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September 1, 2014
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SAM has issued the 2014 Drug Register!

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Read more about the Drug Register

Baltic Statistics on Medicines 2010-2012

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SAM has released the first "Cito!" edition of 2014

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"Cito!" is available at the State Agency of Medicines (Jersikas street 15, Riga), in Room 11

SAM has issued the Annual Report 2013

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SAM has issued the 2013 Statistics on Medicines Consumption

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SAM has issued the Good Clinical Practice

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Read more about this publication

News
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July 2, 2014  


 

Dear Clients,

The State Agency of Medicines (SAM) of Latvia kindly informs that on July 3rd, 2014, from 17:00 till 23:00 the SAM information technologies (IT) systems including webpage will be disconnected due to the previously planned construction works and temporary interruption of electricity supply.

 

June 19, 2014  


 

The 2013 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 2013 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 more than 300 new medicines;
  • More than 9000 variations were made to marketing authorisations of medicines;
  • More than 3500 authorisations were issued for distribution of unauthorised medicines in the Republic of Latvia;
  • More than 1400 authorisations were issued for import/export of narcotic, psychotropic medicines/substances and precursors;
  • More than 110 authorisations were issued for distribution of parallel imported medicines;
  • 59 new authorisations for conduct of clinical trials were issued in 2013;
  • A total number of 237 clinical trials in Latvia in 2013;
  • 375 adverse drug reaction reports were received;
  • The Medicines Examination Laboratory tested 130 samples of medicines, 103 samples of purified water and prepared 500 volumetric solutions, indicators and reagents upon requests from pharmacies in 2013;
  • 353 announcements were registered regarding medical devices’ placement on the market of the Republic of Latvia;
  • 47 Certificates of Free Sale and 51 Certificates of Pharmaceutical Product were issued;
  • Licences were issued to 248 pharmacies and 27 medicines wholesalers.

Read more

 

June 17, 2014  


 

New application forms for renewals and variations of marketing authorisation

Information for marketing authorisation holders

The State Agency of Medicines (SAM) informs that new application forms have been introduced for renewals and variations of marketing authorisations (version June, 2014). When submitting applications for renewals and variations, please use the new application forms available on SAM website: Services > Human Medicines: Authorisation, Renewal, Variations > Application Forms.

 

June 16, 2014  


 

The medicines for cardiovascular diseases treatment - the most consumed medicines in Latvia last year

 For the twelfth time the State Agency of Medicines has published the statistical report on consumption of medicines in the country, this time also including statistical data on consumption of medicines in Latvia from 2009 until 2013.

Like before, also in 2013 there was an increase in the number of packagings of medicines sold (44.33 millions of packagings - 1% increase) and in the turnover of medicines in euros (307.59 EUR - 4% increase). In 2013 the average price per packaging of medicines (~7 EUR) included in the Drug Register of Latvia increased by 3% (in comparison - in 2012 the increase was 2%). The average price per packaging of unauthorised medicines (~12 EUR) increased by 11 % in 2013 (in comparison - there was a decrease in price in the previous two years). Read more

 

May 10, 2014  


 

The 2014 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 6736 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


 

 

March 7, 2014  


 

Information for marketing authorisation holders

The State Agency of Medicines informs that from now the product information (summary of product characteristics, package leaflet and labeling text) in the Medicinal Product Register on SAM website will be published in Word format that will facilitate its use for marketing authorisation holders. Product information in Word format will be available from March 5, 2014, starting with medicinal products included in the Order Regarding Marketing Authorisation of Medicinal Products No 2-20/20 (05.03.2014.). The format of documents published previously will not be changed.

