(2)

In the light of the experience acquired and following the assessment by the Commission of the functioning of the market for veterinary medicinal products, the legal framework for veterinary medicinal products should be adapted to scientific progress, the current market conditions and economic reality.

(2)

In the light of the experience acquired and following the assessment by the Commission of the functioning of the market for veterinary medicinal products, the legal framework for veterinary medicinal products should be adapted to scientific progress, the current market conditions and economic reality , with respect to animals, nature and their interaction with man .

(6)

Animals may suffer from a broad range of diseases which can be prevented or treated. The impact of animal diseases and the measures necessary to control them can be devastating for individual animals, animal populations, animal keepers and the economy. Animal diseases transmissible to humans may also have a significant impact on public health. Therefore sufficient and effective veterinary medicinal products should be available in the Union in order to ensure high standards of animal and public health, and for the development of the agriculture and aquaculture sectors.

(6)

Despite the measures that farmers take on good hygiene, feed, management and biosecurity, animals may suffer from a broad range of diseases which need to be prevented or treated by veterinary medicinal products for both animal health and welfare reasons . The impact of animal diseases and the measures necessary to control them can be devastating for individual animals, animal populations, animal keepers and the economy. Animal diseases transmissible to humans may also have a significant impact on public health. Therefore sufficient and effective veterinary medicinal products should be available in the Union in order to ensure high standards of animal and public health, and for the development of the agriculture and aquaculture sectors. To that end, good husbandry and management practices should be put in place in order to improve animal welfare, limit the spread of diseases, prevent antimicrobial resistance and ensure proper nutrition of livestock.

(7)

This Regulation should set high standards of quality, safety and efficacy for veterinary medicinal products in order to meet common concerns as regards the protection of public and animal health. At the same time, this Regulation should harmonise the rules for the authorisation of veterinary medicinal products and the placing of them on the Union market.

(7)

This Regulation should set high standards of quality, safety and efficacy for veterinary medicinal products in order to meet common concerns as regards the protection of public and animal health and the environment . At the same time, this Regulation should harmonise the rules for the authorisation of veterinary medicinal products and the placing of them on the Union market.

(7a)

This Regulation aims at ensuring a high level of protection of both animal and human health while securing the protection of the environment. Therefore, the precautionary principle should be applied. This Regulation should ensure that industry demonstrates that pharmaceutical substances or veterinary medicinal products produced or placed on the market have no harmful effects on human or animal health nor have any unacceptable effects on the environment.

(9)

The scope of the mandatory use of a centralised authorisation procedure under which the authorisations are valid throughout the Union should cover inter alia products containing new active substances and products which contain or consist of engineered tissues or cells. At the same time, in order to ensure the widest possible availability of veterinary medicinal products in the Union, the centralised authorisation procedure should be extended to allow for applications for authorisations under that procedure to be submitted for any veterinary medicinal product, including for generics of nationally authorised veterinary medicinal products.

(9)

The scope of the mandatory use of a centralised authorisation procedure under which the authorisations are valid throughout the Union should cover inter alia products containing new active substances and products which contain or consist of engineered tissues or cells. At the same time, in order to ensure the widest possible availability of veterinary medicinal products in the Union, the centralised authorisation procedure should be extended to allow for applications for authorisations under that procedure to be submitted for any veterinary medicinal product, including for generics of nationally authorised veterinary medicinal products. The use of the centralised procedure should be encouraged in every way, in particular by facilitating access for small and medium-sized enterprises (SMEs).

(14)

Where a Member State or the Commission considers that there are reasons to believe that a veterinary medicinal product may present a potential serious risk to human or animal health or to the environment, a scientific evaluation of the product should be undertaken at Union level, leading to a single decision on the area of disagreement, binding on the Member States concerned, being taken on the basis of an overall benefit-risk assessment.

(14)

Where a Member State or the Commission considers that there are reasons to believe that a veterinary medicinal product may present a potential serious risk to human or animal health or to the environment, a scientific evaluation of the product should be undertaken at Union level, leading to a single decision on the area of disagreement, binding on the Member States concerned, being taken on the basis of an overall benefit-risk assessment. The authorisation procedure for veterinary medicinal products should be adjusted so as to eliminate other administrative procedures that might hamper the development of research and innovation for the purpose of identifying new medicines.

(17)

However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only. In case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain.

(17)

However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only. In such cases, antimicrobial medicinal products for human use could be employed only subject to the issuing of a prescription by a veterinarian and the granting of authorisation by the veterinary authority responsible for monitoring the work of the veterinarian in question . In case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain , and particular care should therefore be taken when administering antibiotics to food-producing animals.

(18)

Member States should be able to allow exceptional use of veterinary medicinal products without a marketing authorisation where it is necessary to respond to Union listed diseases and where the health situation in a Member State so requires.

(18)

Member States should be able to allow temporary exceptional use of veterinary medicinal products without a marketing authorisation where it is necessary to respond to Union listed diseases or new diseases and where the health situation in a Member State so requires.

(20)

Directive 2010/63/EU of the European Parliament and of the Council (15) lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Clinical trials for veterinary medicinal products are exempted from that Directive. The design and performance of clinical trials, which provide essential information on the safety and efficacy of a veterinary medicinal product, should be such as to provide the most satisfactory results whilst using the minimum number of animals, the procedures should be the least likely to cause pain, suffering or distress to animals and should take into account the principles established by Directive 2010/63/EU.

(20)

Directive 2010/63/EU of the European Parliament and of the Council (15) lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Clinical trials for veterinary medicinal products are exempted from that Directive. The design and performance of clinical trials, which provide essential information on the safety and efficacy of a veterinary medicinal product, should be optimised in order to provide the most satisfactory results whilst using the minimum number of animals, the procedures should be designed to avoid causing pain, suffering or distress to animals and should take into account the principles established by Directive 2010/63/EU.

(23)

Companies have less interest in developing veterinary medicinal products for markets of a limited size. In order to promote the availability of veterinary medicinal products within the Union for those markets, in some cases it should be possible to grant marketing authorisations without a complete application dossier having been submitted, on the basis of a benefit-risk assessment of the situation and, where necessary, subject to specific obligations. In particular, this should be possible in the case of veterinary medicinal products for use in minor species or for the treatment or prevention of diseases that occur infrequently or in limited geographical areas.

