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Decision of 2 November 2012 laying down detailed rules on veterinary medicinal products (Decision on veterinary medicinal products)
We Beatrix, at the grace of God, Queen of the Netherlands, Princess of Orange-Nassau, etc. etc. etc.
On the nomination of the State Secretary for Economic Affairs, Agriculture, and Innovation, from 13 July 2012, no. 283173, Directorate-General for Legislation and Legal Affairs, done in accordance with our Minister for Health, Welfare and Sport, and after consultation with the State Secretary for Social Affairs and Employment;
Having regard to
Directive 90 /167/EEC the Council of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs (PbEG 1990, L 092),
Directive 96 /22/EC of the Council of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists and of the withdrawal of the use of certain substances Directives 81 /602/EEC , 88 /146/EEC and 88 /299/EEC (PbEC 1996, L 125);
Directive 96 /23/EC to the Council of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and their products and repealing the said substances Directives 85 /358/EEC and 86 /469/EEC and Decisions 89 /187/EEC and 91 /664/EEC (PbEC 1996, L 125);
Directive 2001 /82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (PbEG 2001, L 311);
Directive 2004 /28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001 /82/EC adopting a Community code relating to veterinary medicinal products (PbEU 2004, L 136);
Regulation (EC) No 148/EC 726/2004 of the European Parliament and of the Council of the European Union of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing Community procedures for the granting of licences of a European Medicines Agency (PbEU 2004, L 136);
Regulation (EC) No 148/EC 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of limit values for residues of pharmacologically active substances in foodstuffs of animal origin (PbEU 2009, L 152);
The Article 2.7, first paragraph , 2.8, second paragraph, part d, fourth paragraph, part b, and fifth paragraph , 2.19, first and second member, third member, part g, fourth and fifth member , 2.20, first and second members , 2.21, first, fourth and fifth members , 2.22, 1st Member , 2.25, first and third paragraphs , 3.1 , 6.2, 1st Member , 6.3, 1st Member , 7.1 , 7.2 , 7.3, third member , 7.4 , 7.5, fourth member , 7.8 , 7.9 , 10.2 , and 11.1, 1st paragraph, of the Wet Animals ;
The Department for the Advisory Board of the State heard (opinion of 12 September 2012 No W15.12.0298/IV);
Having regard to the further report of the State Secretary for Economic Affairs, Agriculture and Innovation dated 31 October 2012, no. 12332997, Directorate-General for Legislation and Legal Affairs, delivered in accordance with our Minister for Health, Welfare and Sport, and after consultation with the Secretary of State for Social Affairs and Employment;
Have found good and understand:
1 In this Decision and the provisions based thereon, the following definitions shall apply:
- Derogation: the use of a veterinary medicinal product, including the misapplication or serious abuse of the veterinary medicinal product, which is not in accordance with the description in the summary of the product characteristics;
- pharmacist: pharmacist as specified in Article 3, 1st paragraph, of the Act on the professions in the individual health care who exercises his profession in a pharmacy as referred to in Article 1, first paragraph, part oo, of the Medicines Act ;
- Preparation ex tempore: Preparation according to either a formula officinalis or a magistralis formula;
- Outer carton: the packaging in which the primary packaging is placed;
- Bureau: Office referred to in Article 1 of Regulation (EC) No 1481/12 of 726/2004;
- Leaflet: Information sheet for the user accompanying the medicinal product on the immediate packaging in the outer carton;
- Update: an adverse reaction to an animal or an adverse reaction in humans,
- Adverse reaction in an animal: A reaction which is harmful and unintentional, and occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of a disease or for the recovery, improvement or modification of a physiological function;
- Adverse reaction in humans: (a) reaction that is harmful and unintentional and occurs in a human being after exposure to an animal product;
- concentration of the veterinary medicinal product: a level of active substances expressed per dose unit, volume or weight unit in accordance with the dosage form;
- Committee: Committee for Medicinal Products for Veterinary Use as referred to in Article 34, first paragraph, of Directive 2001 /82/EC ;
- Veterinary medicinal product of biological nature: Veterinary medicinal product containing an active substance produced from micro-organisms, organs and tissues of plant or animal origin, cells and liquids, including blood and plasma, of human or animal origin and biotechnological cell preparations, including cell substrates, regardless of whether they are recombinant or not, including primary cells;
- third country: country, other than an EEA Member State;
- Animal pharmacovigilance: systematic collection and management of information on adverse reactions and the use and misuse of veterinary medicinal products for which authorisation is authorised as intended Article 2.1, third paragraph , or 2.12, first paragraph , has been provided, as well as the link between this data and the publicly available data on veterinary medicinal products;
- EEA Member State: Member State of the European Union or any other State party to the Agreement on the European Economic Area;
- serious adverse reaction: Adverse reactions resulting in death, danger of life, significant disability or physical incapacity, congenital disorder or birth defects or resulting in lasting or long lasting effects in animals;
- Labelling: Indication on the outer packaging or the immediate packaging;
- European Pharmacopoeia: -Handbook for the analysis of a medicinal product adopted in accordance with the Treaty on the composition of a European Pharmacopoeia (PbEG 1974, 42);
- Manufacturer: the person who is authorised to be authorised Article 4.1 has been provided;
- pharmaceutical form: physical form in which an animal medicinal product has been placed on the market for the purpose of application to an animal;
