Subgroup of common visual reminder (boxed warning and pictogram) to warn patient about teratogenic or foetotoxic effect on Baltic Package agreed upon the following common pictogram and its layout

For medicinal products where a visual reminder on the outer package to warn patient about teratogenic or foetotoxic effect has been requested as part of additional risk minimisation measure, the pictogram and the boxed warning must be placed on a dedicated surface of the outer packaging bearing no other labelling. Text in boxed warning must contain same languages as on the labelling.

Boxed warning and pictogram must be placed side by side.

The pictogram must take the form of a red triangle on a white background, at least a centimetre in diameter, containing an image of a pregnant woman in black. The dimensions of the pictogram, which must be legible, shall be adapted to the size of the outer packaging of the medicinal product. The use of common pictogram has been agreed by Estonian, Latvian and Lithuanian agencies.

In order to ensure a harmonised risk communication for patients in Latvia, the State Agency of Medicines invites all Marketing authorisation holders of the relevant medicinal products registered in national, decentralised and mutual recognition procedures to use the same visual reminder as recommended for the Baltic Package on the outer packaging of their represented medicinal products.

The 2017 Annual Report of the State Agency of Medicines

The State Agency of Medicines (SAM) has published its Annual Report of the year 2017 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 254 new medicines,
• SAM carried out a total of 182 medicines renewal procedures,
• issued 7248 authorisations for import, export, transit and distribution of medicines,
• 50 authorisations issued for conduct of clinical trials,
• 278 clinical trials took place in Latvia in 2017,
• 588 adverse drug reaction reports were received,
• the Laboratory tested 119 samples of medicines; 97 samples of purified water produced in pharmacies were selected and tested, 349 volumetric solutions, indicators and reagents were prepared,
• 253 announcements of medical devices placement on the market were received and information on them was entered in LATMED medical device database,
• 218 Certificates of Pharmaceutical Product and 30 Certificates of Free Sale were issued,
• 343 licences for the activity of pharmacies, 46 licences for medicines wholesalers, 19 licences for medicines manufacturing or import and 4 licenses for manufacturing of the active substances were issued,
• 17 permits for utilisation of tissues and cells were issued to tissue centres and one permit – to a higher education institution, including 14 related to changes in activity,
• 24 compliance certificates were issued to blood establishments and blood banks.

The 2017 Annual Report of the State Agency of Medicines is available in the section “Publications” on the SAM website.

Changes in office hours of the State Agency of Medicines

Please be informed that on 3 May 2018 working hours of the State Agency of Medicines will be 8.30 – 15.00. Reception hours will be 9.00 – 12.30.

On 4 May 2018 the State Agency of Medicines will be closed.

Changes in office hours of the State Agency of Medicines

Please be informed that on 21 April 2018 working hours of the State Agency of Medicines will be 8.30 – 15.00. Reception hours will be 9.00 – 12.30.

On 30 April 2018 the State Agency of Medicines will be closed.

Amendments to the Procedure for Registration of Medicinal Products

Please note that the amendments to the Cabinet of Ministers Regulation No 376 of 9 May 2006 “Procedure for Registration of Medicinal Products” came into force on 13 April 2018.

The amendments specify the procedure for review, approval and rejection of variations of marketing authorisation documentation in order to ensure compliance with the European Commission Regulation (EC) No. 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products. Read more

Turnover of medicines manufacturers in Latvia last year - 11% higher than in 2016

The State Agency of Medicines informs that the total turnover of products (medicines and other goods) produced by manufacturers in Latvia in 2017 was 174 million EUR (excluding VAT), which is an 11% increase in comparison with 2016.

Last year sales of medicinal products in Latvia decreased by 0.4%, comprising 16.84 million EUR. Whereas sales of medicinal products outside of Latvia increased by 14% and reached 140.35 million EUR. Read more

The State Agency of Medicines has issued the report “Statistics on Medicines Consumption 2017”

The State Agency of Medicines (SAM) has published the new report “Statistics on Medicines Consumption 2017” that includes data on medicines consumption in Latvia from 2013 to 2017.

According to the statistical data the sales volume of authorised medicines in Latvia from 2016 to 2017 has increased by 6%, reaching 392.78 million euros in 2017. Acetylsalicylic acid and ibuprofen were the most selling non-prescription medicines in Latvia in 2017 according to international non-proprietary names (INN). The most sold Latvian manufacturers’ medicines with the respect to the turnover in euros and to the number of packages sold over the last five years were meldonium containing medicines. Read more

The 2018 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 7435 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

Changes in office hours of the State Agency of Medicines

Please be informed that on 29 March 2018 the State Agency of Medicines will be open from 8:30 till 15:00. Customer Service Center will be open from 9:00 till 12:30.

