54 Amendments of Peter LIESE related to 2014/0257(COD)
Amendment 44 #
Proposal for a regulation
Recital 17
Recital 17
(17) However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only, whereby antimicrobial medicinal products for human use may be employed only subject to the issuing of a prescription by a vet and authorisation by the veterinary authority responsible for monitoring the work of the vet in question. In case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain.
Amendment 119 #
Proposal for a regulation
Recital 17
Recital 17
(17) However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only; in such cases antimicrobial medicinal products for human use may be employed only subject to the issuing of a prescription by a veterinarian and the granting of authorisation by the veterinary authority responsible for monitoring the work of the veterinarian in question. In case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain.
Amendment 154 #
Proposal for a regulation
Recital 37
Recital 37
(37) In order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, it may be necessary to reserve those antimicrobials for humans only. Therefore it should be possible to decide that certain antimicrobials, following the scientific recommendations of the Agency, should not be available on the market in the veterinary sector; the decisive criteria should be that the antibiotic is used in human medicine when other antibiotic therapies are no longer effective and that there is evidence that resistance in human beings cannot be excluded by use in animals.
Amendment 156 #
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37a) As Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide there must soon also action be taken in the field of human medicine for example in the form of an instrument incentivising the development of new antibiotics for human use similar to that already proposed within this regulation.
Amendment 207 #
Proposal for a regulation
Article 2 – paragraph 4 – point e a (new)
Article 2 – paragraph 4 – point e a (new)
(ea) substances or preparations which are intended exclusively for external use in animals, to clean or groom them or to alter their appearance or body odour, provided that no substances or preparations subject to veterinary prescription have been added to them.
Amendment 209 #
Proposal for a regulation
Article 2 – paragraph 4 – point e b (new)
Article 2 – paragraph 4 – point e b (new)
(eb) feedingstuffs as defined in Regulation (EU) No 767/2009 of the European Parliament and of the Council.
Amendment 399 #
Proposal for a regulation
Article 29 – paragraph 3 a (new)
Article 29 – paragraph 3 a (new)
3a. In contrast to paragraph 1, medicinal products for veterinary use shall be without prescription if: (a) they are registered as single homeopathic products and released for sale in pharmacies, have a dilution of not less than D4 (1:10 000) and are not produced using alcohol. (b) they are registered as complex homeopathic products, contain no individual components below a dilution of D4, are released for sale in pharmacies and are not produced using alcohol.
Amendment 399 #
Proposal for a regulation
Article 115 – paragraph 1 – point a – point iii
Article 115 – paragraph 1 – point a – point iii
(iii) a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC of the European Parliament and of the Council30 or Regulation (EC) No 726/2004. Antimicrobial medicinal products for human use may only be employed, subject to the issuing of a prescription by a veterinarian and approval by the veterinary authority responsible for monitoring the work of the veterinarian in question, if treatment with a medicinal product as referred to in letter (a)(i) or (ii) is not possible; __________________ 30 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
Amendment 408 #
Proposal for a regulation
Article 116 – paragraph 1 – point c
Article 116 – paragraph 1 – point c
(c) a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004,. Antimicrobial medicinal products for human use may be employed, subject to the issuing of a prescription by a veterinarian and approval by the veterinary authority responsible for monitoring the work of the veterinarian in question, if treatment with a veterinary medicinal product as referred to in letter (a) or (b) is not possible; or
Amendment 426 #
Proposal for a regulation
Article 118 – paragraph 1
Article 118 – paragraph 1
1. Antimicrobial medicinal products shall only be used in accordance with Articles 115 and 116 to treat conditions for which there is no other treatment available, and the proper use of which would not present a risk to public or animal health.
Amendment 561 #
Proposal for a regulation
Article 72 – paragraph 1
Article 72 – paragraph 1
1. Marketing authorisation holders shall carry out regular evaluations of their products and ensure a positive benefit/risk assessment. They shall elaborate and maintain a system for collecting and evaluating information on the risks of veterinary medicinal products as regards animal health, public health and the environment enabling them. The system shall serve to coordinate the necessary measures to fulfil their pharmacovigilance responsibilities listed in Articles 73, 76 and 77 (‘pharmacovigilance system’). e.
