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  

May 27, 2016  


 

Updated information on approval of educational materials and direct healthcare professional communication

Information for marketing authorisation holders

The State Agency of Medicines (SAM) informs that on 27 May 2016 updated information on submission and approval of educational materials (EM) included in the risk management plan for medicines and direct healthcare professional communication (DHPC) was published on SAM website.

Important updates:

  • A new single e-mail address em_dhpc@zva.gov.lv has been established for submission of both types of documents (EM and DHPC).
  • Updated information regarding the approval procedure for EM and DHPC.
  • Updated standard text that regards reporting of adverse drug reactions, including the SAM phone number in cases where it is necessary for a healthcare professional to contact SAM experts, and the supplementary text that should be added in case of biological medicinal products.
  • The information regarding the EM content and format has been updated in accordance with the Guideline on Good Pharmacovigilance Practices, Module XVI, Addendum 1 "Educational Materials".
  • In order to facilitate the preparation of documents for submission of EM SAM recommends that marketing authorisation holders (MAHs) use a checklist (Annex 1) indicating all documents that need to be submitted within EM approval procedure.

We invite the responsible MAHs’ persons, especially national level contact persons for pharmacovigilance issues, to use the updated information. This information is available on SAM website, section "Services > Pharmacovigilance > Information for marketing authorisation holders > Submission and approval of risk minimisation measures".

 

May 20, 2016  


 

Dear Clients!

The State Agency of Medicines (SAM) of Latvia kindly informs that on 20 May 2016 from 5:30pm till 11pm the Public Drug Register of the Republic of Latvia will not be available due to the construction works. We apologize for the inconvenience!

 

April 29, 2016  


 

Changes in office hours of the State Agency of Medicines

Please be informed that on 3 May 2016 the State Agency of Medicines (SAM) is open from 8:30 till 15:00. SAM Customer Service Center is open from 9:00 till 12:30.

  • Thursday, 4 May - closed.

 

April 19, 2016  


 

Medicinal product turnover in Latvia was 336 million euros in 2015

The total turnover of medicinal products in Latvia has constantly increased over the last couple of years. Since 2011 the annual turnover has been close to 300 million euros (including VAT) reaching 336 million euros in 2015 which consisted of the turnover of authorised medicinal products worth 332 million euros and turnover of unauthorised medicinal products worth four million euros. Those are the basic conclusions of the experts of the State Agency of Medicines upon processing the statistical data on consumption of medicines in 2015.

The turnover for Latvian medicines manufacturers in the local market has increased by approximately four million euros since 2011 reaching 16 million euros in 2015 and making up 4.7% of the total amount of medicines sold in Latvia. Meldonium containing medicines have had the highest sales figures in euros among Latvian medicines manufacturers, but the highest number of packages sold were for medicines manufactured in Latvia containing the following combination of active substances: paracetamol, acetylsalicylic acid and caffeine.

Read more

 

April 8, 2016  


 

More convenient way to receive State Agency of Medicines services

In order to ensure a faster and more qualitative circulation of electronic correspondence and payment documents, the State Agency of Medicines kindly asks its clients to submit confirmation regarding the ability to receive electronic documents (with a secure electronic signature) and payment documents (electronically prepared invoices that are valid without a signature or stamp; Comparison acts of reciprocal payments).

Read more

 

March 21, 2016  


 

Changes in office hours of the State Agency of Medicines

Please be informed that on 24 March 2016 the State Agency of Medicines (SAM) is open from 8:30 till 15:00. SAM Customer Service Center is open from 9:00 till 12:30.

  • Friday, 25 March - closed;
  • Monday, 28 March - closed.

 

March 17, 2016  


 

The management of the State Agency of Medicines participates in the meeting of the European Medicines Agency’s Management Board

On 17 March 2016 Svens Henkuzens, the Director of the State Agency of Medicines, and Jānis Zvejnieks, the Deputy Director, are participating in the meeting of the European Medicines Agency’s  (EMA) Management Board in London.

