(fra kommisjonsforordningen)

(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, medical 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, 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