Amendment 567 #
Proposal for a regulation
Article 73 – paragraph 1
Article 73 – paragraph 1
1. Member States, the Commission, and the Agency and marketing authorisation holders shall collaborate in setting up and maintaining ashall collaborate in setting up, interconnecting and further developing their systems to monitor the safety, effectiveness and quality of authorised veterinary medicinal products, enabling them in order to fulfil their responsibilities as listed in Articles 77 and 79 (‘Union pharmacovigilance system’)9. Marketing authorisation holders shall set up and maintain a system to monitor the safety, effectiveness and quality of their products, enabling them to fulfil their responsibilities as listed in Articles 77 and 78.
Amendment 570 #
Proposal for a regulation
Article 73 – paragraph 2 – introductory part
Article 73 – paragraph 2 – introductory part
2. Competent authorities, the Agency and marketing authorisation holders shall make available to healthcare professionals and animal holders different means of reporting to them the following events whether or not the event is considered to be product- related (‘adverse events listed below. An adverse events’) is:
Amendment 574 #
Proposal for a regulation
Article 73 – paragraph 2 – point a
Article 73 – paragraph 2 – point a
(a) any response in an animal to a veterinary or human medicinal product, that is noxious and unintended, regardless of whether the product can be related to the outcome, which manifests after any use of the product (off-label or on-label);
Amendment 576 #
Proposal for a regulation
Article 73 – paragraph 2 – point b
Article 73 – paragraph 2 – point b
(b) any observation of a lack of efficacy of a veterinary medicinal product following administration toits use on an animal in accordance with the details of the summary of product characteristics, including in the event of an overdose;
Amendment 579 #
Proposal for a regulation
Article 73 – paragraph 2 – point c
Article 73 – paragraph 2 – point c
(c) any environm potential incidents observedly harmful and unforeseen impact on the environment following administration of a veterinary medicinal product to an animals; this happens whenever non-target animals, humans or plants might be harmed by the presence and persistence of the veterinary medicinal product in the environment;
Amendment 585 #
Proposal for a regulation
Article 73 – paragraph 2 – point f
Article 73 – paragraph 2 – point f
(f) any finding of an active substance in a produce of a, after the stipulated waiting time has been observed, of a substance in edible materials, milk, eggs or honey from food-producing animals exceeding the levels of residues established in accordance with Regulation (EC) No 470/2009.
Amendment 591 #
Proposal for a regulation
Article 73 – paragraph 2 a (new)
Article 73 – paragraph 2 a (new)
Amendment 593 #
Proposal for a regulation
Article 74 – paragraph 1
Article 74 – paragraph 1
1. The Agency shall establish and maintain a Union database on pharmacovigilance of veterinary medicinal products (the " pharmacovigilance database " ). Maintaining the database shall include electronic archiving of the original reports, related subsequent reports and continuous quality control of the data.
Amendment 599 #
Proposal for a regulation
Article 74 – paragraph 3
Article 74 – paragraph 3
3. The Agency shall ensure that information reported to the pharmacovigilance database is uploaded and made accessible in accordance with Article 75, and that the marketing authorisation holders forward the information to the responsible authorities of the Member States concerned for further evaluation.
Amendment 600 #
Proposal for a regulation
Article 74 – paragraph 3 a (new)
Article 74 – paragraph 3 a (new)
3a. The Agency shall ensure that the movement of information between the EU’s pharmacovigilance database and the national pharmacovigilance databases of the individual Member States is safeguarded.
Amendment 605 #
Proposal for a regulation
Article 76 – paragraph 1
Article 76 – paragraph 1
1. Competent authorities shall record in the pharmacovigilance databaseand assess all adverse events of which were reported to them by healthcare professionals and animal holders and thatthey learn under Article 73 and which occurred in the territory of their Member State, within 30 days following the receipt of the adverse event report and shall enter them immediately, but no later than 15 days following the receipt of the information, in the EU’s pharmacovigilance database.
