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News
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September 1, 2015  


 

Dear Clients!

The State Agency of Medicines (SAM) of Latvia kindly informs that today from 17:00 till 18:00 the SAM portal Latmed will not be available due to the construction works. We apologize for the inconvenience!

 

August 26, 2015  


 

New marks on the educational materials approved by the State Agency of Medicines as risk minimisation measures

Starting from 25 June 2015 the new mark "Important information for healthcare professionals about risk minimisation of medicines" has to be placed on the educational materials for risk minimisation of medicines (EM) approved by the State Agency of Medicines (SAM) for doctors, pharmacists and other healthcare professionals. On the EM for patients (these materials should be given to the patient only by an appropriate healthcare professional) there is the new mark "Important information for patients about risk minimisation of medicines". New marks must be placed on the first page of each material. Read more

 

August 11, 2015  


 

Updated registers of licensed pharmaceutical companies

The State Agency of Medicines of Latvia has updated its registers of licensed pharmaceutical companies in Latvia, which include list of licensed pharmacies, list of online pharmacies, list of licensed medicines wholesalers and list of licensed medicines manufacturers.

 

July 16, 2015  


 

Dear Clients!

The State Agency of Medicines (SAM) of Latvia kindly informs that from July 17th 4pm to July 18th 10pm the Information System of SAM, including the Public Drug Register of the Republic of Latvia may not be available due to the construction works. We apologize for the inconvenience!

 

July 9, 2015  


 

Outcomes of single assessments of periodic safety update reports for active substances of nationally authorised medicines are available online

The European Medicines Agency (EMA) informs that from 6 July 2015 EMA has started to publish the outcomes of single assessments of periodic safety update reports (PSURs) for active substances contained only in nationally authorised medicines. All pharmaceutical companies holding marketing authorisations for medicines at national level are advised to regularly monitor the published information to check for outcomes relevant to their products and make necessary actions according to the outcomes of single assessments. Read more

 

July 8, 2015  


 

Changes in the submission of marketing authorisation documentation

European Medicines Agency (EMA) informs that from 1 July 2015 marketing authorisation holders should send their centralised procedure applications for human medicines to the EMA via eSubmission Gateway/Web Client only. These applications companies should not sent to national agencies of European Union, including the State Agency of Medicines (SAM), on CDs/DVDs or via the Common European Submission Platform (CESP). Read more

 

July 7, 2015  


 

The 2014 Annual Report of the State Agency of Medicines provides insight in the operation of the Agency

The State Agency of Medicines (SAM) has published its Annual Report of the year 2014 which summarises 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 almost 300 new medicines;
  • 9479 variations were made to marketing authorisations of medicines;
  • 4138 authorisations were issued for distribution of unauthorised medicines in the Republic of Latvia;

 Read more

 

July 7, 2015  


 

The results of the survey: Additional risk minimisation measures’ materials are useful to healthcare professionals

The State Agency of Medicines (SAM) from 13 March to 30 April 2015 conducted a survey on additional risk minimisation measures’ materials - SAM approved direct healthcare professional communications (DHPCs) and educational materials on risk minimization (further - educational materials). The results of the survey prove that DHPCs and educational materials provide useful information to healthcare professionals.

The aim of the survey was to find out how well healthcare professionals are supplied with DHPCs and educational materials on risk minimization and to get information regarding usefulness of these materials and suggestions for improvements. The method included an online survey (Google Drive) and a printed survey. Read more

 

June 19, 2015  


 

Implementation of Clinical Trials Regulation discussed at the meeting in Riga

On 16-17 June 2015 the meeting of the Heads of Medicines Agencies (HMA) Clinical Trials Facilitation Group (CTFG) took place in Riga. The main focus was on the implementation of the Regulation (EU) No 536/2004 of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use which came into force in June 2014 and will be applied no sooner than 28 May 2016.