- pharmacologically active substance: substance with pharmacological action, including a substance which is an active substance;
- Pharmacopoeia: a manual for the analysis of a medicinal product or a European pharmacopoeia established by an EEA Member State;
- Magistralis formula: a formula for the preparation of a veterinary medicinal product manufactured in a pharmacy in accordance with a veterinary prescription for a particular animal or a small group of animals;
- Formula officinalis: a formula for the preparation of a veterinary medicinal product manufactured in a pharmacy in accordance with the requirements of a pharmacopoeia for a particular animal or a small group of animals and for direct delivery to an end-user, including the the holder of the animals concerned is intended;
- day of the day: Unit of time and temperature for the calculation of a fish waiting time;
- generic veterinary medicinal product: Veterinary medicinal product with the same qualitative and quantitative composition of active substances and pharmaceutical form as the reference medicinal product, the biological equivalence of which has been demonstrated with the reference medicinal product;
- wholesale trade: trade in veterinary medicinal products with the exception of provision to end-users, including animal-holders;
- Input: in the Netherlands,
- Importer: the person who is authorised to be authorised Article 4.21, first paragraph , has been provided or which brings veterinary medicinal products into the Netherlands according to the Articles 4.20 or 4.21, second member;
- Retail: trade in veterinary medicinal products for the purpose of provision to end-users, including placing on the hand of persons entitled to apply a veterinary medicinal product under the law;
- Official veterinarian: veterinarian attached to the Dutch Food and Warenlicensing Authority;
- unexpected adverse reaction: adverse reaction of which the nature, severity or effect of the product is not compatible with the summary of the product characteristics;
- Primary packaging: any form of packaging that comes directly into contact with the veterinary medicinal product;
- Recipe: document containing the written or electronic procedure for the preparation or delivery of a veterinary medicinal product or animal feed intended for use by a veterinarian or by other person entitled to do so in accordance with the requirements of the Article 4.1, first paragraph, of the Act , shall be provided;
- Reference veterinary medicinal product: Animal medicinal product for which a first marketing authorisation has been issued after consultation in the Netherlands or another EEA Member State of a complete dossier as intended for Article 2.3, first paragraph, part a , respectively, a complete dossier as referred to in Article 12, third paragraph, of Directive 2001 /82/EC ;
- Directive 96 /22/EC: Directive No 96 /22/EC of the Council of the European Union of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists and repealing the said substances The Directives 81 /602/EEC , 88 /146/EEC and 88 /299/EEC (PbEC 1996, L 125);
- Directive 96 /23/EC: Directive 96 /23/EC of the Council of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and products thereof and to withdraw the products thereof and to withdraw the Directives 85 /358/EEC and 86 /469/EEC and Decisions 89 /187/EEC and 91 /664/EEC (PbEC 1996, L 125);
- Directive 2001 /82/EC: Directive 2001 /82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (PbEG 2001, L 311);
- Directive 2004 /28/EC: Directive 2004 /28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001 /82/EC adopting a Community code relating to veterinary medicinal products (PbEU 2004, L 136);
- risks associated with the veterinary application:
a. Any risk to the health of animals or humans by application, under the conditions laid down, under the conditions laid down in Article 2.19, third paragraph, part a, of the Act for the declared properties and qualitative and quantitative composition referred to in Article 2.19, third paragraph, part b, of the Act and
b. any risk of unwanted effects on the environment by means of Article 2.19 (a) (2) (a) of the Act ;
- export: outside the Netherlands,
- Security report: report that the holder of a marketing authorisation for an animal medicinal product shall periodically provide for all side effects;
- declaration of access: document, signed by a rightholder on any request relevant to the application Directive 2001 /82/EC be protected, where it is stated that such data may be used in an application for the granting of a marketing authorisation for a veterinary medicinal product as specified in the Annex. Article 2.19, first paragraph, of the Act ;
- Regulation (EC) No 148/EC 470/2009: Regulation (EC) No 148/EC Council Regulation (EEC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of limit values for residues of pharmacologically active substances in foodstuffs of animal origin, repealing of Regulation (EEC) No 148/ The Council and the Council Directive 2001 /82/EC of the European Parliament and of the Council and of Regulation (EC) No European Parliament and Council (OJ C 2009, L 152);
- Regulation (EC) No 148/EC 504/2008: Regulation (EC) No 148/EC Commission Regulation (EC) No 504/2008 of 6 June 2008 for the implementation of the Directives 90 /426/EEC and 90 /427/EEC of the Council as regards methods for the identification of equidae (PbEU 2008, L149);
- Regulation (EC) No 148/EC 726/2004: Regulation (EC) No 148/EC European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Parliament and Council Decision of 31 March 2004 establishing Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing European Medicines Agency (PbEU 2004, L 136);
- full application: Application to which all the required documents have been submitted;
- Waiting time: period of time which, in accordance with the case of or under Law the conditions laid down and the conditions laid down in the marketing authorisation for an animal medicinal product, at least after the last application of that veterinary medicinal product to an animal prior to the production of food, of that animal, which may be carried out;
- Active substance: substance with effect as defined in the concept of veterinary medicinal product, intended to be used in Article 1.1 of the Act ;
- Law: Animals law .
