15 Jersikas street, Riga, LV-1003, Latvia
Phones: +371-67078424
Mob.: +371-29447659
Fax: +371-67078428
e-mail:
All contacts

Facebook: Zāļu valsts aģentūra Twitter: Zāļu valsts aģentūra LinkedIn: Zāļu valsts aģentūra
News
print print  

February 5, 2016  


 

From 5 February 2016 information regarding MRP/DCP variations with a positive outcome will be published on the website of the State Agency of Medicines

Information for marketing authorisation holders

The State Agency of Medicines (SAM) informs that from 5 February 2016 information regarding variations with a positive outcome for medicines authorised in mutual recognition and decentralised authorisation procedures (MRP/DCP), where Latvia is a Concerned Member State, will be published on the SAM website in the Section “Pakalpojumi → Humāno zāļu reģistrācija, pārreģistrācija un izmaiņas → Rīkojumi par zāļu reģistrāciju (Izmaiņas Latvijas Zāļu reģistrā (ar paziņojumu) – pielikums Nr. 3-3) in Latvian. It will be applied only to MRP/DCP variations with a positive outcome that are not related to amendments to the product information.

After publishing information regarding variations with a positive outcome on the SAM website submitters of variation applications will receive an informative e-mail (the link to the SAM website).

 

January 8, 2016  


 

From 1 February 2016 companies will no longer be required to submit type IA variations in relation to the Qualified Person Responsible for Pharmacovigilance

Information for marketing authorisation holders

The State Agency of Medicines (SAM) informs that as of 1 February 2016, for both centrally and nationally authorised medicines, companies will no longer be required to submit to EU regulatory institutions the type IA variations in relation to the Qualified Person Responsible for Pharmacovigilance (QPPV) and Pharmacovigilance System Master File (PSMF). Read more

 

January 4, 2016  


 

The ISO recertification audit at the State Agency of Medicines has been successfully completed

At the end of 2015 the integrated management system of the State Agency of Medicines (SAM) has been recertified as in accordance with to the requirements of ISO 9001 and ISO 27001 standards.

The scope of certification:

  • Assessment in the field of human medicines and medical devices regarding marketing authorisation and post marketing procedures. Quality control of human medicines products. Pharmacovigilance and vigilance of medical devices.
  • Licensing and marketing authorisation in accordance with power of attorney. Assessment of relevant documentation.
  • Management and publishing of information in accordance with power of attorney.

The recertification audit was performed by Bureau Veritas Latvia.

 

December 29, 2015  


 

Amendments to the paid service price list of the State Agency of Medicines

Please note that the 22 December 2015 Cabinet of Ministers Regulation No. “Amendments to the 17 September 2013 Cabinet of Ministers Regulation No. 873 “State Agency of Medicines Publicly Available Paid Service Price List”” come into force on 1 January 2016. The text of the amendments is available here.

The aforementioned amendments to the price list of paid services of the State Agency of Medicines (hereinafter - SAM) introduce the following changes for marketing authorisation holders that might promote a greater competition in the market of medicines:

  • From now on SAM will accept and adopt a decision regarding waiving the annual post-authorisation maintenance fee, if the turnover of medicines during the previous calendar year will not have exceeded 3000 EUR. Upon reviewing the decision regarding waiving of the annual post-authorisation maintenance fee, the condition regarding the annual turnover not exceeding 3000 EUR will be assessed, basing on the turnover data for 2015.
  • In order to promote marketing authorisation of medicines in Latvia, SAM ensures a 90% discount from the marketing authorisation fee in the national marketing authorisation procedure for expertise on the application and additional documentation for marketing authorisation of similar medicines – generic medicines or biosimilar medicines.

17 September 2013 Cabinet of Ministers Regulation No. 873 "State Agency of Medicines Publicly Available Paid Service Price List” (including amendments coming into force on 1 January 2016). See here.

 

November 24, 2015  


 

Compulsory use of electronic application forms (eAF)

 From 1 January 2016 the use of electronic application forms (eAF) for MRP/DCP and national procedures (initial MAs, renewals, variations) will be mandatory within electronic submissions. These eAFs are designed to reflect and capture the same content as the paper based application forms and offer a range of new possibilities, especially:

  • structured form fields
  • online access to standard terms of EMA while entering data
  • automated duplication of data within the form
  • automated import of application data
  • validation of data input and feedback to the user
Read more

 

November 17, 2015  


 

Common regulation of medical devices in Europe and patient safety are the priorities

Svens Henkuzens, the Director of the State Agency of Medicines, and Daiga Lagzdiņa, the Head of the Medical Devices Evaluation Department, are participating in the meeting of Competent Authorities for Medical Devices in Dublin, Ireland, on 17th and 18th November 2015, thus, continuing the professional discussions started at the previous CAMD meeting in Riga in February 2015 regarding a common, improved regulation of medical devices, market surveillance of medical devices and other new issues in the field in Europe.1

Svens Henkuzens, the Director of the State Agency of Medicines: "The development of the field of medical devices is currently very dynamic, and the European Commission together with the competent authorities of the member states have to be ready to ensure an appropriate legal framework, as well as effective market surveillance mechanisms for the rapidly growing field, so that patients would be equally protected throughout the EU. These regular discussions among experts from competent authorities bring us closer to this goal."

Read more

 

November 5, 2015  


 

New Deputy Director of the State Agency of Medicines Jānis Zvejnieks

The State Agency of Medicines of Latvia (SAM) informs that Jānis Zvejnieks has been appointed as the Deputy Director of SAM. Since September 2013 J. Zvejnieks has been the Head of the Department of Pharmaceuticals of the Ministry of Health of the Republic of Latvia.

