Article 112 Use of medicinal products outside the terms of the marketing authorisation in non-food-producing animal species
1. By way of derogation from Article 106(1), where there is no authorised veterinary medicinal product in a Member State for an indication concerning a non-food-producing animal species, the veterinarian responsible may, under his or her direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat the animals concerned with the following medicinal product: (a) 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; (b) 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; (c) 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. 2. Except as regards immunological veterinary medicinal products, where there is no medicinal product available as referred to in paragraph 1, the veterinarian responsible may under his or her direct responsibility and in particular to avoid causing unacceptable suffering exceptionally treat a non-food-producing animal with a veterinary medicinal product authorised in a third country for the same animal species and same indication. 3. The veterinarian may administer the medicinal product personally or allow another person to do so under the veterinarian’s responsibility, in accordance with national provisions. 4. This Article shall also apply to the treatment by a veterinarian of an animal of the equine species provided that it is declared as not being intended for slaughter for human consumption in the single lifetime identification document referred to in Article 8(4). 5. This Article shall apply also when an authorised veterinary medicinal product is not available in the relevant Member State.
Article 113 Use of medicinal products outside the terms of the marketing authorisation in food-producing terrestrial animal species
1. By way of derogation from Article 106(1), where there is no authorised veterinary medicinal product in a Member State for an indication concerning a food-producing terrestrial animal species, the veterinarian responsible may, under his or her direct personal responsibility, and in particular to avoid causing unacceptable suffering, exceptionally treat the animals concerned with the following medicinal product: (a) 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; (b) 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; (c) 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 (d) 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. 2. Except as regards immunological veterinary medicinal products, where there is no medicinal product available as referred to in paragraph 1, the veterinarian responsible may under his or her direct personal responsibility, and in particular to avoid causing unacceptable suffering, exceptionally treat food-producing terrestrial animals with a veterinary medicinal product authorised in a third country for the same animal species and same indication. 3. The veterinarian may administer the medicinal product personally or allow another person to do so under the veterinarian’s responsibility, in accordance with national provisions. 4. Pharmacologically active substances included in the medicinal product used in accordance with paragraphs 1 and 2 of this Article shall be allowed in accordance with Regulation (EC) No 470/2009 and any acts adopted on the basis thereof. 5. This Article shall apply also when an authorised veterinary medicinal product is not available in the relevant Member State.
Article 114 Use of medicinal products for food-producing aquatic species
1. By way of derogation from Article 106(1), where there is no authorised veterinary medicinal product in a Member State for an indication concerning a food-producing aquatic species, the veterinarian responsible may, under his or her direct personal responsibility, and in particular to avoid causing unacceptable suffering, treat the animals concerned with the following medicinal product: (a) 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; (b) 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; (c) 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 (d) 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. 2. By way of derogation from points (b) and (c) of paragraph 1, and until the list referred to in paragraph 3 is established, the veterinarian responsible may, under his or her direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat food-producing aquatic species of a particular holding with the following medicinal product: (a) 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; (b) 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. 3. The Commission shall, by means of implementing acts, at the latest within five years from 28 January 2022, establish a list of substances used in veterinary medicinal products authorised in the Union for use in food-producing terrestrial animal species or substances contained in a medicinal product for human use authorised in the Union in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004, which may be used in food-producing aquatic species in accordance with paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). The Commission, when adopting those implementing acts, shall take account of the following criteria: (a) risks to the environment if the food-producing aquatic species are treated with those substances; (b) impact on animal and public health if the food-producing aquatic species affected cannot receive an antimicrobial listed in accordance with Article 107(6); (c) availability or lack of availability of other medicinal products, treatments or measures for prevention or treatment of diseases or certain indications in food-producing aquatic species. 4. Except as regards immunological veterinary medicinal products, where there is no medicinal product available as referred to in paragraphs 1 and 2, the veterinarian responsible may, under his or her direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat food-producing aquatic species with a veterinary medicinal product authorised in a third country for the same species and same indication. 5. The veterinarian may administer the medicinal product personally or allow another person to do so under the veterinarian’s responsibility, in accordance with national provisions. 6. Pharmacologically active substances included in the medicinal product used in accordance with paragraphs 1, 2 and 4 of this Article shall be allowed in accordance with Regulation (EC) No 470/2009 and any acts adopted on the basis thereof. 7. This Article shall apply also when an authorised veterinary medicinal product is not available in the relevant Member State.
