2019
01.07.2019.
Health Technology Assessment Department established
2017
22.11.2017.
Start of operation of the updated EudraVigilance system
Start of operation of the updated EudraVigilance system – an information system established and maintained by the European Medicines Agency (EMA) for collection of adverse drug reaction reports regarding medicines authorised and used in clinical research in all EEA countries.
21.11.2017. - 24.11.2017.
Campaign to promote reporting of adverse drug reactions
For the second time the Agency implements a social media campaign simultaneously with other EEA countries to promote reporting of adverse drug reactions. In 2017, campaign activities are mostly aimed at reporting adverse drug reactions caused by non prescription medicines.
03.11.2017.
Improved online search form of the Medicinal Product Register of Latvia
1) Additional parameter “Disease group (by ATC)” allows searching for medicines intended for a specific disease group; 2) Added functionality that allows ordering selected list of medicines according to maximum price allowed in pharmacies.
18.09.2017. - 20.09.2017.
BEMA IV visit at the Agency
28.07.2017.
Design and publication of an online report form on Agency’s website allowing representatives of healthcare institutions to submit electronic vigilance reports related to human blood, tissues, cells and organs.
05.06.2017. - 09.06.2017.
European Medicines Agency and U.S. Food and Drug Administration conducted a joint audit
As part of the Joint audit program (JAP) of the European Union member states, European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) conducted a joint audit (inspection) of the compliance of processes organized and practical activities performed by the Agency with the international requirements in the field of compliance evaluation of good manufacturing practice and good distribution practice.
03.04.2017.
“How not to overpay for medicines?”
In March and April 2017, Agency implemented a public information campaign “How not to overpay for medicines?” in collaboration with the society Health Projects for Latvia. As part of the campaign, an informative bulletin “RATIONAL CHOICE OF MEDICINES” was prepared for doctors .
01.03.2017. - 30.04.2017.
Agency implemented a public information campaign “How not to overpay for medicines?” in collaboration with the society Health Projects for Latvia. An informative bulletin “RATIONAL CHOICE OF MEDICINES” was prepared for doctors.
14.02.2017.
Simplified electronic submission of adverse drug reaction report forms for all users of medicines: on Agency’s website – without authentication via the Latvija.lv portal.
2016
07.11.2016.
The SAM launches a social media campaign “Reporting medicine side effects makes medicine safer”
26.10.2016.
SAM publishes “Baltic Statistics on Medicines 2013–2015”
20.10.2016.
Meeting of the representatives from the medicines agencies of the Baltic states in Riga, Latvia
17.02.2016.
The State Agency of Medicines director Svens Henkuzens participates in the Heads of Medicines Agencies (HMA) meeting in Amsterdam
04.02.2016.
The first three levels of Anatomical Therapeutic Chemical classification system (ATC) are translated into Latvian, creating a precise Latvian equivalent for the English terminology
2015
21.12.2015.
The SAM integrated management system is recertified in accordance with the requirements of the ISO 9001 and 27001 standards
03.11.2015.
Mr Svens Henkuzens becomes the new Director of the SAM
03.09.2015.
Meeting of the representatives from the medicines agencies of the Baltic states in Vilnius, Lithuania
16.06.2015. - 17.06.2015.
Meeting of the Heads of Medicines Agencies (HMA) Clinical Trails Facilitation Group (CTFG) in Riga
11.06.2015. - 12.06.2016.
Meeting of HMA Working Group of Communication Professionals (WGCP) in Jurmala during the Latvian Presidency of the EU Council
02.06.2015. - 03.06.2015.
Meeting of HMA Working Group of Quality Managers (WGQM) in Riga during the Latvian Presidency of the EU Council
06.05.2015. - 07.05.2015.
Informal Meeting of the European Medicines Agencies Cooperation on Legal and Legislative Issues (EMACOLEX) and the Co-ordination Group for Mutual recognition and Decentralised procedures – human (CMDh)
10.03.2015.
SAM prepares and publishes the supplemented list of names of 5000 active substances used in medicines in Latvian, Latin and English
24.02.2015. - 25.02.2015.
Meeting of the Competent Authorities for Medical Devices (CAMD) in Riga during the Latvian Presidency of the EU Council
16.02.2015.
The Human Medicines Evaluation Department is reorganised and a Medicines Marketing Authorisation Department is established
03.02.2015. - 05.02.2015.
HMA meeting in Riga during the Latvian Presidency of the EU Council
01.01.2015.
The SAM introduces a new logotype – the small, enhanced coat of arms of the Republic of Latvia and the orange colour assigned to the healthcare sector
2014
11.09.2014.
Meeting of the representatives from the medicines agencies of the Baltic States in Tartu, Estonia
05.09.2014.
20th anniversary edition of the SAM informative bulletin "Cito!" for doctors, pharmacists and other healthcare professionals
15.06.2014.
SAM performs new functions related to manufacturing, import and distribution of active substances and starts the registration of persons conducting international transactions with medicines
01.05.2014.
SAM introduces the project management system, establishes the SAM Development Plan and the SAM Development Commission and initiates the implementation of 10 projects in accordance with the project management methodology
08.04.2014.
The Adverse Drug Reaction Monitoring Department is reorganised and its functions are transferred to the Human Medicines Evaluation Department
24.02.2014. - 28.02.2014.
The BEMA III visit at the SAM
2013
17.06.2013.
The SAM Medicines Examination Laboratory is re-accredited as compliant with the requirements of the ISO 17025 standard; the fixed area of accreditation is expanded into a flexible one
2012
26.06.2012.
SAM releases a new electronic issue for physicians and pharmacists "DRUG REGISTER of the Republic of Latvia including summaries of product characteristics and package leaflets in DVD format"
2011
09.10.2011.
