15 Jersikas street, Riga, LV-1003, Latvia
Phones: +371-67078424
Mob.: +371-29447659
Fax: +371-67078428
e-mail:
All contacts

Facebook: Zāļu valsts aģentūra Twitter: Zāļu valsts aģentūra LinkedIn: Zāļu valsts aģentūra
News
print print  

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

 

May 14, 2015  


 

The 2015 Drug Register of the Republic of Latvia has been issued

The 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 a total of 6776 medicines authorised in the national, mutual recognition, decentralised, centralised procedures, as well as parallel imported 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, issuance procedure and marketing authorisation holders. Read more

 

May 13, 2015  


 

Lawyers and marketing authorisation experts of European medicines agencies discuss current pharmaceutical issues in Riga

On 6-7 May the meeting of the European Medicines Agencies Group on the Cooperation on Legal and Legislative Issues (EMACOLEX) took place in Riga. This informal working party provides legal advice within the European medicines regulatory framework and the network of regulatory authorities. The informal meeting of the Co-ordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh) also took place with an aim to discuss issues related to the marketing authorisation of medicines in two or more EU Member States via mutual recognition or decentralised procedures. The meeting in Riga brought together almost 100 participants – leading marketing authorisation experts and lawyers from medicines agencies in the EU Member States and EEA countries. Read more

 

May 11, 2015  


 

Medicines turnover in Latvia increases every year

When evaluating the data regarding medicines consumption in 2014, the State Agency of Medicines (SAM) has concluded that the turnover for medicines has continuously increased during the previous years. Since 2010 the average annual turnover of medicines authorised in Latvia has been approximately 300 million euro (including VAT), reaching 316 million euro in 2014. The number of licensed medicines wholesalers has also increased reaching 73 wholesalers operating in Latvia in 2014.

Read more

 

Archive

2015 - 2014 - 2013 - 2012 - 2011 - 2010 - 2009 - 2008

top
@ZVALatvija
Jauna aptauja mūsu mājaslapā: Vai Jūs viegli varat atrast zāles Zāļu reģistra meklētājā @ZVALatvija mājaslapā? http://t.co/5T74VX6YUo
3.08.2015 16:47
Pareizi:ziņot par zāļu blaknēm var mūsu mājaslapā aktivizējot baneri “Atklāj zāļu otru pusi”un informējot ārstu un lūdzot aizpildīt ziņojumu
3.08.2015 16:41
Vairums aptaujas dalībnieku (54%) atbildēja pareizi uz iepriekšējo jautājumu aptaujā mūsu mājaslapā-kā pacients var ziņot par zāļu blaknēm?
3.08.2015 16:41





Last changes made on 03.08.2015.