2 The authorization to place a reference veterinary medicinal product on the market shall include all authorisations for any new animal species, concentrations, pharmaceutical forms, methods of administration and presentations thereof, as well as any modification or extension to be made to or on the veterinary medicinal product.
3 The term 'active substance' means a substance in the form of a salt, ester, ether, isomer, mixture of isomers, complex or derivative of an active substance, unless its properties differ significantly as regards safety or efficacy.
4 In the case of an active substance, the following definitions shall apply: manufacture of a raw material as referred to in Annex I, Title 1, Part 2, Section C, and Annex I, Title 2, Part 2, Section C, to Directive 2001 /82/EC as well as the various processes relating to distribution, packaging or presentation prior to its processing in an animal product and to the import, repackaging and re-labelling.
5 The production of a veterinary medicinal product includes the carrying out of one or more operations which are necessary for the manufacture, including the preparation, processing, processing, labelling, or packaging of which the product is filled and closing the primary packaging of that product.
6 In the manufacture of a medicated feedingstuff, it shall be understood as:
(a) the provision of one or more sub-operations necessary for the manufacture, including preparation, processing, processing, labelling, or packaging, including the filling and closing of the primary packaging of the feed with medical operation;
b. The preparation of a semi-finished product consisting of a medicated pre-mixture and one or more feed.
7 Adverse reaction is included: suspected adverse reaction.
In the case of doubt as to whether a substance can be considered as a veterinary medicinal product as intended in Article 1.1 of the Act , in any case, the substance is assessed as a veterinary medicinal product in accordance with the provisions of this Decision, whether or not the substance concerned has been subject to Community legislation as referred to in Article 2 (2) of the EC Treaty. Directive 2001 /82/EC falls within the scope of any other act or EU legal act.
1 An application for marketing authorisation of an animal medicinal product as referred to in Article 4 (2) of Regulation (EC) No 71/12 Article 2.19, first paragraph, of the Act shall be submitted to our Minister.
2 On an application as referred to in the first paragraph Title 4.1 of the General Law governing the administrative law applicable mutatis mutandis.
3 By way of derogation from the first paragraph, an application for authorization to place a veterinary medicinal product on the market as referred to in Article 3 (1) of Regulation (EC) No 1483/2 shall be applied. 726/2004 submitted to the European Commission.
4 In the case of information as referred to in Article 58 (5) of the EC Treaty, the Directive 2001 /82/EC rules for the implementation of Articles 3, third and fourth paragraphs, 41, second, third and fourth paragraphs, and 42 of Regulation (EC) No 1408/71. 726/2004 and paragraph 34, fourth paragraph, part (e) of the same Regulation, in conjunction with Articles 61, first and second paragraphs, and 67, second paragraph, of Directive 2001 /82/EC .
An application as referred to in Article 2.1, first paragraph , shall be considered only if the applicant is established in an EEA Member State.
1 An application as referred to in Article 2.1, first paragraph , shall be accompanied by administrative data and scientific documentation to demonstrate the quality, safety and efficacy of the veterinary medicinal product, including the following documents or a declaration of access to these documents:
a. A dossier consisting of:
1 °. pharmaceutical tests, including physico-chemical, biological or microbiological tests,
2 °. Non-harmfulness and residue trials,
3 °. preclinical and clinical trials,
4. an evaluation of the risks posed by the veterinary medicinal product to the environment;
5 °. a summary of product characteristics; and
b. Detailed critical summaries of the results of tests in the scientific documentation referred to in (a) (1 °) to (4) °.
2 The documents referred to in paragraph 1 shall be drawn up in accordance with Articles 12 (3) and 14 (15) of the EC Treaty. Directive 2001 /82/EC in conjunction with Annex I to Directive 2001 /82/EC .
3 In the case of ministerial arrangements, detailed rules for the implementation of the first and second paragraphs shall be laid down, and rules may be laid down concerning the presentation of documents necessary for the examination of an application in so far as they do not have rules for the application of the rules are set out in Annex I to: Directive 2001 /82/EC .
