Commission Implementing Regulation (EU) 2025/2091 of 17 October 2025 laying down good manufacturing practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to 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 (1), and in particular Article 93(2) thereof,

Whereas:

(1) In accordance with Regulation (EU) 2019/6, holders of a manufacturing authorisation (‘manufacturers’) are required to comply with good manufacturing practice. Compliance with good manufacturing practice is required for the manufacture of veterinary medicinal products in the Union, including the manufacture of veterinary medicinal products intended for export, as well as for imports of veterinary medicinal products into the Union.

(2) The Commission is to adopt good manufacturing practice for veterinary medicinal products applicable in the Union. The good manufacturing practice for veterinary medicinal products applicable in the Union should continue to be aligned with relevant international standards.

(3) The manufacture of certain types of veterinary medicinal products warrants specific consideration. Additional requirements should be implemented in the manufacture of sterile veterinary medicinal products and for aseptic manufacturing. An end-product test for sterility is limited in its ability to detect contamination. In contrast, data derived from in-process controls and by monitoring relevant sterilisation parameters can provide more accurate and relevant information to support the sterility assurance of the product. Accordingly, sole reliance on end testing for the demonstration of sterility should not be possible.

(4) Additional requirements should also be implemented in the manufacture of biological and immunological veterinary medicinal products, including measures to protect workers and the environment, as well as specific quality and traceability requirements regarding the use of materials of biological origin. In cases where there is a continuous process from the sourcing or isolation of the active substance from a biological source to the manufacture of the finished product (e.g. veterinary medicinal products that consist of cells, viral-based vaccines or phages), the requirements of good manufacturing practice for active substances should not apply; instead the requirements laid down in this Regulation should apply to the entire manufacturing process. However, this Regulation should not apply to the manufacture of inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals in an epidemiological unit and used for the treatment of that animal or those animals in the same epidemiological unit or for the treatment of an animal or animals in a unit having a confirmed epidemiological link.

(5) The manufacture of herbal veterinary medicinal products, veterinary medicinal products intended for incorporation into medicated feedingstuffs, ectoparasitic veterinary medicinal products for external application, liquids creams and ointments, medicinal gases and pressurised metered dose aerosol veterinary medicinal products for inhalation warrants specific consideration. It is therefore necessary to set out certain adjustments to the good manufacturing practice requirements or, where appropriate, additional requirements for those products.

(6) The manufacture of homeopathic veterinary medicinal products subject to a registration procedure pursuant to Article 86(1) of Regulation (EU) 2019/6 is to comply with good manufacturing practice. The requirements set out in this Regulation should apply adapted to the fact that such products do not have a marketing authorisation. Accordingly, references to the terms of the marketing authorisation should, for these products, be understood as referring to the terms of the registration.

(7) In accordance with Regulation (EU) 2019/6, certificates of good manufacturing practice are to be issued when compliance with the requirements set out in this Regulation is demonstrated. To avoid placing any restraint upon the development of any new concepts or new technologies, manufacturers should be allowed to implement alternative approaches to those set out in this Regulation only if they are able to demonstrate that the alternative approach is capable of meeting the same objectives and that the quality, safety and efficacy of the veterinary medicinal product as well as its compliance with the terms of the marketing authorisation is ensured.

(8) Good manufacturing practice should apply throughout the lifecycle of the veterinary medicinal product, including technology transfer and up to the discontinuation of production.

(9) For the manufacturer to be able to comply with good manufacturing practice, cooperation between the manufacturer and the marketing authorisation holder is necessary. Where the manufacturer and the marketing authorisation holder are different legal entities, the obligations of the manufacturer and marketing authorisation holder vis-à-vis each other should be specified in a technical agreement between them.

(10) Manufacturers should ensure that the products are fit for their intended use, comply with the requirements of the marketing authorisation and do not create risks for the treated animals or the user due to inadequate quality. To achieve this objective, manufacturers should implement a comprehensive pharmaceutical quality system.

(11) Through product quality reviews, manufacturers should verify the consistency of the existing processes, the appropriateness of current specifications, detect trends, and identify product and process improvements. Where appropriate, the outcome of such reviews should lead to the implementation of corrective or preventive measures. Regular self-inspections should also be conducted to verify the effectiveness of the pharmaceutical quality system.

