the national procedure laid down in Articles 46 and 47;

the decentralised procedure laid down in Articles 48 and 49;

the mutual recognition procedure laid down in Articles 51 and 52;

the subsequent recognition procedure laid down in Article 53.

the information set out in Annex I;

technical documentation necessary for demonstrating the quality, safety and efficacy of the veterinary medicinal product in accordance with the requirements set out in Annex II;

a summary of the pharmacovigilance system master file.

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

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

a copy of the written consent of the competent authorities to the deliberate release into the environment of the genetically modified organisms for research and development purposes, as provided for in Part B of Directive 2001/18/EC;

the complete technical file supplying the information required under Annexes III and IV to Directive 2001/18/EC;

the environmental risk assessment in accordance with the principles set out in Annex II to Directive 2001/18/EC; and

the results of any investigations performed for the purposes of research or development.

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

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;

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

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

the target species;

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

special storage precautions, if any;

route of administration; and

if applicable, the withdrawal period, even if such period is zero.

the information referred to in Article 10(1);

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

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

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

without prejudice to Article 14(4), a recommendation to read the package leaflet;

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

in the case of veterinary medicinal products not subject to a veterinary prescription, the indication or indications;

the marketing authorisation number.

the name of veterinary medicinal product;

the quantitative particulars of the active substances;

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

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

the name or company 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;

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

qualitative and quantitative composition of the active substance or substances;

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

the indications for use;

the contra-indications and adverse events;

if applicable, the withdrawal period, even if such period is zero;

special storage precautions, if any;

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

information on the collection systems referred to in Article 117 applicable to the veterinary medicinal product concerned;

the marketing authorisation number;

contact details of the marketing authorisation holder or its representative, as appropriate, for the reporting of suspected adverse events;

classification of the veterinary medicinal product as referred to in Article 34.

bioavailability studies have demonstrated bioequivalence of a generic veterinary medicinal product with the reference veterinary medicinal product or a justification is provided as to why such studies were not performed;

the application satisfies the requirements set out in Annex II;

the applicant demonstrates that the application concerns a generic veterinary medicinal product of a reference veterinary medicinal product for which the period of protection of the technical documentation laid down in Articles 39 and 40 has elapsed or is due to elapse in less than two years.

there are changes in the active substance or substances, indications for use, strength, pharmaceutical form or route of administration of the generic veterinary medicinal product compared to the reference veterinary medicinal product;

bioavailability studies cannot be used to demonstrate bioequivalence with the reference veterinary medicinal product; or

there are differences relating to raw materials or in manufacturing processes of the biological veterinary medicinal product and the reference biological veterinary medicinal product.

the benefit of the 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;

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

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

a requirement to notify to the competent authorities or the Agency, as applicable, of any adverse event relating to the use of the veterinary medicinal product;

a requirement to conduct post-authorisation studies.

verify that the data submitted complies with the requirements laid down in Article 8;

assess the veterinary medicinal product regarding the quality, safety and efficacy documentation provided;

draw up a conclusion on the benefit-risk balance for the veterinary medicinal product.

test the veterinary medicinal product, its starting materials and, if necessary, intermediate products or other constituent materials in order to ensure that the control methods employed by the manufacturer and described in the application documents are satisfactory;

verify that, in the case of veterinary medicinal products intended for food-producing animals, the analytical detection method proposed by the applicant for the purposes of residue depletion tests is satisfactory and suitable for use to reveal the presence of residue levels, particularly those exceeding the maximum residue level of the pharmacologically active substance established by the Commission in accordance with Regulation (EC) No 470/2009, and for the purpose of official controls of animals and products of animal origin in accordance with Regulation (EU) 2017/625.

a summary of the product characteristics containing the information laid down in Article 35;

details of any conditions or restrictions to be imposed as regards the supply or safe and effective use of the veterinary medicinal product concerned, including the classification of a veterinary medicinal product in accordance with Article 34;

the text of the labelling and package leaflet referred to in Articles 10 to 14.

veterinary medicinal products which contain narcotic drugs or psychotropic substances, or substances frequently used in the illicit manufacture of those drugs or substances, including those covered by the United Nations Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol, the United Nations Convention on Psychotropic Substances of 1971, the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988 or by Union legislation on drug precursors;

veterinary medicinal products for food-producing animals;

antimicrobial veterinary medicinal products;

veterinary medicinal 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;

veterinary medicinal products used for euthanasia of animals;

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

immunological veterinary medicinal products;

without prejudice to Council Directive 96/22/EC ( 5 ), veterinary medicinal products containing active substances having a hormonal or thyrostatic action or beta-agonists.

