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Notifications regarding start of distribution, supply disruptions and price of medicinal products

Marketing authorisation holders must inform the State Agency of Medicines (SAM) prior to start of distribution of medicinal product in Latvia and in case of temporary or permanent disruptions in medicinal product supply, as well as regarding the price of medicinal product.

 

1. Please indicate the following information in the notification regarding date of starting distribution of medicinal product:
●    For medicinal products authorised and parallel imported in Latvia: product number in the Medicinal Product Register of Latvia.
●    For centrally authorised and parallel imported medicinal products: European Union number assigned by the European Medicines Agency for each authorised medicinal product packaging size.

 

2. Please indicate product number in the notification regarding disruption in medicinal product supply. This notification must be submitted to SAM at least two months before discontinuing the release of medicinal product on the market in Latvia (except extraordinary conditions).

Please inform SAM about medicines shortages via this form below.

 

 

After submitting the notification to SAM please verify whether the information you submitted regarding availability of medicinal product has been updated in the publicly available Medicinal Product Register of Latvia.

 

Important notice: regarding distribution of medicinal products, which are intended for foreign markets, in the market in Latvia*

Prior to initiating distribution of a medicinal product with labelling and package leaflet in a foreign language, the marketing authorisation holder (MAH) must send a letter to SAM with a justified request for distribution of a medicinal product, which is intended for a foreign market, in the market in Latvia. Please add to the letter a verification issued by the qualified person of the medicinal product manufacturer responsible for release of the relevant product batch confirming that the marketing authorisation documentation of the product intended for a foreign market is compliant with the product documentation included in the Medicinal Product Register of Latvia (except for medicinal products authorised via centralised, decentralised or mutual recognition procedures where Latvia and the country of origin are concerned member states).

When distributing medicinal products as aforementioned, the MAH must also ensure translation of package leaflet and labelling in Latvian (there must be at least one translation of product labelling and package leaflet in Latvian per product shipment). Please see more information regarding requirements related to documentation in Latvian in the Cabinet of Ministers Regulation No. 57 of 17 January 2006 “Regulations Regarding Procedures for the Labelling of Medicinal Products and the Requirements to Be Set for the Package Leaflet of Medicinal Products” (Article 7.6).
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* SAM is entitled to waive the requirement for MAH to ensure product labelling and package leaflet in the state language, if the medicinal product is not to be supplied directly to the patient or in case of emergency related to substantial disruptions in availability of medicinal products and serious threat to the health or life of residents.

 

3. Please provide information regarding the retail cost of medicinal product in Latvia, using the SAM-approved table:

Table No. 1 - Determination of the Price of Medicinal Product

Please complete the table using the Microsoft Excel software and submit it in writing to SAM. The table may be submitted electronically on an electronic data carrier or via e-mail: info@zva.gov.lv.

Please note that in accordance with Article 22 of the Cabinet of Ministers Regulation No. 803 of 25 October 2005 “Regulations Regarding the Principles for the Determination of the Price of Medicinal Products” the marketing authorisation holder must submit to SAM information regarding the retail price of medicinal product twice a year on the first day of the six-month period, as well as in case of changes in the manufacturer price.

 

More information

Cabinet of Ministers Regulation No. 416 of 26 June 2007 “Procedures Regarding the Distribution and Quality Control of Medicinal Products” (Article 153.3)

Cabinet of Ministers Regulation No. 803 of 25 October 2005 “Regulations Regarding the Principles for the Determination of the Price of Medicinal Products” (Article 4, 5 and 6)