(fra kommisjonsforordningen)

(1) In accordance with Regulation (EU) 2019/6, veterinary medicinal products manufactured in the Union, including veterinary medicinal products intended for export as well as veterinary medicinal products imported into the Union, are to be manufactured in accordance with good manufacturing practice and contain as starting materials only active substances which have been manufactured in accordance with good manufacturing practice for active substances. 

(2) The Commission is to adopt good manufacturing practice for active substances used as starting materials in veterinary medicinal products (the ‘active substances’) applicable in the Union. The good manufacturing practices applicable in the Union should continue to be aligned with relevant international standards. 

(3) Compliance with the requirements for good manufacturing practice for active substances applicable in the Union should be ensured by manufacturers of active substances (‘manufacturers’). To avoid placing any restraint upon the development of any new concepts or new technologies, manufacturers of active substances 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 and purity of the active substances is ensured. 

(4) The manufacture of sterile active substances presents specific risks that should be addressed with a view to ensure the quality of such active substances. To this end, the sterilisation and aseptic processing of sterile active substances should be performed in accordance with the requirements set out in Annex I of Commission Implementing Regulation (EU) 2025/XX2 [PLAN/2023/2343] on good manufacturing practice for veterinary medicinal products.

(5) The manufacture of active substances from biological origin present specific characteristics that should be addressed with a view to ensure the quality of such active substances. To this end, requirements set out in Annex II of Commission Implementing Regulation (EU) 2025/XX [PLAN/2023/2343] on good manufacturing practice for veterinary medicinal products should be applied as relevant. 

(6) The manufacture of active substances from herbal origin present specific characteristics that should be addressed with a view to ensure the quality of such active substances. To this end, requirements set out in Annex III of Commission Implementing Regulation (EU) 2025/XX [PLAN/2023/2343] on good manufacturing practice for veterinary medicinal products should be applied as relevant. 

(7) Active substances used in parasiticidal veterinary medicinal products for the target species bees and active substances used in ectoparasiticidal veterinary medicinal products for external application are often produced for use in other types of products and the quantity needed for the production of veterinary medicinal products is too small to be economically viable. In order to ensure availability of parasiticidal veterinary medicinal products for bees and ectoparasiticidal veterinary medicinal products, this Regulation should not apply to the production of those active substances. However, the manufacturing process thereof should be adequate to ensure the quality and purity of the active substances. Additionally, the specifications provided for by the manufacturer of the veterinary medicinal product should be complied with. 

(8) Where there is a continuous process from the sourcing or isolation of an active substance from a biological source to the manufacturing of the finished product, such as in the case of veterinary medicinal products that consist of cells, viral-based vaccines or phages, the entire manufacturing process is subject to Commission Implementing Regulation (EU) 2025/XX [PLAN/2023/2343] on good manufacturing practice for veterinary medicinal products and this Regulation should therefore not apply to them. 

(9) Where there is a continuous process from the manufacture of the active substance gas to the manufacturing of the finished product, the entire manufacturing process is subject to Commission Implementing Regulation (EU) 2025/XX [PLAN/2023/2343] on good manufacturing practice for veterinary medicinal products and this Regulation should therefore not apply to them. 

(10) Manufacturers should ensure the identity, integrity, traceability and consistent quality of the active substances during their production. To achieve this objective, manufacturers should implement a comprehensive quality management 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. 

(12) In order to ensure that the active substances meet the required quality standards and comply with the terms of the marketing authorisation and with good manufacturing practice, manufacturers should perform regular self-inspections. 

(13) In order to ensure the quality of the active substances, manufacturers should have an adequate number of competent personnel with clear responsibilities. Initial and ongoing training relevant to the assigned tasks should be provided to the personnel.

(14) Appropriate hygiene standards should be maintained at all times during the manufacturing process. 

(15) In order to ensure the quality of the active substances, manufacturers should have suitable premises and equipment for the manufacture and control of the active substances 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 manufacture of active substances, should be set out as a basic requirement of good manufacturing practice. 

(16) In order to ensure that the use of computerised systems does not increase the risks to the quality of the active substances, certain requirements for the use of such systems should be laid down. 

(17) A comprehensive documentation system should be set out as a key component of the quality management 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 the active substances. Additionally, the documentation system should ensure that all the activities that, directly or indirectly, may affect the quality of the active substances are duly recorded and that the integrity of the data is maintained throughout the relevant retention period. 

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

(19) Production and in-process controls should be performed in order to assure the quality of the active substance and intermediates thereof. 

(20) Laboratory 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, laboratory control should encompass sampling, specifications and testing, as well as organisational measures, documentation and release procedures. 

(21) Correct sampling is essential to ensure the quality of the manufactured products. Reference samples should be kept as a record of the batch of active substance and for assessment in the case of quality investigations. 

(22) 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. 

(23) In order to ensure that the outsourcing of activities related to the manufacture and control of active substances does not increase the risks to the quality of the active substances, 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. 

(24) The manufacture of certain types of active substances warrants specific consideration. Additional requirements should be implemented in the manufacture of active substances or intermediates thereof manufactured by cell culture or fermentation and in the manufacture of active substances gases. It is therefore necessary to set out certain adjustments to the good manufacturing practice requirements or, where appropriate, additional requirements for those products. 

(25) While the good manufacturing practice requirements set out in this Regulation remain aligned with applicable requirements under Directive 2001/82/EC, 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. 

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