Published: 06.05.2021.
Updated: 05.09.2025.

In order to engage in the manufacturing of veterinary medicinal products or investigational veterinary medicinal products, or in their import from third countries (countries that are not Member States of the European Union or member states of the European Free Trade Association that are parties to the Agreement on the European Economic Area), the following are required:

  • a special permit (licence) for the manufacturing or import of veterinary medicinal products (hereinafter – licence);
  • a Good Manufacturing Practice (GMP) certificate.

 

An SAM licence with the special operating condition “manufacture and import of veterinary medicinal products”, as well as a Good Manufacturing Practice (GMP) certificate issued until 31 December 2024, shall remain valid.

Manufacturers and importers of medicinal products who are already manufacturing or importing veterinary medicinal products and who, after 1 January 2025, wish to re-register their existing licences concerning the manufacture or import of veterinary medicinal products must apply to the Food and Veterinary Service (FVS) to obtain a licence for the manufacture and import of veterinary medicinal products, in accordance with Article 51.2 of the Pharmacy Law here.

Manufacturers and importers of medicinal products who will commence manufacturing or importing veterinary medicinal products after 1 January 2025 must obtain a licence for the manufacture or import of veterinary medicinal products and a Good Manufacturing Practice (GMP) certificate issued by the Food and Veterinary Service (FVS), in accordance with Article 51.2 of the Pharmacy Law here.

A licence for the manufacture of veterinary medicinal products is also required in the following cases:

  • if the manufactured veterinary medicinal products are intended solely for export;
  • if involved in the manufacture or preparation of veterinary medicinal products up to the finished product stage, including participation in any part of this process – such as processing, assembling, packaging and repackaging, labelling and relabelling, storage, sterilisation, testing, or release for supply of such products or any of their components;
  • if importing veterinary medicinal products.

The manufacturer/importer of veterinary medicinal products must comply with:

  • 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;
  • 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 set out in Chapters III and VII, and VIII of the Pharmaceutical Law here;
  • Cabinet Regulation No. 35 of 11 January 2011 “Procedure for the Issuance, Suspension, Re-registration and Revocation of Special Permits (Licences) for Veterinary Pharmaceutical Activities”, Chapter 2: here
  • 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
  • Cabinet Regulation No. 326 of 31 May 2016 “Regulations on the Distribution and Control of Veterinary Medicinal Products”, Chapters 2, 7 and 10: here
  • Cabinet Regulation No. 327 of 31 May 2016 “Procedure for the Import and Export of Veterinary Medicinal Products”: here

The person in whose name the licence for the manufacture of veterinary medicinal products is to be issued shall first submit to the central office or a regional structural unit of the Food and Veterinary Service (hereinafter – FVS):

  1. an application for the compliance assessment of a manufacturer or importer of veterinary medicinal products – Annex 1 to Cabinet Regulation No. 35 of 11 January 2011 “Procedure for the Issuance, Suspension, Re-registration and Revocation of Special Permits (Licences) for Veterinary Pharmaceutical Activities” (hereinafter – Regulation No. 35) Annex 1;
  2. a description of the manufacturing site – Annex 2 to Regulation No. 35 Annex 2;
  3. if the veterinary medicinal products are manufactured solely for export, a list of veterinary medicinal products intended for export – Annex 3 to Regulation No. 35 Annex 3.

 

Application Review Period:

The Food and Veterinary Service (FVS) shall review the application and the documents attached thereto within 5 working days. If additional information is required during the examination of the documents, it shall be requested from the applicant.

 

Payment Procedure:

The Food and Veterinary Service (FVS) shall issue or send by post to the applicant an invoice for the document review and compliance assessment in accordance with point 13 of Annex 4 to Cabinet Regulation No. 681 of 17 December 2019 “Regulations on the Procedure for Calculating and Making Payments for State Supervision and Control Activities of the Food and Veterinary Service and Paid Services”: here

 

Actions Following the Compliance Assessment:

  • After conducting the compliance assessment, the Food and Veterinary Service (FVS) shall prepare an inspection report, indicating and classifying the deficiencies identified during the inspection according to their severity. The inspection report, specifying the deadline for submitting a corrective action plan, shall be sent to the applicant.
  • If the inspection report identifies critical or major deficiencies, the manufacturer/importer of veterinary medicinal products shall submit to the FVS a corrective action plan within 5 working days from the receipt of the inspection report, specifying the deadlines for addressing the deficiencies.
  • After evaluating the corrective action plan, the FVS shall inform the applicant of the need to submit an application for obtaining the licence: here
  • The applicant shall submit, together with the application for the licence, a copy of the document confirming payment of the state fee. The amount of the state fee for issuing a licence is determined by Cabinet Regulation No. 716 of 23 October 2007 “Regulations on the State Fee for the Issuance of a Special Permit (Licence) for Veterinary Pharmaceutical Activities”, Subparagraph 2.1: here