Clinical research is a very important and mandatory step in the process of developing new medicines. It is necessary to obtain data regarding the effectiveness and safety of these medicines. A harmonised approach ensures unified principles in the evaluation of applications for clinical trials throughout Europe and a competent benefit/risk assessment. Read more

 

June 18, 2015  


 

Changes in office hours of the State Agency of Medicines

Please be informed that according to the Regulation of the Cabinet No 245 from May 26 of 2014 “On postponement of working days in 2015” the working day – Monday, June 22, 2015 – has been postponed to Saturday, June 27, 2015.

Therefore working hours of the State Agency of Medicines are as follow:

  • Monday, June 22, closed;
  • Saturday, June 27, opened – working hours 8:30 – 15:00;
  • Reception Hours on Saturday, June 27 – 9:00 – 12:30.

Please be informed also that June 23 and June 24 are National Holidays in Latvia.

 

June 16, 2015  


 

Communication professionals of medicines agencies discuss introduction of common logo for internet pharmacies in EU starting from 1 July 2015

On 11-12 June, the meeting of the Heads of Medicines Agencies (HMA) Working Group of Communication Professionals (WGCP) took place in Jūrmala. One of the most important issues on the agenda was the introduction of a common logo for all pharmacies that allow residents to purchase medicines online starting from 1 July 2015.

The introduction of a common logo is laid down by the Directive of the European Parliament and of the EU Council relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products, and the Commission Implementing Regulation on the design of the common logo to identify persons offering medicinal products for sale at a distance to the public and the technical, electronic and cryptographic requirements for verification of its authenticity.

Read more

 

June 10, 2015  


 

From 1 July 2015 a contact person for pharmacovigilance issues at national level is required

The State Agency of Medicines (SAM) reminds marketing authorisation holders that amendments to the Regulation No. 47 of the Cabinet of Ministers of the Republic of Latvia "Procedure for Pharmacovigilance" adopted on 22 January 2013 came into force on 4 October 2014 laying down the requirement for nomination of a contact person for pharmacovigilance issues at national level starting from 1 July 2015. The national level contact person needs to reside and work in Latvia. Read more

 

June 5, 2015  


 

Application of uniform quality management principles in European medicines agencies emphasized in Riga meeting

On 2-3 June 2015 the meeting of the Heads of Medicines Agencies (HMA) Working Group of Quality Managers (WGQM) took place in Riga, Latvia. The agenda of the meeting included implementation and ensuring of the uniform quality management principles in European medicines agencies.

Read more

 

May 26, 2015  


 

Dear Clients,

The State Agency of Medicines (SAM) of Latvia kindly informs that today from 22:00 till 3:00 tomorrow the SAM webpage will not be available due to the construction works. We apologize for the inconvenience!

 

May 19, 2015  


 

Competent Authorities for Medical Devices meeting in Riga

During the 36th Competent Authorities for Medical Devices (CAMD) meeting in February 2015 in Riga under the Latvian Presidency of the Council of the European Union the agenda focused on further developments building upon the achievements of the Joint Plan for Immediate Actions that arose out of the PIP Breast Implant scandal.

In addition to reviewing the successful role out of the notified body joint assessment programme and confirming progress to finesse that activity in light of experience, the attendees learned about the development of databases in Latvia, Estonia and Turkey which are designed to enhance market surveillance capabilities. Read more

 

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@ZVALatvija
Šodien no plkst. 17:00 līdz 18:00 nebūs pieejams mūsu portāls Latmed, jo tiks veikta tā uzlabošana. Atvainojamies par sagādātajām neērtībām!
1.09.2015 12:20
We kindly inform that today from 17:00 till 18:00 our portal Latmed will not be available due to construction.We apologize for inconvenience
1.09.2015 12:18
Infografika: Kā veido zāļu cenas aptiekās? http://t.co/UFzxKyjlVO
1.09.2015 11:28





Last changes made on 02.09.2015.