(23)

Companies have less interest in developing veterinary medicinal products for markets of a limited size. In order to promote the availability of veterinary medicinal products within the Union for those markets, in exceptional cases it should be possible to grant marketing authorisations without a complete application dossier having been submitted, on the basis of a benefit-risk assessment of the situation and, where necessary, subject to specific obligations. In particular, this should be possible in the case of veterinary medicinal products for use in minor species or for the treatment or prevention of diseases that occur infrequently or in limited geographical areas. Such products should only be used on the basis of a prescription.

(25)

Tests, pre-clinical studies and clinical trials represent a major investment for companies which they need to make in order to submit the necessary data with the application for a marketing authorisation or to establish a maximum residue limit for pharmaceutical active substances in the veterinary medicinal product. That investment should be protected in order to stimulate research and innovation, so that it is ensured the necessary veterinary medicinal products are available in the Union. For that reason data submitted to a competent authority or the Agency should be protected against use by other applicants. That protection should, however, be limited in time in order to allow competition.

(25)

Tests, pre-clinical studies and clinical trials represent a major investment for companies which they need to make in order to submit the necessary data with the application for a marketing authorisation or to establish a maximum residue limit for pharmaceutical active substances in the veterinary medicinal product. That investment should be protected in order to stimulate research and innovation, in particular on veterinary medicinal products for minor species and antimicrobials, so that it is ensured the necessary veterinary medicinal products are available in the Union. For that reason data submitted to a competent authority or the Agency should be protected against use by other applicants. That protection should, however, be limited in time in order to allow competition.

(25a)

Research should be incentivised, not only through the commercial protection of innovative active substances, but also through the protection of significant investments in data generated to improve or maintain on the market an existing veterinary medicinal product. In such cases, only the new data package would benefit from the period of protection and not the active substance or any associated products.

(27)

It is recognised that the potential effect of a product on the environment may depend on the volume used and the resulting amount of the pharmaceutical substance that may reach the environment. Therefore, where there is evidence that a constituent of a medicinal product for which a generic application for a marketing authorisation is submitted is a hazard for the environment, it is appropriate to require data on the potential effect on the environment in order to safeguard the environment. In such cases applicants should endeavour to join efforts in generating such data in order to reduce costs and to reduce testing on vertebrate animals.

(27)

It is recognised that the potential effect of a product on the environment may depend on the volume used and the resulting amount of the pharmaceutical substance that may reach the environment. Therefore, where there is evidence that a constituent of a medicinal product for which a generic application for a marketing authorisation is submitted is a hazard for the environment, it is appropriate to require data on the potential effect on the environment in order to safeguard the environment. In such cases applicants should endeavour to join efforts in generating such data in order to reduce costs and to reduce testing on vertebrate animals. The current impact assessment system results in repetitive and potentially divergent assessments of substances' environmental properties. That can lead to divergent decisions being taken on products with similar effects on the environment, especially in the case of products authorised before the environmental impact assessment was carried out. The establishment of a single centralised assessment of the environmental properties of active substances for veterinary use by means of a monograph system could be a potential alternative. The Commission should therefore submit a report to the European Parliament and the Council examining the feasibility of monographs and potential alternative options as soon as possible.

(27a)

In accordance with Directive 2010/63/EU, it is necessary to replace, reduce or refine testing on vertebrate animals. Implementation of this Regulation should therefore be based on the use of alternative test methods, suitable for the assessment of health and environmental hazards of products, wherever possible.

(31)

It is recognised that, in some cases, a scientific risk assessment alone cannot provide all the information on which a risk management decision should be based, and other relevant factors should be taken into account including societal, economical, ethical, environmental and welfare factors and the feasibility of controls.

(31)

It is recognised that, in some cases, a scientific risk assessment alone cannot provide all the information on which a risk management decision should be based, and other relevant factors should also be taken into account including societal, economical, ethical, environmental and welfare factors and the feasibility of controls.

(32)

In certain circumstances where a significant animal or public health concern exists but scientific uncertainty persists, appropriate measures can be adopted taking into account Article 5(7) of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures which has been interpreted for the Union in the Communication from the Commission on the precautionary principle (17). In such circumstances, Member States or the Commission should seek to obtain additional information necessary for a more objective assessment of the particular concern and should review the measure accordingly within a reasonable period of time.

(32)

In certain circumstances where a significant animal , environmental or public health concern exists but scientific uncertainty persists, appropriate measures can be adopted taking into account Article 5(7) of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures which has been interpreted for the Union in the Communication from the Commission on the precautionary principle (17). In such circumstances, Member States or the Commission should seek to obtain additional information necessary for a more objective assessment of the particular concern and should review the measure accordingly within a reasonable period of time.

(33)

Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide. Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are critical for preventing or treating life-threatening infections in humans. In order to fight antimicrobial resistance a number of measures should be taken. It needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary antimicrobials . Use not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be restricted in the veterinary sector . The rules for advertising veterinary antimicrobials should be tightened, and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products.

(33)

Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide , thus involving a common responsibility of all actors concerned . Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are highly critical for preventing or treating life-threatening infections in humans and their use on animals, whether or not covered by the terms of a marketing authorisation, should be prohibited . In order to fight antimicrobial resistance a number of measures should be taken. It needs to be ensured that measures are proportionally applied in both the human and animal sectors and that appropriate warnings and guidance are included on the labels of human and veterinary antimicrobials. The rules for advertising veterinary antimicrobials should be tightened, and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products.

(34a)

The routine prophylactic and metaphylactic use of antimicrobials on groups of food-producing animals should be brought to an end. Disease should be prevented not by routine recourse to antimicrobials but by good hygiene, husbandry and housing, and sound management practices.

(35)

The combined use of several antimicrobial active substances may represent a particular risk with respect to the development of antimicrobial resistance. Combinations of antimicrobial substances should therefore only be authorised where evidence is provided that the benefit-risk balance of the combination is favourable.

(35)

The combined use of several antimicrobial active substances may represent a particular risk with respect to the development of antimicrobial resistance. Combinations of antimicrobial substances should therefore only be authorised exceptionally where evidence is provided that the long-term benefit-risk balance of the combination is favourable.

(36)

The development of new antimicrobials has not kept pace with the increase of resistance to existing antimicrobials. Given the limited innovation in developing new antimicrobials it is essential that the efficacy of existing antimicrobials is maintained for as long as possible. The use of antimicrobials in veterinary medicinal products may accelerate the emergence and spread of resistant micro-organisms and may compromise the effective use of the already limited number of existing antimicrobials to treat human infections. Therefore the misuse of antimicrobials should not be allowed.