 

March 6, 2014  


 

The market value of products made by local manufacturers in 2013 - almost 150 million euros

During the previous year medicinal product manufacturers in Latvia have manufactured products (medicines and other goods) worth 104 million lats (149 mil. euros), which is 3% less than in 2012. The majority (90.4%) of the manufactured products were exported to other countries, but 9.6% were distributed in the local market. Read more

 

March 5, 2014  


 

The State Agency of Medicines increases the number of various e-permits

The State Agency of Medicines informs that it has initiated the issuance of electronic documents (permits, authorisations etc.) as laid down in the normative acts of the Republic of Latvia*. Read more

 

February 4, 2014  


 

Award presented for reporting of adverse drug reactions

Annual Award in Medicine 2013

In the ceremony of the Annual Award in Medicine 2013 organized by the Latvian Physicians Association on January 31st, 2014, the Director of the State Agency of Medicines (hereinafter also - SAM) Inguna Adovica presented an award for ethical behavior and significant contribution in reporting of adverse drug reactions to the Talsi Hospital and its Head Physician Brigita Aispure. Read more

 

December 12, 2013  


 

Baltic Statistics on Medicines Published

“Baltic Statistics on Medicines 2010-2012” is a statistical summary of the medicines consumption data of the Baltic countries over the last three years. The description of the reimbursement systems, an overview of the medicinal products market and other related subjects can be found in the publication as well.

The national consumption statistics have been collected and published annually in all the Baltic countries for several years but this is the first joint publication which provides comparative data illustrating the differences and similarities of the consumption of drugs in our countries. Read more

 

November 15, 2013  


 

From November 18th, 2013, Latvia will ensure submission of marketing authorisation documentation of medicinal products in the Common European Submission Platform (CESP)

The State Agency of Medicines (hereinafter - Agency) informs that starting from November 18th, 2013, the Agency will join the Common European Submission Platform (CESP) for submission of marketing authorisation documentation of medicines. In the portal Agency clients will be able to submit marketing authorisation documentation of medicines simultaneously to all the chosen medicines agencies of European Union (hereinafter - EU) member states. Read more

 

November 14, 2013  


 

Information for marketing authorisation holders

The State Agency of Medicines (hereinafter - SAM) reminds you that the requirements regarding procedure for examination of variations for nationally authorised medicinal products laid down by the Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisation for medicinal products for human use and veterinary medicinal products (hereinafter - Regulation), Chapter IIa “Variations to purely national marketing authorisations” shall come into force on August 4th, 2013. Read more

 

November 13, 2013  


 

Dear clients!

The State Agency of Medicines informs you that due to the end of the financial year no invoices for advance payments will be issued from December 16th, 2013, until December 30th, 2013.

Please take into account that advance payments, where applications for receipt of services will not be submitted until December 2nd, will be returned to the payment maker (if the necessary requisites will have been submitted) or to the marketing authorisation holder.

Our apologies for the inconvenience!

 

November 7, 2013  


 

The State Agency of Medicines organises a meeting of professionals of the European medicines agencies in Riga

The State Agency of Medicines (hereinafter - SAM) organises a meeting for the Working Group of Communication Professionals of the Heads of Medicines Agencies (HMA) network that will take place on 6th-8th of November 2013 in Riga. The meeting will take place under the Lithuanian Presidency of the Council of the European Union to ensure the continuity of the forum operation for field professionals taking into account the capacity of the Medicines Control Agency of Lithuania with regard to organisation of official events. Read more

 

July 19, 2013  


 

Information for marketing authorisation holders

State Agency of Medicines of Latvia (hereinafter - SAM) informs that Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (hereinafter - Regulation), Chapter IIa "Variations to purely national marketing authorisations" requirements regarding variation evaluation procedure for nationally authorised medicinal products will come into effect on August 4th 2013. Read more

 

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@ZVALatvija
RT @EMA_News: We've published a new booklet on how the European regulatory system for #medicines works: http://t.co/mpUaAMFrhX
26.08.2014 16:16
RT @veselibasmin: Noteikta pastiprināta uzraudzība vielai tramadols http://t.co/I1eSeTu1Ib
26.08.2014 09:55
RT @NMPdienests: Atceries - katram medikamentam ir sava vieta! Neatstāj tos brīvi pieejamus bērniem. Vakar slimnīcā ar… http://t.co/5CxvNLo…
26.08.2014 09:54





Last changes made on 29.08.14