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

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

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;

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

the summary of the product characteristics does not refer to contra-indications related to the use of the product concerned in combination with other veterinary medicinal products commonly used without prescription;

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

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

name of the veterinary medicinal product followed by its strength and pharmaceutical form and, where applicable, a list of the names of the veterinary medicinal product, as authorised in different Member States;

qualitative and quantitative composition of the active substance or substances and qualitative composition of excipients and other constituents stating their common name or their chemical description and their quantitative composition, if that information is essential for proper administration of the veterinary medicinal product;

clinical information:

pharmacological information:

In case of an immunological veterinary medicinal product, instead of points (i), (ii) and (iii), immunological information;

pharmaceutical particulars:

name of the marketing authorisation holder;

marketing authorisation number or numbers;

date of the first marketing authorisation;

date of the last revision of the summary of the product characteristics;

if applicable, for veterinary medicinal products referred to in Article 23 or 25, the statement:

information on the collection systems referred to in Article 117 applicable to the veterinary medicinal product concerned;

classification of the veterinary medicinal product as referred to in Article 34 for each Member State in which it is authorised.

the application does not comply with this Chapter;

the benefit-risk balance of the veterinary medicinal product is negative;

the applicant has not provided sufficient information on the quality, safety or efficacy of the veterinary medicinal product;

the veterinary medicinal 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;

the proposed withdrawal period is not long enough to ensure food safety or is insufficiently substantiated;

the risk for public health in case of development of antimicrobial resistance or antiparasitic resistance outweighs the benefits of the veterinary medicinal product to animal health;

the applicant has not provided sufficient proof of efficacy as regards the target species;

the qualitative or quantitative composition of the veterinary medicinal product is not as stated in the application;

risks to public or animal health or to the environment are not sufficiently addressed; or

the active substance within the veterinary medicinal product meets the criteria for being considered persistent, bioaccumulative and toxic or very persistent and very bioaccumulative, and the veterinary medicinal product is intended to be used in food-producing animals, unless it is demonstrated that the active substance is essential to prevent or control a serious risk to animal health.

the period of the protection of technical documentation as set out in Articles 39 and 40 of this Regulation has elapsed, or is due to elapse in less than two years;

the applicants have obtained written agreement in the form of a letter of access with regard to that documentation.

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

14 years for antimicrobial veterinary medicinal products for cattle, sheep for meat production, 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;

18 years for veterinary medicinal products for bees;

14 years for veterinary medicinal products for animal species other than those referred to in points (a) and (c).

a reduction in the antimicrobial or antiparasitic resistance; or

an improvement of the benefit-risk balance of the veterinary medicinal product,

veterinary medicinal products developed by means of one of the following biotechnological processes:

veterinary medicinal products intended primarily for use as performance enhancers in order to promote the growth of treated animals or to increase yields from treated animals;

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;

biological veterinary medicinal products which contain or consist of engineered allogeneic tissues or cells;

novel therapy veterinary medicinal products.

a list of all decisions granting, suspending or revoking marketing authorisations which concern the veterinary medicinal product;

information on the variations introduced since the grant of the marketing authorisation by decentralised procedure laid down in Article 49(7) or by mutual recognition procedure laid down in Article 52(8);

a summary report on pharmacovigilance data.

for veterinary medicinal products authorised within the Union by the Commission and by the competent authorities:

for homeopathic veterinary medicinal products registered in accordance with Chapter V within the Union by the competent authorities:

veterinary medicinal products allowed to be used in a Member State in accordance with Article 5(6);

the annual volume of sales and information on the availability for each veterinary medicinal product.