Depending on the findings of the compliance assessment, the Food and Veterinary Service (FVS), in accordance with the procedure established in the Administrative Procedure Law, shall decide on the licence for the manufacture of veterinary medicinal products within one month:

  • to issue the licence;
  • to issue the licence subject to the applicant fulfilling certain conditions, ensuring within the deadline set by the Service that the premises, equipment, facilities, or personnel comply with the requirements of the regulatory enactments governing the circulation of veterinary medicinal products;
  • to suspend activities concerning the manufacture or import of the specific veterinary medicinal products indicated in the licence case;
  • to resume activities concerning the manufacture or import of specific veterinary medicinal products if the licence had been suspended based on the inspection report of the Service;
  • to extend the deadline for consideration of the licence case if additional information is required (the information provided in the application or attached documents is insufficient or raises doubts about its authenticity), if a supplementary inspection is necessary, or if a request has been received to supplement the licence case with new information or documents;
  • to revoke the licence or annul the specified special operating conditions.

If there are changes to the licence for the manufacture of veterinary medicinal products or to the information specified in its annexes, in particular if the qualified person is changed, the holder of the special permit (licence) shall submit an application for the re-registration of the licence to the central office or regional structural unit of the Food and Veterinary Service (FVS) within five working days after implementing the changes, in accordance with the relevant competence: here.

The licence shall be re-registered by conducting only a document-based compliance assessment if the licence holder submits an application accompanied by information and documents indicating that:

  • the information specified in the licence or its annexes has been changed;
  • certain veterinary medicinal products or dosage forms specified in the licence case will no longer be manufactured;
  • certain veterinary medicinal products specified in the licence case will no longer be imported from third countries;
  • any of the special operating conditions will no longer be complied with;
  • the qualified person specified in the relevant licence has been changed.

The licence shall be re-registered by conducting a compliance assessment or by submitting a Good Manufacturing Practice (GMP) inspection report in the following cases:

  • prior to commencing the manufacture or import of a new type of veterinary medicinal product, a new dosage form, or new narcotic or psychotropic substances, if such are intended to be manufactured or imported;
  • if the laboratory contracted for quality control or the manufacturer contracted for manufacturing operations has been changed;
  • if the scope of veterinary pharmaceutical activities is to be supplemented with any of the special operating conditions;
  • prior to commencing veterinary medicinal product manufacturing activities at a new site;
  • in other cases related to significant changes in manufacturing, quality control, or distribution premises, facilities, equipment, personnel, or documentation;
  • upon a justified request from the licence holder;
  • if the licence has been suspended based on identified violations in the manufacture, import, control, or distribution of veterinary medicinal products.

A copy of the document confirming payment of the state fee shall also be submitted together with the application for licence re-registration.

 

The amount of the state fee for licence re-registration is determined by Subparagraph 2.2 of Cabinet Regulation No. 716 “Regulations on the State Fee for the Issuance of a Special Permit (Licence) for Veterinary Pharmaceutical Activities”: here

In accordance with the procedure established by the Administrative Procedure Law, the Food and Veterinary Service (FVS) shall decide on the licence for the manufacture of veterinary medicinal products:

  • to re-register the licence;
  • to re-register the licence subject to the applicant fulfilling certain conditions, ensuring within the deadline set by the Service that the premises, equipment, facilities, or personnel comply with the requirements of the regulatory enactments governing the circulation of veterinary medicinal products;
  • to extend the deadline for consideration of the licence case if additional information is required (the information provided in the application or attached documents is insufficient or raises doubts as to its authenticity), if a supplementary inspection is necessary, or if a request has been received to supplement the licence case with new information or documents.

Upon identifying significant violations in the practice of veterinary medicinal product manufacture, the Food and Veterinary Service (FVS) shall be entitled to make a decision to:

  • refuse to issue the licence;
  • suspend the licence until the deficiencies are rectified;
  • revoke the licence.

After receiving the licence, the manufacturer shall inform the Food and Veterinary Service (FVS) in writing, by submitting a free-form notification, of the commencement of manufacturing, specifying the date and attaching a list of the products to be manufactured. This information shall be submitted within three working days after the start of manufacturing.

 

Within three to six months after the veterinary medicinal product manufacturer or importer has:

  • received the licence for the manufacture of veterinary medicinal products and commenced operations; or
  • re-registered the licence.