(36)

The development of new antimicrobials has not kept pace with the increase of resistance to existing antimicrobials. Given the limited innovation in developing new antimicrobials it is essential that the efficacy of existing antimicrobials is maintained for as long as possible. The use of antimicrobials in medicinal products may accelerate the emergence and spread of resistant micro-organisms and may compromise the effective use of the already limited number of existing antimicrobials to treat human infections. Therefore, the misuse of antimicrobials should not be allowed. Preventive treatments using antimicrobials should be regulated more strictly and recommended only in certain specific, well-defined cases, in compliance with animal health, biosecurity and nutritional requirements.

(37)

In order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, it may be necessary to reserve those antimicrobials for humans only. Therefore it should be possible to decide that certain antimicrobials, following the scientific recommendations of the Agency, should not be available on the market in the veterinary sector.

(37)

In order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, it is necessary to reserve those antimicrobials for humans only. As a baseline, that should apply for the highest priority critically important antimicrobials identified by the World Health Organisation (WHO). Moreover, it should be possible to decide that other critically important antimicrobials, following the scientific recommendations of the Agency, should not be available on the market in the veterinary sector.

(37a)

As antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide, action also needs to be taken in the field of human medicine, for example in the form of an instrument incentivising the development of new antibiotics for human use similar to that already proposed within this Regulation.

(38)

If an antimicrobial is administered and used incorrectly, this presents a risk to public or animal health. Therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription. Persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials and consequently they should not be influenced, directly or indirectly, by economic incentives when prescribing those products. Therefore the supply of veterinary antimicrobials by those health professionals should be restricted to the amount required for treatment of the animals under their care.

(38)

If an antimicrobial is administered and used incorrectly, this presents a risk to public or animal health. Therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription. Persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials. Veterinarians have a legal obligation, which is part of their professional code of conduct, to ensure responsible use of veterinary medicinal products. They should not be influenced, directly or indirectly, by economic incentives when prescribing those products. The animal health industry and veterinarians should together promote responsible use. Therefore the supply of veterinary antimicrobials by veterinarians or other persons authorised under national law should be restricted to the amount required for treatment of the animals under their care , and only once a veterinary diagnosis has been established following a clinical examination of the animal, or, in exceptional cases, in the light of continuous health checks on the animal .

(38a)

Prudent use of antimicrobials is a cornerstone in addressing antimicrobial resistance. The Guidelines for the prudent use of antimicrobials in veterinary medicine, elaborated by the Commission, need to be considered by Member States.

(38b)

In order to facilitate responsible use of antimicrobials, there is an imperative need for rapid, reliable and efficacious veterinary diagnostics both to identify the cause of disease and to perform antibiotic sensitivity testing. That would facilitate correct diagnosis, allow for a targeted use of antimicrobials, support using as little as possible critically important antimicrobials and therefore, inhibit the development of antimicrobial resistance. There is clear need for future innovation specifically for pen-site diagnosis, and a need to consider carefully whether there is a case for more harmonisation and regulation in this sector.

(39)

It is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit-risk balance of certain veterinary antimicrobials in the Union. Any measure restricting the use of those products may affect the trade of products of animal origin or the competitiveness of certain animal production sectors in the Union. Moreover, antimicrobial resistant organisms can spread to humans and animals in the Union through consumption of products of animal origin imported from third countries, from direct contact with animals or humans in third countries or by other means. Therefore, measures restricting the use of veterinary antimicrobials in the Union should be based on scientific advice and should be considered in the context of cooperation with third countries and international organisations addressing antimicrobial resistance in order the ensure consistency with their activities and policies .

(39)

It is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit-risk balance of certain veterinary antimicrobials in the Union. Antimicrobial resistant organisms can spread to humans and animals in the Union through consumption of products of animal origin imported from third countries, from direct contact with animals or humans in third countries or by other means. Therefore, the Union should be active in advocating the creation of an international strategy to combat antimicrobial resistance , in line with the recent Global Action Plan adopted by the WHO .

(40)

There is still a lack of sufficiently detailed and comparable data at Union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced. Therefore it is important to collect data on the sales and use of antimicrobials in animals, data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals, humans and food. To ensure that the information collected can be used effectively, appropriate rules should be laid down concerning the collection and the exchange of data. The Member States should be responsible for collecting data on the use of antimicrobials under the coordination of the Agency.

(40)

There is still a lack of sufficiently detailed and comparable data at Union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced. Therefore it is important to collect data on the sales and use of antimicrobials in animals, data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals, humans and food. Better data are needed on how, when, where and why antimicrobials are being used. Therefore, the data collected should be broken down by type of antimicrobial, species, disease or infection treated. To ensure that the information collected can be used effectively, appropriate rules should be laid down concerning the collection and the exchange of data. The Member States should be responsible for collecting data on the use of antimicrobials under the coordination of the Agency.

(40a)

Commercial sensitivity should not be used as an excuse to deny citizens access to information about chemicals affecting their bodies or those of other non-target species in the wider environment. Maximum transparency should be ensured while protecting the most commercially sensitive information.

(49)

It is necessary, in specific cases , or from a public health and animal health perspective, to complement the safety and efficacy data available at the time of authorisation with additional information following the placing of the product on the market. Therefore the obligation to conduct post-authorisation studies should be imposed on the marketing authorisation holder.

(49)

In specific cases it is necessary, from a public health, animal health or environmental perspective, to complement the safety and efficacy data available at the time of authorisation with additional information following the placing of the product on the market. Therefore the obligation to conduct post-authorisation studies should be imposed on the marketing authorisation holder.

(50)

A pharmacovigilance database at Union level should be established to record and integrate information of adverse events for all veterinary medicinal products authorised in the Union. That database should improve detection of adverse events and should allow and facilitate the pharmacovigilance surveillance and work-sharing between the competent authorities.

(50)

A pharmacovigilance database at Union level should be established to record and integrate information of adverse events for all veterinary medicinal products authorised in the Union. That database should improve detection of adverse events and should allow and facilitate the pharmacovigilance surveillance and work-sharing between the competent authorities and other concerned authorities, including environmental protection agencies and food safety authorities both at national and Union level .