Jānis Zvejnieks is a pharmacist by education. He has also studied marketing and accounting at BA School of Business and Finance. J. Zvejnieks has worked at Children's Clinical University Hospital, pharmacies in Latvia and abroad, as well as in private sector.


November 4, 2015  


 

Svens Henkuzens begins to fulfil the duties of office as the Director of the State Agency of Medicines

On 3rd November 2015 Svens Henkuzens, previously the Deputy Director of the State Agency of Medicines, begins his work as the Director of the State Agency of Medicines (SAM).

S. Henkuzens was the Deputy Director of SAM from 2nd September until 2nd November 2015. Before that he was the deputy head of the Department of Investments and Monitoring of the European Union Funds at the Ministry of Health. During the Latvian Presidency of the Council of the European Union Henkuzens carried out the responsibilities of a specialised attaché at the Latvian representation in the EU and lead the Council Working Group on Pharmaceuticals and Medical Devices. Read more


November 3, 2015  


 

Inguna Adoviča: “The operational tasks of the State Agency of Medicines is a marathon, but they require a sprint-like concentration of resources and skills“

On 2 November 2015 was the last day of employment of Inguna Adoviča as the Director of the State Agency of Medicines (SAM). The State Agency of Medicines highly appreciates her professionalism and the honesty of her work and her contribution to ensure that the medicines in Latvia are effective, qualitative and safe, as well as to establish the State Agency of Medicines as an equal to other medicines agencies in Europe.

ZVA direktore Inguna Adoviča

Inguna Adoviča began working at SAM in 1998 as the Head of the Clinical Trial Inspection Department. She has established and expanded the clinical trials department by structuring and strengthening the field of clinical research in Latvia. In 2002 she became the Deputy Director, and in 2005 – the Director of SAM. Read more

 

November 3, 2015  


 

Collaboration partners evaluate the work of the State Agency of Medicines in the annual survey

Since 2008 the State Agency of Medicines (SAM) carries out an annual survey of collaboration partners to obtain information regarding the operation of SAM within the year in order to improve the quality of the services provided and make other improvements to the operation of the institution.

In October 2015 (13.10.2015. – 30.10.2015.) the survey took place for the 8th time. In this survey participated 101 respondents. The majority of SAM collaboration partners are marketing authorisation holders, medicines manufacturers, medical devices manufacturers, medicines wholesalers, pharmacies, healthcare professionals, medical treatment institutions and research institutions.

Basing on the suggestions provided in the previous surveys SAM has introduced new initiatives and has always tried to respect the opinion of clients. For example, the Client Service Centre was established in 2010, electronic circulation of documents is gradually being introduced, informative seminars regarding implementation of normative acts, new European Union requirements and other issues are being organised every year for the collaboration partners. Read more


September 25, 2015  


 

Dear Clients!

The State Agency of Medicines (SAM) of Latvia kindly informs that today from 8pm till 10pm the Public Drug Register of the Republic of Latvia may not be available due to the construction works. We apologize for the inconvenience!

September 3, 2015  


 

Experts of medicines agencies of the Baltic States discuss news in the field and sign an updated agreement on the common Baltic Package procedure

On 3rd September 2015 a meeting of the experts of medicines agencies of the Baltic States is taking place in Vilnius, Lithuania, discussing the news and the normative regulation of the field. The meeting agenda contains issues related to the common Baltic Package procedure, strategic development issues of the European Medicines Agency, medicines safety issues and additional safety elements on packages, risks of falsified medicines and other issues.

Guido Rasi, Principal Adviser in Charge of Strategy at the European Medicines Agency, is also participating in the meeting and emphasising the role of national medicines agencies, "Strong national competent authorities are essential in the field of pharmaceutics. They provide their expertise in centralised and national marketing authorisation procedures, they can connect local representatives of the industry with people who carry out scientific expertise on medicines centrally assessed in Europe, they are the national centres for pharmacovigilance and market surveillance issues, they link healthcare systems, healthcare specialists and patients."

Read more

 

September 1, 2015  


 

Dear Clients!

The State Agency of Medicines (SAM) of Latvia kindly informs that today from 17:00 till 18:00 the SAM portal Latmed will not be available due to the construction works. We apologize for the inconvenience!

 

August 26, 2015  


 

New marks on the educational materials approved by the State Agency of Medicines as risk minimisation measures

Starting from 25 June 2015 the new mark "Important information for healthcare professionals about risk minimisation of medicines" has to be placed on the educational materials for risk minimisation of medicines (EM) approved by the State Agency of Medicines (SAM) for doctors, pharmacists and other healthcare professionals. On the EM for patients (these materials should be given to the patient only by an appropriate healthcare professional) there is the new mark "Important information for patients about risk minimisation of medicines". New marks must be placed on the first page of each material. Read more

 

August 11, 2015  


 

Updated registers of licensed pharmaceutical companies

The State Agency of Medicines of Latvia has updated its registers of licensed pharmaceutical companies in Latvia, which include list of licensed pharmacies, list of online pharmacies, list of licensed medicines wholesalers and list of licensed medicines manufacturers.

 

Archive

2016 - 2015 - 2014 - 2013 - 2012 - 2011 - 2010 - 2009 - 2008

top
@ZVALatvija
RT @EMA_News: EMA sets up task force on Zika virus to provide support to global response on the emerging epidemic: https://t.co/y4b8gTxehy
vakar, 10:03
Perorāli lietojamais risperidons (risperidonum): atgādinājums par reģistrētām indikācijām un lietošanu pediatrijā: https://t.co/1p7QOp6YEa
8.02.2016 16:13
Zāļu lieltirgotavu realizācijas apgrozījums 2015. gada pēdējā ceturksnī Latvijā bija 117,28 miljoni eiro. Vairāk: https://t.co/jGAaotvO3d
8.02.2016 13:16





Last changes made on 10.02.2016.