 

FVS shall conduct a follow-up compliance assessment to ensure that Good Manufacturing Practice (GMP) for veterinary medicinal products is being maintained in accordance with the regulatory enactments on the manufacture and control of veterinary medicinal products. A GMP inspection report shall be prepared following this assessment. In addition, a supervision risk assessment shall also be conducted.

Within 90 days following the compliance assessment, the Food and Veterinary Service (FVS) shall make one of the following decisions:

  • to issue a Good Manufacturing Practice (GMP) compliance certificate, if the inspection confirms compliance with the principles and guidelines of Good Manufacturing Practice;
  • to temporarily postpone the issuance of a GMP compliance certificate, specifying the reasons and the timeframe within which the necessary corrective measures must be taken;
  • to refuse to issue a GMP compliance certificate.

 

After receiving the Good Manufacturing Practice (GMP) compliance certificate, the Food and Veterinary Service (FVS) shall conduct follow-up GMP inspections at the manufacturing site at least once every three years or based on a risk assessment. The company is assigned a risk level based on the findings of the inspection, and the frequency of inspections is determined accordingly—the lower the risk level, the less frequent the inspections. The FVS shall agree with the veterinary medicinal product manufacturer or importer on the timing of the inspection and provide written notice no later than 10 working days before the inspection.

The FVS shall also be entitled to carry out unannounced inspections if:

  • there are justified suspicions that the principles and guidelines of GMP are not being observed;
  • a request to conduct such an inspection has been received from another Member State, the European Commission, or the European Medicines Agency.

A trader shall be entitled to export veterinary medicinal products to a third country (hereinafter – “export”) if the trader:

  • has obtained a licence for the manufacture of veterinary medicinal products; or
  • holds a special permit (licence) for the manufacture of medicinal products, where the scope of activities in the licence includes the manufacture of veterinary medicinal products, and exports only veterinary medicinal products it has manufactured itself; or
  • is an importer who exports only the veterinary medicinal products it has imported.

Veterinary medicinal products may be exported only if the manufacturer has produced them in compliance with the principles of Good Manufacturing Practice (GMP) for veterinary medicinal products as laid down in the regulatory enactments on the manufacture and control of veterinary medicinal products.

The trader must comply with the provisions specified in the regulatory enactments described in the section “Requirements for Veterinary Medicinal Product Manufacturers and Importers” and with the provisions of Chapter 3 “Export of Veterinary Medicinal Products to Third Countries” of Cabinet Regulation No. 327 of 31 May 2016 “Procedure for the Import and Export of Veterinary Medicinal Products”, as applicable to veterinary medicinal product manufacturers.

Veterinary medicinal products from a country that is not a Member State of the European Union or a member of the European Economic Area (hereinafter – “third country”) may be imported by a trader who:

  • has obtained a licence for the manufacture of veterinary medicinal products, provided that the scope of activities includes the import of veterinary medicinal products; or
  • holds a special permit (licence) for the manufacture of medicinal products, provided that the scope of activities includes the import of veterinary medicinal products.

The trader must comply with the provisions specified in the regulatory enactments described in the section “Requirements for Veterinary Medicinal Product Manufacturers and Importers” and with the provisions of Chapter 2 “Import of Veterinary Medicinal Products from Third Countries” of Cabinet Regulation No. 327 of 31 May 2016 “Procedure for the Import and Export of Veterinary Medicinal Products”.

Information on costs related to:

  • the review of an application, compliance assessment inspection, and the issuance of a Good Manufacturing Practice (GMP) certificate is available in Subparagraph 14.1 of Annex 4 to Cabinet Regulation No. 681 of 17 December 2019: here;
  • the state fee for a special permit (licence) – in Paragraph 2 of Cabinet Regulation No. 716: here
  • Important! In accordance with Paragraph 12 of Article 10 of the Pharmacy Law, the State Agency of Medicines (SAM) issued licences for pharmaceutical activities, in which the special scope of activity included the manufacture and import of veterinary medicinal products, until 31 December 2024. More detailed information is available here: šeit.
  • Information on all companies that have been issued a licence for veterinary pharmaceutical activities by both the Food and Veterinary Service (FVS) and SAM is available in the FVS register of supervised companies: šeit.
  • Information on holders of licences for veterinary pharmaceutical activities issued by the FVS is available on the FVS website: šeit.
  • Information on issued, suspended, or revoked licences and Good Manufacturing and Distribution Practice compliance certificates is also recorded in the Union’s EudraGMDP database, which covers manufacture, import, and wholesale activities: šeit.

For questions or clarifications, please write to the FVS email address: vzr@pvd.gov.lv or call +371 67095267.