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Legislation

Medicinal product registration

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.

 

Clinical trials

Regulation No 286 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


1. Clinical trials related European directives (also in Latvian), guidelines, application forms, „Q&A document” and other relevant information can be found on: eudract.ema.europa.eu > 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.

Imports and distribution of medicines

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

 

 

Narcotic, psychotropic substances and precursors

 

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


Regulation No 847 of the Cabinet of Ministers of the Republic of Latvia "Regulations Regarding Narcotic Substances, Psychotropic Substances and Precursors to be Controlled in Latvia", adopted on 8 November 2005

Regulation No 1142 of the Cabinet of Ministers of the Republic of Latvia "Procedure of Registering and Licensing of Operators", adopted on 21 December, 2010 (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

 

Manufacturing, quality and controls

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

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

 

 

Paid service price list

Regulation No 873 of the Cabinet of Ministers of the Republic of Latvia "State Agency of Medicines Publicly Available Paid Service Price List" adopted on 17 September 2013 (including amendments coming into force on 16 July 2019)

 

  • Regarding application of annual pharmacovigilance fee
  • Free of charge variations to the medicinal products authorisation documentation: according to the amendments of the Cabinet of Ministers of Latvia Regulation No 873 "State Agency of Medicines Publicly Available Paid Service Price List” (in force since September 5th, 2014) fee is not applicable for the review of Type IA administrative variations as defined in the European Commission Guidelines. Considering the mentioned amendments, please be informed that fee is not applicable for the following items of the Type IA variations: A.1; A.3; A.4; A.5.a and A.5.b; A.6; A.7; A.8.

 

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