the technical specifications of the product database including the electronic data exchange mechanism for exchanging with the existing national systems and the format for electronic submission;

the practical arrangements for the functioning of the product database, in particular to ensure protection of commercially confidential information and security of exchange of information;

detailed specifications of the information to be included, updated and shared in the product database and by whom;

contingency arrangements to be applied in case of unavailability of any of the functionalities of the product database;

where appropriate, data to be included in the product database in addition to the information referred to in paragraph 2 of this Article.

the types of antimicrobial medicinal products used in animals for which data shall be collected;

the quality assurance that Member States and the Agency shall put in place to ensure quality and comparability of data; and

the rules on the methods of gathering data on the use of the antimicrobial medicinal products used in animals and on the method of transfer of those data to the Agency.

within two years from 28 January 2022, data shall be collected at least for the species and categories included in Commission Implementing Decision 2013/652/EU ( 6 ) in its version of 11 December 2018;

within five years from 28 January 2022, data shall be collected for all food-producing animal species;

within eight years from 28 January 2022, data shall be collected for other animals which are bred or kept.

the need for a scientific assessment of changes in order to determine the risk to public or animal health or to the environment;

whether changes have an impact on the quality, safety or efficacy of the veterinary medicinal product;

whether changes imply no more than a minor alteration to the summary of product characteristics;

whether changes are of an administrative nature.

a description of the variation;

data referred to in Article 8 relevant to the variation;

details of the marketing authorisations affected by the application;

where the variation leads to consequential variations to the terms of the same marketing authorisation, a description of those consequential variations;

where the variation concerns marketing authorisations granted under the mutual recognition or decentralised procedures, a list of Member States which granted those marketing authorisations.

target species;

clinical information referred to in point (c) of Article 35(1);

the withdrawal period.

any unfavourable and unintended reaction in any animal to a veterinary medicinal product;

any observation of a lack of efficacy of a veterinary medicinal product following its administration to an animal, whether or not in accordance with the summary of product characteristics;

any environmental incidents observed following the administration of a veterinary medicinal product to an animal;

any noxious reaction in humans exposed to a veterinary medicinal product;

any finding of a pharmacologically active substance or marker residue in a product of animal origin exceeding the maximum levels of residues established in accordance with Regulation (EC) No 470/2009 after the set withdrawal period has been respected;

any suspected transmission of an infectious agent via a veterinary medicinal product;

any unfavourable and unintended reaction in an animal to a medicinal product for human use.

the number and at the latest within two years from 28 January 2022 the incidence of suspected adverse events reported each year, broken down by veterinary medicinal product, animal species and type of suspected adverse event;

the results and outcomes referred to in Article 81(1) that arise from the signal management process performed by the marketing authorisation holder for veterinary medicinal products or groups of veterinary medicinal products.

elaborating and maintaining the pharmacovigilance system master file;

allocating reference numbers to the pharmacovigilance system master file and communicating that reference number to the pharmacovigilance database for each product;

notifying the competent authorities and the Agency, as applicable, of the place of operation;

establishing and maintaining a system which ensures that all suspected adverse events which are brought to the attention of the marketing authorisation holder are collected and recorded in order to be accessible at least at one site in the Union;

compiling the suspected adverse event reports referred to in Article 76(2), evaluating them, where necessary, and recording them in the pharmacovigilance database;

ensuring that any request from the competent authorities or the Agency for the provision of additional information necessary for the evaluation of the benefit-risk balance of a veterinary medicinal product is answered fully and promptly;

providing competent authorities or the Agency, as applicable, with any other information relevant to detecting a change to the benefit-risk balance of a veterinary medicinal product, including appropriate information on post-marketing surveillance studies;

applying the signal management process referred to in Article 81 and ensuring that any arrangements for the fulfilment of responsibilities referred to in Article 77(4) are in place;

monitoring the pharmacovigilance system and ensuring that if needed, an appropriate preventive or corrective action plan is prepared, implemented and, where necessary, ensuring changes to the pharmacovigilance system master file;

ensuring that all personnel of the marketing authorisation holder involved in the performance of pharmacovigilance activities receives continued training;

communicating any regulatory measure that is taken in a third country and is related to pharmacovigilance data to the competent authorities and to the Agency within 21 days of receipt of such information.