1 If an application as referred to in Article 2.1, first paragraph , has been submitted or submitted before, at the same time as or after an application for marketing authorization of a veterinary medicinal product subject to the application of Directive 2001 /82/EC has been submitted or is being filed in one or more other EEA Member States, our Minister shall deal with this application only if:
a. The documents submitted to the application, as referred to in Article 2.3, first paragraph , are identical to the documents filed or submitted in other Member States and
(b) a list of the EEA Member States in which a corresponding application has been submitted has been attached.
2 In dealing with an application as referred to in paragraph 1, our Minister shall arrange for the implementation of Articles 31 to 38 of this Regulation. Directive 2001 /82/EC , except that:
a. A representative as referred to in Article 31, second paragraph, of Directive 2001 /82/EC , means a representative appointed by our Minister;
b. An applicant as referred to in Article 32, first paragraph, of Directive 2001 /82/EC , means an applicant who has submitted an application to our Minister;
(c) a file as referred to in Article 32, first paragraph, of Directive 2001 /82/EC The following definitions shall apply to the documents referred to in paragraph 1. Article 2.3 , as well as a list of the EEA Member States to which the application relates shall contain.
3 Where, pursuant to Article 33 (4) of the second paragraph of Article 33, Directive 2001 /82/EC implementation of Articles 36, 37 and 38 of that Directive and authorisation without prejudice to the outcome of the procedure provided for in Articles 36, 37 and 38 of that Directive. Directive 2001 /82/EC Our Minister may issue an authorization, whether temporary or non-temporary, subject to any rules relating to the possibility of carrying out the measures referred to in Article 3 (2) of the EC Treaty. Article 5.11, second paragraph, of the Act .
4 In the absence of specific Community legislation concerning the use of an immunological veterinary medicinal product for an animal disease, the Minister may invoke Article 71, first paragraph, of the Directive 2001 /82/EC to refuse treatment of an application as referred to in paragraph 1, if the marketing of an immunological veterinary medicinal product crosses a programme in relation to an animal disease, gives rise to difficulties for certification the absence of an illness in animals or products, or where the disease to be combated with the veterinary medicinal product is negligible. Our Minister will inform the European Commission of a refusal.
1 The time limit for a decision on an application as referred to in Article 2.1, first paragraph , after an application has been considered to be complete by our Minister, and shall not exceed 210 days.
2 In the case of ministerial arrangements, a shorter period may be fixed for the adoption of a decision as referred to in the first paragraph.
1 Our Minister gives an applicant an opportunity to supplement the application in writing as intended Article 4:5, first to third paragraphs, of the General Law on administrative law , whether orally, to be informed and aort to that end the period specified in Article 2.5 with application of Article 4:15, first paragraph, part a, of the General Administrative Law on if:
a. the documents referred to in Article 2.3, first paragraph , do not contain all the necessary particulars or documents for the consideration of an application, or
b. the documents referred to in Article 2.3, first paragraph , do not contain sufficient information to enable the veterinary medicinal product to be applied in accordance with the requirements specified in the Annex to this Regulation. Article 2.19, third paragraph, part a, introductory sentence, of the Act complies with Article 2.19 (a) (a) (1) and (2), as well as (b), (c), (d) and (g) of the Act.
2 A decision to suspend as referred to in paragraph 1 shall leave the power to suspend intended to be suspended, Article 4:15, first paragraph, part b, and second paragraph, of the General Law on administrative law , without prejudice.
The treatment of an application for a permit as referred to in Article 2.1, first paragraph , has been suspended for the duration of procedures as referred to in the Article 2.4, second and third paragraphs , 2.23 , 2.24 and 2.25 , except that the period provided for in Article 4:15 of the General Administrative Law , shall be suspended until 30 days from the date of adoption of the general agreement referred to in Article 32 (4) and the notification of the decision referred to in the second sentence of Article 38 (3) of the Decision, of the Directive 2001 /82/EC .
1 On application of a licence as referred to in Article 2.1, first paragraph , is Section 4.1.3.3 of the General Administrative Law Act applicable mutatis mutandis.
2 By way of derogation from the first paragraph Section 4.1.3.3 of the General Administrative Law Act Not applicable to an application:
a. For a first marketing authorization for an animal medicinal product;
(b) amending an authorisation for cases designated under ministerial arrangements for the implementation of Article 39, first paragraph, of the Directive 2001 /82/EC ,
(c) renewing a marketing authorisation.
3 By way of derogation from the first and second paragraphs Section 4.1.3.3 of the General Administrative Law Act of corresponding application after 30 days following the notification of:
(a) the general agreement referred to in Article 32 (4) of Directive 2001 /82/EC , or
(b) the order referred to in the second sentence of Article 38, second sentence, of Directive 2001 /82/EC ,
except that our Minister makes a notice as intended in Article 4:20c of the General Administrative Law Law in accordance with the overall agreement referred to in subparagraph (a) or in the Decision referred to in subparagraph (b).