15 years since the establishment of the SAM. To celebrate the 15th anniversary the SAM personnel plants a white fir in the Garden of Destiny with an inscription "Pledge to Motherland"
26.08.2011. - 31.10.2011.
Participation as co-rapporteur in the repeated review of the EMA Committee for Advanced Therapy by authorising the newly introduced therapeutic medicines
16.05.2011.
The first digital map of pharmacies with broad search options is developed on SAM website
02.02.2011.
Contract between the Baltic State Agencies of Medicines regarding the united packaging of medicines in three languages
2010
01.10.2010.
The compliance evaluation and monitoring of procurement and storage organisations of human tissues, cells, organs and blood establishment, hospital blood banks and the State Blood Donor Centre is initiated
01.10.2010.
The function of compliance evaluation, authorisation and monitoring of safety of medical devices is introduced
06.09.2010. - 08.09.2010.
The European Union Benchmarking (BEMA II) takes place
09.07.2010.
Memorandum of Agreement with the EMA regarding exchange of information and documentation
25.06.2010.
Memorandum of Agreement with the Food and Drug Administration of the People's Republic of China about cooperation regarding normative regulation of medicines
01.02.2010.
Establishment of the Client Service Centre
2009
11.08.2009.
Contract between the Baltic State Agencies of Medicines regarding a united packaging of medicines in three languages
2008
19.09.2008.
Recognition from the Riga City Council for original front lawn greenery
14.01.2008.
Memorandum of Agreement with Lithuania regarding cooperation in monitoring of medicines
01.01.2008.
The first Mutual Recognition Procedure was carried out where Latvia was the Reference Member State
2007
27.12.2007.
Memorandum of Agreement between national medicines agencies of the EEA member states and the European Medicines Agency about the exchange of information and documents regarding pharmacovigilance
01.09.2007. - 31.12.2007.
The concept for the e-prescription information system is developed
11.07.2007.
Memorandum of Agreement with Estonia regarding cooperation in monitoring of medicines
01.02.2007.
Civil service is introduced at the SAM
2006
15.12.2006.
The technological updating and structural modification of the Drug Register is carried out and the State Agency of Medicines Information System SAMIS is developed
10.11.2006.
Meeting of the State Agencies of Medicines of the Baltic States takes place in Riga
01.07.2006.
Due to the introduction of new principles in the quality control of medicines prepared in pharmacies, the Medicines Quality Control Laboratory and its branches in Riga, Daugavpils, Cesis and Liepaja cease their operation
10.04.2006.
The pharmaceutical Activities Compliance Evaluation Department is established
06.02.2006. - 10.02.2006.
The European Union Benchmarking (BEMA I) takes place
02.01.2006. - 31.12.2010.
The authorisation and monitoring the circulation of veterinary medicines is delegated to the SAM
02.01.2006.
The Pharmaceutical Activities Company Licensing Department is established by reorganising the Legal Department and adopting from it the function of licensing pharmaceutical activity companies
02.01.2006.
The Information Department is reorganized and the Department of Information on Medicines Distribution and the Information Technology Department are established
01.01.2006.
Participation within PIC/S is initiated
01.01.2006.
For the first time the evaluation of staff members performance and results is initiated and completed
2005
15.12.2005.
A new function is delegated to SAM - to develop and maintain a system for the monitoring of prices of medicines
02.11.2005.
The Cabinet of Ministers of the Republic of Latvia appoints Ms Inguna Adoviča as the Director of the SAM
01.01.2005.
An educational issue "Introduction to Pharmacovigilance" is published
2004
15.11.2004.
The Archive building is commissioned
01.11.2004.
The non-profit organisation, state JSC "State Medicines Agency" is reorganised as the public agency "State Agency of Medicines" and Jānis Ozoliņš is reappointed as the Director
15.06.2004.
Access to an unified operation in databases of EU member states is established via the EudraNET network
2003
01.07.2003.
Legal Department in the Agency is established
15.06.2003.
The first edition of "Statistics of Medicines Consumption" is published
15.05.2003.
The first Benchmarking visit (BEMA) in the Agency
2002
01.10.2002.
Internal audit is introduced and the development of a Quality Management System is initiated
15.07.2002.
The Agency is welcomed into the WHO International Drug Monitoring Program as the 66th member state
15.06.2002.
The Medicines Examination Laboratory is welcomed into the international network of Official Medicines Control Laboratories (OMCL)
17.03.2002. - 18.03.2002.
The 5th European Union meeting of associated drug regulatory authorities takes place in Latvia - within the CADREAC cooperation agreement
2001
03.01.2001.
The development of an independent informative publication "CITO" for doctors and pharmacists is issued
02.01.2001.
Adverse Drug Reactions Monitoring Department is established
02.01.2001. - 31.12.2009.
The function of approval of the advertisements of medicines is carried out
2000
15.12.2000.
International Harmonisation Conference guidelines regarding Good Clinical Practice are published (in Latvian and English)
15.11.2000.
The second section of the Agency's building is commissioned
1999
15.06.1999.
The first Agency's website is developed
01.01.1999.
The first Annual Report is published
1998
02.03.1998.
Clinical Trial Inspection Department is established
01.01.1998.
The electronic record keeping program "Lotus Notes" was introduced
1997
15.06.1997.
The publication of the annual issue "Drug Register of Latvia" was established
05.03.1997.
The first marketing authorisation No. 97-0001 is issued for the medicine "PNU-Imune 23" (Marketing authorisation holder - Cyanamid-Lederle Arzneimittel GMbH)
1996
09.10.1996.