the applicant has at its disposal technically competent staff and in particular at least one person designated as responsible person, meeting the conditions provided for in national law;

the applicant has suitable and sufficient premises complying with the requirements laid down by the relevant Member State as regards the storage and handling of veterinary medicinal products;

the applicant has a plan guaranteeing effective implementation of any withdrawal or recall from the market ordered by the competent authorities or the Commission or undertaken in cooperation with the manufacturer or marketing authorisation holder of the veterinary medicinal product concerned;

the applicant has an appropriate record-keeping system ensuring compliance with the requirements referred to in Article 101;

the applicant has a statement to the effect that it fulfils the requirements referred to in Article 101.

inform the applicant of the outcome of the evaluation;

grant, refuse or change the wholesale distribution authorisation; and

upload the relevant information of the authorisation in the manufacturing and wholesale distribution database referred to in Article 91.

date of the transaction;

name of the veterinary medicinal product including, as appropriate, pharmaceutical form and strength;

batch number;

expiry date of the veterinary medicinal product;

quantity received or supplied, stating pack size and number of packs;

name or company name and permanent address or registered place of business of the supplier in the event of purchase or of the recipient in the event of sale.

they have the same qualitative and quantitative composition in terms of active substances and excipients;

they have the same pharmaceutical form;

they have the same clinical information and, if applicable, withdrawal period; and

they have been manufactured by the same manufacturer or by a manufacturer working under licence according to the same formulation.

submit a declaration to the competent authority in the destination Member State and take appropriate measures to ensure that the wholesale distributor in the source Member State will keep it informed of any pharmacovigilance issues;

notify the marketing authorisation holder in the destination Member State about the veterinary medicinal product to be obtained from the source Member State and intended to be placed on the market in the destination Member State at least one month prior to submitting to the competent authority the application for parallel trade in that veterinary medicinal product;

submit a written declaration to the competent authority of the destination Member State that the marketing authorisation holder in the destination Member State was notified in accordance with point (b) together with a copy of that notification;

not trade a veterinary medicinal product which has been recalled from the market of the source Member State or destination Member State for quality, safety or efficacy reasons;

collect suspected adverse events and report them to the marketing authorisation holder of the parallel-traded veterinary medicinal product.

name of the veterinary medicinal products;

active substances;

pharmaceutical forms;

classification of the veterinary medicinal products in the destination Member State;

marketing authorisation number of the veterinary medicinal products in the source Member State;

marketing authorisation number of the veterinary medicinal products in the destination Member State;

name or company name and permanent address or registered place of business of the wholesale distributor in the source Member State and of the wholesale distributor in the destination Member State.

date of the transaction;

name of the veterinary medicinal product including, as appropriate, pharmaceutical form and strength;

batch number;

quantity received or supplied;

name or company name and permanent address or registered place of business of the supplier in the event of purchase, or of the recipient in the event of sale;

name and contact details of the prescribing veterinarian and, where appropriate, a copy of the veterinary prescription;

marketing authorisation number.

the contact details of the competent authority of the Member State in which the retailer offering the veterinary medicinal products is established;

a hyperlink to the website of the Member State of establishment set up in accordance with paragraph 8 of this Article;

the common logo established in accordance with paragraph 6 of this Article is clearly displayed on every page of the website that relates to the offer for sale at a distance of veterinary medicinal products and contains a hyperlink to the entry of the retailer in the list of permitted retailers referred to in point (c) of paragraph 8 of this Article.

information on its national law applicable to the offering of veterinary medicinal products for sale at a distance by means of information society services, in accordance with paragraphs 1 and 2, including information on the fact that there may be differences between Member States regarding the classification of the supply of the veterinary medicinal products;

information on the common logo;

a list of retailers established in the Member State permitted to offer veterinary medicinal products for sale at a distance by means of information society services in accordance with paragraphs 1 and 2 as well as the website addresses of those retailers.

identification of the animal or groups of animals to be treated;

full name and contact details of the animal owner or keeper;

issue date;

full name and contact details of the veterinarian including, if available, the professional number;

signature or an equivalent electronic form of identification of the veterinarian;

name of the prescribed medicinal product, including its active substances;

pharmaceutical form and strength;

quantity prescribed, or the number of packs, including pack size;

dosage regimen;

for food-producing animal species, withdrawal period even if such period is zero;

any warnings necessary to ensure the proper use including, where relevant, to ensure prudent use of antimicrobials;

if a medicinal product is prescribed in accordance with Articles 112, 113 and 114, a statement to that effect;

if a medicinal product is prescribed in accordance with Article 107(3) and (4), a statement to that effect.