1 Our Minister refuses to grant a licence as intended Article 2.1, first paragraph , to be provided where:
a. the documents referred to in Article 2.3, first paragraph , not complete or not correct,
b. an application by the European Commission or another EEA Member State for the provision of a licence as referred to in the first subparagraph of Article 5 of this Regulation; Directive 2001 /82/EC is pending, or that permit has been granted, and the documents referred to in Article 2.3, first paragraph , not according to Article 2.1, fourth paragraph , or Article 2.4 submitted;
c. the assessment of the positive therapeutic effects of the veterinary medicinal product in relation to the risks associated with the veterinary application under the intended conditions of use is not favourable;
The veterinary medicinal product has no therapeutic effect or its therapeutic efficacy has not been sufficiently demonstrated, without prejudice to Article 2.19, sixth paragraph, of the Act ;
e. the waiting period specified in the file:
1 °. is not sufficient to ensure that any foodstuff derived from a treated animal does not contain any residue that presents a hazard to human health; or
2 °. insufficient justification;
f. the labelling or package leaflet proposed in the application does not comply with the requirements of the Ministerial Article 2.13, first paragraph shall be set;
g. the veterinary medicinal product is offered for an application prohibited by an EU regulation or decision;
h. The application relates to substances designated by EU legal act and fails to comply with the rules governing the placing on the market and the application, which under ministerial arrangement under Article 8.4 shall be set; or
i. for the assessment of the veterinary medicinal product in respect of parts a to h, no EU regulation, EU decision, or any EU directive to be taken under a ministerial arrangement has been adopted and the refusal of the authorisation necessary for the protection of public health, the consumer or the health of animals, including a case referred to in Article 71, first paragraph, of Directive 2001 /82/EC , where the European Commission is informed of the application of that Article.
2 Our Minister applies, when implementing the first paragraph, assessment methods as set out in the Article 2.19, fourth paragraph, of the Act , established jointly by experts of the EEA Member States in relation to the implementation of Directive 2001 /82/EC , in so far as these assessment methods are designated by ministerial arrangement.
3 In the assessment referred to in paragraph 1 (c) of a zootechnical application for zootechnical application, special consideration shall be given to advantages for:
a. the health and well-being of the animal; and
b. safety for the consumer.
1 An authorisation as referred to in Article 2.1, first paragraph In the case of a veterinary medicinal product for use in one or more foodstuffs intended for the production of foodstuffs, only if the pharmacologically active substances of that veterinary medicinal product are subject to a veterinary medicinal product for use in the production of foodstuffs intended for the production of foodstuffs. EU legal act taken in the course of the operation of the EU legal act.
2 For the purpose of application of paragraph 1, an application for a veterinary medicinal product placed on the market for one or more animal species intended for the production of foodstuffs and containing one or more pharmacologically active substances shall be have not been authorised under the EU legal act referred to in paragraph 1, shall not be submitted earlier than six months after a valid application for the establishment of maximum residue limits in accordance with the provisions of Regulation (EC) No 470/2009 was done.
1 By way of derogation from Article 2.10 Our Minister may use a permit as intended Article 2.1, first paragraph , for a veterinary medicinal product containing a pharmacologically active substance, in the case of:
a. This pharmacologically active substance under a under Regulation (EC) No 148/EC 470/2009 may be approved and the EU legal act may be authorised; and
(b) they shall be subject to such authorization, which shall include:
1 °. this veterinary medicinal product shall be administered only to specific animals of the family of the equidae which are not intended for the supply of animal products after slaughter; and
2 °. the veterinary medicinal product shall be applied only in the case of an animal registered in accordance with the requirements of Regulation (EC) No 2382/2. 504/2008.
2 The authorisation referred to in paragraph 1 shall not be issued if the veterinary medicinal product is intended for the treatment of a condition as defined in the approved summary of product characteristics, in animals for which the veterinary medicinal product is subject to a condition of a veterinary medicinal product may be placed on the market for animals of the equine family under a licence as referred to in Article 2.1, first or third member .
The marketing authorisation for an animal medicinal product shall include:
(a) the application and the requirements of the authorisation;
b. the documents referred to in Article 2.3, first paragraph ;
c. an ex officio assessment report with justification.
2 By way of derogation from paragraph 1 (b), our Minister shall, where appropriate, draw up a summary of the product characteristics, which deviates from the summary submitted, as referred to in paragraph 1, as appropriate, Article 2.3, first paragraph, part a, below 5 ° .
3 The assessment report referred to in paragraph 1 (c) shall be updated as soon as new data are made available which are relevant for the assessment of the quality, safety and efficacy of the veterinary medicinal product.
