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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

 

October 20, 2016  


 

Common approach in the Baltics to introduction of additional safety features on medicinal product packages

Today, on 20 October 2016, the annual meeting of experts from the Baltic state agencies of medicines is taking place in Riga in order to discuss the normative regulation of the pharmaceutical field and the latest developments within the industry. The meeting agenda included a review of the trends in consumption of medicines in the Baltic States, safety issues of medicines and additional safety features on medicinal product packages, as well as solutions for issues regarding disruptions in supply of medicines.

Participants of the meeting of the state agencies of medicines in the Baltic States
Participants of the meeting of the state agencies of medicines in the Baltic States

Representatives of the state agencies of medicines in Latvia, Estonia and Lithuania meet every year to discuss pharmaceutical regulatory issues. The collaboration between the Baltic States is important not only from a regional unity perspective, but also due to the importance of establishing stable conditions for all the participants in the markets of smaller countries. On 22 November 2012 three directors of state agencies of medicines of the Baltic States signed an agreement in Riga to ensure collaboration in the areas of good manufacturing practice, good distribution practice, good pharmacovigilance practice and good clinical practice, as well as collaboration of the laboratories in the Baltic States with regard to testing of medicines authorised via the national procedure. Read more

 

October 18, 2016  


 

Implementation of the ISO IDMP standards

The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). These are a set of common global standards for data elements, formats and terminologies for the unique identification of and the exchange of information on medicines. Following a phased implementation process, pharmaceutical companies will be required to submit data on medicines to EMA in accordance with these formats and terminologies. Read more

 

August 3, 2016  


 

The 2015 Annual Report of the State Agency of Medicines

The State Agency of Medicines (SAM) has published its Annual Report of the year 2015 which summarizes information regarding the operation of the Agency during the previous year.

Svens Henkuzens, the Director of the State Agency of Medicines: “2015 has been a year filled with challenges for the State Agency of Medicines. Latvia assumed the responsibilities of the presiding member state of the Council of the European Union and the State Agency of Medicines organized seven events within the collaboration network of pharmaceutical regulatory authorities in Europe. The Latvian presidency was an opportunity to influence processes and priorities on the European Union agenda and to prove that the State Agency of Medicines is an equal partner within the collaboration network of European agencies.”

Read more

 

July 27, 2016  


 

Public consultation on documents in the context of the new Clinical Trials Regulation

The State Agency of Medicines informs that the European Commission (EC) has released for public consultation documents in the context of the new Clinical Trials Regulation (EU) No. 536/2014. Stakeholders are invited to send their comments by 31 August 2016 via e-mail to: SANTE-B4-GL-risk-proportionate-approach@ec.europa.eu

Documents for public consultation:

  1. “Risk proportionate approaches in clinical trials”
  2. “Summary of Clinical Trial Results for Laypersons”
  3. “Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)” (previously called "Guidance on Investigational Medicinal Products (IMPS) and Non-Investigational Medicinal Products (NIMPs)”)
  4. “Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors”

Documents are available on the EC website.

 

June 15, 2016  


 

From 16 June 2016 information regarding all MRP/DCP variations* with a positive outcome will be published on the website of the State Agency of Medicines

Information for marketing authorisation holders

The State Agency of Medicines (SAM) informs that from 16 June 2016 information regarding all variations with a positive outcome for medicines authorised in mutual recognition and decentralised authorisation procedures (MRP/DCP), where Latvia is a Concerned Member State, will be published on the SAM website in the Section “Pakalpojumi → Humāno zāļu reģistrācija, pārreģistrācija un izmaiņas → Rīkojumi par zāļu reģistrāciju” (Izmaiņas Latvijas Zāļu reģistrā (ar paziņojumu) – pielikums Nr. 3-3) in Latvian. After publishing information regarding variations with a positive outcome on the SAM website submitters of variation applications will receive an informative e-mail (with the link to the SAM website).

Before this informing procedure was applied only to MRP/DCP variations with a positive outcome that were not related to amendments to the product information.

* excluding variations, which include time for the distribution of the remaining stocks of medicines, and variations which are related to the issue of an updated marketing authorization.

 

June 7, 2016  


 

Information on shortages of medicines will be regularly published

 Starting from 1 June 2016 the list of medicinal products that are permanently or temporarily not placed on the market of Latvia is being published on the website of the State Agency of Medicines (SAM).

The list contains information regarding the name of the medicinal product, package size, product No., strength, name of active substances, starting date of the disruption in the supply of the product and the estimated date for renewal of the supply, as well as information on alternative medicines.

The list is available in the “Register” section of the website. Read more

 

June 2, 2016  


 

From 13 June 2016 all PSURs have to be submitted only to the PSUR Repository

Information for marketing authorisation holders

The State Agency of Medicines (SAM) informs that as of 13 June 2016, the European Medicines Agency (EMA) has adopted as a mandatory requirement to submit all PSURs only to the Repository. PSUR Repository supports both the PSUR Single Assessment Procedure as governed by the EURD list and the single, pure NAP procedures where the active substance is only authorised in one Member State. From that date PSURs can no longer be submitted to SAM.

If PSUR for the medicinal product authorised only in Latvia and will be evaluated at the national level is submitted to the Repository the marketing authorisation holders are recommended to use the EMA template table cover letter to accompany submission of purely national PSURs to the PSUR repository. For more details, please visit the EMA website.

 

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Last changes made on 24.03.2017.