Commission Implementing Regulation (EU) 2021/1280 of 2 August 2021 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)
Commission Implementing Regulation (EU) 2021/1280of 2 August 2021as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council(Text with EEA relevance)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/ECOJ L 4, 7.1.2019, p. 43., and in particular Article 95(8) thereof,Whereas:(1)Article 93(1)(j) of Regulation (EU) 2019/6 requires the holders of a manufacturing authorisation to use as starting materials only active substances which have been manufactured in accordance with good manufacturing practice for active substances and distributed in accordance with good distribution practice for active substances.(2)Article 95(1) of Regulation (EU) 2019/6 requires importers, manufacturers and distributors of active substances used as starting materials in veterinary medicinal products, that are established in the Union, to comply with good manufacturing practice or good distribution practice, as applicable.(3)Measures on good distribution practice should ensure the identity, integrity, traceability and quality of active substances used as starting materials in veterinary medicinal products during their movements from the premises where they are manufactured to the manufacturers of veterinary medicinal products by means of various modes of transport and by the use of various storage methods, as well as that those active substances remain within the legal supply chain during storage and transport.(4)Several international standards and guidelines on good distribution practice exist for active substances for medicinal products for human useGood trade and distribution practices for pharmaceutical starting materials. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations: fiftieth report. Geneva: World Health Organization; 2016: Annex 6 (WHO Technical Report Series, No 996).,Guidelines on the principles of Good Distribution Practice of active substances for medicinal products for human use, PIC/S, PI 047-1 Annex, 1.7.2018.. At Union level, guidelines on good distribution practice have been adopted only in respect of active substances for medicinal products for human useGuidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01) (OJ C 95, 21.3.2015, p. 1).. Corresponding measures in the veterinary domain should take into account the experience gained with the application of the current system under Directive 2001/83/EC of the European Parliament and of the CouncilDirective 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). in light of the similarities and potential differences between the requirements on good distribution practice for active substances used as starting materials in medicinal products for human use and in veterinary medicinal products.(5)A significant number of active substances are used as starting materials both in medicinal products for human use and in veterinary medicinal products. Importers, manufacturers and distributors often deal with such active substances. In addition, good distribution practice inspections for both types of medicinal products are often to be performed by the same competent authority experts. Therefore, in order to avoid unnecessary administrative burden on the industry and the competent authorities, it is practical to apply similar measures to the veterinary domain as in the human domain, unless specific needs dictate otherwise.(6)In order not to affect negatively the availability of veterinary medicinal products in the Union, the good distribution practice requirements for active substances used as starting materials in veterinary medicinal products should not be more stringent than the corresponding ones for those used as starting materials in medicinal products for human use.(7)The measures on good distribution practice for active substances used as starting materials in veterinary medicinal products laid down in this Regulation should ensure consistency with and complement the implementing measures on good manufacturing practice for veterinary medicinal products and active substances used as starting materials provided for in Article 93(2) of Regulation (EU) 2019/6 and good distribution practice for veterinary medicinal products provided for in Article 99(6) of that Regulation.(8)Relevant sections of good distribution practice for active substances used as starting materials in veterinary medicinal products should also be adhered to by third-party actors involved in the distribution of active substances used as starting materials in veterinary medicinal products and should be part of their contractual obligations. A consistent approach by all partners in the supply chain is required in order to be successful in the fight against falsified active substances used as starting materials in veterinary medicinal products.(9)A quality system is required to ensure that the objectives of good distribution practice are achieved and should clearly set out responsibilities, processes and risk management principles in relation to the activities of the persons involved throughout the distribution chain. That quality system should be the responsibility of the organisation’s management, requires their leadership and active participation, and should be supported by personnel commitment.(10)The correct distribution of active substances used as starting materials in veterinary medicinal products relies significantly on an adequate number of competent personnel to carry out all the tasks for which the importers, manufacturers and distributors of active substances used as starting materials in veterinary medicinal products are responsible. Individual responsibilities should be clearly understood by personnel and be recorded.(11)The persons distributing active substances used as starting materials in veterinary medicinal products should have suitable and adequate premises, installations and equipment, in order to ensure proper storage and distribution of active substances used as starting materials in veterinary medicinal products.(12)Good documentation should be an essential part of any quality system. Written documentation should be required in order to prevent errors from oral communication and permit the tracking of relevant operations during the distribution of active substances used as starting materials in veterinary medicinal products. All types of documents should be defined and adhered to.(13)Procedures should describe all distribution activities that affect the identity, traceability and quality of the active substances used as starting materials in veterinary medicinal products.(14)Records of all significant activities or events should be made and kept to ensure the traceability of the origin and destination of active substances used as starting materials in veterinary medicinal products, as well as the identification of all suppliers of, or those supplied with, such active substances.(15)The quality system should fully describe all key operations in appropriate documentation.(16)Complaints, returns, and recalls should be recorded and handled carefully in accordance with established procedures. Records should be made available to the competent authorities. An assessment of returned active substances used as starting materials in veterinary medicinal products should be performed before any approval for resale.(17)Any activity covered by good distribution practice for active substances used as starting materials in veterinary medicinal products that is outsourced should be correctly defined and agreed in order to avoid misunderstandings that could affect the integrity of such substances. A written contract between the contract giver and the contract acceptor should clearly establish the duties of each party.(18)Regular self-inspections are necessary to monitor the implementation of and compliance with good distribution practice for active substances used as starting materials for veterinary medicinal products.(19)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products referred to in Article 145 of Regulation (EU) 2019/6,HAS ADOPTED THIS REGULATION: