Commission Implementing Regulation (EU) 2021/1248 of 29 July 2021 as regards measures on good distribution practice for 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/EC (1), and in particular Article 99(6) thereof,

Whereas:

(1) Article 101(5) of Regulation (EU) 2019/6 requires wholesale distributors to comply with good distribution practice for veterinary medicinal products, as adopted by the Commission.

(2) Measures on good distribution practice should ensure the identity, integrity, traceability and quality of veterinary medicinal products across the supply chain. Furthermore, those measures should guarantee that veterinary medicinal products are appropriately stored, transported and handled, as well as ensure that they remain within the legal supply chain during storage and transport.

(3) Several international standards and guidelines on good distribution practice exist for medicinal products for human use (2) (3) (4) (5). At Union level, guidelines on good distribution practice have been adopted only in respect of medicinal products for human use (6). 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 Council (7) in light of the similarities and potential differences between the requirements on good distribution practice for medicinal products for human use and for veterinary medicinal products.

(4) Wholesale distributors often deal with both medicinal products for human use and veterinary medicinal products. 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.

(5) In order not to affect negatively the availability of veterinary medicinal products in the Union, the good distribution practice requirements for veterinary medicinal products should not be more stringent than the corresponding ones for medicinal products for human use.

(6) The measures on good distribution practice for 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 active substances used as starting materials in veterinary medicinal products provided for in Article 95(8) of that Regulation.

(7) Any person acting as a wholesale distributor of veterinary medicinal products must hold a wholesale distribution authorisation in accordance with Article 99(1) of Regulation (EU) 2019/6 and comply with good distribution practice for veterinary medicinal products in accordance with Article 101(5) of that Regulation. In accordance with Article 99(5) of that Regulation, a manufacturing authorisation allows for the wholesale distribution of the veterinary medicinal products covered by that manufacturing authorisation. Therefore, manufacturers performing any such distribution activities with their own veterinary medicinal products are also to comply with good distribution practice for veterinary medicinal products.

(8) The definition of wholesale distribution as laid down in Article 4(36) of Regulation (EU) 2019/6 does not exclude wholesale distributors established or operating under specific customs regimes, such as free zones or customs warehouses. Therefore, all obligations related to wholesale distribution activities (such as exporting, holding or supplying) also apply to those wholesale distributors in respect of good distribution practice for veterinary medicinal products.

(9) Relevant sections of good distribution practice for veterinary medicinal products should also be adhered to by third-party actors involved in the wholesale distribution of 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 veterinary medicinal products.

(10) 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 wholesale distributor’s activities. 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.

(11) The correct distribution of veterinary medicinal products relies significantly on an adequate number of competent personnel to carry out all the tasks for which the wholesale distributor is responsible. Individual responsibilities should be clearly understood by personnel and be recorded.

(12) The persons distributing veterinary medicinal products should have suitable and adequate premises, installations and equipment, in order to ensure proper storage and distribution of veterinary medicinal products.

(13) 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 wholesale distribution of veterinary medicinal products. All types of documents should be defined and adhered to.

(14) Procedures should describe all distribution activities that affect the identity, traceability and quality of the veterinary medicinal products.

(15) Records of all significant activities or events should be made and kept to ensure the traceability of the origin and destination of veterinary medicinal products, as well as the identification of all suppliers of, or those supplied with, such veterinary medicinal products. Such records should facilitate the recall of a batch of a veterinary medicinal product, if necessary, as well as the investigation of falsified or suspected falsified veterinary medicinal products.

(16) With regard to the processing of personal data of employees, complainants or any other natural person, Regulation (EU) 2016/679 of the European Parliament and of the Council (8) on the protection of natural persons should apply to the processing of personal data and on the free movement of such data.

(17) The quality system should fully describe all key operations in appropriate documentation.

(18) Complaints, returns, suspected falsified veterinary medicinal products 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 veterinary medicinal products should be performed before any approval for resale.

(19) Any activity covered by good distribution practice for veterinary medicinal products that is outsourced should be defined, agreed and controlled in order to avoid misunderstandings that could affect the integrity of the veterinary medicinal product. A written contract between the contract giver and the contract acceptor should clearly establish the duties of each party.

(20) Regardless of the mode of transport, it should be possible to demonstrate that the veterinary medicinal products have not been exposed to conditions that may compromise their quality and integrity. A risk-based approach should be used when planning transport of and for transporting veterinary medicinal products.