The Agency will be closed on Friday, 30 March, and Monday, 2 April.

Changes in the Medicinal Product Register in XML format

The State Agency of Medicines kindly asks users of the Medicinal Product Register in XML format to pay attention that on 16th February 2018 there will be changes to the file’s structure introduced – several fields will be renamed or removed. Please follow actual changes on the website’s section Register > Medicinal Product Register of Latvia > The Medicinal Product Register of Latvia in XML format.

Since 2016 anyone can download publicly available information of the Medicinal Product Register in a structured format XML from the website of the State Agency of Medicines. The Medicinal Product Register in XML format contains data on nationally authorised medicines as well as centrally authorised and parallel imported medicines. It includes names and pharmaceutical forms of medicines, international non-proprietary names of active substances, strength/concentration, the Anatomical Therapeutic Chemical (ATC) classification codes, marketing authorisation numbers, dispensing status and names of marketing authorisation holders.

Invitation to sign an agreement on the documentation submission via CESP

The State Agency of Medicines (SAM) invites Marketing Authorisation Holders to sign a mutual agreement on the acceptance of documentation submission via Common European Submission Platform (CESP) without an original signature. It will allow submission of documents for marketing authorisation, renewal and variations of the medicinal products using CESP without the submission of an originally signed cover letter and application form in parallel. It will also lower administrative burdens and simplify circulation of documentation. Please read more about this option on the SAM website section eSubmission/CESP.

Article by Estonian colleagues on measuring effectiveness of risk minimisation measures in Estonia using large volume e-health data

As part of the collaboration agreement between medicines agencies in the Baltic States, we publish an original article by our Estonian colleagues regarding the use of large volume e‑health data in assessing the effectiveness of risk minimisation measures for medicines ”Measuring effectiveness of risk minimisation measures in Estonia using health care databases”. The article was created during the Estonian Presidency of the Council of the European Union.

The authors of the article are employees of the State Agency of Medicines of Estonia – Katrin Kurvits, aRMM assessment specialist, Maia Uusküla, Member of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency, Head of the Bureau of Pharmacovigilance, and Ott Laius, Head of the Department of Post-authorisation Safety.

In the article, the authors emphasise the following with regard to availability and analysis of electronic prescription data:

“To evaluate whether Risk minimisation measures (RMMs) serve their purpose, the knowledge on how the drug is used in clinical practice is necessary. Health care databases provide good opportunity for that – they contain data on large number of patients over many years, data are readily available and can be analysed rather quickly. Increasing variety of data available enhances the possibility to perform more in-depth studies.”

The article was also published in the latest issue of “Cito!” (4/2017 (71)), the State Agency’s of Medicines publication for doctors, pharmacists and other healthcare specialists. “Cito!” is available in electronic format on the Agency’s website, in the section “Publications” (in Latvian).

New updates of online search functionality for the Medicinal Product Register

The Medicinal Product Register of Latvia is an online database including detailed information regarding medicinal products authorised in Latvia and in Europe via the centralised procedure, as well as medicinal products authorised in other countries, and distributed in Latvia. The database is maintained by the State Agency of Medicines (SAM) and is regularly updated with additional functionalities to allow healthcare professionals and other users to search the database more easily and gain access to information more quickly.

The Register includes an online search form. SAM informs about a new parameter added to the advanced search form – “Disease group (by ATC)” that allows searching for medicines intended for treatment of a particular group of diseases. For example, when the user starts to type “respiratory…” in the search field the Register will offer to choose one of the disease groups containing this word and by entering the full name the user will be provided with a long list of medicines intended for treatment of diseases affecting the respiratory tract. Read more

Latvia as Reference Member State during Medicines Authorization Procedures

In order to provide more detailed information on specific aspects of medicines authorization procedure for marketing authorization holders as well to facilitate course of procedures, the State Agency of Medicines has improved respective section of the website here Services > Human Medicines: Authorisation, Renewal, Variations. There is a new section Latvia as Reference Member State (RMS) introduced with two new subsections. Under certain circumstances a Marketing Authorisation Holder (MAH) may request a change of the Reference Member State (RMS). SAM has published more detailed information regarding transfer of RMS. The RMS from another member state to Latvia is free of charge.

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