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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.

 

May 3, 2017  


 

Changes in office hours of the State Agency of Medicines

Please be informed that on 3 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.

  • Thursday, 4 May – closed.
  • Friday, 5 May – closed.

 

April 19, 2017  


 

Total turnover of medicines in Latvia in 2016 – nearly 375 million euros

 Since 2012, the total turnover of medicines has exceeded 300 million euros (incl. VAT) per year reaching nearly 375 million euros in 2016. These data and more statistics can be found in the new book “Statistics on Medicines Consumption 2016” that has been prepared and published by the State Agency of Medicines of Latvia.

Statistical data show that the market share between POM (prescription only medicines) and non-prescription medicines according to medicines sales in euros is similar every year and it is dominated by the prescription only medicines (82% in 2016).

Most of medicines (incl. unauthorised medicines) sold by wholesalers in 2016 were supplied to pharmacies (64%). Three largest wholesalers provided 75% of the total volume sold to pharmacies in Latvia in 2016. Meldonium containing medicines were the most sold Latvian manufacturers’ medicines with the respect to the turnover in euros and to the number of packages sold.

“Statistics on Medicines Consumption 2016” includes statistical data on medicines consumption from 2012 to 2016. The medicines consumption is expressed as defined daily doses (DDD) per 1000 inhabitants in Latvia per day (DID).

The book is available on the website of the State Agency of Medicines: “Publications” > “Statistics on Medicines Consumption”.

 

April 11, 2017  


 

Changes in office hours of the State Agency of Medicines

Please be informed that on 13 April 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.

  • Friday, 14 April – closed.
  • Monday, 17 April – closed.

 

April 3, 2017  


 

The 2017 Drug Register of the Republic of Latvia has been issued

Zāļu reģistrs 2017The 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 7244 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

 

March 15, 2017  


 

Submission and approval of risk minimisation measures: updated versions of documents are published

The State Agency of Medicines (SAM) informs that updated information is published on the SAM website regarding the submission and approval of Educational Materials (EMs) and Direct Healthcare Professional Communications (DHPCs) laid down in the risk management plan of medicinal products. The previous versions of the documents, dated 27 May 2016, have been replaced with updated versions of 20 February 2017, and a new document “DHPC sample form - Annex 2” has also been published.

Several changes have been made to the aforementioned documents, including the additional information that the approved versions of EMs and DHPCs are added to the respective medicinal product in the public Medicinal Product Register of Latvia, that is available in the “Register” section of the SAM website. Upon drafting DHPCs, it is recommended to use the sample form (Annex 2), which is a new document.

The documents are intended for marketing authorisation holders’ responsible persons, especially national level contact persons for pharmacovigilance issues. The updated versions of the documents are available on the SAM website (section “Services > Pharmacovigilance > Information to marketing authorisation holders > Submission and approval of risk minimisation measures”).

 

March 14, 2017  


 

Medicines manufacturers of Latvia raise turnover – 19% increase in 2016

In 2016 the total turnover of the products (medicines and other goods) manufactured by medicines manufacturers of Latvia was 157.39 mln EUR (excluding VAT), which is a 19% increase comparing to 2015.

Medicines manufacturers of Latvia in 2016

The majority of the produced goods, comprising 87% of the total volume, was sold outside of Latvia. The value of the products sold in EEA countries was 25.94 mln EUR, but the value of products sold in the so called “third” countries (countries outside of the EEA) – 110.90 mln EUR.

During the previous year, 13% of the manufactured products were sold in the local market for the value of 20.55 mln EUR, which is a 15% increase in comparison to 2015. The amount of medicines sold in Latvia increased by 18% and reached the value of 16.91 mln EUR, but the amount of medicines sold outside of Latvia increased by 22% and comprised the value of 122.68 mln EUR.

In 2016, JSC “Olainfarm” maintained its position as the leader among medicines manufacturers with regard to the total amount of products sold, but JSC “Grindeks” increased the amount of products sold in the local market by 25%, maintaining its leader position with regard to the turnover of products sold in Latvia.

 

January 23, 2017  


 

More convenient search and overview in the Medicinal Product Register of Latvia

By clicking on the link in the Medicinal Product Register of Latvia (available on the website of the State Agency of Medicines (SAM), “Register” section > “Open the Medicinal product register search form”) now it is possible to view also the summary of product characteristics, package leaflet and labelling text approved by the European Medicines Agency (EMA).