Article 115 Withdrawal period for medicinal products used outside the terms of the marketing authorisation in food-producing animal species
1. For the purpose of Articles 113 and 114, unless a medicinal product used has a withdrawal period provided in its summary of the product characteristics for the animal species in question, a withdrawal period shall be set by the veterinarian in accordance with the following criteria: (a) for meat and offal from food-producing mammals and poultry and farmed game birds the withdrawal period shall not be less than: (i) the longest withdrawal period provided in its summary of the product characteristics for meat and offal multiplied by factor 1,5; (ii) 28 days if the medicinal product is not authorised for food-producing animals; (iii) one day, if the medicinal product has a zero withdrawal period and is used in a different taxonomic family than the target species authorised; (b) for milk from animals producing milk for human consumption the withdrawal period shall not be less than: (i) the longest withdrawal period for milk provided in the summary of the product characteristics for any animal species multiplied by factor 1,5; (ii) seven days, if the medicinal product is not authorised for animals producing milk for human consumption; (iii) one day, if the medicinal product has a zero withdrawal period; (c) for eggs from animals producing eggs for human consumption the withdrawal period shall not be less than: (i) the longest withdrawal period for eggs provided in the summary of the product characteristics for any animal species multiplied by factor 1,5; (ii) 10 days, if the product is not authorised for animals producing eggs for human consumption; (d) for aquatic species producing meat for human consumption the withdrawal period shall not be less than: (i) the longest withdrawal period for any of the aquatic species indicated in the summary of the product characteristics multiplied by factor of 1,5 and expressed as degree-days; (ii) if the medicinal product is authorised for food-producing terrestrial animal species, the longest withdrawal period for any of the food-producing animal species indicated in the summary of product characteristics multiplied by a factor of 50 and expressed as degree-days, but not exceeding 500 degree-days; (iii) 500 degree-days, if the medicinal product is not authorised for food-producing animal species; (iv) 25 degree-days if the highest withdrawal period for any animal species is zero. 2. If the calculation of the withdrawal period according to points (a)(i), (b)(i), (c)(i), (d)(i) and (ii) of paragraph 1 results in a fraction of days, the withdrawal period shall be rounded up to the nearest number of days. 3. The Commission shall adopt delegated acts in accordance with Article 147 in order to amend this Article by amending the rules laid down in paragraphs 1 and 4 thereof in the light of new scientific evidence. 4. For bees, the veterinarian shall determine the appropriate withdrawal period by assessing the specific situation of the particular beehive or beehives on a case-by-case basis and in particular the risk of residue in honey or in any other foodstuffs harvested from beehives intended for human consumption. 5. By way of derogation from Article 113(1) and (4), the Commission shall, by means of implementing acts, establish a list of substances which are essential for the treatment of equine species, or which bring added clinical benefit compared to other treatment options available for equine species and for which the withdrawal period for equine species shall be six months. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 116 Health situation
By way of derogation from Article 106(1), a competent authority may allow the use in its territory of veterinary medicinal products not authorised in that Member State, where the situation of animal or public health so requires, and the marketing of those veterinary medicinal products is authorised in another Member State.
Article 117 Collection and disposal of waste of veterinary medicinal products
Member States shall ensure that appropriate systems are in place for the collection and disposal of waste of veterinary medicinal products.
Article 118 Animals or products of animal origin imported into the Union
1. Article 107(2) shall apply, mutatis mutandis , to operators in third countries and those operators shall not use the designated antimicrobials referred to in Article 37(5), insofar as relevant in respect of animals or products of animal origin exported from such third countries to the Union. 2. The Commission shall adopt delegated acts in accordance with Article 147 in order to supplement this Article by providing the necessary detailed rules on the application of paragraph 1 of this Article.
Article 119 Advertising of veterinary medicinal products
1. Only veterinary medicinal products that are authorised or registered in a Member State may be advertised in that Member State, unless otherwise decided by the competent authority in accordance with applicable national law. 2. The advertising of a veterinary medicinal product shall make it clear that it aims at promoting the supply, sale, prescription, distribution or use of the veterinary medicinal product. 3. The advertising shall not be formulated in such a way as to suggest that the veterinary medicinal product could be a feed or a biocide. 4. The advertising shall comply with the summary of the product characteristics of the advertised veterinary medicinal product. 5. The advertising shall not include information in any form which could be misleading or lead to incorrect use of the veterinary medicinal product. 6. The advertising shall encourage the responsible use of the veterinary medicinal product, by presenting it objectively and without exaggerating its properties. 7. The suspension of a marketing authorisation shall preclude any advertising, during the period of that suspension, of the veterinary medicinal product in the Member State in which it is suspended. 8. Veterinary medicinal products shall not be distributed for promotional purposes except for small quantities of samples. 9. Antimicrobial veterinary medicinal products shall not be distributed for promotional purposes as samples or in any other presentation. 10. The samples referred to in paragraph 8 shall be appropriately labelled indicating that they are samples and shall be given directly to veterinarians or other persons allowed to supply such veterinary medicinal products during sponsored events or by sales representatives during their visits.
Article 120 Advertising of veterinary medicinal products subject to veterinary prescription
1. The advertising of veterinary medicinal products that are subject to veterinary prescription in accordance with Article 34 shall be allowed only when made exclusively to the following persons: (a) veterinarians; (b) persons permitted to supply veterinary medicinal products in accordance with national law. 2. By way of derogation from paragraph 1 of this Article, advertising of veterinary medicinal products that are subject to veterinary prescription in accordance with Article 34 to professional keepers of animals may be permitted by the Member State provided the following conditions are met: (a) the advertising is limited to immunological veterinary medicinal products; (b) the advertising includes an express invitation to the professional keepers of animal to consult the veterinarian about the immunological veterinary medicinal product. 3. Notwithstanding paragraphs 1 and 2, the advertising of inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals in an epidemiological unit and used for the treatment of that animal or those animals in the same epidemiological unit or for the treatment of an animal or animals in a unit having a confirmed epidemiological link shall be prohibited.
Article 121 Promotion of medicinal products used in animals
1. Where medicinal products are being promoted to persons qualified to prescribe or supply them in accordance with this Regulation, no gifts, pecuniary advantages or benefit in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of prescription or supply of medicinal products. 2. Persons qualified to prescribe or supply medicinal products as referred to in paragraph 1 shall not solicit or accept any inducement prohibited under that paragraph. 3. Paragraph 1 shall not prevent hospitality being offered, directly or indirectly, at events for purely professional and scientific purposes. Such hospitality shall always be strictly limited to the main objectives of the event. 4. Paragraphs 1, 2 and 3 shall not affect existing measures or trade practice in Member States relating to prices, margins and discounts.
Article 122 Implementation of advertising provisions
Member States may lay down any procedures they deem necessary for the implementation of Articles 119, 120 and 121.