Amendment 609 #
Proposal for a regulation
Article 76 – paragraph 2
Article 76 – paragraph 2
2. Marketing authorisation holders shall record in the pharmacovigilance databasand evaluate all adverse events which were reported to them by healthcare professionals and animal holders and that occurred within the Union or in a third country with regard to their authorised veterinary medicinal products,. Serious adverse events should be reported without delay, and at the latest within 3015 days following the receipt of the adverse event reportof their coming to light; less serious adverse events should be reported within 90 days. Competent authorities may, on their own initiative or on request from the Agency, request the marketing authorisation holder to collect specific pharmacovigilance data and to notify other competent authorities and the Agency accordingly. Marketing authorisation holders shall be required to comply with such a request within an appropriate deadline set by the competent authority.
Amendment 615 #
Proposal for a regulation
Article 76 – paragraph 3 a (new)
Article 76 – paragraph 3 a (new)
3a. Marketing authorisation holders shall submit reports on their ongoing risk- benefit balance evaluation on a regular basis and as required in response to requests from the competent authorities. The reporting intervals and requisite data lock points, with associated submission deadlines, shall be set by the competent authorities, in accordance with a risk- based approach, when marketing authorisations are issued. Data lock points already determined under a harmonised EU-wide approach for existing authorisations shall continue to apply.
Amendment 618 #
Proposal for a regulation
Article 77 – paragraph 1
Article 77 – paragraph 1
1. The marketing authorisation holder shall be responsible for the pharmacovigilance of the products for which he holds a marketing authorisation and shall take all appropriate steps to encourage members of the health professions and animal holders to report adverse events.
Amendment 620 #
Proposal for a regulation
Article 77 – paragraph 1 a (new)
Article 77 – paragraph 1 a (new)
1a. Marketing authorisation holders shall ensure, by regularly conducting and updating evaluations of their veterinary medicinal products using signal-detection methods, and taking any measures thus found to be necessary, that the risk- benefit balance is favourable.
Amendment 622 #
Proposal for a regulation
Article 77 – paragraph 2
Article 77 – paragraph 2
2. Where the pharmacovigilance tasks have been contracted out by the marketing authorisation holder to a third party, those arrangements shall be set out in details (contractor), the responsibilities of both parties shall be set out explicitly in a contract and in the pharmacovigilance system master file.
Amendment 623 #
Proposal for a regulation
Article 77 – paragraph 2 a (new)
Article 77 – paragraph 2 a (new)
2a. The marketing authorisation holder shall be required to check regularly that the contractor is carrying out the work in accordance with the stipulations of the contract.
Amendment 624 #
Proposal for a regulation
Article 77 – paragraph 3
Article 77 – paragraph 3
3. The marketing authorisation holder shall permanently have at his disposal one or morean appropriately qualified persons responsible for pharmacovigilance. Thoseat persons shall reside and operate in the Union. Only onThe qualified person shall be designated byresponsible for pharmacovigilance may delegate specific areas of work to appropriately trained staff but shall remain responsible for the marketing authorisation holder per’s pharmacovigilance system master fileand for the safety profile of his veterinary medicinal products.
Amendment 626 #
Proposal for a regulation
Article 77 – paragraph 4
Article 77 – paragraph 4
4. Where the tasks of the qualified person responsible for pharmacovigilance listed in Article 78 have been contracted out to a third party, thosee relevant arrangements shall be dsetailed out explicitly in thea contract.
Amendment 631 #
Proposal for a regulation
Article 78 – paragraph 1 – point a a (new)
Article 78 – paragraph 1 – point a a (new)
(aa) elaborating and maintaining a detailed description of the pharmaceutical business’s pharmacovigilance system;
Amendment 637 #
Proposal for a regulation
Article 78 – paragraph 1 – point k
Article 78 – paragraph 1 – point k
(k) ensuring that all personnel involved in the performance of pharmacovigilance activities receives continued training tailored to their duties, on an ongoing basis; training courses should be documented and their effectiveness reviewed;
Amendment 640 #
Proposal for a regulation
Article 78 – paragraph 1 – point l a (new)
Article 78 – paragraph 1 – point l a (new)
(la) The authorisation holder shall be required to ensure that the qualified person responsible for pharmacovigilance is authorised to maintain and develop the pharmacovigilance system and to improve compliance with requirements.