(12) In order to ensure the quality of veterinary medicinal products, manufacturers should have an adequate number of competent personnel with clear responsibilities. Initial and on-going training relevant to the assigned tasks should be provided to the personnel.

(13) In order to ensure the quality of veterinary medicinal products, manufacturers should have suitable premises and equipment for the manufacture and control of the veterinary medicinal products as well as suitable premises for the storage of materials and products. Such premises and equipment should be adequately maintained. Qualification and validation of the premises and equipment, including utilities and systems used during the manufacture of veterinary medicinal products, should be set out as a basic requirement of good manufacturing practice.

(14) In order to ensure the quality of veterinary medicinal products, manufacturers should ensure that appropriate hygiene standards are maintained at all times during the manufacturing process.

(15) A comprehensive documentation system should be set out as a key component of the pharmaceutical quality system. The documentation system should ensure that appropriate instructions and specifications are laid down, including relevant controls and monitoring procedures, with a view to ensuring the quality of veterinary medicinal products and compliance with the terms of the marketing authorisation. Additionally, the documentation system should ensure that all the activities that, directly or indirectly, may affect the quality of veterinary medicinal products are duly recorded and that the integrity of the data is maintained throughout the relevant retention period.

(16) Through process validation, the manufacturers should ensure that the critical aspects of the manufacturing process are duly controlled and that a consistent production is ensured in accordance with the quality requirements set out in the marketing authorisation.

(17) Requirements concerning the handling of materials and products, the qualification of suppliers, the prevention of cross-contamination and packaging operations should be set out.

(18) Quality control procedures should be implemented to ensure that materials are not released for use and products are not released for supply until their quality has been verified. As such, quality control should encompass sampling, specifications and testing, as well as organisational measures, documentation and release procedures.

(19) Correct sampling is essential to ensure the quality of veterinary medicinal products. Reference samples and retention samples should be kept as a record of the batch of finished product or of batches of materials used in the manufacture of the veterinary medicinal product and for assessment in the case of quality investigations.

(20) In order to ensure the quality of veterinary medicinal products and compliance with the terms of the marketing authorisation, manufacturers should perform batch release tests and in-process controls. An on-going stability programme should be implemented also.

(21) Real time testing and parametric release testing should be acceptable under certain conditions.

(22) Details on the process of certification by the qualified person and batch release should be laid down. In the case of veterinary medicinal products manufactured outside the Union, the certification process should be regarded as the final step in the manufacturing process which precedes the actual placing on the market.

(23) In order to ensure that the use of computerised systems does not increase the risks to the quality of veterinary medicinal products, certain requirements for the use of such systems should be laid down.

(24) In order to ensure that the outsourcing of activities related to the manufacture and control of veterinary medicinal products does not increase the risks to the quality of the product, certain requirements should be laid down. In particular, the outsourcing should be done in writing and there should be a clear delineation of the responsibilities of each party.

(25) In order to ensure that quality problems are swiftly identified and addressed, a system to record and investigate suspected quality defects and quality-related complaints should be put in place by manufacturers. In addition, procedures should be established to deal with recalls.

(26) Specific requirements for the use of ionising radiation in the manufacture of veterinary medicinal products should be laid down.

(27) While the good manufacturing practice requirements set out in this Regulation remain aligned with applicable requirements under Directive 2001/82/EC of the European Parliament and of the Council (2), time should be given to competent authorities and concerned stakeholders to become acquainted with the provisions of this Regulation. Accordingly, the application thereof should be deferred.

(28) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

HAS ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter and scope

(a) herbal veterinary medicinal products;

(b) veterinary medicinal products intended for incorporation into medicated feeding stuffs;

(c) ectoparasitic veterinary medicinal products for external application;

(d) liquids creams and ointments;

(e) medicinal gases;

(f) pressurised metered dose aerosol products for inhalation.