Article 123 Controls
1. Competent authorities shall carry out controls of the following persons: (a) manufacturers and importers of veterinary medicinal products and active substances; (b) distributors of active substances; (c) marketing authorisation holders; (d) holders of a wholesale distribution authorisation; (e) retailers; (f) owners and keepers of food-producing animals; (g) veterinarians; (h) holders of a registration for homeopathic veterinary medicinal products; (i) holders of veterinary medicinal products referred to in Article 5(6); and (j) any other persons having obligations under this Regulation. 2. The controls referred to in paragraph 1 shall be carried out regularly, on a risk-basis, in order to verify that the persons referred to in paragraph 1 comply with this Regulation. 3. The risk-based controls referred to in paragraph 2 shall be carried out by the competent authorities taking account of at least: (a) the intrinsic risks associated with the activities of the persons referred to in paragraph 1 and the location of their activities; (b) the past record of the persons referred to paragraph 1 as regards the results of controls performed on them and their previous compliance; (c) any information that might indicate non-compliance; (d) the potential impact of non-compliance on public health, animal health, animal welfare and the environment. 4. Controls may also be carried out on the request of a competent authority of another Member State, the Commission or the Agency. 5. Controls shall be carried out by representatives of the competent authority. 6. Inspections may be carried out as part of the controls. Such inspections may be made unannounced. During those inspections the representatives of a competent authority shall at least be empowered to: (a) inspect the premises, equipment, means of transport, records, documents and systems, related to the objective of the inspection; (b) inspect and take samples with a view to submitting them for an independent analysis by an Official Medicines Control Laboratory or by a laboratory designated for that purpose by a Member State; (c) document any evidence deemed necessary by the representatives; (d) carry out the same controls on any parties performing the tasks required under this Regulation with, for or on behalf of the persons referred to in paragraph 1. 7. The representatives of the competent authorities shall keep a record of every control that they carry out and where necessary shall draw up a report. The person referred to in paragraph 1 shall be promptly informed in writing by the competent authority of any case of non-compliance identified through the controls and shall have the opportunity to submit comments within a time limit set by the competent authority. 8. The competent authorities shall have procedures or arrangements in place to ensure that staff performing controls are free from any conflict of interest.
Article 124 Audits by the Commission
The Commission may carry out audits in Member States on their competent authorities for the purpose of confirming the appropriateness of the controls carried out by those competent authorities. Such audits shall be coordinated with the relevant Member State and shall be carried out in a manner which avoids unnecessary administrative burden. After each audit, the Commission shall draft a report containing, where appropriate, recommendations to the relevant Member State. The Commission shall send the draft report to the competent authority for comments and shall take into account any such comments in drawing up the final report. The final report and the comments shall be made public by the Commission.
Article 125 Certificate of suitability
In order to verify whether the data submitted for obtaining a certificate of suitability complies with the monographs of the European Pharmacopoeia , the standardisation body for nomenclatures and quality norms within the meaning of the Convention on the elaboration of a European Pharmacopoeia accepted by Council Decision 94/358/EC ( 27 ) (European Directorate for the Quality of Medicines and Healthcare (‘EDQM’)) may ask the Commission or the Agency to request an inspection by a competent authority when the starting material concerned is subject to a European Pharmacopoeia monograph.
Article 126 Specific rules on pharmacovigilance inspections
1. The competent authorities and the Agency shall ensure that all pharmacovigilance system master files in the Union are regularly checked and that the pharmacovigilance systems are being correctly applied. 2. The Agency shall coordinate and the competent authorities shall carry out inspections on the pharmacovigilance systems of veterinary medicinal products authorised in accordance with Article 44. 3. The competent authorities shall carry out inspections on the pharmacovigilance systems of veterinary medicinal products authorised in accordance with Articles 47, 49, 52 and 53. 4. The competent authorities of the Member States in which the pharmacovigilance system master files are located shall carry out inspections of the pharmacovigilance systems master files. 5. Notwithstanding paragraph 4 of this Article and pursuant to Article 80, a competent authority may enter into any work-sharing initiatives and delegation of responsibilities with other competent authorities to avoid the duplication of inspections of pharmacovigilance systems. 6. The results of the pharmacovigilance inspections shall be recorded in the pharmacovigilance database as referred to in Article 74.
Article 127 Proof of the product quality for veterinary medicinal products
1. The marketing authorisation holder shall have at its disposal the results of the control tests carried out on the veterinary medicinal product or on the constituents and intermediate products of the manufacturing process, in accordance with the methods laid down in the marketing authorisation. 2. If a competent authority concludes that a batch of a veterinary medicinal product is not in conformity with the control report of the manufacturer or the specifications provided for in the marketing authorisation, it shall take measures in relation to the marketing authorisation holder and the manufacturer, and shall inform accordingly the competent authorities of other Member States in which the veterinary medicinal product is authorised, and also the Agency in case the veterinary medicinal product is authorised under the centralised procedure.