(52a)

In order to ensure that the imports from third countries of veterinary medicinal products, active substances, intermediate products and excipients used as starting materials have been manufactured in accordance with the animal welfare standards established in the Union, unlike for instance the current production method utilised in third countries for ‘pregnant mare serum gonadotropin’ (PMSG), the Commission should revise Directive 91/412/EEC and include animal welfare standards in the good manufacturing practice for veterinary medicinal products.

(56)

The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union. Veterinary medicinal products should only be supplied by persons authorised to do so by the Member State where they are established. At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State where they are established should be allowed to sell prescription and non-prescription veterinary medicinal products via the Internet to buyers in other Member States.

(56)

The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union. Veterinary medicinal products should only be supplied by veterinarians or other persons authorised to do so by the Member State where they are established . However, Member States which do not allow prescriptions to be issued by persons other than veterinarians could refuse to recognise prescriptions issued by persons other than veterinarians in other Member States in accordance with their national laws . At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State where they are established should be allowed to sell prescription and non-prescription veterinary medicinal products , except for antimicrobials, via the Internet to buyers in their own or other Member States. In order to minimise the risk to animal and human health, online sales of antimicrobials should be prohibited .

(56a)

In order to ensure that the lines of distribution and the supply of veterinary medicines are not restricted, where Member States have a legally defined, professionally qualified animal medicines advisor, the professionally qualified animal medicines advisors should continue to prescribe and supply certain veterinary medicines.

(56b)

Any ban on veterinarians supplying medicines could make it impossible for some Member States to maintain a network of veterinarians covering all of their territory. Such territorial coverage is of key importance in ensuring high-quality epidemiological monitoring of existing and emerging diseases.

(57)

The illegal sale of veterinary medicinal products to the public via the Internet may represent a threat to public and animal health, as falsified or substandard medicines may reach the public in this way. It is necessary to address this threat. Account should be taken of the fact that specific conditions for supply of medicinal products to the public have not been harmonised at Union level and, therefore , Member States may impose conditions for supplying medicinal products to the public within the limits of the Treaty.

(57)

The illegal sale of veterinary medicinal products to the public via the Internet may represent a threat to public and animal health, as falsified or substandard medicines may reach the public in this way. A system should be introduced to ensure that such products are properly sold and that controls are placed on the distribution and falsification of substances that are potentially dangerous for human use. Account should be taken of the fact that specific conditions for supply of medicinal products to the public have not been harmonised at Union level. To minimise the risks to animal and human health, the online sale of antimicrobials should be prohibited. Member States might impose conditions for supplying medicinal products to the public within the limits of the Treaty.

(58a)

Member States should, after informing the Commission, be able to subject the supply of veterinary medicinal products offered for sale to stricter conditions justified by the protection of public health, animal health and the environment, provided that these conditions are proportionate to the risk and do not unduly restrict the functioning of the internal market.

(62)

Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a  member of a regulated animal health profession for an individual animal or group of animals, it should in principle be possible for that veterinary prescription to be recognised and for the medicinal product to be dispensed in another Member State. The removal of regulatory and administrative barriers to such recognition should not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription.

(62)

Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a  veterinarian or other persons authorised to do so under national law for an individual animal or group of animals, it should in principle be possible for that veterinary prescription to be recognised and for the medicinal product to be dispensed in another Member State , provided that the other Member State authorises persons with similar qualifications to issue prescriptions . The removal of regulatory and administrative barriers to such recognition should not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription.

(65)

The verification of compliance with the legal requirements through controls is of fundamental importance to ensure that the objectives of the Regulation are effectively achieved across the Union. Therefore the competent authorities of the Member States should have the power to perform inspections at all stages of production, distribution and use of veterinary medicinal products. In order to preserve the effectiveness of the inspections, authorities should have the possibility to perform unannounced inspections.

(65)

The verification of compliance with the legal requirements through controls is of fundamental importance to ensure that the objectives of the Regulation are effectively achieved across the Union. Therefore the competent authorities of the Member States should have the power to perform inspections at all stages of production, distribution and use of veterinary medicinal products and should publish annual inspection reports . In order to preserve the effectiveness of the inspections, all inspections should be unannounced inspections.

(67)

In certain cases failures in Member States' control system can substantially hinder the achievement of the objectives of this Regulation and may lead to the emergence of risks to public and animal health and the environment. To ensure a harmonised approach to inspections throughout the Union, the Commission should be able to carry out audits in the Member States to verify the functioning of national control systems.

(67)

In certain cases failures in Member States' control system can substantially hinder the achievement of the objectives of this Regulation and may lead to the emergence of risks to public and animal health and the environment. The Commission should ensure a harmonised approach to inspections throughout the Union, and should be able to carry out audits in the Member States to verify the functioning of national control systems.

(71)

Having regard to the special characteristics of homeopathic veterinary medicinal products, especially the constituents of these products, it is desirable to establish a special, simplified registration procedure and to provide specific provisions for labelling for certain homeopathic veterinary medicinal products which are placed on the market without therapeutic indications. Immunological homeopathic products cannot follow the simplified registration procedure as immunologicals may initiate a response at a high dilution rate. The quality aspect of a homeopathic medicinal product is independent of its use so no specific provisions should apply with regard to the necessary quality requirements and rules.

(71)

Having regard to the special characteristics of homeopathic veterinary medicinal products, especially the constituents of these products, it is desirable to establish a special, simplified registration procedure and to provide specific provisions for labelling for certain homeopathic veterinary medicinal products which are placed on the market without therapeutic indications. Immunological homeopathic products cannot follow the simplified registration procedure as immunologicals may initiate a response at a high dilution rate. The quality aspect of a homeopathic medicinal product is independent of its use so no specific provisions should apply with regard to the necessary quality requirements and rules. Furthermore, it is desirable to generally allow, under specific conditions, the use of homeopathic medicinal products designed for human use, including immunological homeopathic products that have a potency starting from D4, on all animals, including food producing animals .

(71a)

The usual rules governing the authorisation to market veterinary medicinal products should be applied to homeopathic veterinary medicinal products marketed with therapeutic indications or in a form which might present risks which should be balanced against the desired therapeutic effect. Member States should be able to apply particular rules for the evaluation of the results of tests and trials intended to establish the safety and efficacy of these medicinal products for pet animals and exotic species, provided that they notify these rules to the Commission.