4 Provisions relating to a licence as referred to in paragraph 1 shall apply to any person who carries out an act as referred to in the first paragraph.
The holder of the authorisation referred to in Article 2.12, first paragraph , shall ensure that:
a. A veterinary medicinal product shall be placed on the market only in accordance with the rules on packaging and information on, in the case of or in the packaging including labelling, the immediate packaging, the package leaflet and the outer packaging, including rules for the marketing of veterinary medicinal products. implementation of Regulation (EC) 504/2008 in relation to veterinary medicinal products for equidae intended for use in animals Article 2.11 , which shall be subject to ministerial arrangements;
b. A timely application is made to amend the permit to ensure that the veterinary medicinal product is manufactured and controlled according to generally accepted scientific methods, taking into account the progress of science and technique, according to rules to be provided for that purpose by ministerial arrangement, including rules for the implementation of veterinary pharmacovigilance;
c. if, in the course of the amendment, referred to in subparagraph (b), a modification of a document as referred to in Article 2.3, first paragraph an application for amendment of the authorization shall be made without delay, unless a request is made pursuant to Article 39, first paragraph, of the Directive 2001 /82/EC any EU legal act adopted by the European Commission determines otherwise;
d. for the supervision of compliance by officials or other persons as intended in the Articles 8.1, 1st paragraph , and 10.2 of the Act sufficient quantities of veterinary medicinal products or other substances are kept available until the expiry date necessary to enable the presence of residues of veterinary medicinal products or other substances to be examined and Cases may be designated by Ministerial Regulations where documents relating to these substances are also submitted;
e. at the request of officials or other persons referred to in the Articles 8.1, 1st paragraph , and 10.2 of the Act , is to contribute to the implementation of analytical methods for the detection of residues of veterinary medicinal products for the purpose of implementing Directive 96 /23/EC at a reference laboratory designated for that purpose by ministerial arrangement;
f. without delay and on its own initiative, information shall be submitted to our Minister:
1 °. which may result in a change of documents as referred to in Article 2.3 , including suspected carry-over of infectious substances or any other non-conformity of the veterinary medicinal product;
2 °. in respect of a prohibition or restriction imposed by a competent authority of a country in which the veterinary medicinal product is placed on the market;
3 °. on the assessment referred to in Article 2.9 (c) (c) and
4 °. any step taken to suspend the placing on the market of an animal medicinal product or to withdraw from the market, stating the reasons for this step;
g. at the request of officials or other persons referred to in the Articles 8.1, 1st paragraph , and 10.2 of the Act , data is provided for the purpose of weighing or assessing the assessment of the Article 2.9 (c) (c) , continues to be favourable;
(h) the date on which the veterinary medicinal product or its derivative form is effectively placed on the market shall be communicated to Our Minister in good time;
(i) the date on which trade in the veterinary medicinal product or any derivative offer shall be temporarily or definitively discontinued, except in exceptional circumstances, at least two months in advance and on the date of its effective date; He communicated to our Minister;
j. periodically, information is provided to Our Minister according to rules laid down by ministerial rules on security reports and sales volume data;
k. the under Article 8.4 comply with the rules laid down for the implementation of an EU legal act designating substances and laying down requirements for the placing on the market of such substances.
1 The regulations to be made by Our Minster to be subject to a licence, Article 2.12, first paragraph, part a , please refer to:
a. the application, intended in Article 2.19, third paragraph, part a, introductory sentence, of the Act , of the veterinary medicinal product in relation to:
1 °. the effect in question, which is to be found in Article 2.19, third paragraph, point (a) (1) of the Act ;
2 °. The prevention of hazards, Article 2.19 (a) (2) (a) of the Act ;
3 °. the properties specified in Article 2.19, third paragraph, part b, of the Act ;
4 °. the guidelines and principles referred to in Article 2.19, third paragraph, part f, of the Act ;
b. The packaging and information on, in the case of, or in the packaging, as intended Article 2.13, part a , and
(c) the procedures which may apply in exceptional circumstances for the safety of the veterinary medicinal product, and may include:
1 °. to inform Our Minister about incidents related to the application and the measures to be taken, and
2. the requirements of the authorisation relating to these procedures shall be reassessed each year.
2 A ministerial arrangement may lay down rules on cases where and how the rules referred to in paragraph 1 are to be laid down.
The permit, intended to Article 2.12, first paragraph It has a duration of five years.
1 The Articles 2.1 to 2.15 shall apply to an application for renewal, amendment or withdrawal of an authorisation as referred to in the Article 2.1, first paragraph .
2 By way of derogation from the first paragraph, the Articles 2.7 and 2.8 not applicable in the case of the time limit for processing an application for renewal, modification or withdrawal of an authorisation as referred to in Article 4 (1) of the EC Treaty. Article 2.19, first paragraph , under the third paragraph of that Article, 60 days.
