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News
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April 20, 2015  


 

Regarding application of annual pharmacovigilance fee

Taking into account that compliance with pharmacovigilance requirements is a mandatory condition for all marketing authorisation holders, the functionally related paid service is to be set as a specific annual pharmacovigilance fee for medicines authorised in the national procedure (including mutual recognition and decentralised procedure).

The annual pharmacovigilance fee is not applied to parallel imported and unauthorised medicines. The State Agency of Medicines does not apply the annual pharmacovigilance fee to medicines authorised in the centralised procedure, because for these medicines the amount and procedure for the payment of the fee regarding pharmacovigilance activities to the European Medicines Agency has been laid down in the Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicine Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use. Read more

 

 

April 17, 2015  


 

State Agency of Medicines reminds about the safe use of medicines

Rational use of medicines is based on the prescription of the accurate dosage of medicines in the pharmaceutical form most appropriate for the patient at the right time, providing also precise information about the instructions for use of medicines and warning about possible adverse reactions. The State Agency of Medicines invites the public to use medicines in accordance with the recommendations of the doctor or pharmacist, as well as the instructions provided in the package information leaflet. If suspicions of adverse drug reactions arise in association with the use of medicines, we invite you to report this to the State Agency of Medicines by filling out the Patient Report Form, as well consult your doctor to receive further recommendations.

In 2014 the State Agency of Medicines received a total of 290 adverse drug reaction reports. The main reporters in Latvia were doctors. Total number of adverse drug reaction reports (2001-2014).

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April 2, 2015  


 

Dear Clients!

The State Agency of Medicines (SAM) of Latvia kindly informs that from April 3rd to April 6th 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!

 

March 27, 2015  


 

Market value of products made by national manufacturers decreased by 9% in 2014

The data collected by the State Agency of Medicines (hereinafter - SAM) regarding operating results of medicines manufacturers indicate a decrease in the total turnover of the products of Latvian medicines manufacturers in 2014. The total value of manufactured products (medicines and other products) sold was 135 million Euros (without VAT), which was decreased by 9% in comparison with 2013. The majority of the manufactured products (90%) were exported, but 10% of the manufactured products were sold in the local market. Read more

 

March 19, 2015  


 

A conference in honour of the 20th anniversary of the European Medicines Agency


A conference "Science, Medicines, Health: Patients at the heart of innovation" took place on 18th March 2015 to celebrate the 20th anniversary of the European Medicines Agency (EMA). Among the participants was Inguna Adoviča, the Director of the State Agency of Medicines (SAM) and a member of the EMA Management Board already for 10 years.

For 20 years EMA has worked across the EU and globally to protect public health by assessing medicines to rigorous scientific standards and by providing partners and stakeholders with independent, science-based information on medicines. It has ensured the efficacy and safety of medicines for humans and animals across Europe, and promoted research and innovation in medical science. Read more

 

March 11, 2015  


 

Update published of nearly 5 000 substances used in medicinal products: list in Latvian, Latin and English

The State Agency of Medicines (SAM) has prepared and published an updated list containing names of active substances and excipients in Latvian, Latin and English, thus, providing a more accurate and complete clarification of pharmaceutical terms. The list contains nearly 5 000 names and it is available in the Section "Names of substances used in medicines in Latvian, Latin, English" of the SAM website. Read more

 

February 24, 2015  


 

Discussions on market surveillance related to medical devices in Europe take place in Riga

The meeting of the European Competent Authorities for Medical Devices (CAMD) is taking place on 24-25 February 2015 in Riga. The purpose of this meeting is the collaboration of Member States in the implementation of legal regulation in the field of medical devices in the interests of the public health, thus, promoting a unified understanding and identification of problems in this area.


Foto: EU2015.LV

In Riga, it is the 36th meeting of the competent authorities since the establishment of this forum. Since then, the field of medical devices has changed significantly and it has been reflected in the normative acts of the European Union (EU). More than 70 delegates are participating in the meeting in Riga and during the seven sessions taking place over one and a half days they will discuss issues on legal regulation, national approaches in different countries, issues on market surveillance related to medical devices and other topics. Read more

 

February 11, 2015  


 

General practitioner from Riga receives an award for reporting adverse drug reactions

At the "Annual Awards in Medicine 2014" event on February 6th, 2015, organized by the Latvian Medical Association and the Ministry of Health Andris Baumanis, a general practitioner from Riga, received a special award from the State Agency of Medicines (SAM) for responsible and ethical behavior by reporting adverse drug reactions several times during the year. Read more

 

February 6, 2015  


 

European Heads of Medicines Agencies discuss the availability of medicines in Riga

The European Heads of Medicines Agencies (HMA) meeting took place in Riga from February 3rd till February 5th, 2015, as part of the Latvian Presidency of the Council of the European Union. The meeting was attended by 80 participants from European medicines agencies, the European Commission and the European Medicines Agency (EMA).

Several strategically important issues were on the meeting agenda such as ensuring the availability of medicines in Europe, the shortages of medicines, news in the pharmacovigilance (medicines safety monitoring) in Europe and the development of a united EMA and HMA strategy for the next five years. Read more

 

January 30, 2015  


 

Meeting of the Heads of Medicines Agencies of Europe in Riga

The Meeting of the Heads of Medicines Agencies (HMA) of Europe will be held from 3rd to 5th of February, 2015 in Riga at the National Library of Latvia also called the Castle of Light (“Gaismas pils” in Latvian) within the Latvian Presidency of the Council of the EU.

More than 80 representatives from EU and EEA countries, as well as from the European Commission and the European Medicines Agency (EMA) will participate in this meeting.

Read more

 

January 28, 2015  


 

ISO 9001 and ISO 27001 surveillance audit at the State Agency of Medicines has been concluded

Near the end of 2014 the certification institution Bureau Veritas Latvia carried out a surveillance audit of the ISO 9001 and ISO 27001 certification at the State Agency of Medicines; also assessing the transition to the ISO 27001:2013 version. It was successfully concluded with the issuance of a new compliance document on 16th of January 2015 in accordance with the ISO/IEC 27001:2013 standard.

Read more

 

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

 

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@zanejakobsone @farmacijaMIC Grāmatas vēl ir pieejamas, un tās var saņemt @ZVALatvija Rīgā, Jersikas ielā 15, iepriekš uzzvanot 67078422
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European Medicines Agency - Regulatory information - EMA provides advice notes on pharmacovigilance annual fees http://t.co/Q2mT9t25GB
22.04.2015 10:49
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Last changes made on 24.04.2015.