Article 128 Proof of the product quality specific for immunological veterinary medicinal products
1. For the purposes of application of Article 127(1), competent authorities may require the holder of a marketing authorisation for immunological veterinary medicinal products to submit to the competent authorities the copies of all the control reports signed by the qualified person in accordance with Article 97. 2. The holder of a marketing authorisation for immunological veterinary medicinal products shall ensure that an adequate number of representative samples of each batch of veterinary medical products is held in stock at least up to the expiry date, and provide samples promptly to the competent authorities on request. 3. Where necessary for reasons of human or animal health, a competent authority may require the holder of a marketing authorisation for an immunological veterinary medicinal product to submit samples of batches of the bulk product or of the immunological veterinary medicinal product for control by an Official Medicines Control Laboratory before the product is placed on the market. 4. On the request of a competent authority, the marketing authorisation holder shall promptly supply the samples referred to in paragraph 2, together with the control reports referred to in paragraph 1, for control testing. The competent authority shall inform the competent authorities in other Member States in which the immunological veterinary medicinal product is authorised, as well as the EDQM and the Agency in case the immunological veterinary medicinal product is authorised under the centralised procedure, of its intention to control batches of the immunological veterinary medicinal product. 5. On the basis of the control reports referred to in this Chapter, the laboratory responsible for the control shall repeat, on the samples provided, all the tests carried out by the manufacturer on the finished immunological veterinary medicinal product, in accordance with the relevant specifications in its dossier for marketing authorisation. 6. The list of tests to be repeated by the laboratory responsible for the control shall be restricted to justified tests, provided that all competent authorities in the relevant Member States, and, if appropriate, the EDQM, agree to such a restriction. For immunological veterinary medicinal products authorised under the centralised procedure, the list of tests to be repeated by the control laboratory may be reduced only upon agreement of the Agency. 7. The competent authorities shall recognise the results of the tests referred to in paragraph 5. 8. Unless the Commission is informed that a longer period is necessary to conduct the tests, the competent authorities shall ensure that the control is completed within 60 days of receipt of the samples and control reports. 9. The competent authority shall notify the competent authorities of other relevant Member States, the EDQM, the marketing authorisation holder and, if appropriate, the manufacturer, of the results of the tests within the same period of time. 10. The competent authority shall verify that the manufacturing processes used in the manufacture of immunological veterinary medicinal products are validated and that batch-to-batch consistency is ensured.
Article 129 Temporary safety restrictions
1. The competent authority and, in the case of centrally authorised veterinary medicinal products, also the Commission may, in the event of a risk to public or animal health or to the environment that requires urgent action, impose temporary safety restrictions on the marketing authorisation holder and other persons having obligations under this Regulation. Those temporary safety restrictions may include: (a) restriction of supply of the veterinary medicinal product at the request of the competent authority and, in the case of centrally authorised veterinary medicinal products, also at the request of the Commission to the competent authority; (b) restriction of the use of the veterinary medicinal product at the request of the competent authority and, in the case of centrally authorised veterinary medicinal products, also at the request of the Commission to the competent authority; (c) suspension of a marketing authorisation by the competent authority having granted that marketing authorisation and, in the case of centrally authorised veterinary medicinal products, by the Commission. 2. The competent authority concerned shall inform, at the latest on the following working day, the other competent authorities and the Commission of any temporary safety restriction imposed. In the case of centralised marketing authorisations, the Commission shall inform, within the same time, the competent authorities of any temporary safety restriction imposed. 3. Competent authorities and the Commission may, at the same time as imposing a restriction in accordance with paragraph 1 of this Article, refer the issue to the Agency in accordance with Article 82. 4. Where applicable, the marketing authorisation holder shall submit an application for a variation to the terms of the marketing authorisation in accordance with Article 62.
Article 130 Suspending, revoking, or varying the terms, of marketing authorisations
1. The competent authority or, in the case of centralised marketing authorisations, the Commission shall suspend or revoke the marketing authorisation or request the marketing authorisation holder to submit an application for a variation to the terms of the marketing authorisation if the benefit-risk balance of the veterinary medicinal product is no longer positive or is insufficient to ensure food safety. 2. The competent authority or, in the case of centralised marketing authorisations, the Commission, shall revoke the marketing authorisation if the marketing authorisation holder no longer fulfils the requirement on establishment in the Union referred to in Article 5(4). 3. The competent authority or, in the case of centralised marketing authorisations, the Commission may suspend or revoke the marketing authorisation or request the marketing authorisation holder to submit an application for a variation to the terms of the marketing authorisation, as applicable, in the case of one or more of the following reasons: (a) the marketing authorisation holder does not comply with the requirements set out in Article 58; (b) the marketing authorisation holder does not comply with the requirements set out in Article 127; (c) the pharmacovigilance system established in accordance with Article 77(1) is inadequate; (d) the marketing authorisation holder does not fulfil its obligations laid down in Article 77; (e) the qualified person responsible for pharmacovigilance does not fulfil his or her tasks as laid down in Article 78. 4. For the purpose of paragraphs 1, 2 and 3, in the case of centralised marketing authorisations, before taking action, the Commission shall request, where appropriate, the opinion of the Agency within a time limit which it shall determine in view of the urgency of the matter, in order to examine the reasons referred to in those paragraphs. The holder of the marketing authorisation for the veterinary medicinal product shall be invited to provide oral or written explanations within a given time limit set by the Commission. Following an opinion of the Agency, the Commission shall adopt, where necessary, provisional measures, which shall be applied immediately. The Commission shall, by means of implementing acts, take a final decision. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 5. Member States shall lay down procedures for application of paragraphs 1, 2 and 3.
Article 131 Suspending or revoking a wholesale distribution authorisation
1. In the event of non-compliance with the requirements laid down in Article 101(3), the competent authority shall suspend or revoke the wholesale distribution authorisation of veterinary medicinal products. 2. In the event of non-compliance with the requirements laid down in Article 101, other than paragraph 3 thereof, the competent authority may, without prejudice to any other appropriate measures under national law, take one or more of the following measures: (a) suspend the wholesale distribution authorisation; (b) suspend the wholesale distribution authorisation for one or more categories of veterinary medicinal products; (c) revoke the wholesale distribution authorisation for one or more categories of veterinary medicinal products.
