Legislation

Pharmaceutical Law

Regulation No 376 of the Cabinet of Ministers of the Republic of Latvia  "Procedures for the Registration of Medicinal Products" adopted on 9 May 2006

Regulation No 57 of the Cabinet of Ministers of the Republic of Latvia "Regulations Regarding Procedures for the Labelling of Medicinal Products and the Requirements to Be Set for Package Leaflets of Medicinal Products" adopted on 17 January 2006

Regulation No 885 of the Cabinet of Ministers of the Republic of Latvia  "Procedure for the Classification of Medicinal Products" adopted on 22 November 2005

Related information:

Heads of Medicines Agencies (HMA): marketing authorisations for medicinal products within the EU

European Medicines Agency (EMA): human medicines – regulatory information

Legal framework governing medicinal products for human use in the EU

Procedures and requirements for marketing authorisation, regulatory guidelines

Coordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh): Procedural quidance

Frequently asked questions

Common Baltic Package Guidance

Medicines for children – legislation:

European Commission: 

Information on medicines for children

Major developments regarding medicines for children

The 2017 Commission Report on the Paediatric Regulation

EMA: 

Paediatric Committee (PDCO)

Paediatric medicines: post-authorisation

Paediatric investigation plans: 

European Commission: Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies (2014/C 338/01)

Opinions and decisions on paediatric investigation plans

Submitting results of paediatric studies

CMDh information on medicines for children

Assessment reports on paediatric data: Article 45 and Article 46 work-sharing

According to the legislation the marketing authorisation holders must submit all paediatric studies to the State Agency of Medicines of Latvia via an e-mail: paediatric@zva.gov.lv and to EMA via e-mail: paedstudies@emea.europa.eu.

Regulation No 47 of the Cabinet of Ministers of the Republic of Latvia "Pharmacovigilance Procedures" adopted on 22 January 2013

EU guidelines: 

Good Pharmacovigilance Practices

Related information:

European Medicines Agency about Pharmacovigilance

Clinical Trials Regulation (Regulation (EU) No 536/2014)

Regulation No 289 of the Cabinet of Ministers of the Republic of Latvia "Regulations Regarding the Procedures for Conduct of Clinical Trials and Non-interventional Trials of Medicinal Products, Labelling of Investigational Medicinal Products and the Procedures for Assessment of Conformity of Clinical Trial of Medicinal Products with the Requirements of Good Clinical Practice" adopted on 23 March 2010

Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19)

1. Clinical trials related European directives (also in Latvian), guidelines, application forms, „Q&A document” and other relevant information can be found on: EudraCT public home page > Access to EudraCT Supporting Documentation > EudraLex Volume 10

2. Information about the activities of the Clinical Trial Facilitation Group (CTFG) established by EU Heads of Medicines Agencies and Voluntary Harmonization Procedure for assessment of multicenter clinical trials can be found on: www.hma.eu/ctfg.html

Guidance document for sponsors for a Voluntary Harmonisation Procedure for the assessment of multinational Clinical Trial Applications find in this PDF document.

Regulation No 436 of the Cabinet of Ministers of the Republic of Latvia "Procedures for the Importation and Exportation of Medicinal Products " adopted on 26 June 2007

Regulation No 416 of the Cabinet of Ministers of the Republic of Latvia “Procedures regarding the Distribution and Quality Control of Medicinal Products” adopted on 26 June 2007

Regulation No 220 of the Cabinet of Ministers of the Republic of Latvia "Procedures for Acquisition, Storage, Use, Registration and Disposal of Medicinal Products in Medical Treatment Institutions and Social Care Institutions” adopted on 27 March 2007

Regulation No 803 of the Cabinet of Ministers of the Republic of Latvia “Regulations regarding the Principles for the Determination of the Price of Medicinal Products” adopted on 25 October 2005

Regulation No 378 of the Cabinet of Ministers of the Republic of Latvia "Procedures for the Advertising Medicinal Products and Procedures by Which a Medicinal Product Manufacturer is Entitled to Give Free Samples of Medicinal Products to Physicians " adopted on 17 May 2011

Regulation No 57 of the Cabinet of Ministers of the Republic of Latvia "Regulations Regarding Procedures for the Labelling of Medicinal Products and the Requirements to Be Set for Package Leaflets of Medicinal Products" adopted on 17 January 2006

Regulation No 175 of the Cabinet of Ministers of the Republic of Latvia "Regulations for Manufacture and Storage of Prescription Forms, as well as Writing out and Storage Prescriptions" adopted on 8 March 2006

Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use

Law "On Procedures for the Legal Trade of Narcotic and Psychotropic Substances and Medicinal Products"

Law “On the Procedures for the Coming into Force and Application of the Criminal Law”

Regulation No 505 of the Cabinet of Ministers of the Republic of Latvia "Procedures of Circulation of Non-classified Substances to Be Controlled in Latvia", adopted on 29 October 2019 (available only in Latvian)

Regulation No 441 of the Cabinet of Ministers of the Republic of Latvia "Procedures for the Purchase, Receipt, Storage, Distribution, Dispensation, Accounting and Destruction of Narcotic and Psychotropic Substances and Medicinal Products in Manufacturing of Medicinal Products and Veterinary Medicinal Products, at Drug and Veterinary Drug Wholesalers and Pharmacies