Amendment 671 #
Proposal for a regulation
Article 89 – paragraph 1 a (new)
Article 89 – paragraph 1 a (new)
1a. Registration shall not be required in the case of medicinal products placed on the market by a pharmaceutical business in volumes of up to 1 000 packets in a year unless: (a) they contain preparations made from the bodies of animals, including living animals, human or animal body parts, components or metabolites in processed or unprocessed form, or micro-organisms, including viruses, or components or metabolites thereof; (b) they contain more than the one- hundredth part of the minimum dose of a non-homeopathic medicine subject to prescription; (c) any of the following apply: – the medicinal product does not meet recognised pharmaceutical quality standards, – there is reason to suspect that, when used according to the instructions, the medicinal product may have harmful effects to a degree that is medically unacceptable, – the specified withdrawal period is insufficient, – the medicinal product is subject to medical prescription, except in the case of products containing exclusively substances listed in the Annex to Regulation (EU) No 37/2010 as substances for which no maximum limits need to be set, – the medicinal product has not been produced in accordance with a process described in the homeopathic section of the pharmacopoeia, – marketing the medicinal product or using it on animals would be unlawful.
Amendment 675 #
Proposal for a regulation
Article 91 – paragraph 1 – point b a (new)
Article 91 – paragraph 1 – point b a (new)
(ba) In addition to a manufacturing authorisation, the manufacturers in question shall be required to have proof and confirmation of compliance with good manufacturing practices (GMP).
Amendment 680 #
Proposal for a regulation
Article 93 – paragraph 5
Article 93 – paragraph 5
5. A manufacturing authorisation may be granted conditionally where minor shortcomings are identified, subject to a requirement for the applicant to undertake actions or introduce specific procedurerectify the shortcomings within a given time period. The manufacturing authorisation may be suspended if these requirements are not complied with.
Amendment 685 #
Proposal for a regulation
Article 98 – paragraph 1 a (new)
Article 98 – paragraph 1 a (new)
Amendment 728 #
Proposal for a regulation
Article 108 – paragraph 7 a (new)
Article 108 – paragraph 7 a (new)
7a. Retail of biological/immunological veterinary medicinal products at a distance shall be prohibited.
Amendment 772 #
Proposal for a regulation
Article 110 – paragraph 4
Article 110 – paragraph 4
4. Veterinary prescriptions shall be recognised throughout the Union. The removal of regulatory and administrative barriers to such recognition should not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription. A veterinary medicinal product prescribed shall be supplied in accordance with applicable national law.
Amendment 801 #
Proposal for a regulation
Article 112 – paragraph 2 – point d
Article 112 – paragraph 2 – point d
(d) name and address of the supplier and, if applicable, a copy of the delivery note;
Amendment 802 #
Proposal for a regulation
Article 112 – paragraph 2 a (new)
Article 112 – paragraph 2 a (new)
2a. Particulars already contained in the prescription or in a delivery note need not be recorded again if a clear reference can be made to the corresponding prescription and delivery note.
Amendment 803 #
Proposal for a regulation
Article 112 a (new)
Article 112 a (new)
Amendment 804 #
Proposal for a regulation
Article 112 b (new)
Article 112 b (new)
Article 112 b Reduction of therapy approaches based on antibacterial substances (1) In order to facilitate the effective reduction regarding the use of pharmaceuticals which contain antibacterial substances, anyone who engages in animal husbandry has to: 1. determine, respectively, two months after the disclosure of the key figures of the in accordance with paragraph 112b established therapy prevalence, if the biannual therapy prevalence concerning his reared animal species, and considering the type-of-use during the elapsed time frame, lies above the average therapy prevalence. 2. take immediate record of the results of the assessment under #1 (2) In a case where the operational, biannual therapy prevalence of the animal husbandman with respect to his business lies above the biannual average, the animal husbandman under consultation of a veterinarian has to assess the reasons that may have led to exceeding the average, and how the treatment of his cattle with pharmaceuticals containing antibacterial substances may be decreased. If the assessment of the animal husbandman comes to the result that a therapy by means of the concerned pharmaceuticals may be reduced, the husbandman has to take all necessary steps in order to accomplish the reduction. The husbandman has to consider the wellbeing of his cattle and guarantee the required medical care. (3) Member States may determine measures extending beyond the above mentioned requirements
Amendment 819 #
Proposal for a regulation
Article 115 – paragraph 1 – point a – point iii
Article 115 – paragraph 1 – point a – point iii
(iii) a medicinal product for human use authorised in the Member State concerned or another Member State in accordance with Directive 2001/83/EC of the European Parliament and of the Council30 or Regulation (EC) No 726/2004. Antimicrobial medicinal products for human use may only be employed, subject to the issuing of a prescription by a veterinarian and approval by the veterinary authority responsible for monitoring the work of the veterinarian in question, if treatment with a medicinal product as referred to in point (a)(i) or (ii) is not possible; __________________ 30 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
Amendment 829 #
Proposal for a regulation
Article 115 – paragraph 1 a (new)
Article 115 – paragraph 1 a (new)
1a. Homoeopathic veterinary medicinal products may be given to non-food producing animals by way of derogation from paragraph 1.