3 An application as referred to in paragraph 1 shall be considered only if the application is submitted by the holder of the authorisation.
1 An application for renewal of a licence as referred to in Article 2.1, first paragraph , it shall be submitted at least 26 weeks prior to the expiry of the period of validity of the licence.
2 In the case of an application as referred to in paragraph 1, the applicant may, by way of derogation from Article 2.3, first paragraph -shall be sufficient to submit a list of all the documents submitted to previous applications and any changes made thereto, including the amendment or extension of the information on the operation of the veterinary medicinal product as referred to in the Annex. 6.1, first paragraph , and 6.2, 1st Member .
3 Our Minister renews a permit as intended in Article 2.12, first paragraph , on an initial application for an extension for an indefinite period.
4 By way of derogation from the third paragraph, an authorisation may be extended for up to five years for justified grounds relating to veterinary pharmacovigilance. In the case of a subsequent application, that authorisation shall be extended for an indefinite period.
1 An application for amendment of a licence as referred to in Article 2.1, first paragraph The following shall be considered only if the application relates to a:
a. Species;
b. concentration of the veterinary medicinal product;
c. pharmaceutical form;
d. application method; or
e. presentation.
2 Under an application for the amendment of an authorization referred to in paragraph 1, the following definitions shall be understood:
a. An application for the extension of an authorization with a different type of animal, pharmaceutical form, method of application or presentation; or
b. Any other application for amendment with the exception of:
1 °. a modification such that it is no longer the same active substance, or
2 °. an addition of another active substance.
3 An application for an amendment of a licence as referred to in the second paragraph shall be taken into consideration as a first application for the authorisation of the Article 2.1, first paragraph , if the application is not in accordance with an Article 39, first paragraph, of Directive 2001 /82/EC European Union legal act adopted by the European Commission.
4 By ministerial arrangements, rules are laid down for examining applications as referred to in paragraph 1 and third paragraph, and for examining applications for which Article 39, first paragraph, of Directive 2001 /82/EC an EU legal act has been adopted by the European Commission.
5 Any intention to amend a permit issued with the application of Article 2.4, second paragraph , 2.23 or 2.24 shall be submitted to all Member States authorised for the placing on the market of the veterinary medicinal product concerned.
1 The holder of the authorisation referred to in Article 2.12, first paragraph , an amendment to, or revocation of, that authorisation shall be requested after an amendment to a change in the Official Journal of the European Union has been published in accordance with Articles 14 and 27 of Regulation (EC) No 248/EC. EU legal act adopted in relation to a pharmacologically active substance in a veterinary medicinal product for which the authorisation was issued.
2 Our Minister shall amend the authorization referred to in paragraph 1 if necessary ex officio or, if necessary, in accordance with the EU legal act referred to in paragraph 1, if our Minister has proved to be satisfied that no such authorization has been granted by the Secretary of State. the application referred to in paragraph 1 shall be submitted.
3 Our Minister, by way of derogation from the second Member, Article 2.16, first paragraph , a decision to amend or withdraw the licence, referred to in paragraph 2, within 60 days of the publication referred to in paragraph 1, as the EU legal act referred to in that paragraph, which justifies and submit an application for the modification or withdrawal of the authorisation or the examination of that application cannot be made.
4 The holder of a licence as referred to in paragraph 1 shall not be allowed to apply if the maximum residue limit has been increased by the publication provided for in paragraph 1 and our Minister decides that an application has been made to the Commission for the purpose of the application. Do not take judgement. This Decision shall be published in accordance with Article 3:42, 1st paragraph, of the General Law governing the administrative law .
1 Our Minister may, in order to achieve a limitation of indications or availability, change of dosage or the addition of a contraindication or precautionary measure, amend the rules on an official ' s own motion or permit the permit, intended Article 2.12, first paragraph , suspend, if he has a serious suspicion that the regulations, intended in the Articles 2.13 or 2.14 , non-compliance, the veterinary medicinal product does not comply with Article 2.19, second and third paragraphs, of the Act or has been shown after the receipt of information as intended Article 6.1, first paragraph The Agency, the other Member States and the holder of the authorisation shall be informed immediately.
2 The authorization shall not be suspended or amended after:
(a) a request from the European Commission has been received for the adoption of temporary measures; or
b. an EU decision has been taken after a procedure as referred to in Article 2.25, first paragraph .
3 By way of derogation from the second paragraph, a licence may be suspended if there is:
a. an emergency concerning the protection of human or animal health and the Agency, the European Commission and the other EEA Member States shall be informed by the following working day at the latest;
b. an exceptional case as specified in Article 2.25, second paragraph , or
c. Another case where the Articles 2.24 and 2.25 shall not apply, including a case referred to in Article 71, first paragraph, of Directive 2001 /82/EC .
4 Our Minister shall inform the European Commission of the application of Article 71, first paragraph, of the Directive 2001 /82/EC referred to in point (c) of the third paragraph.