The agenda of the meeting includes evaluation of EMA involvement in international projects such as Innovative Medicines Initiative aiming to speed up the development of better and safer medicines for patients, update on development of EU clinical trial portal and database, pharmacovigilance data collection, election of the Chair of the Management Board and other important issues.

On 18 March 2016 Svens Henkuzens and Jānis Zvejnieks have the bilateral meeting with Guido Rasi, the Executive Director of EMA, to discuss issues related to the availability of medicines on the market of Latvia.

 

March 1, 2016  


 

Latvian manufacturers sold medicines and other products worth 132 million euros in 2015

 According to the data gathered by the State Agency of Medicines (SAM) regarding operation of medicines manufacturers, the total turnover of the products of Latvian medicines manufacturers once again experienced a slight decrease in 2015. The total turnover of the manufactured products (medicines and other products) was 132 million euros (excluding VAT) and that is 2% less than in 2014. In 2015 the proportion of production sold in the local market increased by 4 percentage points and made up 14% of the total products manufactured. Thus, 86% of the manufactured products were exported. In comparison with 2014, last year the amount of medicines sold in Latvia increased by 32% and the amount of medicines sold abroad decreased by 4%.

Director of the State Agency of Medicines Svens Henkuzens, 'The contribution and presence of local medicines manufacturers is felt not only by every patient who has medicines manufactured in Latvia in their first aid kit at home, but also by the national economy. Even though the total production amount has slightly decreased in 2015, it still remains a great benefit for Latvia.' Read more

 

February 18, 2016  


 

Implementation of the updates in line with the QRD template for medicinal products

Information for marketing authorisation holders

The European Medicines Agency’s Working Group on Quality Review of Documents revised the Quality Review of Documents (QRD) template for the product information for medicinal products (Summary of product characteristics, Patient information leaflet and labelling text) in April 2013.

The information regarding national reporting system of suspected adverse reactions for healthcare professionals and patients was added. Applicants were encouraged to implement the updates in line with the QRD template for medicinal products with regulatory activity until April 2015 and for medicinal products without regulatory activity until April 2016. Further information please see The Heads of Medicines Agencies website Q&A section (answers to Q 2.11.a and 2.11.b).

 

February 17, 2016  


 

Latvian delegate participates in the Heads of Medicines Agencies meeting

NL EU 2016
HMA

On 17th and 18th February 2016 Svens Henkuzens, the Director of the State Agency of Medicines (SAM), is attending the scheduled Heads of Medicines Agencies (HMA) meeting in Amsterdam which is being organised by the Medicines Evaluation Board of the Netherlands as part of the Netherlands Presidency of the Council of the European Union (EU).

The meeting agenda contains several important issues related to the pharmaceutical field, including:

  • Priorities of the Netherlands Presidency of the EU Council in the field of collaboration of pharmaceutical regulators – more rapid availability of new medicinal products (innovation) to patients; fighting the antimicrobial resistance, interruptions in the supply of medicines in Europe and solutions for prevention of such interruptions;
  • Approval of the long-term work plans for HMA and EMA in accordance with the 2016 2020 operational strategy of both organisations.

Read more

 

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

 

Archive

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

top
@ZVALatvija
RT @EMA_News: Two new combination therapies against chronic hepatitis C recommended for approval by #CHMP: https://t.co/QlLQxWlbMY #medicin…
šodien, 15:49
RT @VMNVD: Saslimi brīvdienā? Lai saņemtu medic.padomu, zvani uz valsts organizēto Ģimenes ārstu konsultatīvo tālruni 66016001! https://t.c…
27.05.2016 16:47
RT @LV_portals: #teirdarbs Zāļu valsts aģentūrā! Aicina pievienoties komandai kolēģi UZRAUDZĪBAS AUDITORA amatā https://t.co/Up7JGgkBmW @ZV
26.05.2016 15:40





Last changes made on 30.05.2016.