Published: 04.09.2025.

In order to engage in the manufacture, import and distribution of active substances for veterinary medicinal products from third countries (countries that are not Member States of the European Union or States of the European Free Trade Association that have signed the European Economic Area Agreement), it is necessary to obtain:

  • a registration certificate;
  • a Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP) certificate.

Manufacturers, importers and distributors of active substances for veterinary medicinal products must comply with the following in their operations:

  • the principles and guidelines of Good Manufacturing Practice (GMP), as laid down in the European Commission guidelines published in Volume 4 of the Rules Governing Medicinal Products in the European Union here;
  • the requirements of Chapter VI, Article 95 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC here;
  • the requirements set out in Chapters III and VII of the Pharmaceutical Law here;
  • Commission Implementing Regulation (EU) 2021/1248 of 29 July 2021 laying down measures on good distribution practice of veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council here;
  • the requirements of Chapter IV¹ of Cabinet Regulation No. 319 of 15 May 2007 "Regulations on the Manufacture and Control of Veterinary Medicinal Products, the Procedure for Issuing a Good Manufacturing Practice Certificate to a Manufacturer of Veterinary Medicinal Products, and the Qualification and Professional Experience Requirements for Persons Responsible for the Manufacture of Veterinary Medicinal Products here

ISubmission of Application to the Food and Veterinary Service (FVS)

 

As of 1 January 2025, manufacturers, importers and distributors of active substances must register their activities with the Food and Veterinary Service (FVS) (until 31 December 2024 with the State Agency of Medicines (SAM)). At least 60 days prior to the intended commencement of activities, an 'Application for the Registration of Manufacturers, Importers and Distributors of Active Substances Used as Starting Materials for Veterinary Medicinal Products' must be submitted to the central office or a regional unit of the FVS here.

 

Application Review

The Food and Veterinary Service (FVS) examines the application and assesses the compliance of the manufacturer, importer, or distributor of active substances with the requirements of Chapter IV¹ of Regulation No. 319 and Articles 95(1) and 123(3) of Regulation (EU) 2019/6.

The application is reviewed within a reasonable period, with the registration process expected to be completed within 60 days from the date of receipt of the application.

Possible Actions After Application Review

After reviewing the application, the Food and Veterinary Service (FVS), in accordance with Article 123(3) of Regulation (EU) 2019/6, may:

  • not carry out a compliance check of the manufacturer, importer, or distributor of active substances prior to registration;
  • carry out a compliance check prior to registration if it is determined that an on-site inspection of the company is necessary to assess the specific manufacturer’s, importer’s, or distributor’s compliance with GMP or GDP requirements.

Information on compliance inspections can be found in the section “Pre-Registration Compliance Assessment”.

 

Actions After the Compliance Assessment

  • After the compliance assessment, the Food and Veterinary Service (FVS) prepares an inspection report indicating the identified deficiencies and their classification according to the level of significance. The inspection report, which specifies the deadline for submitting a corrective action plan, is sent to the applicant.
  • If the inspection report identifies critical or major deficiencies, the manufacturer or importer of active substances must submit a corrective action plan to the FVS within 5 working days of receiving the inspection report, specifying the deadlines for addressing the deficiencies.

After reviewing the application and, if conducted, the compliance assessment, the Food and Veterinary Service (FVS) makes a decision to:

  • register the manufacturer, importer, or distributor of active substances if the company complies with Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP);
  • refuse registration if the manufacturer, importer, or distributor of active substances does not comply with GMP or GDP.

Registration Certificate

If the Food and Veterinary Service (FVS) decides to register a manufacturer, importer, or distributor of active substances, the company is issued a registration certificate entitled “Registration Form for Manufacturers, Importers and Distributors of Active Substances Used as Starting Materials for Veterinary Medicinal Products”, Annex 4 to Cabinet Regulation No. 319 here.

Along with the registration certificate, a distributor of active substances may also be issued a certificate of compliance with Good Distribution Practice (GDP), Annex 5 to Cabinet Regulation No. 319 here.