shall not be used in accordance with Articles 112, 113 and 114; or

shall only be used in accordance with Articles 112, 113 and 114 subject to certain conditions.

date of the first administration of the medicinal product to the animals;

name of the medicinal product;

quantity of the medicinal product administered;

name or company name and permanent address or registered place of business of the supplier;

evidence of acquisition of the medicinal products they use;

identification of the animal or group of animals treated;

name and contact details of the prescribing veterinarian, if applicable;

withdrawal period even if such period is zero;

duration of treatment.

the administration of the product to animals may interfere with the implementation of a national programme for the diagnosis, control or eradication of animal disease;

the administration of the product to animals may cause difficulties in certifying the absence of disease in live animals or contamination of foodstuffs or other products obtained from treated animals;

the strains of disease agents to which the product is intended to confer immunity is largely absent in terms of geographic spread from the territory concerned.

a marketing authorisation for the veterinary medicinal product to be administered to the animals has been granted by the competent authorities of the Member State in which the veterinarian is established or by the Commission;

the veterinary medicinal products concerned are transported by the veterinarian in their original packaging;

the veterinarian follows the good veterinary practice applied in the host Member State;

the veterinarian sets the withdrawal period specified on the labelling or package leaflet of the veterinary medicinal product used;

the veterinarian does not retail any veterinary medicinal product to an owner or keeper of animals treated in the host Member State unless this is permissible under the rules of the host Member State.

a veterinary medicinal product authorised under this Regulation in the relevant Member State or in another Member State for use in the same species or another animal species for the same indication or for another indication;

if there is no veterinary medicinal product as referred to in point (a) of this paragraph, a medicinal product for human use authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004;

if there is no medicinal product as referred to in point (a) or (b) of this paragraph, a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription.

a veterinary medicinal product authorised under this Regulation in the relevant Member State or in another Member State for use in the same or in another food-producing terrestrial animal species for the same indication, or for another indication;

if there is no veterinary medicinal product as referred to in point (a) of this paragraph, a veterinary medicinal product authorised under this Regulation in the relevant Member State for use in a non-food-producing animal species for the same indication;

if there is no veterinary medicinal product as referred to in point (a) or (b) of this paragraph, a medicinal product for human use authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004; or

if there is no medicinal product as referred to in point (a), (b) or (c) of this paragraph, a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription.

a veterinary medicinal product authorised under this Regulation in the relevant Member State or in another Member State for use in the same or in another food-producing aquatic species and for the same indication or for another indication;

if there is no veterinary medicinal product as referred to in point (a) of this paragraph, a veterinary medicinal product authorised under this Regulation in the relevant Member State or in another Member State for use with a food-producing terrestrial species containing a substance present in the list established in accordance with paragraph 3;

if there is no veterinary medicinal product as referred to in point (a) or (b) of this paragraph, a medicinal product for human use authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 and containing substances present in the list established in accordance with paragraph 3 of this Article; or

if there is no medicinal product as referred to in point (a), (b) or (c) of this paragraph, a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription.

a veterinary medicinal product authorised under this Regulation in the relevant Member State or in another Member State for use with a food-producing terrestrial animal species;

if there is no veterinary medicinal product as referred to in point (a) of this paragraph, a medicinal product for human use authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004.

for meat and offal from food-producing mammals and poultry and farmed game birds the withdrawal period shall not be less than:

for milk from animals producing milk for human consumption the withdrawal period shall not be less than:

for eggs from animals producing eggs for human consumption the withdrawal period shall not be less than:

for aquatic species producing meat for human consumption the withdrawal period shall not be less than:

veterinarians;

persons permitted to supply veterinary medicinal products in accordance with national law.

the advertising is limited to immunological veterinary medicinal products;

the advertising includes an express invitation to the professional keepers of animal to consult the veterinarian about the immunological veterinary medicinal product.