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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.

 

May 27, 2016  


 

Updated information on approval of educational materials and direct healthcare professional communication

Information for marketing authorisation holders

The State Agency of Medicines (SAM) informs that on 27 May 2016 updated information on submission and approval of educational materials (EM) included in the risk management plan for medicines and direct healthcare professional communication (DHPC) was published on SAM website.

Important updates:

  • A new single e-mail address em_dhpc@zva.gov.lv has been established for submission of both types of documents (EM and DHPC).
  • Updated information regarding the approval procedure for EM and DHPC.
  • Updated standard text that regards reporting of adverse drug reactions, including the SAM phone number in cases where it is necessary for a healthcare professional to contact SAM experts, and the supplementary text that should be added in case of biological medicinal products.
  • The information regarding the EM content and format has been updated in accordance with the Guideline on Good Pharmacovigilance Practices, Module XVI, Addendum 1 "Educational Materials".
  • In order to facilitate the preparation of documents for submission of EM SAM recommends that marketing authorisation holders (MAHs) use a checklist (Annex 1) indicating all documents that need to be submitted within EM approval procedure.

We invite the responsible MAHs’ persons, especially national level contact persons for pharmacovigilance issues, to use the updated information. This information is available on SAM website, section "Services > Pharmacovigilance > Information for marketing authorisation holders > Submission and approval of risk minimisation measures".

 

May 20, 2016  


 

Dear Clients!

The State Agency of Medicines (SAM) of Latvia kindly informs that on 20 May 2016 from 5:30pm till 11pm the Public Drug Register of the Republic of Latvia will not be available due to the construction works. We apologize for the inconvenience!

 

April 29, 2016  


 

Changes in office hours of the State Agency of Medicines

Please be informed that on 3 May 2016 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.

 

April 19, 2016  


 

Medicinal product turnover in Latvia was 336 million euros in 2015

The total turnover of medicinal products in Latvia has constantly increased over the last couple of years. Since 2011 the annual turnover has been close to 300 million euros (including VAT) reaching 336 million euros in 2015 which consisted of the turnover of authorised medicinal products worth 332 million euros and turnover of unauthorised medicinal products worth four million euros. Those are the basic conclusions of the experts of the State Agency of Medicines upon processing the statistical data on consumption of medicines in 2015.

The turnover for Latvian medicines manufacturers in the local market has increased by approximately four million euros since 2011 reaching 16 million euros in 2015 and making up 4.7% of the total amount of medicines sold in Latvia. Meldonium containing medicines have had the highest sales figures in euros among Latvian medicines manufacturers, but the highest number of packages sold were for medicines manufactured in Latvia containing the following combination of active substances: paracetamol, acetylsalicylic acid and caffeine.

Read more

 

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Last changes made on 07.12.2016.