Changes in office hours of the State Agency of Medicines

Please be informed about the working hours of the State Agency of Medicines during summer period (until 10 September):

Monday: 8:30 – 17:00
Tuesday: 8:15 – 17:00
Wednesday: 8:15 – 17:00
Thursday: 8:15 – 17:00
Friday: 8:15 – 16:00

In pre-holiday days: until 15:00.

Reception hours have not changed and are available in the section “About Us > Contacts”.

A publicly available Register of Pharmaceutical Activity Companies has been established

Establishment of the new Register makes searching for information much faster and easier and provides a more convenient overview of the information

In order to ensure that updated and official information regarding pharmaceutical activity companies licensed in Latvia* is easy to find and overview, the State Agency of Medicines (SAM) has established the Register of Pharmaceutical Activity Companies with interactive search functionalities.

The Register includes information regarding licensed pharmacies, manufacturers, distributors and importers of medicines and active substances, medicines wholesalers, including also companies that are licensed in EU and EEA countries and have notified SAM regarding initiation of wholesale distribution in Latvia.

Register of Pharmaceutical Activity Companies

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Transfer of Marketing Authorisation Holder

Please note that transfer of marketing authorisation holder (the new marketing authorisation holder is a different legal entity) is a national variation to marketing authorisation documentation that will be evaluated by the State Agency of Medicines (SAM) for medicinal products authorised in the national, mutual recognition (MRP) and decentralised (DCP) procedures.

In order to change the marketing authorisation holder, the current marketing authorisation holder must submit to the SAM an application for type II variations. Read more

Information regarding variations to marketing authorisation documentation is available on the website of the State Agency of Medicines

In accordance with the 13 April 2018 amendments to the Cabinet of Ministers Regulation No. 376 of 9 May 2006 “Procedure for Registration of Medicinal Products”* (subparagraph 122.1), changes have been made to the procedure how the marketing authorisation holder (MAH)/applicant shall be informed of approval or refusal of variations to marketing authorisation documentation.

Hereafter, all information regarding approved, refused or partially approved variations to marketing authorisation documentation will be published on the State Agency of Medicines’ (SAM) website, section “Services > Human medicines: Authorisation, Renewal, Variations > Variations in the Medicinal Product Register of Latvia”. Please note, that this section includes information assembled starting from 13 April 2018.

Variations in the Medicinal Product Register of Latvia

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The Baltic meeting in Estonia

The meeting of regulatory agencies of human and veterinary medicinal products of the Baltic States took place on 10 May 2018 in Tartu, Estonia. The aim of the meeting was to exchange information, to find new areas where the agencies could promote Baltic strength based on long term cooperation and to harmonize the positions for different procedures in the area of regulation of medicinal products. Heads of Estonian, Latvian and Lithuanian agencies together with 40 specialists participated in the meeting. The organisations participating were Estonian State Agency of Medicines, Latvian State Agency of Medicines, Latvian Food and Veterinary Service, Lithuanian State Medicines Control Agency, Lithuanian National Food and Veterinary Risk Assessment Institute and Lithuanian State Food and Veterinary Service.

The update on the actions under the Agreement on the co-operation in the area of GMP, GDP, GCP, PhV inspections and laboratory testing between Estonia, Latvia and Lithuania and on the Common Baltic Labelling Procedure was given. The co-operation in these fields continues. In regards to the common labelling procedure for human medicines small amendments were proposed to the template (related to safety features). Regarding the common labelling procedure for veterinary medicines some practical aspects were also discussed in parallel session. It was agreed that the management of the applications for the Baltic packages shall be considered as a priority in all the agencies. Read more

Subgroup of common visual reminder (boxed warning and pictogram) to warn patient about teratogenic or foetotoxic effect on Baltic Package agreed upon the following common pictogram and its layout

For medicinal products where a visual reminder on the outer package to warn patient about teratogenic or foetotoxic effect has been requested as part of additional risk minimisation measure, the pictogram and the boxed warning must be placed on a dedicated surface of the outer packaging bearing no other labelling. Text in boxed warning must contain same languages as on the labelling.

Boxed warning and pictogram must be placed side by side.

The pictogram must take the form of a red triangle on a white background, at least a centimetre in diameter, containing an image of a pregnant woman in black. The dimensions of the pictogram, which must be legible, shall be adapted to the size of the outer packaging of the medicinal product. The use of common pictogram has been agreed by Estonian, Latvian and Lithuanian agencies.

In order to ensure a harmonised risk communication for patients in Latvia, the State Agency of Medicines invites all Marketing authorisation holders of the relevant medicinal products registered in national, decentralised and mutual recognition procedures to use the same visual reminder as recommended for the Baltic Package on the outer packaging of their represented medicinal products.

The 2017 Annual Report of the State Agency of Medicines

The State Agency of Medicines (SAM) has published its Annual Report of the year 2017 which summarizes information regarding the operation of the Agency during the previous year.