Zāļu reģistrs
Zāļu reģistrs

In order to view these documents, please click on the name of the selected medicinal product in the Medicinal Product Register of Latvia, then you will open the “Information regarding medicinal product” window. This window includes information regarding the selected medicinal product (for example, regarding use in children, pharmaceutical form, etc.). In addition, a new field “Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website” has been created for medicinal products authorised via the centralised procedure. The aforementioned documents are available also in Latvian on the EMA website. Read more

December 12, 2016  


 

Amendments to Guideline for Good Clinical Practice published

The State Agency of Medicines informs that the amendments to Guideline for Good Clinical Practice (GCP) have been published on the website of the International Council for Harmonisation (ICH) www.ICH.org. The Guideline for GCP with integrated amendments is available in English (PDF file).

The Guideline for GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. It provides a unified standard for the European Union, Japan, the United States, Canada, and Switzerland to facilitate the mutual acceptance of data from clinical trials by the regulatory authorities in these jurisdictions.

This Guideline has been amended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.

 

November 11, 2016  


 

Changes in office hours of the State Agency of Medicines

Please be informed that due to the national holidays on 17th of November 2016 working hours of the State Agency of Medicines will be 8:30 – 15:00. Reception hours will be 9:00 – 12:30.

On 18th of November 2016 the State Agency of Medicines will be closed.

Congratulations on the Independence Day of Latvia!

November 10, 2016  


 

Changes in assessment and publication of information on the mock-ups of medicinal products

Information for marketing authorisation holders

The State Agency of Medicines informs that starting from 14 November 2016 the mock-ups of the inner and outer packaging might be submitted by marketing authorisation holders only for information without any further assessment and publication on the website of the State Agency of Medicines www.zva.gov.lv.

Read more

 

November 10, 2016  


 

Report suspected side effects to help make medicines safer

State Agency of Medicines of Latvia is running a social media campaign between 7-11 November 2016 to promote reporting of suspected medicines side effects, as part of an EU-wide awareness week.


Infographic

Medicines have the potential to harm as well as cure. While, for most patients, medicines are safe and effective, side effects can happen. It is important that the risks associated with medicines are understood and communicated to health professionals and patients. Regulators like State Agency of Medicines of Latvia rely on the reporting of suspected side effects to make sure medicines on the market are acceptably safe. Unfortunately, all reporting systems suffer from under reporting, and this is why this campaign is important to both raise awareness and help strengthen the system.

At the centre of the campaign is an animation showing the story of a patient who has a suspected adverse reaction. It shows the medicine being taken, a suspected side effect being experienced, how reports are made by patients or healthcare professionals to the medicines regulator, and how this benefits future patients.

Read more

 

October 26, 2016  


 

Cardiovascular system medicines – the most consumed in all Baltic States

Baltic Statistics on Medicines 2013 - 2015

The most consumed medicines in the Baltic States from 2013 to 2015 were medicines used to treat cardiovascular system diseases similar as during the period from 2010 to 2012, shows the new book “Baltic Statistics on Medicines 2013–2015”. The consumption of these medicines more than threefold exceeded the consumption of the second most used groups of medicines in each of the Baltic States (the group of alimentary tract and metabolism medicines in Latvia and Estonia and the nervous system medicines in Lithuania).

According to statistical data the overall consumption of medicines from 2013 until 2015 increased in all three Baltic States. Some groups of medicines were being consumed similarly in the Baltic States, but other had substantial consumption differences, for example, antidepressants, anxiolytics, sleep and sedative medicines and statins. Top 15 of over-the-counter medicines in 2015 were rather similar in Latvia, Lithuania and Estonia – the most consumed were medicines with an active substance acetylsalicylic acid.

Above mentioned and more statistics can be found in the new statistical book on consumption of medicines “Baltic Statistics on Medicines 2013-2015” that is being prepared and published by the State Agency of Medicines of Latvia, State Agency of Medicines of Estonia and the State Medicines Control Agency of Lithuania. The book includes data on medicines consumption in the Baltic States over the last three years, as well as short descriptions of the pharmaceutical market, regulatory requirements and reimbursement systems of medicinal products in these countries.

Read more

 

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Last changes made on 22.06.2017.