Information on the issued registration certificate is entered into the Union database covering manufacturing, import, and wholesale activities (EudraGMDP) here.

  • Within 6 to 12 months after the issuance of the registration certificate, a follow-up compliance assessment of Good Manufacturing Practice (GMP) may be conducted if the manufacturer has commenced the production of active substances after registration.
  • The Food and Veterinary Service (FVS) agrees on the date of the assessment with the respective manufacturer or importer and provides written notification at least 10 working days before the assessment.
  • The FVS is also entitled to carry out unannounced inspections if it is necessary to verify information in its possession regarding potential non-compliance.

 

To ensure regular supervision of manufacturers and importers of active substances, the FVS, based on a risk assessment, conducts compliance assessments for GMP at least once every 3 years after the issuance of a GMP certificate and at least once every 5 years after the issuance of a GDP certificate."

The Food and Veterinary Service (FVS) agrees with the applicant on the date of the assessment and, no later than 10 working days before the compliance assessment, provides the applicant with written information regarding the date, procedure, documents to be reviewed, and the inspectors who will participate in the assessment.

  • During the assessment, it is verified whether the manufacturer, importer, or distributor operates in compliance with Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP) requirements.
  • Depending on the size of the company and the specifics of its activities, the assessment may last 1 to 5 working days.
  • After the compliance assessment, the FVS prepares an inspection report indicating and classifying deficiencies identified during the assessment according to their level of significance. The inspection report, which specifies the deadline for submitting a corrective action plan, is sent to the applicant.
  • If the inspection report identifies critical or major deficiencies, the manufacturer, importer, or distributor of veterinary medicinal products must submit a corrective action plan to the FVS within 5 working days of receiving the inspection report, specifying the deadlines for addressing the deficiencies.

After the compliance assessment, the Food and Veterinary Service (FVS) makes one of the following decisions:

  • issue a GMP or GDP certificate;
  • postpone the issuance of a GMP or GDP certificate if non-compliances were identified during the assessment that do not affect the quality of the active substance and do not pose a risk to human or animal health or the environment, and an agreement on a corrective action plan has been reached with the manufacturer or distributor;
  • refuse to issue a GMP or GDP certificate.

Registered manufacturers, importers, and distributors of active substances must report any changes to the information provided in their registration application to the Food and Veterinary Service (FVS) each year by submitting a completed registration application with details of the changes. If no changes have occurred during the calendar year, no information needs to be submitted.

Any changes that may affect the quality or safety of the manufactured, imported, or distributed active substances must be reported immediately.

After reviewing the application, the Food and Veterinary Service (FVS) makes one of the following decisions:

  • approve the changes to the information provided in the registration application of the manufacturer, importer, or distributor of active substances without a compliance assessment;
  • conduct a compliance assessment prior to approving the changes in the registration application. The compliance assessment is carried out only for the changes specified in the registration application;
  • reject the changes if they require the issuance of a new registration certificate or if GMP or GDP requirements are not met.

If significant violations of veterinary medicinal product manufacturing or distribution practices are identified, the Food and Veterinary Service (FVS) is entitled to decide to:

  • partially or fully suspend the activities of the manufacturer, importer, or distributor of active substances in the scope specified in the registration certificate;
  • cancel the registration of the manufacturer, importer, or distributor of active substances.

The costs related to the registration of a manufacturer, importer, or distributor of active substances, compliance assessment inspections, changes to registration information, and the issuance of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) certificates shall be borne by the inspected entity in accordance with point 14 of Annex 4 of Cabinet Regulation No. 681 of 17 December 2019, “Regulations on the Procedure for Calculating and Making Payments for the State Supervision and Control Activities of the Food and Veterinary Service and Paid Services” here.

  • Information on manufacturers, importers, and distributors of veterinary active substances registered with the Food and Veterinary Service (FVS) is available here.
  • Information on issued, suspended, or cancelled registration certificates and GMP and GDP compliance certificates is also entered into the Union database covering manufacturing, import, and wholesale activities here.

For questions or clarifications, please email the Food and Veterinary Service (FVS) at vzr@pvd.gov.lv or call +371 67095267.