processes, quality system, and GMP.

The three pathways are submitted using IMA's designated forms or written procedures and cannot be combined into one “all-business-types pharmacy licence.” The pharmacy pathway focuses on a licensed pharmacist, two years' experience, premises information, and pre-opening inspection; wholesale/import focuses on the entity, activities, premises/equipment, products/dosage forms, quality system, and responsible person; manufacturing additionally requires the manufacturing/quality-control addresses, processes, and GMP.

A pharmacist's licence to practise is an individual application handled by the Directorate of Health; pharmacists cannot use the electronic route on that page. The project should first identify whether the business also involves products, investigational medicinal products, or controlled substances, then prepare the documentation under the relevant IMA pathway and undergo any applicable inspection.

— First separate the application pathways according to the actual business activities, then prepare personnel, premises, product scope, and quality-system documentation using the relevant IMA forms and undergo any applicable inspection.

IMA has a three-month processing period for a new pharmacy application; an inspection application after the pharmacy is ready has a four-week processing period. The premises plan and quality manual have separate submission milestones relative to the planned opening; none of these guarantees opening if documentation is incomplete or observations remain unresolved.

New wholesale/import and manufacturing applications each take 90 days, with the clock suspended while further information is awaited. Wholesale/import licences are valid for up to five years; renewal requires a new application and updated information. A validity period is stated for manufacturing licences, but no uniform duration in years has been verified. The ordinary licence pages reviewed do not list a standard fee, and the controlled-substances page only refers to the IMA fee schedule; accordingly, no fee quotation or commitment to an overall timeframe is given.

— New pharmacy: three months; its inspection application: four weeks. New wholesale/import and manufacturing: 90 days each, with the clock suspended while further information is awaited; wholesale/import: up to five years.

Pharmacy licence holders must provide information on medicines, their use, and storage; serious dispensing or supply incidents must be reported to IMA immediately, with an incident record submitted. Closure also involves unfilled prescriptions, records, controlled-medicine stock, and notifying customers. Renewal of an expired wholesale/import licence requires a new application and updated information.

Manufacturers must continue to comply with GMP; an MIA remains valid only while the relevant GMP certificate in EudraGMDP remains valid. Manufacture, import, and distribution of active substances are activities registered with IMA and should not be misrepresented as automatically included in a finished-medicinal-product manufacturing licence.

— Pharmacy: ongoing safe dispensing, counselling, and incident reporting; wholesale: renewal and updated information; manufacturing: maintain GMP and MIA/GMP status, and handle active-substance registration separately.

A pharmacy licence involves an individual licence holder and individual professional responsibility. For a change of licence holder at an operating pharmacy, IMA requires the new applicant to meet the Medicinal Products Act and relevant regulations, and to submit proof of two years' work as a pharmacist in Iceland, a signed statement from the former licence holder relinquishing the licence, and confirmation of cooperation with the holder of the operating licence (if different). IMA allows at least four weeks for processing after receiving all documents.

Wholesale/import and manufacturing licences both require the licence holder to apply to IMA for an amendment when information forming the basis of the licence changes. The standard processing period for both wholesale/import and manufacturing is 30 days and may be extended to 90 days in specific cases; the clock is suspended while further information is awaited. The Manufacturing Regulations also require IMA to be notified immediately when a QP leaves, together with the identity of the new QP.

The materials verified do not specify whether ordinary share transactions, changes of control, company mergers, name changes, or asset acquisitions automatically trigger any particular licensing procedure for each licence type. It therefore cannot be claimed that a licence transfers automatically with shares or assets; before signing a transaction, consult IMA based on the actual structure, licence-holding entity, premises, personnel, and product scope.

— Pharmacy change of licence holder: new application and relinquishment statement from the former holder; changes to the basis of a wholesale/manufacturing licence: application required; manufacturing: notify IMA immediately when a QP leaves.

A product marketing authorisation is different from a business operating licence. IMA's guidance lists centralised, mutual-recognition, decentralised, and Icelandic national authorisation pathways; under the EEA framework, the centralised pathway still involves corresponding issuance steps for Iceland, while national authorisation applies only in Iceland. Authorisation of a product for marketing does not mean that a pharmacy, wholesale warehouse, or manufacturing site is authorised to operate.

Medicinal products should generally be imported by a licensed medicinal-product wholesaler, including investigational medicinal products; a company holding a manufacturing licence may distribute products covered by that licence through wholesale channels. A wholesale licence for importing finished medicinal products or active substances does not replace the marketing authorisation for a specific product, clinical-trial arrangements, or a manufacturing licence.

Each consignment of narcotic drugs requires an import or export permit from IMA. The import section states that a written application must be made by a company holding a medicinal-product import licence; the export section separately states that a manufacturing or wholesale licence holder may apply, and that the application must include an import permit from the competent authority in the destination country. DI/DII controlled substances may obtain an import certificate valid for the remainder of the calendar year; ephedrine and pseudoephedrine require a separate application for each consignment. Applicants also have obligations concerning information on permits used or unused, quantities, and year-end stock/activity reports.

— Product marketing, general imports, investigational medicinal products, and controlled substances are separate procedures; narcotic drugs require an application for each consignment, while DI/DII are generally handled by annual certificates.