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February 13, 2018  


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.


February 8, 2018  


Invitation to sign an agreement on the documentation submission via CESP

The State Agency of Medicines (SAM) invites Marketing Authorisation Holders to sign a mutual agreement on the acceptance of documentation submission via Common European Submission Platform (CESP) without an original signature. It will allow submission of documents for marketing authorisation, renewal and variations of the medicinal products using CESP without the submission of an originally signed cover letter and application form in parallel. It will also lower administrative burdens and simplify circulation of documentation. Please read more about this option on the SAM website section eSubmission/CESP.


January 19, 2018  


Article by Estonian colleagues on measuring effectiveness of risk minimisation measures in Estonia using large volume e-health data

As part of the collaboration agreement between medicines agencies in the Baltic States, we publish an original article by our Estonian colleagues regarding the use of large volume e‑health data in assessing the effectiveness of risk minimisation measures for medicines Measuring effectiveness of risk minimisation measures in Estonia using health care databases”. The article was created during the Estonian Presidency of the Council of the European Union.

The authors of the article are employees of the State Agency of Medicines of Estonia – Katrin Kurvits, aRMM assessment specialist, Maia Uusküla, Member of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency, Head of the Bureau of Pharmacovigilance, and Ott Laius, Head of the Department of Post-authorisation Safety.

In the article, the authors emphasise the following with regard to availability and analysis of electronic prescription data:

“To evaluate whether Risk minimisation measures (RMMs) serve their purpose, the knowledge on how the drug is used in clinical practice is necessary. Health care databases provide good opportunity for that – they contain data on large number of patients over many years, data are readily available and can be analysed rather quickly. Increasing variety of data available enhances the possibility to perform more in-depth studies.”

The article was also published in the latest issue of “Cito!” (4/2017 (71)), the State Agency’s of Medicines publication for doctors, pharmacists and other healthcare specialists. “Cito!” is available in electronic format on the Agency’s website, in the section “Publications” (in Latvian).


November 30, 2017  


New updates of online search functionality for the Medicinal Product Register

The Medicinal Product Register of Latvia is an online database including detailed information regarding medicinal products authorised in Latvia and in Europe via the centralised procedure, as well as medicinal products authorised in other countries, and distributed in Latvia. The database is maintained by the State Agency of Medicines (SAM) and is regularly updated with additional functionalities to allow healthcare professionals and other users to search the database more easily and gain access to information more quickly.

The Register includes an online search form. SAM informs about a new parameter added to the advanced search form – “Disease group (by ATC)” that allows searching for medicines intended for treatment of a particular group of diseases. For example, when the user starts to type “respiratory…” in the search field the Register will offer to choose one of the disease groups containing this word and by entering the full name the user will be provided with a long list of medicines intended for treatment of diseases affecting the respiratory tract. Read more


November 24, 2017  


Latvia as Reference Member State during Medicines Authorization Procedures

In order to provide more detailed information on specific aspects of medicines authorization procedure for marketing authorization holders as well to facilitate course of procedures, the State Agency of Medicines has improved respective section of the website here Services > Human Medicines: Authorisation, Renewal, Variations. There is a new section Latvia as Reference Member State (RMS) introduced with two new subsections. Under certain circumstances a Marketing Authorisation Holder (MAH) may request a change of the Reference Member State (RMS). SAM has published more detailed information regarding transfer of RMS. The RMS from another member state to Latvia is free of charge.


November 23, 2017  


Help making medicines safer by reporting suspected side effects: State Agency of Medicines of Latvia launches second social media campaign

From 20-24 November, State Agency of Medicines of Latvia is running a social media campaign to promote the reporting of suspected side effects of medicines. The campaign forms part of the second EU-wide awareness week with a focus this year on over-the-counter medicines.

Click on the image

While medicines are safe and effective, side effects can happen, even with over-the-counter medicines. It is important that the risks associated with the use of medicines are understood and communicated to healthcare professionals and patients. Read more


October 13, 2017  


Recommendations for better identification of medicinal product information

Information for marketing authorisation holders

Currently medicinal product information (summary of product characteristics, patient information leaflet, labelling text) available on the State Agency of Medicines (SAM) website could be identified by information placed on the upper edge of the page “Approved by the SAM” However, representatives of the marketing authorization holders time by time requested to adjust published medicinal product information with the regard to specific marketing authorization, renewal or variation procedure.

In order to provide better link between published medicinal product information and specific marketing authorization, renewal or variation procedure, the State Agency of Medicines kindly asks marketing authorization holders to identify submitted product information by adding an appropriate reference in header or footer.


Please be informed also that reference used by the company will be displayed unchanged in the medicinal product information published on the SAM website.


October 11, 2017  


New EudraVigilance system and go-live plan

Information for marketing authorisation holders and sponsors of clinical trials

The European Medicines Agency (EMA) informs that on 22 November 2017, EMA will launch a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). Read more


October 6, 2017  


New feature “Biosimilar medicines” introduced in the Medicinal Product Register of Latvia

In accordance with the Cabinet of Ministers regulation regarding the procedure for prescribing recipes, the pharmacist or pharmacist’s assistant, upon dispensing biological medicines, shall indicate the serial number of medicines dispensed. However, this is only one of the conditions that healthcare professionals are required to comply with when prescribing biological or biosimilar medicines. Stricter pharmacovigilance measures have been applied to these medicines because special attention is being paid to the risk management for these medicines. The objective of pharmacovigilance is to identify changes in the safety profile of medicines as early as possible in the life-cycle of these medicines, to conduct research and implement risk minimisation measures.