(73)

In order to protect public health, animal health and the environment, the activities and tasks attributed to the Agency in this Regulation should be adequately funded. Those activities, services and tasks should be funded through fees charged to enterprises. Those fees, however, should not affect the right of Member States to charge fees for activities and tasks at national level.

(73)

In order to protect public health, animal health and the environment, the activities and tasks attributed to the Agency in this Regulation should be adequately funded. Those activities, services and tasks , including the establishment of new information technology services with the aim of reducing bureaucracy, should be funded through fees charged to enterprises and through an increased financial contribution from the Commission . Those fees, however, should not affect the right of Member States to charge fees for activities and tasks at national level.

(ea)

substances or preparations which are intended exclusively for external use in animals, to clean or groom them or to alter their appearance or body odour, provided that no substances or preparations subject to veterinary prescription have been added to them;

(eb)

medicated feed and intermediate products as defined, respectively, in points (a) and (b) of Article 2(2) of Regulation (EÚ) …/… of the European Parliament and of the Council  (1a) ;

(ec)

feedingstuffs as defined in Regulation (EC) No 767/2009 of the European Parliament and of the Council.

(b)

its purpose is to be used in or administered to animals with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;

(b)

it may be used in, or administered to, animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;

(c)

its purpose is to be used for euthanasia of animals;

(c)

it may be used for euthanasia in animals;

(2)

‘substance’ means any matter of the following origin:

(2)

‘substance’ means any matter irrespective of its origin which may be:

(a)

human,

(a)

human, for example human blood and human blood products;

(b)

animal,

(b)

animal, for example micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products;

(c)

vegetable,

(c)

vegetable, for example micro-organisms, plants, parts of plants, vegetable secretions, extracts;

(ca)

fungal;

(cb)

microbial;

(d)

chemical;

(d)

chemical , for example elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis;

(da)

mineral.

(2a)

‘active substance’ means a substance with a pharmacological activity;

(3)

‘immunological veterinary medicinal product’ means a veterinary medicinal product consisting of vaccines, toxins, sera or allergen products and intended to be administered to an animal in order to produce active or passive immunity or to diagnose its state of immunity;

(3)

‘immunological veterinary medicinal product’ means a veterinary medicinal product, such as vaccines, toxins, sera or allergen products intended to be administered to an animal in order to produce active or passive immunity or to diagnose its state of immunity;

(7)

‘homeopathic veterinary medicinal product’ means a veterinary medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially in Member States;

(7)

‘homeopathic veterinary medicinal product’ means a veterinary medicinal product prepared in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially in Member States; a homeopathic veterinary medicinal product may contain a number of active ingredients;

(7a)

‘herbal medicinal product’ means any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations;

(8)

‘antimicrobial resistance’ means the ability of microorganisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to inhibit or kill microorganisms of the same species;

(8)

‘antimicrobial resistance’ means the ability of microorganisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to halt the growth of or kill microorganisms of the same species;

(8a)

‘antimicrobial’ means any compound with a direct action on micro-organisms used for treatment or prevention of infections; antimicrobials include anti-bacterials, anti-virals, anti-fungals and anti-protozoals; in the context of this Regulation, an antimicrobial substance refers to an antibacterial;

(8b)

‘antiparasitic’ means a medicinal product or substance used in the treatment of parasitic diseases attributable to various causes;

(8c)

‘antibacterial’ means a compound with a direct action on bacteria used for treatment or prevention of infections;

(9)

‘clinical trial’ means a study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product or both under normal conditions of animal husbandry or as part of normal veterinary practice for the purpose of obtaining a marketing authorisation or a change thereof ;

(9)

‘clinical trial’ means a study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product or both under normal conditions of animal husbandry or as part of normal veterinary practice;

(10)

‘pre-clinical study’ means a study not covered by the definition of clinical trial which aims to investigate the safety or efficacy of a veterinary medicinal product for the purpose of obtaining a marketing authorisation or a change thereof ;

(10)

‘pre-clinical study’ means a study not covered by the definition of clinical trial;

(11)

‘benefit-risk balance’ means an evaluation of the positive effects of the veterinary medicinal product in relation to the following risks relating to the use of that product:

(11)

‘benefit-risk balance’ means an evaluation of the positive therapeutic effects of the veterinary medicinal product in relation to the following risks relating to the use of that product:

(12)

‘common name’ means the international non-proprietary name recommended by the World Health Organisation for a veterinary medicinal product , or, if one does not exist, the name generally used ;

(12)

‘common name’ means the international non-proprietary name recommended by the World Health Organisation, or, if one does not exist, the usual common name;

(18)

‘package leaflet’ means a documentation leaflet on a veterinary medicinal product which contains information to ensure its safe and efficacious use;

(18)

‘package leaflet’ means an information leaflet attached to a veterinary medicinal product which is intended for a user of the veterinary medicinal product and which contains information to ensure its safe and efficacious use which are compliant with the information provided for in the summary of product characteristics of the veterinary medicinal product ;

(b)

veterinary medicinal products for animal species other than cattle, sheep, pigs, chickens, dogs and cats ;

(b)

veterinary medicinal products for animal species other than cattle, pigs, chickens, dogs , cats, salmon and sheep reared for their meat ;

(21)

‘pharmacovigilance’ means the process of monitoring and investigating adverse events;

(21)

‘pharmacovigilance’ means scientific, control and administrative activities relating to detection, reporting, assessment, understanding, prevention and communication of adverse events which include continuous evaluation of the risk-benefit balance of veterinary medicinal products ;

(24)

‘veterinary prescription’ means any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national law;

(24)

‘veterinary prescription’ means any prescription for a veterinary medicinal product issued by a  veterinarian or another professional person qualified to do so in accordance with applicable national law once a veterinary diagnosis has been established following a clinical examination of the animal ;

(25)

‘withdrawal period’ means the minimum period between the last administration of a veterinary medicinal product to an animal and the production of foodstuffs from that animal which under normal conditions of use is necessary to ensure that such foodstuffs do not contain residues in quantities harmful to public health ;

(25)

‘withdrawal period’ means the period necessary between the last administration of a veterinary medicinal product to an animal under normal conditions of use, and the production of foodstuffs from that animal , for the purpose of ensuring that such foodstuffs do not contain residues in quantities greater than the maximum limits established under Regulation (EC) No 470/2009 of the European Parliament and of the Council  (1a);

(26)

