13/14 December 2023
With Regulation (EU) 2019/6 on veterinary medicinal products, which will apply from 28 January 2022, the European Union has revised the veterinary medicinal products legislation.
On 30 July 2021, the "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" was published in the Official Journal of the European Union. The Regulation entered into force in August 2021.
The requirements are very detailed and, in parts, go beyond the GDP requirements for active substances of veterinary medicinal products ("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").
The new Implementing Regulation (EU) 2021/1248 is strongly based on the GDP Guidelines for Medicinal Products for Human Use ("Guidelines of 5 November 2013 on Good Distribution Practice for Medicinal Products for Human Use - 2013/C 343/01"). This is already shown by the headings of the individual chapters. Many sections have been taken over verbatim or at least in analogy. Nevertheless, there are also some differences.
In the following, you will get an overview of the structure and the most important requirements of the new document.
Article 1 of the new Implementing Regulation (EU) 2021/1248 first states the subject matter and scope: The Regulation lays down the measures on good distribution practice for veterinary medicinal products. It applies "to holders of a manufacturing authorisation performing wholesale distribution of the veterinary medicinal products covered by that manufacturing authorisation, and to holders of a wholesale distribution authorisation, including those established or operating under specific customs regimes, such as free zones or customs warehouses."
Article 2 contains a comprehensive list of definitions relevant to the Regulation.
Article 3 requires the manufacturing authorisation/wholesale distribution authorisation holders referred to in Article 1 to develop and maintain a quality system.
Article 4 describes the requirements for the quality system. The quality system shall ensure the quality and integrity of the veterinary medicinal products supplied. It also aims to ensure that they remain within the legal supply chain during storage or transport.
Article 5 clarifies that the quality system also covers the control and review of any outsourced activities related to the wholesale distribution of veterinary medicinal products.
According to Article 6, there must be management review and monitoring of the quality system, including an assessment of performance indicators. The results of external assessments (e.g. inspections, audits) must also be included.
As per Article 7, the implementation of quality risk management is explicitly required.
Article 8 first deals with the obligations of persons responsible for wholesale distribution (‘the responsible persons’). The responsible person "shall have appropriate competence and experience as well as knowledge of, and training in, compliance with good distribution practice for veterinary medicinal products", although no specific information is given on the nature of this knowledge. Responsible persons shall be personally responsible for fulfilling their obligations and shall be contactable at any time. They may delegate their tasks but not their responsibilities. Article 8 continues to list elements that fall under the responsibility of the responsible persons.
Article 9 deals with other personnel. An adequate number of competent staff must be available at all levels.
Article 10 requires all personnel involved in wholesale distribution activities to be trained in the requirements of good distribution practice for veterinary medicinal products.
Article 11 points out that the principles of personal hygiene must be followed during work and that appropriate clothing must be worn.
Article 12 describes the requirements for the premises. These must be suitable for the activity, e.g. in terms of size, lighting, cleanliness, temperature, etc.
Article 13 deals with temperature and environmental control. In particular, it requires that an initial temperature mapping exercise be carried out on the storage area before use under representative conditions.
The equipment used shall be suitable for its intended purpose in accordance with Article 14, regularly maintained and repaired if necessary and calibrated if required. Records shall be retained.
Where computerised systems are used, they shall be validated in advance or, in any case, verification studies shall be carried out in accordance with Article 15. There shall be a written, detailed description of the computerised system and the data shall be secured and protected against accidental or unauthorised modification.
Article 16 additionally clarifies that the type and scope of qualification and validation must be determined on the basis of a documented risk assessment approach. Qualification and validation reports shall be prepared.
Article 17 first describes the documentation requirements in general. The documentation must be readily available or retrievable clearly and unambiguously formulated and written in a language understood by personnel.
Wholesale distribution activities affecting the quality of veterinary medicinal products shall be described in procedures in accordance with Article 18 and shall be approved, signed and dated by the responsible person. The following activities shall be described:
According to Article 19, records of all transactions involving veterinary medicinal products (purchase or sales invoices and delivery slips) must be prepared and/or kept.
Article 20 sets out general requirements for operations to ensure that the identity of the veterinary medicinal product is not lost during wholesale distribution and that no falsified veterinary medicinal products enter the legal supply chain.
Article 21 sets out the requirements for the verification of eligibility and approval of suppliers and Article 22 for the verification of eligibility and approval of customers.
In accordance with Article 23, during receipt of veterinary medicinal products, the responsible persons shall ensure that the arriving consignment is correct, that the veterinary medicinal products originate from approved suppliers and that they have not been damaged during transport.
Veterinary medicinal products shall be stored separately from products that might alter the veterinary medicinal products, according to Article 24, and shall also be protected from the harmful effects of light, temperature, moisture and other external factors.
Article 25 states that veterinary medicinal products intended for destruction shall be appropriately identified, kept separately and handled in accordance with a procedure.
Article 26 makes clear that the picking of goods must also be controlled.
Article 27 requires all supplies to be accompanied by an electronic or physical document containing a unique number identifying the delivery order and the applicable transport and storage conditions.
Article 28 states that when veterinary medicinal products are exported for which there is no marketing authorisation in the EU, it shall be ensured that the veterinary medicinal products concerned are not placed on the Union market.
Article 29 requires complaints to be accurately recorded and investigated. If the complaint concerns the quality of a veterinary medicinal product and a possible product defect, the manufacturer or the marketing authorisation holder shall be informed immediately.
Article 30 requires that returns be handled in accordance with a written, risk-based process. Article 30 also specifies the conditions for return into the saleable stock.
Article 31 says that in the event of (suspected) falsified veterinary medicinal products, the competent authority must be involved immediately.
Article 32 specifies what is to be done in the event of a recall.
For outsourced activities, Article 33 sets out the obligations of the contract giver and Article 34 the obligations of the contract acceptor.
According to Article 35, a self-inspection programme shall be implemented.
Article 36 specifies the requirements for conducting and recording self-inspections. If irregularities or deficiencies are found, the reasons for them must be investigated and CAPA must be documented and followed up.
Article 37 lists a number of transport requirements. These include:
Article 38 lists what must be considered in the selection of containers, packaging and labelling.
For products requiring special conditions (for example narcotics or psychotropic substances), special safety and control systems shall be established in accordance with Article 39.
Article 40 finally says that the Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall be binding in its entirety and directly applicable in all Member States.