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.

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

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

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

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

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.

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.

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”.

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.

The 2017 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 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

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”).

Medicines manufacturers of Latvia raise turnover – 19% increase in 2016

In 2016 the total turnover of the products (medicines and other goods) manufactured by medicines manufacturers of Latvia was 157.39 mln EUR (excluding VAT), which is a 19% increase comparing to 2015.

The majority of the produced goods, comprising 87% of the total volume, was sold outside of Latvia. The value of the products sold in EEA countries was 25.94 mln EUR, but the value of products sold in the so called “third” countries (countries outside of the EEA) – 110.90 mln EUR.

During the previous year, 13% of the manufactured products were sold in the local market for the value of 20.55 mln EUR, which is a 15% increase in comparison to 2015. The amount of medicines sold in Latvia increased by 18% and reached the value of 16.91 mln EUR, but the amount of medicines sold outside of Latvia increased by 22% and comprised the value of 122.68 mln EUR.

In 2016, JSC “Olainfarm” maintained its position as the leader among medicines manufacturers with regard to the total amount of products sold, but JSC “Grindeks” increased the amount of products sold in the local market by 25%, maintaining its leader position with regard to the turnover of products sold in Latvia.

More convenient search and overview in the Medicinal Product Register of Latvia

By clicking on the link in the Medicinal Product Register of Latvia (available on the website of the State Agency of Medicines (SAM), “Register” section > “Open the Medicinal product register search form”) now it is possible to view also the summary of product characteristics, package leaflet and labelling text approved by the European Medicines Agency (EMA).

In order to view these documents, please click on the name of the selected medicinal product in the Medicinal Product Register of Latvia, then you will open the “Information regarding medicinal product” window. This window includes information regarding the selected medicinal product (for example, regarding use in children, pharmaceutical form, etc.). In addition, a new field “Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website” has been created for medicinal products authorised via the centralised procedure. The aforementioned documents are available also in Latvian on the EMA website. Read more

Amendments to Guideline for Good Clinical Practice published

The State Agency of Medicines informs that the amendments to Guideline for Good Clinical Practice (GCP) have been published on the website of the International Council for Harmonisation (ICH) www.ICH.org. The Guideline for GCP with integrated amendments is available in English (PDF file).

The Guideline for GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. It provides a unified standard for the European Union, Japan, the United States, Canada, and Switzerland to facilitate the mutual acceptance of data from clinical trials by the regulatory authorities in these jurisdictions.

This Guideline has been amended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.

Changes in office hours of the State Agency of Medicines

Please be informed that due to the national holidays on 17th of November 2016 working hours of the State Agency of Medicines will be 8:30 – 15:00. Reception hours will be 9:00 – 12:30.

On 18th of November 2016 the State Agency of Medicines will be closed.

Congratulations on the Independence Day of Latvia!