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April 18, 2018  


 

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.


April 16, 2018  


 

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


April 12, 2018  


 

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.

LV_manufacturers

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

 

April 11, 2018  


 

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

 

April 3, 2018  


 

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

 

March 26, 2018  


 

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.


February 13, 2018  


 

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.

 

February 8, 2018  


 

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.

 

January 19, 2018  


 

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).

 

November 30, 2017  


 

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

 

November 24, 2017  


 

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.

 

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

 

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Last changes made on 24.04.2018.