Article 2

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1) ‘pharmaceutical quality system’ means the total sum of the measures implemented as part of the manufacturing process to ensure that medicinal products are of the quality required for their intended use;

(2) ‘quality risk management’ means a systematic process, applied both proactively and retrospectively, for the assessment, control, communication and review of risks to the quality of the veterinary medicinal product across the product’s lifecycle;

(3) ‘manufacturing site’ means a site that is engaged in any of the activities for which a manufacturing authorisation is required in accordance with Article 88(1) of Regulation (EU) 2019/6;

(4) ‘batch’ means a defined quantity of materials or product that undergo the same process(es) so that it can be expected to be homogeneous. For the control of the finished product, a batch of a veterinary medicinal product comprises all the units of a pharmaceutical form which are made from the same initial mass of materials and have undergone a single series of manufacturing operations or a single sterilisation operation or, in the case of a continuous production process, all the units manufactured in a given period of time. In the case of continuous manufacturing, a batch corresponds to a defined fraction of the production, characterised by its intended homogeneity;

(5) ‘bulk product’ means any product which has completed all processing stages up to, but not including, final packaging;

(6) ‘intermediate product’ means a partly processed material which must undergo further manufacturing steps before it becomes a bulk product;

(7) ‘finished product’ means a veterinary medicinal product that has undergone all the stages of production, including packaging in its final container;

(8) ‘packaging’ means all operations, including filling (with the exception of sterile filling) and labelling, which a bulk product has to undergo in order to become a finished product;

(9) ‘packaging material’ means any material employed in the packaging of a veterinary medicinal product, excluding any outer packaging used for transportation or shipment. Packaging material can relate to immediate packaging or outer packaging;

(10) ‘in-process controls’ means the checks performed during production in order to monitor and, if necessary, adjust the process to ensure that the product conforms to the required specifications. Environmental monitoring and equipment controls are part of in-process controls;

(11) ‘qualification’ means the process of demonstrating that entities, premises, equipment, utilities, systems or materials are suitable for the intended task and can deliver the expected outcomes;

(12) ‘validation’ means the process of demonstrating that a method or process is suitable for its intended use;

(13) ‘reference sample’ means a sample of a batch of materials used in the manufacture of a veterinary medicinal product or finished product which is stored for the purpose of being analysed should the need arise during the shelf life of the batch concerned;

(14) ‘retention sample’ means a sample of a fully packaged unit from a batch of finished product which is stored for identification purposes;

(15) ‘reprocessing’ means the treatment of all or part of a batch of product of an unacceptable quality from a defined stage of production so that its quality may be rendered acceptable by one or more additional operations;

(16) ‘area’ means a space. A specific set of rooms within a building associated with the manufacture of one or more products that has a common air handling unit is considered as a single area;

(17) ‘clean area’ means an area designed, maintained, and controlled to prevent particle and microbiological contamination;

(18) ‘contained area’ means an area that is designed (including air handling and filtration), maintained and controlled so as to prevent contamination of the external environment by biological or other agents;

(19) ‘segregated area’ means an area within a manufacturing site that has separate storage, separate production suite with separate HVAC (heat, ventilation and air conditioning), dedicated equipment reserved solely for the production of one type of product with a specific risk profile and restrictions on the movement of personnel and equipment;

(20) ‘airlock’ means an enclosed space with interlocked doors, constructed to maintain air pressure control between adjoining rooms (generally with different air cleanliness standards). The intent of an airlock is to preclude ingress of particle matter and microorganism contamination from a lesser controlled area. A pass-through hatch has the same meaning as ‘airlock’ but is typically of a smaller size;

(21) ‘closed system’ means a system designed and operated so as to avoid exposure of the product or material to the room environment. Materials may be introduced to a closed system, but the addition must be done in such a way so as to avoid exposure of the product to the room environment (e.g. by means of sterile connectors or fusion systems). A closed system may need to be opened (e.g. to install a filter or make a connection) but it is returned to a closed state through a sanitisation or sterilisation step prior to process use;

(22) ‘cross-contamination’ means the contamination of a material or a product with another material or product;

(24) ‘campaign manufacture’ means the manufacture of a series of batches of the same product in sequence in a given period of time followed by strict adherence to preestablished control measures before transfer to another product. Use of the same equipment for distinct products is possible in campaign manufacture provided that appropriate control measures are applied;

(25) ‘aseptic processing/manufacturing’ means processing or manufacturing activities performed under conditions which prevent contamination;