On 28 January 2022, ‘Regulation (EU) 2019/6 of the European Parliament and of the Council, repealing Directive 2001/82/EU’, comes into force. It introduces rules for the authorisation, use and control of veterinary medicinal products.
The definition of veterinary medicinal products
As defined in Regulation 2019/6, veterinary medicinal products are every substance intended for animals and used for the following purposes:
- treating or preventing disease in animals;
- modifying an animal’s physiological functions by exerting a drug-like effect on the immune system or metabolism, which is to say, the internal processes supporting vital functions;
- making a medical diagnosis or carrying out euthanasia.
The main objectives of the Regulation
The ideas behind the introduction of the new regulation include:
- modernising the legislation;
- supporting innovation in terms of the availability of veterinary medicinal products;
- increasing the availability of veterinary medicinal products;
- preventing the emergence of antimicrobial resistance.
In accordance with the provisions of the Regulation, medicinal products placed on the market in line with Directive 2001/82/EC or Regulation (EC) No. 726/2004 may continue to be made available until 29 January 2027, even if they are not in compliance with the Regulation which comes into force on 28 January 2022.
Registering veterinary medicinal products
Regulation 2019/6 organises the rules for registering veterinary medicinal products which were previously regulated by Directive 2001/82/EC. It contains the following:
- the procedures set out for registering veterinary medicinal products:
- the national procedure set out in Articles 46 and 47 of Regulation 2019/6;
- the mutual recognition procedure set out in Articles 51 and 52 of Regulation 2019/6;
- the subsequent recognition procedure, as part of mutual recognition, set out in Article 53 of Regulation 2019/6;
- the type of application appropriate to the veterinary medicinal products discussed under Articles 19 to 22 of Regulation 2019/6;
- the introduction of unlimited duration for new registrations (in certain situations, the Agency has the possibility of limiting their validity period);
- requirements concerning the form of a registration dossier, which should contain details covering qualitative, clinical and pre-clinical aspects of using the veterinary medicinal product.
Pharmacovigilance of veterinary medicinal products
The Regulation also contains rules relating to pharmacovigilance. This includes the following points:
- it will no longer be obligatory to compile periodic safety update reports (PSURs);
- it will be necessary to report signals from the market to the European Pharmacovigilance Database at least once a year. They should be collected in accordance with the established management process, which includes their detection, prioritisation, validation and assessment and the relevant documentation.
At present, the European Medicines Agency (EMA) is implementing new guidelines regarding veterinary good pharmacovigilance practices (VGVP). The guidelines include:
- information on the role and responsibilities of a Qualified Person Responsible for Pharmacovigilance (QPPV);
- information on the Pharmacovigilance System Master File (PSMF);
- guidelines on communicating as regards veterinary pharmacovigilance, such as the obligation to have a communications plan which takes all the stakeholders into account.
The manufacture and distribution of veterinary medicinal products
In the case of rules concerning the manufacture and distribution of veterinary medicinal products, the primary points worth remembering are as follows:
- manufacturers and importers of active substances used in the production of veterinary products, are obliged to register, as is the case with medicinal products for human use;
- introducing the new Good Manufacturing Practices (GMP) guidelines is required for veterinary medicinal products. These guidelines are still being produced, so the completion of the process is scheduled for 2025. They will cover autological vaccinations and new therapies, for example;
- the necessity of entering the following into the database:
- substance, product, organisation and referential data (SPOR);
- organisation management service (OMS);
- the possibility of additional GMP inspections at veterinary medicinal product manufacturers in relation to the implementation of Regulation 2019/6.
Moreover, ‘Regulations: Commission implementing Regulation (EU) 2021/1280 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’ comes into force in January 2022.
Implementation of Regulation (EU) 2019/6 of the European Parliament and of the Council is scheduled to last until 29 January 2025. However, for herbal products, which are also covered by the regulation, the European Commission has until 29 January 2027.
If you would like to find out more about Regulation (EU) 2019/6 of the European Parliament and of the Council, the full document can be found in the Official Journal of the European Union and on EUR-Lex, an official website of the European Union.
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