Some of the numbers that show Agency’s achievements last year:

• marketing authorisations were issued for 254 new medicines,
• SAM carried out a total of 182 medicines renewal procedures,
• issued 7248 authorisations for import, export, transit and distribution of medicines,
• 50 authorisations issued for conduct of clinical trials,
• 278 clinical trials took place in Latvia in 2017,
• 588 adverse drug reaction reports were received,
• the Laboratory tested 119 samples of medicines; 97 samples of purified water produced in pharmacies were selected and tested, 349 volumetric solutions, indicators and reagents were prepared,
• 253 announcements of medical devices placement on the market were received and information on them was entered in LATMED medical device database,
• 218 Certificates of Pharmaceutical Product and 30 Certificates of Free Sale were issued,
• 343 licences for the activity of pharmacies, 46 licences for medicines wholesalers, 19 licences for medicines manufacturing or import and 4 licenses for manufacturing of the active substances were issued,
• 17 permits for utilisation of tissues and cells were issued to tissue centres and one permit – to a higher education institution, including 14 related to changes in activity,
• 24 compliance certificates were issued to blood establishments and blood banks.

The 2017 Annual Report of the State Agency of Medicines is available in the section “Publications” on the SAM website.

Changes in office hours of the State Agency of Medicines

Please be informed that on 3 May 2018 working hours of the State Agency of Medicines will be 8.30 – 15.00. Reception hours will be 9.00 – 12.30.

On 4 May 2018 the State Agency of Medicines will be closed.

Changes in office hours of the State Agency of Medicines

Please be informed that on 21 April 2018 working hours of the State Agency of Medicines will be 8.30 – 15.00. Reception hours will be 9.00 – 12.30.

On 30 April 2018 the State Agency of Medicines will be closed.

Amendments to the Procedure for Registration of Medicinal Products

Please note that the amendments to the Cabinet of Ministers Regulation No 376 of 9 May 2006 “Procedure for Registration of Medicinal Products” came into force on 13 April 2018.

The amendments specify the procedure for review, approval and rejection of variations of marketing authorisation documentation in order to ensure compliance with the European Commission Regulation (EC) No. 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products. Read more

Turnover of medicines manufacturers in Latvia last year - 11% higher than in 2016

The State Agency of Medicines informs that the total turnover of products (medicines and other goods) produced by manufacturers in Latvia in 2017 was 174 million EUR (excluding VAT), which is an 11% increase in comparison with 2016.

Last year sales of medicinal products in Latvia decreased by 0.4%, comprising 16.84 million EUR. Whereas sales of medicinal products outside of Latvia increased by 14% and reached 140.35 million EUR. Read more

The State Agency of Medicines has issued the report “Statistics on Medicines Consumption 2017”

The State Agency of Medicines (SAM) has published the new report “Statistics on Medicines Consumption 2017” that includes data on medicines consumption in Latvia from 2013 to 2017.

According to the statistical data the sales volume of authorised medicines in Latvia from 2016 to 2017 has increased by 6%, reaching 392.78 million euros in 2017. Acetylsalicylic acid and ibuprofen were the most selling non-prescription medicines in Latvia in 2017 according to international non-proprietary names (INN). The most sold Latvian manufacturers’ medicines with the respect to the turnover in euros and to the number of packages sold over the last five years were meldonium containing medicines. Read more

The 2018 Drug Register of the Republic of Latvia has been issued

The State Agency of Medicines (hereinafter – SAM) has prepared electronic and printed versions of the Drug Register of the Republic of Latvia that will be useful for physicians and pharmacists, as it contains thorough and objective information regarding medicines registered in the Republic of Latvia.

The SAM specialists have prepared a printed version of the Drug Register of the Republic of Latvia containing information regarding 7435 medicines authorised in the national, mutual recognition, decentralised, centralised procedures, as well as parallel imported and parallel distributed medicines. This issue contains trade names of medicines, pharmaceutical forms, international nonproprietary names (INN) of actives substances, strength/concentration, pharmacotherapeutic group, Anatomical Therapeutic Chemical (ATC) classification code, authorisation number, information on medicines price, reimbursed medicines, marketing authorisation holders and parallel distributers. Read more

Changes in office hours of the State Agency of Medicines

Please be informed that on 29 March 2018 the State Agency of Medicines will be open from 8:30 till 15:00. Customer Service Center will be open from 9:00 till 12:30.

The Agency will be closed on Friday, 30 March, and Monday, 2 April.

Changes in the Medicinal Product Register in XML format

The State Agency of Medicines kindly asks users of the Medicinal Product Register in XML format to pay attention that on 16th February 2018 there will be changes to the file’s structure introduced – several fields will be renamed or removed. Please follow actual changes on the website’s section Register > Medicinal Product Register of Latvia > The Medicinal Product Register of Latvia in XML format.

Since 2016 anyone can download publicly available information of the Medicinal Product Register in a structured format XML from the website of the State Agency of Medicines. The Medicinal Product Register in XML format contains data on nationally authorised medicines as well as centrally authorised and parallel imported medicines. It includes names and pharmaceutical forms of medicines, international non-proprietary names of active substances, strength/concentration, the Anatomical Therapeutic Chemical (ATC) classification codes, marketing authorisation numbers, dispensing status and names of marketing authorisation holders.