Obligations of pharmaceutical companies in medicine shortages

Marketing authorisation holders must report medicine shortages to the Icelandic Medicines Agency (IMA) in accordance with the Medicinal Products Act, No. 100/2020 and the Regulation on Marketing Authorisations for Proprietary Medicinal Products, their Labelling and Package Leaflets, No. 545/2018.

A shortage of a medicinal product, i.e. a marketed medicinal product that is temporarily not on the market, shall be reported at least two months in advance, unless special circumstances apply. Where special circumstances apply, it is important that the report states why it was not made two months in advance. The reporting form for medicine shortages is available on My pages on IMA's website.

Wholesale distribution licence holders are obliged to report impending shortages of medicinal products to IMA, cf. paragraph 5 of Article 29 of the Medicinal Products Act, No. 100/2020.

Wholesalers shall at all times hold stocks of the main medicinal products that have a marketing authorisation in Iceland and that the wholesaler distributes. Wholesalers shall supply medicinal products that are not in stock as quickly as possible and shall provide comparable service to all regions of the country, cf. Article 10 of Reglugerð um innflutning, heildsöludreifingu og miðlun lyfja, No. 699/1996.

Wholesalers of exempt medicines (undanþágulyf) are not required to report anticipated medicine shortages to IMA, and IMA is consequently unable to mitigate the impact of shortages of such medicines on patients and the healthcare system. It is important that medicinal products in regular use in Iceland are placed on the market.

IMA points out that if marketing authorisation holders fail to report a medicine shortage, such failure may be considered a breach of the provisions of the Medicinal Products Act, No. 100/2020 and the Regulation on Marketing Authorisations for Proprietary Medicinal Products, their Labelling and Package Leaflets, No. 545/2018. Breaches may result in a reprimand or fines.

Marketing authorisation holders must report to IMA any medicine shortage resulting from deregistration, i.e. withdrawal of a marketing authorisation or removal from the registers of medicinal products, in good time, or at least two months before stocks run out.

It is preferable for marketing authorisation holders to apply for removal or withdrawal of the marketing authorisation and report the medicine shortage at the same time, cf. the guidelines.