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News
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November 23, 2017  


 

Help making medicines safer by reporting suspected side effects: State Agency of Medicines of Latvia launches second social media campaign

From 20-24 November, State Agency of Medicines of Latvia is running a social media campaign to promote the reporting of suspected side effects of medicines. The campaign forms part of the second EU-wide awareness week with a focus this year on over-the-counter medicines.


Click on the image

While medicines are safe and effective, side effects can happen, even with over-the-counter medicines. It is important that the risks associated with the use of medicines are understood and communicated to healthcare professionals and patients. Read more

 

October 13, 2017  


 

Recommendations for better identification of medicinal product information

Information for marketing authorisation holders

Currently medicinal product information (summary of product characteristics, patient information leaflet, labelling text) available on the State Agency of Medicines (SAM) website could be identified by information placed on the upper edge of the page “Approved by the SAM dd.mm.yyyy.” However, representatives of the marketing authorization holders time by time requested to adjust published medicinal product information with the regard to specific marketing authorization, renewal or variation procedure.

In order to provide better link between published medicinal product information and specific marketing authorization, renewal or variation procedure, the State Agency of Medicines kindly asks marketing authorization holders to identify submitted product information by adding an appropriate reference in header or footer.

Example

Please be informed also that reference used by the company will be displayed unchanged in the medicinal product information published on the SAM website.

 

October 11, 2017  


 

New EudraVigilance system and go-live plan

Information for marketing authorisation holders and sponsors of clinical trials

The European Medicines Agency (EMA) informs that on 22 November 2017, EMA will launch a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). Read more

 

October 6, 2017  


 

New feature “Biosimilar medicines” introduced in the Medicinal Product Register of Latvia

In accordance with the Cabinet of Ministers regulation regarding the procedure for prescribing recipes, the pharmacist or pharmacist’s assistant, upon dispensing biological medicines, shall indicate the serial number of medicines dispensed. However, this is only one of the conditions that healthcare professionals are required to comply with when prescribing biological or biosimilar medicines. Stricter pharmacovigilance measures have been applied to these medicines because special attention is being paid to the risk management for these medicines. The objective of pharmacovigilance is to identify changes in the safety profile of medicines as early as possible in the life-cycle of these medicines, to conduct research and implement risk minimisation measures.

Medicinal Product Register

In order to facilitate the availability of information regarding the potential biological origin of medicines and compliance with the aforementioned regulation to healthcare professionals, as well as to allow other users of the Medicinal Product Register of Latvia to better orient themselves among the medicinal products included in the register, the State Agency of Medicines introduces a new feature “biosimilar medicines” that will be visible beside the name of the active substance.

From now on the “biosimilar medicines” criteria will also be available as a search parameter in the advanced search form of the Medicinal Product Register of Latvia. Read more

 

August 15, 2017  


 

Frequently asked questions on medicinal products marketing authorisation

 The State Agency of Medicines (SAM) of Latvia launches a new subsection on the Agency’s web page Frequently asked questions under the section Services – Human Medicines: Authorisation, Renewal, Variations . In order to addresses a number of questions that have been brought to the attention of the SAM by Marketing Authorisation Holders (MAHs) on matters related to quality of medicinal products a new subsection was developed. It provides harmonised position on issues that can be subject to different interpretation or require clarification, typically arising from discussions or correspondence during assessment procedures. Information under this subsection will be updated regularly.

July 20, 2017  


 

Terms/abbreviations for “batch number” and “expiry date” to be used on the labelling of human medicinal products: updated version of document is published

 The State Agency of Medicines (SAM) informs that the most recent version of Appendix IV Terms/abbreviations for “batch number” and “expiry date” to be used on the labelling of human medicinal products (PDF) is published on the European Medicines Agency (EMA) website.

The footnotes 1 and 2 limiting the use of the abbreviations Lot un EXP have been omitted. The abbreviations Lot un EXP may now also be used on the outer packaging. Read more

 

July 18, 2017  


 

Implementation plan for the introduction of the safety features on the packaging of nationally authorised medicinal products for human use

Information for marketing authorisation holders

In February 2016, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human, established by the Heads of Medicines Agencies, prepared the Implementation plan for the introduction of the safety features on the packaging of medicinal products . It contains detailed information for marketing authorisation holders (and applicants) regarding the procedure for the introduction of these safety features. The plan also explains the timelines for implementation.

See contents of the aforementioned plan here (PDF).

As the State Agency of Medicines (SAM) informed before, the Falsified Medicines Directive (Directive 2011/62/EU) and the new delegated act on the safety features to appear on medicinal product packaging (Commission Delegated Regulation (EU) 2016/161) that came into force on 29 February 2017 lay down detailed regulations regarding safety features on packaging of medicinal products for human use, including the placing of two safety features, a unique identifier (UI) carried by a 2-D barcode and an anti- tampering device (ATD), on the packaging of the majority of medicinal products for human use. Marketing authorisation holders shall implement the required safety features for the relevant medicinal products by 9 February 2019. Read more

 

June 5, 2017  


 

Regulatory guidance for industry to prepare for the United Kingdom’s withdrawal from the EU

EMA and the European Commission publish first in a series of Q&As for companies

The European Medicines Agency (EMA) and the European Commission have published guidance to help pharmaceutical companies to prepare for the United Kingdom's withdrawal from the European Union. The guidance relates to both human and veterinary medicines.

