The right of the public, stakeholders and others to access documents and information relating to the activities of the Icelandic Medicines Agency.

Access to information on marketing authorisations for medicinal products, etc.

The right of the public, stakeholders and others to access documents and information, for example in connection with the granting of marketing authorisations for medicinal products, supervision by the Icelandic Medicines Agency or other matters relating to the Agency’s activities, is governed by the following legislation:

Medicinal Products Act, No. 100/2020, as amended

1. Publication of information on the granting of marketing authorisations

In accordance with Article 68 of Regulation No. 545/2018 on marketing authorisations for proprietary medicinal products, their labelling and package leaflets, the Icelandic Medicines Agency publishes information each month, in list form, on marketing authorisations granted and marketing authorisations withdrawn.

2. Online medicinal products register

The Icelandic Medicines Agency operates the website www.serlyfjaskra.is, which contains information on medicinal products with marketing authorisation in Iceland, including the SmPC/SPC and package leaflet.

3. Medicinal product statistics

The Icelandic Medicines Agency maintains statistics on medicinal products on the domestic market, including the number of marketing authorisations, the status of medicinal products on the market, use of medicinal products and other matters. Access to such information is provided upon request.

4. Enquiries

The Icelandic Medicines Agency provides information on medicinal products to the public, healthcare professionals and other stakeholders. Enquiries may be directed to the Icelandic Medicines Agency, and the Agency’s experts will endeavour to respond.

Information Act, No. 140/2012, as amended

1. General access

Under Article 5(1) of the Information Act No. 140/2012, public authorities are required, upon request, to provide the public with access to existing documents concerning a specific matter, subject to the limitations set out in Articles 6–10 of the Act.

Article 5(2) of the Information Act provides that the right of access to documents extends to:

• all documents concerning a matter, including transcripts of letters sent by a public authority or another party under Chapter I of the Information Act, provided that it may be assumed that they have reached the recipient;

• log entries relating to the documents of the matter and lists of case documents.

Under Article 11 of the Information Act, access to documents may be granted to a greater extent than required under the Act, provided that other legal rules do not prevent this, including provisions on confidentiality and data protection.

2. Limitations on the right to information

Articles 6–10 of the Information Act contain provisions limiting public access to documents held by public authorities. These are exceptions to the main rule on the public’s right to information and are exhaustively listed in the Act.

• Documents relating to staff matters and working documents: Article 6 of the Information Act provides that the public’s right of access to documents does not extend to working documents or to documents relating to staff matters. Notwithstanding this, Article 7 of the Information Act provides for the public’s right to certain specified documents relating to staff matters, and Article 8 addresses working documents and how they are defined.

• Limitations on the right to information due to private interests: Under Article 9 of the Information Act, public access may not be granted to documents concerning the private or financial affairs of individuals where it is reasonable and natural that such information remain confidential, unless the person concerned consents. The same limitations apply to access to documents concerning important financial or commercial interests of companies and other legal entities.

Administrative Procedures Act, No. 37/1993, as amended

1. Right of a party to a case to information

Article 15 of the Administrative Procedures Act No. 37/1993 provides for the right of a party to a case to information. A party to a case has the right to familiarise themselves with documents and other materials concerning the case and, if they request copies of case documents, that request shall be granted unless the nature or number of the documents is such that doing so would involve significant difficulties. Article 15 also provides that statutory provisions on the confidentiality obligations of staff do not limit the obligation to provide access to documents under the provision.

2. Restricted access to documents

In special circumstances, a public authority may restrict a party’s access to case documents if the party’s interest in using the knowledge contained in them is considered to have to give way to much stronger public or private interests, cf. Article 17 of the Administrative Procedures Act. This authorising provision is a narrow exception to the main rule. The Article also states that the rule on access to case documents does not affect individuals’ rights under data protection legislation.