‘making available on the market’ means any supply of a veterinary medicinal product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

(26)

‘making available on the market’ means any supply of a veterinary medicinal product for distribution, consumption or use on the market of a Member State in the course of a commercial activity, whether in return for payment or free of charge;

(27a)

‘ essentially similar product ’ means a generic product that satisfies the criteria of having the same qualitative and quantitative composition in terms of active substances, of having the same pharmaceutical form, and of being bioequivalent to the original product, unless it is apparent in the light of scientific knowledge that it differs from the original product as regards safety and efficacy;

(27b)

‘marketing authorisation holder’ means the holder of a marketing authorisation granted in accordance with this Regulation;

(27c)

‘good animal husbandry’ means the management and care of farm animals by humans for profit whilst ensuring the health and welfare of these animals by respecting and safeguarding the specific needs of each species and by minimising as much as possible the need to use veterinary pharmaceutical products;

(27d)

‘responsible use of veterinary medicinal products’ means ensuring good husbandry and management practices such as biosecurity measures aiming to keep groups of animals healthy or to limit the spread of disease within an animal population, as well as asking veterinary advice, following vaccination programmes and prescription instructions, and ensuring good hygiene, appropriate nutrition and regular monitoring of health and welfare;

(27e)

‘adverse events’ means any of the undesirable events set out in Article 73(2);

(27f)

‘serious adverse events’ means any adverse event which results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly or birth defect, or which results in permanent or prolonged signs in the animals treated;

(27 g)

‘curative (therapeutic) treatment’ means the treatment of an ill animal or group of animals, when the diagnosis of disease or infection has been made;

(27h)

‘control treatment (metaphylaxis)’ means the treatment of a group of animals after the diagnosis of clinical disease in part of the group, with the aim of treating the clinically sick animals and controlling the spread of the disease to animals in close contact and at risk which may already be subclinically infected; the presence of such a disease in the group shall be established before the product is used;

(27i)

‘preventive treatment (prophylaxis)’ means the treatment of an animal or a group of animals before clinical signs of disease emerge, in order to prevent the occurrence of disease or infection;

(27j)

‘parallel importation’ means the importation into a Member State of a veterinary medicinal product authorised in another Member State in accordance with this Regulation and having the same characteristics as the veterinary medicinal product authorised in the Member State of import, in particular with:

(27k)

‘parallel distribution’ means distribution from one Member State to another Member State of a veterinary medicinal product authorised under a centralised procedure by an establishment authorised as referred to in Article 105 which is independent of the holder of the marketing authorisation;

(27l)

‘wholesale distribution’ means all activities consisting of procuring, holding, supplying or exporting veterinary medicinal products, whether in return for payment or free of charge, apart from retail supply; such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorised or entitled to supply medicinal products to the public in accordance with applicable national law;

(27m)

‘name of veterinary medicinal product’ means the name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trademark or the name of the marketing authorisation holder;

(27n)

‘pre-mix for medicated feedingstuffs’ means any veterinary medicinal product prepared in advance with a view to the subsequent manufacture of medicated feeding stuffs in accordance with Regulation (EU) …/… of the European Parliament and of the Council  (*1) .

(c)

the mutual recognition procedure laid down in Articles 47 and 48.

(c)

the mutual recognition procedure laid down in Articles 47, 48 and 57 .

(a)

documentation on the direct or indirect risks to public or animal health of use of the antimicrobial veterinary medicinal product in animals,

(a)

documentation on the direct or indirect risks to public or animal health or the environment of use of the antimicrobial veterinary medicinal product in animals,

(b)

information about risk mitigation measures to limit antimicrobial resistance development related to the use of veterinary medicinal product.

(b)

information about risk mitigation measures to limit antimicrobial resistance development related to the use of veterinary medicinal product , including specifications that the product is not to be used as a routine prophylactic or metaphylactic measure in food-producing animals, and is not to be used in prophylactic group treatments where there has been no diagnosis of disease .

(a)

the tested product is a veterinary medicinal product authorised for the food-producing species used in the clinical trial, and the withdrawal period set out in the summary of the product characteristics is respected, or

(a)

be at least as long as the withdrawal period laid down in Article 117, including, where appropriate, a safety factor reflecting the nature of the substance being tested; or

(b)

the tested product is an authorised veterinary medicinal product for target species other than the food-producing species used in the clinical trial and the withdrawal period set out in accordance with Article 117 is respected.

(b)

if maximum residue limits have been established by the Union in accordance with Regulation (EC) No 470/2009, the period shall be such as to ensure that those residue limits will not be exceeded in foodstuffs.

(a)

the name of the veterinary medicinal product, followed by its strength and pharmaceutical form;

(a)

the name of the veterinary medicinal product, followed by its strength and pharmaceutical form;

(b)

a statement of the active substances expressed qualitatively and quantitatively per unit or according to the form of administration for a particular volume or weight, using their common names;

(b)

a statement of the active substances expressed qualitatively and quantitatively per unit or according to the form of administration for a particular volume or weight, using their common names;

(c)

the batch number, preceded by the word ‘Lot’;

(c)

the batch number, preceded by the word ‘Lot’;

(d)

the name or corporate name or logo name of the marketing authorisation holder;

(d)

the name or corporate name or logo name of the marketing authorisation holder;

(e)

the target species;

(e)

the target species;

(f)

the expiry date, in the format: ‘mm/yyyy’, preceded by the abbreviation ‘Exp.’;

(f)

the expiry date, in the format: ‘mm/yyyy’, preceded by the abbreviation ‘Exp.’;

(g)

special storage precautions, if any.

(g)

special storage precautions, if any.

(a)

the information listed in Article 9(1);

(a)

the information listed in Article 9(1);

(b)

the contents by weight, volume or number of immediate packaging units of the veterinary medicinal product;

(b)

the contents by weight, volume or number of immediate packaging units of the veterinary medicinal product;

(c)

warning that the veterinary medicinal product must be kept out of the sight and reach of children;

(c)

warning that the veterinary medicinal product must be kept out of the sight and reach of children;

(d)

warning that the veterinary medicinal product is for animal treatment only;

(d)

a common pictogram warning that the veterinary medicinal product is for animal treatment only;

(e)

recommendation to read the package leaflet;

(e)

recommendation to read the package leaflet;

(f)

requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions as regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products;

(f)

requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products in accordance with the applicable law;

(g)

in case of homeopathic veterinary medicinal products, the statement ‘homeopathic veterinary medicinal product’.

