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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

 

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

 

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@ZVALatvija
2015. gada 28. februārī Reto slimību diena, vairāk lasiet: http://t.co/T9HiTocG7Q
vakar, 12:12
Raise awareness in the Rare Disease Day February 28th, 2015, video: https://t.co/09kdyl07rs
vakar, 11:54
RT @EMA_News: #Regulatory information: electronic application forms become mandatory for centralised procedures from July: http://t.co/8oEL…
26.02.2015 09:27





Last changes made on 02.03.2015.