Safe medicinal treatment of food-producing animals
UN Sustainable Development Goal 2:
2.1 End hunger by 2030 and ensure that everyone, especially the poor and the disadvantaged, including young children, receive enough safe and nutritious food throughout the year.
Challenge
Safe and effective medicines are needed for the treatment of food-producing animals for the appropriate prevention and treatment of animal diseases. Only medicines for which the safety of residues has been studied may be used for food-producing animals.
The excessive use and misuse of antimicrobials (antibiotics) in both humans and animals increases the risk of developing antimicrobial resistance (increased bacterial resistance to antibiotics) and poses a threat to human and animal health worldwide. Antimicrobial resistance knows no geographical boundaries or the differences between species. That is why it is a threat we must combat collectively in human and veterinary medicine (One Health), and prevention is an essential part of animal health care and welfare. As a result of climate change, new animal diseases can also be expected in Finland, which requires preparations such as vaccinations. Vaccines help protect animals from serious diseases. Vaccinations can reduce the need for antibiotics, which helps prevent the development of antimicrobial resistance. When a new animal disease is diagnosed in food-producing animals in Finland, vaccination against the disease can be permitted in cooperation with the Ministry of Agriculture and Forestry and the Finnish Food Authority.
Fimea’s role and objective
Fimea’s objective is to promote the safe medication of food-producing animals and prevent the development of antimicrobial resistance. Fimea grants marketing authorisations for veterinary medicines and vaccines after assessing their efficacy, safety and quality. Fimea also monitors adverse reactions to veterinary medicines and notifications of insufficient withdrawal periods. The availability of veterinary medicines is also promoted by granting special permits or exemptions. In addition, Fimea monitors the wholesales of veterinary antimicrobials.
How the successful attainment of the objective is promoted
The safe medication of food-producing animals is promoted in the following ways:
The marketing authorisation process for medicines and vaccines includes assessing product-specific withdrawal periods for food-producing animals’ medicines, their suitability for the Finnish animal disease situation and the risks to the user or the environment caused by the use of the product. Where necessary, instructions will be added to the product information to minimise risks. The withdrawal period is the minimum period of time from administering the last dose of medication during which slaughtered meat or other animal-derived products may not be released for food use due to potential medicinal residue.
The Anatomical Therapeutic Chemical (ATC) classification system divides medicines into groups based on their receptor and their chemical, pharmacological and therapeutic properties. Special groups have been created for veterinary medicines whose therapeutic indications differ from those of human medicines. The ATCvet QI category contains vaccines and other immunological products, such as allergens and various antibody products for different animal species.
Certain new kinds and biological veterinary medicines allow flexible indication of the use by date on the outer and inner packaging of the medicine as a derogation from Fimea’s administrative regulation. This promotes the availability of the medicine.
In accordance with the EU pharmaceutical strategy and Finland’s National Action Plan on Antimicrobial Resistance, Fimea participates in the control of antimicrobial resistance.
Fimea is actively involved in the EU One Health project titled “Joint Action Antimicrobial Resistance and Healthcare-Associated Infections” (JAMRAI 2). The project aims to raise awareness of antimicrobial resistance, promote the preservation of antimicrobial efficacy, maintain a good state of antimicrobial resistance and secure the availability of old narrow-spectrum antibiotics. The majority of antibiotics used in animals in Finland are narrow-spectrum, first-line antibiotics, so ensuring their availability is important.
Fimea collects information on the sale of veterinary antibiotics for supervising the consumption of veterinary antimicrobials and for monitoring antimicrobial resistance measures. The information is reported annually to the European Medicines Agency and nationally in the joint Finres vet report (helda.helsinki.fi, pdf) of the Finnish Food Authority, Fimea and the University of Helsinki. The total sales of antibiotics for production animals increased in 2023, but was still at the second lowest level ever measured. In 2024, EU reporting on the wholesales of antimicrobials switched to new practices in accordance with the Veterinary Medicinal Products Regulation, which also required changes in Fimea’s operations. The ASU-FI project, funded by the EU Commission, developed the automation and quality of reporting. Sales data was reported with a new method to the European Medicines Agency in the target schedule.