(g)

in case of homeopathic veterinary medicinal products, the statement ‘homeopathic veterinary medicinal product’.

(a)

the name of veterinary medicinal product;

(a)

the name of veterinary medicinal product;

(b)

the quantitative particulars of the active substances;

(b)

the quantitative particulars of the active substances, unless the product exists in only one concentration or the concentration is reflected in the name;

(c)

the batch number, preceded by the word ‘Lot’;

(c)

the batch number, preceded by the word ‘Lot’;

(d)

the expiry date, in the format: ‘mm/yyyy’, preceded by the abbreviation ‘Exp.’

(d)

the expiry date, in the format: ‘mm/yyyy’, preceded by the abbreviation ‘Exp.’.

(a)

the name or corporate name and permanent address or registered place of business of the marketing authorisation holder and of the manufacturer and, where applicable, of the representative of the marketing authorisation holder;

(a)

the name or corporate name and permanent address or registered place of business of the marketing authorisation holder and of the manufacturer and, where applicable, of the representative of the marketing authorisation holder;

(b)

the name of the veterinary medicinal product or, where applicable, a list of the names of the veterinary medicinal product, as authorised in different Member States;

(b)

the name of the veterinary medicinal product or, where applicable, a list of the names of the veterinary medicinal product, as authorised in different Member States;

(c)

the strength and pharmaceutical form of the veterinary medicinal product;

(c)

the strength and pharmaceutical form of the veterinary medicinal product;

(d)

the target species, the dosage for each species, the method and route of administration and advice on correct administration , if necessary ;

(d)

the target species, the dosage for each species, the method and route of administration and , if necessary, advice on correct administration;

(e)

the therapeutic indications;

(e)

the therapeutic indications;

(f)

the contra-indications and adverse events in so far as this information is necessary for the use of the veterinary medicinal product;

(f)

the contra-indications and adverse events in so far as this information is necessary for the use of the veterinary medicinal product;

(g)

the withdrawal period, even if this is nil, in the event that the target species are food-producing animals;

(g)

the withdrawal period, even if this is nil, in the event that the target species are food-producing animals;

(h)

special storage precautions, if any;

(h)

special storage precautions, if any;

(i)

information essential for safety or health protection, including any special precautions relating to use and any other warnings;

(i)

information essential for safety or health protection, including any special precautions relating to use and any other warnings;

(j)

requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products;

(j)

requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products in accordance with the applicable law;

(k)

the marketing authorisation number;

(l)

in case of generic veterinary medicinal products, the statement ‘generic veterinary medicinal product’;

(l)

in case of generic veterinary medicinal products, the statement ‘generic veterinary medicinal product’;

(m)

in case of homeopathic veterinary medicinal products, the statement ‘homeopathic veterinary medicinal product’.

(m)

in case of homeopathic veterinary medicinal products, the statement ‘homeopathic veterinary medicinal product’;

(ma)

qualitative and quantitative composition.

(a)

the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the European Pharmacopoeia or, in the absence thereof, of the pharmacopoeias currently used officially in Member States;

(a)

the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the European Pharmacopoeia or, in the absence thereof, of the pharmacopoeias currently used officially in Member States; if the homeopathic veterinary medicinal product is composed of more than one stock, the scientific names of the stocks may be supplemented by a brand name in the label;

(b)

name and address of the marketing authorisation holder and, where appropriate, of the manufacturer;

(b)

name and address of the marketing authorisation holder and, where appropriate, of the manufacturer;

(c)

method of administration and, if necessary, route;

(c)

method of administration and, if necessary, route;

(d)

the expiry date, in the format ‘mm/yyyy’, preceded by the abbreviation ‘Exp.’;

(e)

pharmaceutical form;

(e)

pharmaceutical form;

(f)

special storage precautions, if any;

(f)

special storage precautions, if any;

(g)

target species;

(g)

target species, as well as dosage levels for the different target species;

(h)

a special warning if necessary for the medicinal product;

(h)

a special warning if necessary for the medicinal product;

(i)

the batch number, preceded by the word ‘Lot’;

(j)

registration number;

(j)

registration number;

(k)

withdrawal period, if applicable.

(k)

withdrawal period, if applicable;

(l)

the statement ‘homeopathic veterinary medicinal product’.

(l)

the statement ‘homeopathic veterinary medicinal product’.

(a)

the benefit of the immediate availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain documentation has not been provided;

(a)

the benefit of the immediate availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain documentation has not been provided;

(b)

the applicant provides the evidence that the veterinary medicinal product is intended for a limited market.

(b)

the applicant provides the evidence that the veterinary medicinal product is intended for a limited market.

(a)

a requirement to introduce conditions or restrictions, in particular concerning the safety of the veterinary medicinal product;

(a)

a requirement to introduce conditions or restrictions, in particular concerning the safety of the veterinary medicinal product;

(b)

a requirement to notify the competent authorities of any incident relating to the use of the veterinary medicinal product;

(b)

a requirement to notify the competent authorities of any adverse event relating to the use of the veterinary medicinal product;

(c)

a requirement to conduct post-authorisation studies.

(c)

a requirement to provide further data based on either post-authorisation studies or on data collected on the performance of the product in the field, where data from the field is identified as more appropriate based on a risk-benefit assessment.

(a)

veterinary medicinal products which contain psychotropic drugs or narcotics, including those covered by the United Nations Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol and the United Nations Convention on Psychotropic Substances of 1971;

(a)

veterinary medicinal products which contain psychotropic drugs or narcotics, including those covered by the United Nations Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol and the United Nations Convention on Psychotropic Substances of 1971;

(b)

veterinary medicinal products for food-producing animals;

(b)

veterinary medicinal products for food-producing animals;

(c)

antimicrobial veterinary medicinal products;

(c)

antimicrobial veterinary medicinal products;

(d)

products intended for treatments of pathological processes which require a precise prior diagnosis or the use of which may have effects which impede or interfere with subsequent diagnostic or therapeutic measures;

(d)

products intended for treatments of pathological processes which require a precise prior diagnosis or the use of which may have effects which impede or interfere with subsequent diagnostic or therapeutic measures;

(e)

officinal formulae intended for food-producing animals;

(e)

officinal formulae intended for food-producing animals;

(f)

veterinary medicinal products containing an active substance that has been authorised for less than 5 years in the Union.

