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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.

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April 29, 2015  


 

State Agency of Medicines accepts electronically signed documents from Latvia and other countries

Please pay attention that the State Agency of Medicines accepts electronically signed documents from Latvia and other countries. SAM accepts documents signed with secure electronic signatures from other countries, if the authenticity of the signature can be verified. A description (instruction, link to a website) should be provided together with the documents on how to open the document and how to verify the security of the electronic signature. More information about e-submission.

 

April 20, 2015  


 

Regarding application of annual pharmacovigilance fee

Compliance with pharmacovigilance requirements is a mandatory condition for all marketing authorisation holders in accordance with EU legislative acts. In accordance with the Section 10, Article 18 of the Pharmaceutical Law the State Agency of Medicines (hereinafter - the Agency) performs the functions of pharmacovigilance, including supervision of the adverse effects caused by the use of medicinal products, as well as creates and maintains a database in relation to supervision of safe use of medicinal products. By ensuring the aforementioned functions the Agency streamlines the requirements laid down for supervision of the safety of medicinal products, as well as establishes a team of competitive experts to ensure these tasks, therefore, a paid service has been established for the performance of pharmacovigilance related functions - an annual pharmacovigilance fee for medicinal products authorised through the national procedure (including mutual recognition and decentralised procedure). The annual pharmacovigilance fee includes.. 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

 

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@ZVALatvija
RT @EMA_News: Updated advice on use of high-dose #ibuprofen and #cardiovascular risk: http://t.co/QqdCkeHcwA
vakar, 23:43
RT @dblv: Intervija: Par drošu un kvalitatīvu zāļu tirgu http://t.co/Hgot3CEvBO via @dblv
vakar, 09:53
RT @farmacijaMIC: Latvijā plānotie grozījumi zāļu apritē sāk uztraukt Eiropu: http://t.co/rXwWpgGc3I
20.05.2015 16:31





Last changes made on 22.05.2015.