Amendment 849 #
Proposal for a regulation
Article 116 – paragraph 1 – point c
Article 116 – paragraph 1 – point c
(c) a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004, o. Antimicrobial medicinal products for human use may be employed, subject to the issuing of a prescription by a veterinarian and approval by the veterinary authority responsible for monitoring the work of the veterinarian in question, if treatment with a veterinary medicinal product as referred to in point (a) or (b) is not possible. Or
Amendment 864 #
Proposal for a regulation
Article 116 – paragraph 3 a (new)
Article 116 – paragraph 3 a (new)
3a. By way of derogation from paragraphs 1 to 3, homoeopathic veterinary medicinal products may be administered to treat food-producing animals under the responsibility of the veterinarian provided that they exclusively contain active ingredients listed in Table 1 of Regulation (EU) No 37/2010 as substances for which no maximum limit needs to be set.
Amendment 874 #
Proposal for a regulation
Article 117 – paragraph 3
Article 117 – paragraph 3
3. For bees, the veterinarian shall determine the appropriate withdrawal period by assessing the specific situation of the particular beehive(s) on a case-by- case basisconditions of use must be chosen in such a way as to ensure that possible residues are harmless at all times after treatment, and consequently no withdrawal period is necessary.
Amendment 879 #
Proposal for a regulation
Article 118 – title
Article 118 – title
Use of antimicrobialbiotic veterinary medicinal products for species or indications outside the terms of the marketing authorisation
Amendment 882 #
Proposal for a regulation
Article 118 – paragraph 1
Article 118 – paragraph 1
1. Antimicrobialbiotic medicinal products shall only be used in accordance with Articles 115 and 116 to treat conditions for which there is no other treatment available, and the use of which would not present a risk to public or animal health.
Amendment 887 #
Proposal for a regulation
Article 118 – paragraph 2 – subparagraph 1
Article 118 – paragraph 2 – subparagraph 1
The Commission may, by means of implementing acts in accordance with the examination procedure referred to in Article 145(2), and taking into consideration scientific advice of the Agency, establish a list of antimicrobial medicinal productbiotic substances or groups of substances that cannot be used in accordance with paragraph 1, or which can only be used for treatment in accordance with paragraph 1 subject to certain conditions.
Amendment 889 #
Proposal for a regulation
Article 118 – paragraph 2 – subparagraph 2 – point a
Article 118 – paragraph 2 – subparagraph 2 – point a
(a) risks to public health if the antimicrobialbiotic product is used in accordance with paragraph 1;
Amendment 894 #
Proposal for a regulation
Article 119 – paragraph 2
Article 119 – paragraph 2
2. By way of derogation from Article 111, in the event of an outbreak of a listed disease as referred to in Article 5 of Regulation (EC) No…/…. of the European Parliament and the Council31 [Office of Publications, please insert number and, in a footnote, date, title and the OJ reference for the Regulation on animal health] or any critical health situation acknowledged by the Chief Veterinary Officer of the Member State a competent authority may allow, for a limited period of time and under specific restrictions, the use of an immunological veterinary medicinal product without a marketing authorization in the Member State in question but which is authorised either in another Member State or under the legislation of a the third country, in the absence of a suitable medicinal product and after informing the Commission of the detailed conditions of use. __________________ 31 Regulation of the European Parliament and the Council of….. on animal health (OJ L……).
Amendment 902 #
Proposal for a regulation
Article 125 – paragraph 4 a (new)
Article 125 – paragraph 4 a (new)
4a. Inspections may also be carried out on the premises of manufacturers of active substances used as starting materials for veterinary medicinal products where there are grounds for suspecting non- compliance with GMP.