Article 132 Removal of importers, manufacturers and distributors of active substance from the manufacturing and wholesale distribution database
In the event of non-compliance by importers, manufacturers and distributors of active substances with the requirements laid down in Article 95, the competent authority shall, temporarily or definitively, remove those importers, manufacturers and distributors from the manufacturing and wholesale distribution database.
Article 133 Suspending or revoking manufacturing authorisations
In the event of non-compliance with the requirements laid down in Article 93, the competent authority shall, without prejudice to any other appropriate measures under national law, take one or more of the following measures: (a) suspend the manufacture of veterinary medicinal products; (b) suspend imports of veterinary medicinal products from third countries; (c) suspend or revoke the manufacturing authorisation for one or more pharmaceutical forms; (d) suspend or revoke the manufacturing authorisation for one or more activities in one or more manufacturing sites.
Article 134 Prohibiting the supply of veterinary medicinal products
1. In the event of a risk to public or animal health or to the environment, the competent authority or, in the case of centrally authorised veterinary medicinal products, the Commission, shall prohibit the supply of a veterinary medicinal product and require the marketing authorisation holder or suppliers to cease the supply or recall of the veterinary medicinal product from the market if any of the following conditions apply: (a) the benefit-risk balance of the veterinary medicinal product is no longer positive; (b) the qualitative or quantitative composition of the veterinary medicinal product is not as stated in the summary of the product characteristics referred to in Article 35; (c) the recommended withdrawal period is insufficient to ensure food safety; (d) the control tests referred to in Article 127(1) have not been carried out; or (e) the incorrect labelling might lead to a serious risk to animal or public health. 2. The competent authorities or the Commission may confine the prohibition on supply and recall from the market solely to the contested production batches of the veterinary medicinal product concerned.
Article 135 Penalties imposed by Member States
1. Member States shall lay down rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by 28 January 2022, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendments affecting them. 2. The competent authorities shall ensure the publication of information on the type and number of cases where financial penalties were imposed, having regard to the legitimate interest of the concerned parties for the protection of their business secrets. 3. Member States shall inform the Commission immediately of any litigation against the holders of marketing authorisations for centrally authorised veterinary medicinal products brought for infringement of this Regulation.
Article 136 Financial penalties imposed by the Commission on holders of marketing authorisation for centrally authorised veterinary medicinal products
1. The Commission may impose financial penalties in the form of fines or periodic penalty payments on the holders of marketing authorisation for centrally authorised veterinary medicinal products granted under this Regulation if they fail to comply with any of their obligations laid down in Annex III in connection with the marketing authorisations. 2. The Commission may, insofar as specifically provided for in the delegated acts referred to in point (b) of paragraph 7, impose the financial penalties referred to in paragraph 1 also on a legal entity or legal entities other than the marketing authorisation holder provided that such entities form part of the same economic entity as the marketing authorisation holder and that such other legal entities: (a) exerted a decisive influence over the marketing authorisation holder; or (b) were involved in, or could have addressed, such failure to comply with the obligation by the marketing authorisation holder. 3. Where the Agency or a competent authority of a Member State is of the opinion that a marketing authorisation holder has failed to comply with any of the obligations, as referred to in paragraph 1, it may request the Commission to investigate whether to impose financial penalties pursuant to that paragraph. 4. In determining whether to impose a financial penalty and in determining its appropriate amount, the Commission shall be guided by the principles of effectiveness, proportionality and dissuasiveness and take into consideration, where relevant, the seriousness and the effects of the failure to comply with the obligations. 5. For the purposes of paragraph 1, the Commission shall also take into account: (a) any infringement procedure initiated by a Member State against the same marketing authorisation holder on the basis of the same legal grounds and the same facts; and (b) any sanctions, including penalties, already imposed on the same marketing authorisation holder on the basis of the same legal grounds and the same facts. 6. Where the Commission finds that the marketing authorisation holder has failed, intentionally or negligently, to comply with its obligations, as referred to in paragraph 1, it may adopt a decision imposing a fine not exceeding 5 % of the marketing authorisation holder’s Union turnover in the business year preceding the date of that decision. Where the marketing authorisation holder continues to fail to comply with its obligations referred to in paragraph 1, the Commission may adopt a decision imposing periodic penalty payments per day not exceeding 2,5 % of the marketing authorisation holder’s average daily Union turnover in the business year preceding the date of that decision. Periodic penalty payments may be imposed for a period running from the date of notification of the relevant Commission's decision until the failure to comply with the obligation by the marketing authorisation holder, as referred to in paragraph 1, has been brought to an end. 7. The Commission shall adopt delegated acts in accordance with Article 147 in order to supplement this Regulation by laying down: (a) procedures to be applied by the Commission when imposing fines or periodic penalty payments, including rules on the initiation of the procedure, measures of inquiry, rights of defence, access to file, legal representation and confidentiality; (b) further detailed rules on the imposition by the Commission of financial penalties on legal entities other than the marketing authorisation holder; (c) rules on duration of procedure and limitation periods; (d) elements to be taken into account by the Commission when setting the level of, and imposing, fines and periodic penalty payments, as well as the conditions and methods for their collection. 8. When conducting the investigation on a failure to comply with any of the obligations referred to in paragraph 1, the Commission may cooperate with national competent authorities and rely on resources provided by the Agency. 9. Where the Commission adopts a decision imposing a financial penalty, it shall publish a concise summary of the case, including the names of the marketing authorisation holders involved and the amounts of, and reasons for, the financial penalties imposed, having regard to the legitimate interest of the marketing authorisation holders for the protection of their business secrets. 10. The Court of Justice of the European Union shall have unlimited jurisdiction to review decisions whereby the Commission has imposed financial penalties. The Court of Justice of the European Union may cancel, reduce or increase the fine or periodic penalty payment imposed by the Commission.
