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Regarding timely reporting of medicinal product supply disruptions


Please note that in accordance with Subparagraphs 153.1, 153.3.2 of the Cabinet of Ministers Regulation No. 416 on 26 June 2007 “Procedures for Distribution and Quality Control of Medicinal Products”, medicinal product marketing authorisation holder or their authorised representative (hereinafter – MAH) is responsible for placement of medicinal product on the market and for timely notification of medicinal product supply disruptions. Such notification must be submitted to the State Agency of Medicines (hereinafter – Agency) at least two months prior to the supply disruption or discontinuation of medicinal product release on the market. Submission of notification shortly before a supply disruption is critical, but must be viewed as an extraordinary situation.

We would like to inform you that there is no definition of medicinal product supply disruption included in the normative acts of Latvia, but in essence it is a situation where none of the medicinal product wholesalers in the Republic of Latvia are able to purchase a medicinal product. We wish to thank the MAHs who submit timely notifications of shorter or longer supply disruptions. However, overall from 1 January until 15 February 2020, forty-six MAH notifications regarding medicinal product supply disruptions were received by the Agency only after request, following reports of unavailability submitted by pharmacies, healthcare institutions or residents.

We wish to emphasise that it is in the public interest to have access to timely information regarding availability of medicinal products on the Agency’s website, allowing search for alternatives in case of shortage of medicinal products. Please note that the Medicinal Product Register on the Agency’s website provides information regarding both estimated start date of medicinal product shortage, as well as date of renewal of availability, therefore, please also notify the Agency in a timely manner regarding renewal of medicinal product availability. Please submit notifications also in case where the date of medicinal product supply or shortage is not known or cannot be estimated, indicating an approximate date in the notification. MAHs may submit an additional notification in order to clarify the planned date for supply or shortage of medicinal product.

Seeing as from 1 April 2020 the international non-patented names (INN) of medicinal products will be used as part of the List A reimbursement system and pharmacists will be obligated to dispense equivalent therapeutic efficacy medicinal products with the lowest price, the information included in the Medicinal Product Register will be very important. Therefore, it is of the highest importance that the Agency receives information regarding shortages of medicinal products or renewal of their availability as soon as possible.

We wish to inform that starting from 1 March 2020 the Agency plans on publishing information on its website regarding MAHs who are non-compliant with the requirements of normative acts and have not notified of medicinal product supply disruptions in a timely manner, and have not given a prompt response (within 8 hours on a working day) to the Agency’s requests for information regarding availability of medicinal products.

In addition, we would like to inform that, in accordance with Section 175.2 of the Latvian Administrative Violations Code, legal persons may be fined up to 700 euros for not providing information in a timely manner.