Medicinal Product Register

In order to facilitate the availability of information regarding the potential biological origin of medicines and compliance with the aforementioned regulation to healthcare professionals, as well as to allow other users of the Medicinal Product Register of Latvia to better orient themselves among the medicinal products included in the register, the State Agency of Medicines introduces a new feature “biosimilar medicines” that will be visible beside the name of the active substance.

From now on the “biosimilar medicines” criteria will also be available as a search parameter in the advanced search form of the Medicinal Product Register of Latvia. Read more


August 15, 2017  


Frequently asked questions on medicinal products marketing authorisation

 The State Agency of Medicines (SAM) of Latvia launches a new subsection on the Agency’s web page Frequently asked questions under the section Services – Human Medicines: Authorisation, Renewal, Variations . In order to addresses a number of questions that have been brought to the attention of the SAM by Marketing Authorisation Holders (MAHs) on matters related to quality of medicinal products a new subsection was developed. It provides harmonised position on issues that can be subject to different interpretation or require clarification, typically arising from discussions or correspondence during assessment procedures. Information under this subsection will be updated regularly.

July 20, 2017  


Terms/abbreviations for “batch number” and “expiry date” to be used on the labelling of human medicinal products: updated version of document is published

 The State Agency of Medicines (SAM) informs that the most recent version of Appendix IV Terms/abbreviations for “batch number” and “expiry date” to be used on the labelling of human medicinal products (PDF) is published on the European Medicines Agency (EMA) website.

The footnotes 1 and 2 limiting the use of the abbreviations Lot un EXP have been omitted. The abbreviations Lot un EXP may now also be used on the outer packaging. Read more


July 18, 2017  


Implementation plan for the introduction of the safety features on the packaging of nationally authorised medicinal products for human use

Information for marketing authorisation holders

In February 2016, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human, established by the Heads of Medicines Agencies, prepared the Implementation plan for the introduction of the safety features on the packaging of medicinal products . It contains detailed information for marketing authorisation holders (and applicants) regarding the procedure for the introduction of these safety features. The plan also explains the timelines for implementation.

See contents of the aforementioned plan here (PDF).

As the State Agency of Medicines (SAM) informed before, the Falsified Medicines Directive (Directive 2011/62/EU) and the new delegated act on the safety features to appear on medicinal product packaging (Commission Delegated Regulation (EU) 2016/161) that came into force on 29 February 2017 lay down detailed regulations regarding safety features on packaging of medicinal products for human use, including the placing of two safety features, a unique identifier (UI) carried by a 2-D barcode and an anti- tampering device (ATD), on the packaging of the majority of medicinal products for human use. Marketing authorisation holders shall implement the required safety features for the relevant medicinal products by 9 February 2019. Read more


June 5, 2017  


Regulatory guidance for industry to prepare for the United Kingdom’s withdrawal from the EU

EMA and the European Commission publish first in a series of Q&As for companies

The European Medicines Agency (EMA) and the European Commission have published guidance to help pharmaceutical companies to prepare for the United Kingdom's withdrawal from the European Union. The guidance relates to both human and veterinary medicines.

The questions-and–answers document concerns information related to the location of establishment of a company in the context of centralised procedures and certain activities, including the location of orphan designation holders, qualified persons for pharmacovigilance (QPPVs) and companies’ manufacturing and batch release sites. Read more


June 2, 2017  


The 2016 Annual Report of the State Agency of Medicines

 The State Agency of Medicines (SAM) has published its Annual Report of the year 2016 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 272 new medicines,
  • SAM carried out a total of 214 medicines renewal procedures,
  • issued 6854 authorisations for import, export, transit and distribution of medicines (including authorisations for distribution of unauthorized medicines and authorisations for distribution of parallel imported medicines),
  • 76 new authorisations issued for conduct of clinical trials,
  • 288 clinical trials took place in Latvia in 2016,
  • 341 adverse drug reaction reports were received,
  • the Laboratory tested 107 samples of medicines; 96 samples of purified water produced in pharmacies were selected and tested, 431 volumetric solutions, indicators and reagents were prepared,
  • 269 announcements of medical devices placement on the market were received and information on them was entered in LATMED medical device database,
  • 147 Certificates of Pharmaceutical Product and 29 Certificates of Free Sale were issued,
  • 310 licences for the activity of pharmacies, 52 licences for medicines wholesalers, 19 licences for medicines manufacturing or import and 4 licenses for manufacturing of the active substances were issued.

Read more


May 11, 2017  


Changes in office hours of the State Agency of Medicines

Please be informed that on 13 May 2017 the State Agency of Medicines (SAM) is open from 8:30 till 15:00. SAM Customer Service Center is open from 9:00 till 12:30.



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Last changes made on 23.03.2018.