Article 137 Competent authorities
1. Member States shall designate the competent authorities to carry out tasks under this Regulation. 2. Member States shall ensure that adequate financial resources are available to provide the staff and other resources necessary for the competent authorities to carry out the activities required by this Regulation. 3. The competent authorities shall cooperate with each other in the performance of their tasks under this Regulation and shall give the competent authorities of other Member States necessary and useful support to this end. Competent authorities shall communicate the appropriate information to each other. 4. On reasoned request, the competent authorities shall forthwith communicate the written records referred to in Article 123 and control reports referred to in Article 127 to the competent authorities of other Member States.
Article 138 Scientific opinion for international organisations for animal health
1. The Agency may give scientific opinions, in the context of cooperation with international organisations for animal health, for the evaluation of veterinary medicinal products intended exclusively for markets outside the Union. For that purpose, an application shall be submitted to the Agency in accordance with Article 8. The Agency may, after consulting the relevant organisation, draw up a scientific opinion. 2. The Agency shall establish specific procedural rules for the implementation of paragraph 1.
Article 139 Committee for Veterinary Medicinal Products
1. A Committee for Veterinary Medicinal Products (‘the Committee’) is hereby set up within the Agency. 2. The Executive Director of the Agency or his or her representative and representatives of the Commission shall be entitled to attend all meetings of the Committee, working parties and scientific advisory groups. 3. The Committee may establish standing and temporary working parties. The Committee may establish scientific advisory groups in connection with the evaluation of specific types of veterinary medicinal products, to which the Committee may delegate certain tasks associated with drawing up the scientific opinions referred to in point (b) of Article 141(1). 4. The Committee shall establish a standing working party with the sole remit of providing scientific advice to undertakings. The Executive Director, in consultation with the Committee shall set up the administrative structures and procedures allowing the development of advice for undertakings, as referred to in point (n) of Article 57(1) of Regulation (EC) No 726/2004, particularly regarding the development of novel therapy veterinary medicinal products. 5. The Committee shall establish a standing working party for pharmacovigilance with a remit including evaluating potential signals in pharmacovigilance arising from the Union pharmacovigilance system, proposing the options for risk management referred to in Article 79 to the Committee and to the coordination group, and coordinating the communication about pharmacovigilance between the competent authorities and the Agency. 6. The Committee shall establish its own rules of procedure. Those rules shall, in particular, lay down: (a) procedures for appointing and replacing the Chair; (b) the appointment of members of any working parties or scientific advisory groups on the basis of the lists of accredited experts referred to in the second subparagraph of Article 62(2) of Regulation (EC) No 726/2004 and procedures for consultation of working parties and scientific advisory groups; (c) a procedure for urgent adoption of opinions, particularly in relation to the provisions of this Regulation on market surveillance and pharmacovigilance. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency. 7. The Secretariat of the Agency shall provide technical, scientific and administrative support for the Committee, and shall ensure consistency and quality of opinions of the Committee and appropriate coordination between the Committee and other committees of the Agency referred to in Article 56 of Regulation (EC) No 726/2004 and the coordination group. 8. The opinions of the Committee shall be publicly accessible.
Article 140 Members of the Committee
1. Each Member State shall, after consultation of the Management Board of the Agency, appoint for a three-year term which may be renewed, one member and an alternate member of the Committee. The alternates shall represent and vote for the members in their absence and may also be appointed to act as rapporteurs. 2. Members and alternates of the Committee shall be appointed on the basis of their relevant expertise and experience in the scientific assessment of veterinary medicinal products, in order to guarantee the highest level of qualifications and a broad spectrum of relevant expertise. 3. A Member State may delegate its tasks within the Committee to another Member State. Each Member State may represent no more than one other Member State. 4. The Committee may co-opt a maximum of five additional members chosen on the basis of their specific scientific competence. Those members shall be appointed for a term of three years, which may be renewed, and shall not have alternates. 5. With a view to the co-opting of such members, the Committee shall identify the specific complementary scientific competence of the additional members. Co-opted members shall be chosen among experts nominated by Member States or the Agency. 6. The Committee may appoint, for the purpose of performing its tasks referred to in Article 141, one of its members to act as rapporteur. The Committee may also appoint a second member to act as a co-rapporteur. 7. The members of the Committee may be accompanied by experts in specific scientific or technical fields. 8. Members of the Committee and experts responsible for assessing veterinary medicinal products shall rely on the scientific evaluation and resources available to competent authorities. Each competent authority shall monitor and ensure the scientific level and independence of the evaluation carried out and provide appropriate contribution to the tasks of the Committee, and facilitate the activities of appointed Committee members and experts. To that end, Member States shall provide adequate scientific and technical resources to the members and experts they have nominated. 9. Member States shall refrain from giving Committee members and experts instructions incompatible with their own individual tasks, or with the tasks of the Committee and responsibilities of the Agency.
