The objective of the State Agency of Medicines (hereinafter - the Agency) is to work in the public interest so that the population has access to safe and effective medicinal products.
In accordance with Sub-paragraph 146.16 of Regulation No 416 of 26 June 2007 “Procedures Regarding the Distribution and Quality Control of Medicinal Products” (hereinafter - Regulation No 416) the Agency shall follow the availability of medicinal products and analyze it, forecast tendencies and public health risks.
Having assessed the situation and concluded that interruptions in the availability of medicinal products cannot be completely avoided, it is important for the Agency to take timely action to reduce the risks to public health that may arise from medicinal product shortages. In order to ensure continuous and sufficient supplies of medicinal products essential for medical treatment institutions and society in the approaching autumn/winter season, we kindly ask marketing authorization holders to evaluate and find an opportunity to ensure sufficient supplies of medicinal products for medicinal products registered in Latvia (including antibiotics, nonsteroidal anti-inflammatory drugs for children and oncological medicines).
We would like to kindly remind that in cases where it is not possible to supply medicinal products in packages for which information is indicated on the labelling and package leaflet in the official language (including when repackaging medicinal products by the manufacturer of medicinal products), in accordance with 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” requirements there are exceptional cases for the distribution of medicinal products in Latvia in packages intended for the market of another country. Please refer to the information on the Agency's website in order to make an application or notification.
In order for the Agency to be informed and to obtain more complete information on medicinal products actually on the Latvian market and to be able to solve the issues of supply interruptions in a timely and effective manner, we kindly ask to provide information on interruptions in the supply of medicinal products in accordance with the requirements of Regulation No 416. A statement that the medicinal product has interruptions in supply (shortage) can be submitted using this form.
Please note that English version of regulations may not include latest amendments, therefore, for reference use Latvian original version.