The questions-and–answers document concerns information related to the location of establishment of a company in the context of centralised procedures and certain activities, including the location of orphan designation holders, qualified persons for pharmacovigilance (QPPVs) and companies’ manufacturing and batch release sites. Read more

 

June 2, 2017  


 

The 2016 Annual Report of the State Agency of Medicines

 The State Agency of Medicines (SAM) has published its Annual Report of the year 2016 which summarizes information regarding the operation of the Agency during the previous year.

Some of the numbers that show Agency’s achievements last year:

  • marketing authorisations were issued for 272 new medicines,
  • SAM carried out a total of 214 medicines renewal procedures,
  • issued 6854 authorisations for import, export, transit and distribution of medicines (including authorisations for distribution of unauthorized medicines and authorisations for distribution of parallel imported medicines),
  • 76 new authorisations issued for conduct of clinical trials,
  • 288 clinical trials took place in Latvia in 2016,
  • 341 adverse drug reaction reports were received,
  • the Laboratory tested 107 samples of medicines; 96 samples of purified water produced in pharmacies were selected and tested, 431 volumetric solutions, indicators and reagents were prepared,
  • 269 announcements of medical devices placement on the market were received and information on them was entered in LATMED medical device database,
  • 147 Certificates of Pharmaceutical Product and 29 Certificates of Free Sale were issued,
  • 310 licences for the activity of pharmacies, 52 licences for medicines wholesalers, 19 licences for medicines manufacturing or import and 4 licenses for manufacturing of the active substances were issued.

Read more

 

May 11, 2017  


 

Changes in office hours of the State Agency of Medicines

Please be informed that on 13 May 2017 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.

 

May 3, 2017  


 

Changes in office hours of the State Agency of Medicines

Please be informed that on 3 May 2017 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.
  • Friday, 5 May – closed.

 

April 19, 2017  


 

Total turnover of medicines in Latvia in 2016 – nearly 375 million euros

 Since 2012, the total turnover of medicines has exceeded 300 million euros (incl. VAT) per year reaching nearly 375 million euros in 2016. These data and more statistics can be found in the new book “Statistics on Medicines Consumption 2016” that has been prepared and published by the State Agency of Medicines of Latvia.

Statistical data show that the market share between POM (prescription only medicines) and non-prescription medicines according to medicines sales in euros is similar every year and it is dominated by the prescription only medicines (82% in 2016).

Most of medicines (incl. unauthorised medicines) sold by wholesalers in 2016 were supplied to pharmacies (64%). Three largest wholesalers provided 75% of the total volume sold to pharmacies in Latvia in 2016. Meldonium containing medicines were the most sold Latvian manufacturers’ medicines with the respect to the turnover in euros and to the number of packages sold.

“Statistics on Medicines Consumption 2016” includes statistical data on medicines consumption from 2012 to 2016. The medicines consumption is expressed as defined daily doses (DDD) per 1000 inhabitants in Latvia per day (DID).

The book is available on the website of the State Agency of Medicines: “Publications” > “Statistics on Medicines Consumption”.

 

April 11, 2017  


 

Changes in office hours of the State Agency of Medicines

Please be informed that on 13 April 2017 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, 14 April – closed.
  • Monday, 17 April – closed.

 

April 3, 2017  


 

The 2017 Drug Register of the Republic of Latvia has been issued

Zāļu reģistrs 2017The 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 7244 medicines authorised in the national, mutual recognition, decentralised, centralised procedures, as well as parallel imported and parallel distributed 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, information on medicines price, reimbursed medicines, marketing authorisation holders and parallel distributers. Read more

 

March 15, 2017  


 

Submission and approval of risk minimisation measures: updated versions of documents are published

The State Agency of Medicines (SAM) informs that updated information is published on the SAM website regarding the submission and approval of Educational Materials (EMs) and Direct Healthcare Professional Communications (DHPCs) laid down in the risk management plan of medicinal products. The previous versions of the documents, dated 27 May 2016, have been replaced with updated versions of 20 February 2017, and a new document “DHPC sample form - Annex 2” has also been published.

Several changes have been made to the aforementioned documents, including the additional information that the approved versions of EMs and DHPCs are added to the respective medicinal product in the public Medicinal Product Register of Latvia, that is available in the “Register” section of the SAM website. Upon drafting DHPCs, it is recommended to use the sample form (Annex 2), which is a new document.

The documents are intended for marketing authorisation holders’ responsible persons, especially national level contact persons for pharmacovigilance issues. The updated versions of the documents are available on the SAM website (section “Services > Pharmacovigilance > Information to marketing authorisation holders > Submission and approval of risk minimisation measures”).

 

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Last changes made on 24.11.2017.