(21) Regular self-inspections are necessary to monitor the implementation of and compliance with good distribution practice for veterinary medicinal products and to propose necessary corrective and preventive measures.

(22) 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:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter and scope

Article 2

Definitions

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

(a) ‘good distribution practice for veterinary medicinal products’ means the part of the quality assurance throughout the supply chain which ensures that the quality of veterinary medicinal products is maintained throughout all stages of the supply chain from the site of their manufacturer to the persons referred to in Article 101(2) of Regulation (EU) 2019/6;

(b) ‘free zone’ means any free zone designated by the Member States in accordance with Article 243 of Regulation (EU) No 952/2013 of the European Parliament and of the Council (9);

(c) ‘customs warehouse’ means any of the warehouses referred to in Article 240(1) of Regulation (EU) No 952/2013;

(d) ‘quality system’ means the sum of all aspects of a system that implements quality policy and ensures that quality objectives are met;

(e) ‘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;

(f) ‘validation’ means a documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria;

(g) ‘procedure’ means a documented description of the operations to be performed, the precautions to be taken and measures to be applied directly or indirectly related to the distribution of veterinary medicinal products;

(h) ‘documentation’ means written procedures, instructions, contracts, records and data, in paper or in electronic form;

(i) ‘procuring’ means obtaining, acquiring or purchasing veterinary medicinal products from manufacturers, importers or other wholesale distributors;

(j) ‘holding’ means storing veterinary medicinal products;

(k) ‘supplying’ means all activities of providing, selling or donating veterinary medicinal products to the persons referred to in Article 101(2) of Regulation (EU) 2019/6;

(l) ‘transport’ means moving veterinary medicinal products between two locations without storing them for unjustified periods of time;

(m) ‘deviation’ means departure from approved documentation or an established standard;

(o) ‘contamination’ means the undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a veterinary medicinal product during production, sampling, packaging or repackaging, storage or transport;

(p) ‘calibration’ means the set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding known values of a reference standard;

(q) ‘qualification’ means the action of proving that any equipment works correctly and actually leads to the expected results;

(r) ‘signed’ means the record of the individual who performed a particular action or review. This record can be initials, a full handwritten signature, a personal seal, or an advanced electronic signature as defined in Article 3(11) of Regulation (EU) No 910/2014 of the European Parliament and of the Council (10);

(s) ‘batch’ means a defined quantity of starting material, packaging material or product processed in a single process or series of processes, so that it is expected to be homogeneous;

(t) ‘expiry date’ means the date placed on the packaging of a veterinary medicinal product designating the time during which that veterinary medicinal product is expected to remain within established shelf life specifications if stored under defined conditions, and after which it should not be used;

(u) ‘batch number’ means a distinctive combination of numbers or letters that uniquely identifies a batch.

CHAPTER II

QUALITY MANAGEMENT

Article 3

Development and maintenance of a quality system

Article 4

Requirements for the quality system

(a) the procuring, holding, supplying, transport or export of veterinary medicinal products comply with the requirements of good distribution practice for veterinary medicinal products laid down in this Regulation;

(b) management responsibilities are clearly specified;

(c) veterinary medicinal products are delivered to the correct consignees within an appropriate time period;

(d) records are made contemporaneously;

(e) deviations are documented and investigated;

(f) appropriate corrective and preventive actions (‘CAPA’) are taken in line with the principles of quality risk management;

(g) changes that may affect the storage and distribution of veterinary medicinal products are evaluated.

Article 5

Management of outsourced activities

The quality system shall cover the control and review of any outsourced activities related to the wholesale distribution of veterinary medicinal products. Such control and review shall incorporate quality risk management and shall include:

(a) assessment of the suitability and competence of the contract acceptor to carry out the activity and checking authorisation status, if required;

(b) definition of the responsibilities and communication processes for the quality-related activities of the parties involved;

(c) regular monitoring and review of the performance of the contract acceptor, and the identification and implementation of any required improvements on a regular basis.

Article 6

Management review and monitoring

(a) a measurement of achievement of the objectives of the quality system;

(c) emerging regulations, guidance and quality issues that can impact the quality system;

(d) innovations that might enhance the quality system;

(e) changes in business environment and objectives.

Article 7

Quality risk management

CHAPTER III

PERSONNEL REQUIREMENTS

Article 8

Obligations of persons responsible for wholesale distribution