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News
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January 23, 2015  


 

Dear Clients,

The State Agency of Medicines (SAM) of Latvia kindly informs that today from 17:00 till 20:00 the SAM webpage will not be available due to the construction works. We apologize for the inconvenience!

 

January 5, 2015  


 

The State Agency of Medicines begins the year of 2015 with a new image

 With the introduction of a unified identity within the state administration starting from January 1st, 2015, the State Agency of Medicines (SAM) begins the use of a new graphic standard - the small enhanced coat of arms of the Republic of Latvia and the colour assigned to the field of health - orange of the Latvian calendula which symbolises health, vitality, youth and the sun.

Therefore, changes have been introduced in all document forms of the State Agency of Medicines and in the visual appearance of its website www.zva.gov.lv. The new graphic standard of the Agency is visible also on social network profiles, employee business cards, employee identification cards and elsewhere.

Read more

 

December 16, 2014  


 

Free of charge variations to the medicinal products authorisation documentation

Please be informed that according to the amendments of the Cabinet of Ministers of Latvia Regulation No 873 "State Agency of Medicines Publicly Available Paid Service Price List” (in force since September 5th, 2014) fee is not applicable for the review of Type IA administrative variations as defined in the European Commission Guidelines. The amendments to the Public Price List are available here.

Considering the mentioned amendments, please be informed that fee is not applicable for the following items of the Type IA variations: A.1; A.3; A.4; A.5.a and A.5.b; A.6; A.7; A.8.

 

November 24, 2014  


 

New tool for companies to facilitate maintenance of information on authorised medicines

The European Medicines Agency (EMA) has made available a new tool to facilitate editing of key data fields by marketing-authorisation holders as part of the maintenance of information on authorised medicines that they have submitted to EMA. Read more

 

November 20, 2014  


 

Survey of the collaboration partners of the State Agency of Medicines

We would appreciate your participation in the annual survey about the services of the State Agency of Medicines.

The survey is anonymous and the results of it will be summarized. The survey in English is available here.
Please answer to the questions in the survey by December 5th, 2014.

Thank you in advance!

 

November 20, 2014  


 

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 15th, 2014, until December 30th, 2014.

Please take into account that advance payments, where applications for receipt of services will not be submitted until December 1st, will be returned to the payment maker (if the necessary requisites will have been submitted) or to the marketing authorisation holder.

We apologize for the inconvenience!

 

November 7, 2014  


Seminar “Clinical trials and perspectives for their development in Latvia” for stakeholders at the State Agency of Medicines

On November 11th, 2014, the State Agency of Medicines is organising an informative seminar for stakeholders - “Clinical trials and perspectives for their development in Latvia”.

The Agenda items are following:

  • Introduction by Inguna Adoviča, the Director of the State Agency of Medicines
  • Clinical trials with medicines in Latvia. Statistics
  • Results of the survey of collaboration partners
  • Main changes in the field of clinical trials according to the new Regulation (EU) 536/2014 of the European Parliament and of the Council on clinical trials with medicinal products for human use
  • Discussion

 

October 17, 2014  


 Cito!

The State Agency of Medicines has released the anniversary issue of the drug bulletin “Cito!”

The State Agency of Medicines informs about the release of the newest issue of the informative drug bulletin “Cito!” intended for doctors, pharmacists and other healthcare professionals. This issue is especially significant because September of 2014 marks the 20th anniversary of this bulletin. “Cito!” is a member of the International Society of Drug Bulletins (ISDB) – a world wide network of bulletins and journals on drugs and therapeutics that are financially and intellectually independent of pharmaceutical industry, founded in 1986.

In the introduction of the anniversary issue memories and opinions about “Cito!” are shared by the people who have been the creators of this bulletin over the years – Inguna Adoviča, Inta Saprovska, Ilze Aizsilniece, Ināra Rubene, Zane Neikena and Uģis Desmitnieks, all wishing for the bulletin to continue to be an independent source of information about medicines. Read more

 

October 14, 2014  


 

Notification of the emerging safety issues (ESI) to the State Agency of Medicines of Latvia

The marketing authorization holders should notify the emerging safety issues (ESI) regarding the medicinal products authorized in Latvia to the State Agency of Medicines of Latvia in writing:

via e-mail using the safe electronic signature (info@zva.gov.lv)
or
submit as an official paper form documents.
Read more

 

September 24, 2014  


 

Baltic meeting in Estonia

The meeting of drug regulatory agencies of Baltic States took place on 11th of September 2014 in Tartu, Estonia. The aim of the meeting was to exchange information, to find new areas where we could promote Baltic strength based on our long cooperation and to harmonize the positions for different procedures in the area of regulation of medicinal products. Heads of Estonian, Latvian and Lithuanian agencies together with 35 specialists participated in the meeting. Read more

 

September 5, 2014  


 

Amendments to the State Agency of Medicines price list of public services

Please note that the September 2nd, 2014, Cabinet of Ministers Regulation No. 527 “Amendments to the September 17th, 2013, Cabinet of Ministers Regulation No. 873 "State Agency of Medicines Publicly Available Paid Service Price List” came into force on September 5th, 2014. The text of the amendments is available here.

 

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

 

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@ZVALatvija
Aicinām audu centrus iesniegt gada pārskatus līdz 15. februārim! Lasīt vairāk: http://t.co/Ehwx3ZfWD8
šodien, 13:46
RT @LV_portals: 5 vakances @ZVALatvija: nodaļu vadītāju vietnieki, vecākais grāmatvedis un vecākie eksperti http://t.co/EMHfG7sKRA #teirdar…
šodien, 12:46
Today from 17:00 till 20:00 our webpage will not be available due to the construction works. We apologize for the inconvenience!
23.01.2015 16:01





Last changes made on 26.01.15