Regulation No 293 of the Cabinet of Ministers of the Republic of Latvia "Procedures by which a Permit for the Utilisation of Plants, Substances and Medicinal Products Included in Schedules I, II or III of Narcotic Substances, Psychotropic Substances and Precursors Controlled in Latvia for Medical and Veterinary Medical Scientific Research, Specification of Physical and Chemical Properties or for Educational Purposes is Issued, Suspended and Revoked", adopted on 21 April 2008

Regulation No 327 of the Cabinet of Ministers of the Republic of Latvia „Regulations on the Transit of Narcotic and Psychotropic Substances and Drugs”, adopted on 13 August 1996

Commission Delegated Regulation (EU) 2015/1011of 24 April 2015 supplementing Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors, and repealing Commission Regulation (EC) No 1277/2005

Commission Implementing Regulation (EU) 2015/1013 of 25 June 2015 laying down rules in respect of Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and of Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors

Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drug precursors

Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors

Regulation No 610 of the Cabinet of Ministers of the Republic of Latvia “Criteria for the Location of Pharmacies and Pharmacy Branches” adopted on 2 August 2011

Regulation No 288 of the Cabinet of Ministers of the Republic of Latvia “Regulations Regarding Operating of Pharmacies” adopted on 23 March 2010

Regulation No 800 of the Cabinet of Ministers of the Republic of Latvia “Procedures for the Licensing of Pharmaceutical Activity” adopted on 19 October 2011

Regulation No 304 of the Cabinet of Ministers of the Republic of Latvia "Regulations Regarding the Procedures for the Manufacture and Control of Medicinal Products, the Requirements for the Qualification and Professional Experience of a Qualified Person and the Procedures for the Issuance of the Certificate of Good Manufacturing Practice to a Medicinal Products Manufacturing Undertaking" adopted on 18 April 2006

Regulation No 416 of the Cabinet of Ministers of the Republic of Latvia "Procedures Regarding the Distribution and Quality Control of Medicinal Products" adopted on 26 June 2007

Regulation No 436 of the Cabinet of Ministers of the Republic of Latvia "Procedures for the Importation and Exportation of Medicinal Products" adopted on 26 June 2007

Regulation No 319 of the Cabinet of Ministers of the Republic of Latvia "Regulations Regarding the Manufacture and Control of Veterinary Medicinal Products, the Procedure for the Issuance of a Good Manufacturing Practice Certificate to a Manufacturer of Veterinary Medicinal Products and Regarding the Requirements for the Qualification and Professional Experience of the Official Responsible for the Manufacture of Veterinary Medicinal Products" adopted on 15 May 2007

Regulation No 800 of the Cabinet of Ministers of the Republic of Latvia "Procedures for the Licensing of Pharmaceutical Activity" adopted on 19 October 2011

Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use Text with EEA relevance

European Commision Good Manufacturing Practice (GMP) guidelines

Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use Text with EEA relevance

Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use Text with EEA relevance

Medical Treatment Law

Regulation No. 455 of the Cabinet of Ministers "Procedures for conducting clinical investigations of medical devices and performance studies of in vitro diagnostic medical devices for human use" adopted on 15 August 2023
Regulation No. 461 of the Cabinet of Ministers "Medical Devices Regulations" adopted on 15 August 2023
Regulation No. 582 of the Cabinet of Ministers "In vitro Diagnostic Medical Devices Regulations" adopted on 10 October 2023

Related information:

European Commission > Growth > Sectors > Medical devices > Guidance

EU Regulation on standards of quality and safety for substances of human origin intended for human application

On the Protection of the Body of Deceased Human Beings and the Use of Human Tissues and Organs in Medicine

Sexual and Reproductive Health Law

Regulation No 70 of the Cabinet of Ministers of the Republic of Latvia "Regulations Regarding Use of Human Organs in Medicine, as well as Use of Human Organs and Body of Deceased Human Being for Medical Studies" adopted on 29 January 2013

Regulation No 468 of the Cabinet of Ministers of the Republic of Latvia "Procedures for Approving Medical Technologies to be Used in Medical Treatment and the Procedures for Introducing New Medical Technologies"

Regulation No 899 of the Cabinet of Ministers of the Republic of Latvia "Procedures for the Reimbursement of Expenditures for the Acquisition of Medicinal Products and Medical Devices Intended for the Outpatient Medical Treatment"

On the Protection of the Body of Deceased Human Beings and the Use of Human Tissues and Organs in Medicine

Sexual and Reproductive Health Law

Regulation No 70 of the Cabinet of Ministers of the Republic of Latvia "Regulations Regarding Use of Human Organs in Medicine, as well as Use of Human Organs and Body of Deceased Human Being for Medical Studies" adopted on 29 January 2013

Regulation No 344 of the Cabinet of Ministers of the Republic of Latvia "Procedures for Importing and Distributing Active Substances " adopted on 25 June 2013

Regulation No 641 of the Cabinet of Ministers of the Republic of Latvia "State Agency of Medicines Publicly Available Paid Service Price List" adopted on 10 December 2019 (updated 07.03.2024.)

Requisites

State Agency of Medicines of Latvia
Jersikas street 15, Riga, LV-1003, Latvia
VAT reg. No. LV90001836181
The Treasury of the Republic of Latvia
LV24TREL9290579005000
BIC TRELLV 22XXX