(f)

veterinary medicinal products containing an active substance that has been authorised for less than 5 years in the Union;

(fa)

veterinary medicinal products for which marketing authorisations have been granted in accordance with Article 21 and/or 22.

(a)

the target species,

(a)

the target species,

(b)

the person administering the products to the animal,

(b)

the person administering the products to the animal,

(c)

the environment

(c)

the environment.

(a)

the administration of the veterinary medicinal product is restricted to pharmaceutical forms requiring no particular knowledge or skill in using the products;

(a)

the administration of the veterinary medicinal product is restricted to pharmaceutical forms requiring no particular knowledge or skill in using the products;

(b)

the veterinary medicinal product does not present a direct or indirect risk, even if administered incorrectly, to the animal(s) treated, to the person administering the product or to the environment;

(b)

the veterinary medicinal product does not present a direct or indirect risk, even if administered incorrectly, to the animal(s) treated, to the person administering the product or to the environment;

(c)

the summary of the product characteristics of the veterinary medicinal product does not contain any warnings of potential serious side effects deriving from its correct use;

(c)

the summary of the product characteristics of the veterinary medicinal product does not contain any warnings of potential serious adverse events deriving from its correct use;

(d)

neither the veterinary medicinal product nor any other product containing the same active substance has previously been the subject of frequent adverse event reporting;

(d)

neither the veterinary medicinal product nor any other product containing the same active substance has previously been the subject of frequent adverse event reporting;

(e)

the summary of the product characteristics does not refer to contraindications related to other veterinary medicinal products commonly used without prescription;

(e)

the summary of the product characteristics does not refer to contraindications related to other veterinary medicinal products commonly used without prescription;

(f)

the veterinary medicinal product is not subject to special storage conditions;

(g)

there is no risk for public health as regards residues in food obtained from treated animals even where the veterinary medicinal products are used incorrectly;

(g)

there is no risk for public health as regards residues in food obtained from treated animals even where the veterinary medicinal products are used incorrectly;

(h)

there is no risk to public or animal health as regards the development of resistance to anthelmintic substances even where the veterinary medicinal products containing those substances are used incorrectly.

(h)

there is no risk to public or animal health as regards the development of antiparasitic resistance even where the veterinary medicinal products containing those substances are used incorrectly.

(a)

they are registered as single homeopathic products and released for sale in pharmacies, have a dilution of not less than D4 (1:10 000 ) and are not produced using alcohol;

(b)

they are registered as complex homeopathic products, contain no individual components below a dilution of D4, are released for sale in pharmacies and are not produced using alcohol.

(b)

qualitative and quantitative composition of the active substances or other constituents stating the common name or the chemical description of the substances or other constituents;

(b)

qualitative and quantitative composition of the active substances and all the essential constituents, stating the common name or the chemical description of the substances or other constituents;

(vi)

frequency and seriousness of adverse events ,

(vi)

frequency and seriousness of adverse reactions ,

(xiii)

special conditions for use, including restrictions on the use of antimicrobials in order to limit the risk of development of antimicrobial resistance,

(xiii)

special conditions for use, including restrictions on the use of antimicrobials in order to limit the risk of development of antimicrobial resistance, and specifying that the product is not allowed to be used as a routine preventive measure,

(iiia)

list of excipients,

(ea)

information from the environmental risk assessment of the product, in particular environmental endpoints and risk characterisation data, including ecotoxicological information on effects on non-target species and persistence of active substances and active metabolites in soil and water;

(ja)

when the veterinary medical product is authorised to be administered via medicated feed, information on the possibility to have interaction between the veterinary medicinal products and the feed impairing the safety or the efficacy of the medicated feed shall be provided through a list of incompatibilities.

(d)

the product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals or to increase yields from treated animals;

(d)

the product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals, or to increase yields from treated animals , or as a routine prophylactic in food producing animals, or to be added to feed or water for mass medication when no disease has been diagnosed in any of the animals;

(e)

the withdrawal period is not long enough to ensure food safety ;

(e)

the proposed withdrawal period to ensure food safety is not well justified, or the proposed withdrawal period by the Agency or by the competent authorities is not taken into account ;

(ga)

the product is a substance of high concern;

(gb)

active substances within the product which meet the criteria for being persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to EMA guidelines, or are considered as having endocrine-disrupting properties that risk causing adverse effects in the environment;

(ha)

the product poses significantly higher risks to the treated animal, public health or the environment compared to the standard reference treatment;

(hb)

unacceptable side effects or secondary effects on the treated animal;

(a)

10 years for the veterinary medicinal products for cattle, sheep, pigs, chickens, dogs and cats;

(a)

10 years for the veterinary medicinal products for cattle, sheep (reared for meat) , pigs, chickens, salmon, dogs and cats;

(b)

14 years for antimicrobial veterinary medicinal products for cattle, sheep, pigs, chickens, dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application;

(b)

14 years for antimicrobial veterinary medicinal products for cattle, sheep, pigs, chickens, salmon , dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application;

(c)

18 years for veterinary medicinal products for bees;

(c)

20 years for veterinary medicinal products for bees;

(d)

14 years for veterinary medicinal products for animal species other than listed in paragraph 1(a) and (c).

(d)

14 years for veterinary medicinal products for animal species other than listed in paragraph 1(a) and (c).

(a)

needed to extend a marketing authorisation in respect of dosages, pharmaceutical forms or routes of administration;

(b)

needed for a reevaluation requested by the Agency or the competent authorities post-authorisation, unless they have been requested by competent authorities as a follow-up to post authorisation pharmacovigilance concerns, or requested as a condition of authorisation or as a post-authorisation commitment at the time of authorisation. Each period of protection shall operate independent from any other that may operate concurrently and shall therefore not be cumulated.

(c)

veterinary medicinal products containing an active substance which has not been authorised as a veterinary medicinal product within the Union at the date of the submission of the application;

(c)

veterinary medicinal products containing an active substance which has not been authorised as a veterinary medicinal product within the Union at the date of the submission of the application , with the exception of veterinary medicinal products subject to authorisation under Articles 21 and 22 ;

(e)

generic veterinary medicinal products of reference veterinary medicinal products authorised under the centralised authorisation procedure.

(c)

an information about the Member States in which an application for a marketing authorisation submitted by the applicant for the same veterinary medicinal product is under examination;