Case study: Fimea’s role in the control of highly pathogenic avian influenza in veterinary medicine
The highly pathogenic H5N1 avian influenza virus (EMA) has spread as epidemics in wild birds and poultry on several continents and may cause serious disease, especially in birds. In winter 2024–2025, more and more outbreaks have also occurred in Europe. Avian influenza viruses pose a growing threat because they have the potential to adapt to humans and cause future pandemics. The virus can also infect other mammals, such as pigs, fur animals and cattle.
Vaccination may reduce the spread of the avian influenza virus in birds and poultry, which in turn reduces the risk of its transmission to humans. In May 2024, Fimea cooperated with other EU Member States’ agencies to grant marketing authorisations for two H5 avian influenza virus vaccines intended for hens. The vaccines have been banned for the time being. However, they can be introduced quickly if the disease is diagnosed in Finland and the situation requires the vaccine to protect animals and humans.
Protection of the environment and reduction of national pharmaceutical waste
UN Sustainable Development Goal 3:
3.9 By 2030, significantly reduce deaths and diseases caused by hazardous chemicals and air, water and soil contamination and pollution.
UN Sustainable Development Goal 12:
12.4 By 2030, ensure environmentally sustainable handling of chemicals and waste throughout their life cycle in accordance with agreed international frameworks and significantly reduce their release to air, water or land in order to minimise adverse effects on health and the environment.
Challenge and objective
Pharmacotherapy is a key part of the treatment of illnesses. Successful pharmacotherapy can be used to prevent and cure illnesses, alleviate symptoms and slow down the progression of illnesses. Pharmacotherapy is rational when the user takes the medicines that they need and uses them according to instructions, at the right time and at suitable doses.
Pharmacies’ medicine sales transactions in 2019-2023
* Includes human and veterinary medicines x1000.. ** Medicine sales transactions in pharmacies, subsidiary pharmacies, pharmacy service points and online pharmacy services. *** With a prescription issued by a physician, dentist, veterinarian or, in certain cases, a nurse. Source: Finnish Statistics on Medicines 2023.
In practice, rational pharmacotherapy is not always realised. According to research data, only about one third of medicinal treatments are carried out as planned. Outdated and unused medicines produce a lot of pharmaceutical waste every year, which is disposed of by incineration. The materials and energy spent in the lifecycle of an unused medicine are wasted. For this reason, attention must be paid to the appropriate manufacture, packaging and package size, transport, use, storage and disposal of a medicine or medical product.
Incineration of pharmaceutical waste generated in Finland in 2020–2024, t/year
Pharmaceutical waste delivered to incineration abroad
201
173
196
57
132
Pharmaceutical waste arrived to incineration from abroad
0
0
0
22
132
Total
1 120
1 158
1 231
899
Total 0
Total 1
Total
* Waste categories LoW 180108, 180109, 180207, 180208, 200131 and 200132, includes both human and veterinary medicines. Source: YLVA information system.
Pharmaceutical packaging has strict quality requirements: the packaging material and method are primarily chosen so that it is appropriate and adequately protects the product. The packaging must also be as easy to use as possible and safe for transport, storage and children. Due to the quality requirements of medicines, recyclable packaging materials have so far not been suitable for packaging medicines. Pharmaceutical residues may also be a challenge in the recycling of used pharmaceutical packaging.
Fimea’s role
Fimea aims to promote rational pharmacotherapy even from the environmental perspective. The rational use, manufacture, distribution and disposal of medicines can help protect the environment and prevent unnecessary wastage of medicines.
The majority of medicines sold in Finland and Europe and their active substances are manufactured outside the EU, especially in Asia. Fimea supervises the industrial manufacture of medicines in Finland and in so-called third countries. Factory inspections of pharmaceutical manufacturers focus on ensuring the quality of medicines, but inspections also involve assessing the treatment of pharmaceutical waste. Fimea regularly supervises large pharmaceutical plants around the world that manufacture medicines for animals and humans. Routine supervision also includes manufacturers of environmentally critical antibiotics.
How the successful attainment of the objective is promoted
Fimea promotes environmental protection in ways including the following:
In the marketing authorisation application process, an environmental risk assessment (ERA) of the active substance of the medicine is carried out.
Where necessary, various risk management measures will be taken to reduce the environmental risks posed by medicines used in humans.
A negative ERA score of a veterinary medicine may lead to the rejection of its marketing authorisation application.
Fimea’s internal environmental working group of experts participates in commenting on regulations, provides instructions and offers preventive advice to operators from an environmental perspective.