Article 141 Tasks of the Committee
1. The Committee shall have the following tasks: (a) carry out the tasks conferred on it under this Regulation and Regulation (EC) No 726/2004; (b) prepare scientific opinions of the Agency on questions relating to the evaluation and use of veterinary medicinal products; (c) prepare opinions on scientific matters concerning the evaluation and use of veterinary medicinal products on the request of the Executive Director of the Agency or the Commission; (d) prepare opinions of the Agency on questions concerning the admissibility of applications submitted in accordance with the centralised procedure, and on granting, varying, suspending or revoking marketing authorisations for centrally authorised veterinary medicinal products; (e) take due account of any request made by Member States for scientific opinions; (f) provide guidance on important questions and issues of general scientific nature; (g) give a scientific opinion, in the context of cooperation with the World Organisation for Animal Health, concerning the evaluation of certain veterinary medicinal products intended exclusively for markets outside the Union; (h) advise on the maximum limits for residues of veterinary medicinal products and biocidal products used in animal husbandry which may be accepted in foodstuffs of animal origin in accordance with Regulation (EC) No 470/2009; (i) provide scientific advice on the use of antimicrobials and antiparasitics in animals in order to minimise the occurrence of resistance in the Union, and update that advice when needed; (j) provide objective scientific opinions to the Member States on the questions which are referred to the Committee. 2. The members of the Committee shall ensure that there is appropriate coordination between the tasks of the Agency and the work of competent authorities. 3. When preparing opinions, the Committee shall use its best endeavours to reach a scientific consensus. If such consensus cannot be reached, the opinion shall consist of the position of the majority of members and divergent positions, with the grounds on which they are based. 4. If there is a request for re-examination of an opinion where this possibility is provided for in the Union law, the Committee shall appoint a different rapporteur and, where necessary, a different co-rapporteur from those appointed for the opinion. The re-examination procedure may deal only with the points of the opinion initially identified by the applicant and may be based only on the scientific data available when the Committee adopted the opinion. The applicant may request that the Committee consult a scientific advisory group in connection with the re-examination.
Article 142 Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products
1. The coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (‘the coordination group’) shall be set up. 2. The Agency shall provide a secretariat for the coordination group to assist in the operations of the procedures of the coordination group and to ensure an appropriate liaison between this group, the Agency and competent authorities. 3. The coordination group shall draw up its rules of procedure, which shall enter into force after receiving a favourable opinion from the Commission. Those rules of procedure shall be made public. 4. The Executive Director of the Agency or his or her representative and representatives of the Commission shall be entitled to attend all meetings of the coordination group. 5. The coordination group shall cooperate closely with the competent authorities and the Agency.
Article 143 Members of the coordination group
1. The coordination group shall be composed of one representative per Member State appointed for a renewable period of three years. Member States may appoint an alternate representative. Members of the coordination group may arrange to be accompanied by experts. 2. Members of the coordination group and their experts shall rely on the scientific and regulatory resources available to their competent authorities, on the relevant scientific assessments and on the recommendations of the Committee for the fulfilment of their tasks. Each competent authority shall monitor the quality of the evaluations carried out by their representative and facilitate their activities. 3. Members of the coordination group shall use their best endeavours to reach consensus on matters under discussion.
Article 144 Tasks of the coordination group
The coordination group shall have the following tasks: (a) examine questions concerning mutual recognition and decentralised procedures; (b) examine advice from the pharmacovigilance working party of the Committee concerning risk management measures in pharmacovigilance related to veterinary medicinal products authorised in Member States and issue recommendations to the Member States and to the marketing authorisation holders, as necessary; (c) examine questions concerning variations to the terms of marketing authorisations granted by Member States; (d) provide recommendations to Member States whether a specific veterinary medicinal product or a group of veterinary medicinal products is to be considered a veterinary medicinal product within the scope of this Regulation; (e) coordinate the selection of the lead authority responsible for the assessment of the results of the signal management process referred to in Article 81(4); (f) draw up and publish an annual list of reference veterinary medicinal products which shall be subject to harmonisation of the summaries of product characteristics in accordance with Article 70(3).
Article 145 Standing Committee on Veterinary Medicinal Products
1. The Commission shall be assisted by the Standing Committee on Veterinary Medicinal Products (‘the Standing Committee’). The Standing Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Article 146 Amendments to Annex II
1. The Commission is empowered to adopt delegated acts in accordance with Article 147(2) in order to amend Annex II by adapting the requirements regarding the technical documentation on the quality, safety and efficacy of veterinary medicinal products to technical and scientific progress. 2. The Commission shall adopt delegated acts in accordance with Article 147(3) amending Annex II in order to achieve a sufficient level of detail that ensures legal certainty and harmonisation as well as any necessary updating, while avoiding unnecessary disruption with Annex II, including as regards the introduction of specific requirements for novel therapy veterinary medicinal products. When adopting those delegated acts, the Commission shall have due regard to animal and public health and environmental considerations.
Article 147 Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 37(4), 57(3), 106(6), 109(1), 115(3), 118(2), 136(7) and 146(1) and (2) shall be conferred on the Commission for a period of five years from 27 January 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for the periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The power to adopt delegated acts referred to in Article 146(2) shall be conferred on the Commission for a period from 27 January 2019 until 28 January 2022. 4. The delegation of power referred to in Articles 37(4), 57(3), 106(6), 109(1), 115(3), 118(2), 136(7) and 146(1) and (2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 5. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law Making. 6. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 7. A delegated act adopted pursuant to Articles 37(4), 57(3), 106(6), 109(1), 115(3), 118(2), 136(7) and 146(1) and (2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 148 Data protection
1. Member States shall apply Regulation (EU) 2016/679 of the European Parliament and of the Council ( 28 ) to the processing of personal data carried out in the Member States pursuant to this Regulation. 2. Regulation (EU) 2018/1725 of the European Parliament and of the Council ( 29 ) shall apply to the processing of personal data carried out by the Commission and the Agency pursuant to this Regulation.
Article 149 Repeal
Directive 2001/82/EC is repealed. References to the repealed Directive shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in Annex IV.