Inspections of hospital pharmacies, pharmaceutical centres and contract manufacturing pharmacies are used to follow up on inspection findings of deficiencies related to pharmaceutical waste and supervise that the deficiencies are corrected appropriately.
Since spring 2024, Fimea has approved recycling labels on the packaging materials of medicines in Finland, placed on the inside of the outer packaging so that the labels become visible when the packaging is opened. With regard to the external surfaces of medicines packages, Finland complies with the guidelines of the European Medicines Agency’s Working Group on Quality Review of Documents (QRD), which currently does not allow recycling labels on the external surfaces of the outer or inner packaging of a medicine.
The Nordic hospital product packages pilot project aims to reduce the environmental load caused by packaging, as companies will not need to produce separate national packaging for each Nordic country.
In March 2024, the EU F-gas Regulation on fluorinated greenhouse gases entered into force. The regulation aims to reduce emissions of gases affecting climate change by imposing new requirements, for example on the labelling and import of products containing HFC compounds. Another aim is to ensure that greenhouse gases contained in products are clearly labelled and that their use and import are closely controlled. The new labels were required to be on products by 1 January 2025; the tight schedule of the regulation posed challenges for the marketing authorisation holders of inhalation products containing greenhouse gases. Fimea cooperated with the Finnish Environment Institute to prepare national guidelines on how the objectives of the F-gas Regulation concerning the labelling of medicines could be met so that the distribution of inhalation products does not get interrupted in Finland.
Fimea’s Medical Devices Unit is part of the European Commission’s Environmental Matters task force (EMTF), which was launched in 2024. The task force focuses on the environmental impacts of medical devices and sustainable development through legislation.
The Medical Device Regulation (EUR-Lex) requires criteria for the use of hazardous substances, CRMs (carcinogenic, mutagenic and reprotoxic agents) and phthalates (chemicals suspected to be endocrine disruptors). The RoHS Directive (Restriction of Hazardous Substances) (EUR-Lex), which is within Fimea’s scope of supervision, restricts the use of certain harmful substances, flame retardants and plasticisers in medical electrical and electronic equipment. Market surveillance of medical devices, such as inspections of manufacturers, is used to supervise these prohibited or restricted hazardous substances in electrical equipment. Fimea’s RoHS supervision involves close cooperation with the Ministry of the Environment and the Finnish Safety and Chemicals Agency (Tukes).
Inspections of manufacturers of medical devices including RoHS requirements in 2022–2024
Fimea aims to reduce pharmaceutical wastage at the national level in ways including:
Supporting the implementation of rational pharmacotherapy:
Rational pharmacotherapy aims to improve the health of patients and reduce the amount of pharmaceutical waste.
Correct practices and accurate information can be used to support the success of patients’ pharmacotherapy and to reduce the use of unnecessary medicines.
Assessing the appropriate packaging size in connection with the marketing authorisation application for medicines.
The purpose of mandatory reserve supplies is to secure the availability of medicines in Finland in circumstances where standard availability is restricted as a result of suspension of deliveries, a serious crisis or other similar reason. The number of medicines in the mandatory reserve is calculated on the basis of the previous year’s consumption of medicines. Sometimes there are significant changes in pharmaceutical consumption, for example due to changed treatment practices, in which case the amount of medicine in the mandatory reserve is too large or a reserve is completely unnecessary. In these situations, Fimea may grant an exemption to the party subject to the mandatory reserve obligation, in which case the medicines can be taken elsewhere to be used if necessary.
In 2024, Fimea launched a study commissioned by the Ministry of Social Affairs and Health (in Finnish)to develop multidose drug dispensing. Multidose drug dispensing is a service where the customer receives their regularly taken tablets and capsules that are suitable for dose-dispensing, packaged in single-dose plastic bags, usually for two weeks at a time. In the outpatient dose-dispensing process, the customer’s medication is checked regularly, and any changes to the medication are recommended to be scheduled for when the dose-dispensing period changes, which can reduce drug wastage.
Communicating about the sensible use of medicines also from an environmental perspective. The Finnish National Medicines Day (in Finnish) was celebrated for the 13th time on 13 March 2025. The theme was sustainable and responsible use of medicines. The main event of the day was an open webinar “Your choice matters – the appropriate use of medicines also helps save the environment”. The National Medicines Information Network coordinated by Fimea is responsible for planning the Finnish National Medicines Day.