Article 150 Relation with other Union acts
1. Nothing in this Regulation shall be understood to affect the provisions of Directive 96/22/EC. 2. Commission Regulation (EC) No 1234/2008 ( 30 ) shall not apply to veterinary medicinal products covered by this Regulation. 3. Commission Regulation (EC) No 658/2007 ( 31 ) shall not apply to veterinary medicinal products covered by this Regulation.
Article 151 Prior applications
1. The procedures concerning the applications for marketing authorisations for veterinary medicinal products or for variations that have been validated in accordance with Regulation (EC) No 726/2004 before 28 January 2022 shall be completed in accordance with Regulation (EC) No 726/2004. 2. The procedures concerning the applications for marketing authorisations for veterinary medicinal products that have been validated in accordance with Directive 2001/82/EC before 28 January 2022 shall be completed in accordance with that Directive. 3. Procedures initiated on the basis of Articles 33, 34, 35, 39, 40 and 78 of Directive 2001/82/EC before 28 January 2022 shall be completed in accordance with that Directive.
Article 152 Existing veterinary medicinal products, marketing authorisations and registrations
1. Marketing authorisations of veterinary medicinal products and registrations of homeopathic veterinary medicinal products granted in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004 before 28 January 2022 shall be deemed to have been issued in accordance with this Regulation, and are, as such, subject to the relevant provisions of this Regulation. The first subparagraph of this paragraph shall not apply to marketing authorisations for antimicrobial veterinary medicinal products containing antimicrobials which have been reserved for treatment in humans in accordance with implementing acts referred to in Article 37(5). 2. Veterinary medicinal products placed on the market in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004 may continue to be made available until 29 January 2027, even if they are not in compliance with this Regulation. 3. By way of derogation from paragraph 1 of this Article, the periods of protection referred to in Article 39 shall not apply to reference veterinary medicinal products for which an authorisation has been granted before 28 January 2022 and, instead, the corresponding provisions in the repealed acts referred to in paragraph 1 of this Article shall continue to apply in that respect.
Article 153 Transitional provisions regarding delegated and implementing acts
1. The delegated acts referred to in Article 118(2) and the implementing acts referred to in Articles 37(5), 57(4), 77(6), 95(8), 99(6) and 104(7) shall be adopted before 28 January 2022. Such delegated and implementing acts shall apply from 28 January 2022. 2. Without prejudice to the date of application of this Regulation, the Commission shall adopt the delegated acts referred to in Article 37(4) at the latest by 27 September 2021. Such delegated acts shall apply from 28 January 2022. 3. Without prejudice to the date of application of this Regulation, the Commission shall adopt the delegated acts referred to in Articles 57(3) and 146(2) and the implementing acts referred to in Articles 55(3) and 60(1) at the latest by 27 January 2021. Such delegated and implementing acts shall apply from 28 January 2022. 4. Without prejudice to the date of application of this Regulation, the Commission shall adopt the delegated acts referred to in Article 109(1) and the implementing acts referred to in Articles 17(2) and (3), 93(2), 109(2) and 115(5) at the latest by 29 January 2025. Such delegated and implementing acts shall apply at the earliest on 28 January 2022. 5. Without prejudice to the date of application of this Regulation, the Commission is empowered to adopt delegated and implementing acts provided for in this Regulation as from 27 January 2019. Such delegated and implementing acts, unless otherwise provided in this Regulation, shall apply from 28 January 2022. When adopting the delegated and implementing acts referred to in this Article, the Commission shall allow sufficient time between their adoption and their start of application.
Article 154 Establishment of the pharmacovigilance database and of the manufacturing and wholesale distribution database
Without prejudice to the date of application of this Regulation, the Agency, in collaboration with the Member States and the Commission, shall, in accordance with Articles 74 and 91 respectively, ensure the establishment of the pharmacovigilance database and of the manufacturing and wholesale distribution database at the latest by 28 January 2022.
Article 155 Initial input to the product database by competent authorities
At the latest by 28 January 2022, the competent authorities shall submit, electronically, information on all veterinary medicinal products authorised in their Member State at that time to the Agency, using the format referred to in point (a) of Article 55(3).
Article 156 Review of rules for environmental risk assessment
By 28 January 2022, the Commission shall present a report to the European Parliament and to the Council on a feasibility study of an active substance based review system (‘monographs’) and other potential alternatives for the environmental risk assessment of veterinary medicinal products, to be accompanied, if appropriate, by a legislative proposal.
Article 157 Commission report on traditional herbal products used to treat animals
The Commission shall report to the European Parliament and to the Council by 29 January 2027, on traditional herbal products used to treat animals in the Union. If appropriate, the Commission shall make a legislative proposal in order to introduce a simplified system for registering traditional herbal products used to treat animals. The Member States shall provide information to the Commission on such traditional herbal products within their territories.
Article 158 Review of measures regarding animals of the equine species
No later than 29 January 2025, the Commission shall present a report to the European Parliament and to the Council on its assessment of the situation as regards the treatment with medicinal products of animals of the equine species and their exclusion from the food chain, including with regard to imports of animals of the equine species from third countries, to be accompanied by any appropriate action by the Commission taking into account, in particular, public health, animal welfare, the risks of fraud and the level playing field with third countries.
Article 159 Transitional provisions regarding certain certificates of good manufacturing practice
Without prejudice to the date of application of this Regulation, the obligations regarding certificates of good manufacturing practice for inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals in an epidemiological unit and used for the treatment of that animal or those animals in the same epidemiological unit or for the treatment of an animal or animals in a unit having a confirmed epidemiological link shall only start to apply from the date of application of the implementing acts laying down specific measures on good manufacturing practice for those veterinary medicinal products referred to in Article 93(2).
Article 160 Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union . It shall apply from 28 January 2022.