1 The authorisation, for the purpose of Article 2.12, first paragraph , may, without prejudice to Article 2.16, first and third paragraphs , where it is clear from the facts or circumstances, of its own motion, that:
a. the documents referred to in Article 2.3, first paragraph , to be incorrect or incomplete, that another decision would have been taken on the application, if the correct information had been disclosed in the assessment of that application;
b. the requirements specified in the Articles 2.13 or 2.14 are not complied with; or
(c) the veterinary medicinal product does not comply with the product or Article 2.19, second and third paragraphs, of the Act set.
2 Our Minister shall without delay inform the Office, other EEA Member States and the holder of the authorisation of the intention to revoke them.
3 Our Minister does not withdraw a licence than after an EU decision has been taken, if there is any withdrawal due to a particular case referred to in Article 2.24 or a proposed decision to withdraw as referred to in Article 2.25 .
1 The authorisation, for the purpose of Article 2.12, first paragraph If the veterinary medicinal product has not actually been placed on the market or is no longer on the market for a period of three years after the granting of the authorisation.
2 Our Minister may postpone, in exceptional circumstances or for reasons of human or animal health, the expiry of the three-year period referred to in paragraph 1 with a period to be determined in the interest of animal welfare, animal health, public health or the environment.
Our Minister may, prior to, before or after a decision to provide, change, suspend or revoke a licence, it appears that different decisions have been or are being taken by several EEA Member States. submit to the Committee for the implementation of the Community procedure laid down in Article 34 (1), (1), (3) to (38) of the Directive 2001 /82/EC to follow.
1 Our Minister follows the Community procedure under Article 35 (1), (1), (36) to (38) of Directive 2001 /82/EC Where, in particular, the interests of the European Union are at stake and the decision is necessary, in particular, to take account of the data collected from pharmacovigilance, as provided for in Title VII, of the Directive 2001 /82/EC .
2 In carrying out the first paragraph, Our Minister shall forward to the Committee any available information relating to the procedure in question.
3 The first and second members shall apply mutatis mutandis to a marketing authorisation holder.
1 Our Minister submits a proposed decision to amend, suspend or revoke an authorization which is intended to be used in the application of a Community procedure. Article 2.4, second paragraph , 2.23 or 2.24 if that decision is intended to protect human or animal health or the protection of the environment, has been provided or proposed to be amended by a proposed amendment to the Agency without delay.
2 Our Minister may, in exceptional cases, decide on a licence, which shall apply to Article 2.4, second paragraph , 2.23 or 2.24 shall suspend, suspend, if it is necessary for the protection of human or animal health or the protection of the environment, urgent measures shall be taken. Our Minister shall give the European Commission and the other EEA Member States a statement of reasons at the latest on the following working day.
3 The first and second paragraphs shall apply mutatis mutandis to the marketing authorizations of an animal medicinal product which have been issued before 1 January 1995 and on which the Committee referred to in Article 34, first paragraph, of Directive 2001 /82/EC issued an opinion.
1 The authorisation, for the purpose of Article 2.12, first paragraph , except for the documents referred to in Article 2.12 (1), paragraph 1 (b) shall be published in the Official Gazette and communicated to the applicant.
2 By way of derogation from the first paragraph, the assessment report shall be: Article 2.12, first paragraph, part c , disclosed only with the omission of confidential commercial information.
3 Our Minister is responsible for a register as intended Article 7.2, first paragraph, of the Act the endorsement of any authorisation and decision to renew, change, suspend or revoke such authorisation.
1 Chapter 2 shall apply to an application as referred to in this Chapter, to the extent that (2) to (5) no provisions to the contrary are contained in this Chapter.
2 In the case of a ministerial arrangement, detailed rules may be laid down in respect of a permit referred to in the first paragraph with regard to the specific characteristics of the veterinary medicinal product and the nature of the application.
1 The Article 2.1, second paragraph , 2.2 , 2.6 , 2.9, first paragraph, part a and parts c to h , 2.13 , 2.14 , 2.18 to 2.21, first and second members , 2.23 and 2.26 shall apply mutatis mutandis to an application for a derogation as referred to in Section 5 This chapter, where otherwise provided for in that paragraph, are not provided for.
2 In the case of ministerial arrangements, detailed rules may be laid down for the specific characteristics of the veterinary medicinal product or the purpose for which the derogation may be granted.
This paragraph does not apply to veterinary medicinal products with an indication for use as an immunological veterinary medicinal product.
1 An application as referred to in Article 2.1, first paragraph , for a homeopathic veterinary medicinal product, by derogation from Article 2.3, first paragraph, parts a and b, and the second member , in conjunction with Annex I of Directive 2001 /82/EC and, where the application relates to an application to animals intended for or co-intended for the production of foodstuffs in accordance with Articles 14 and 27 of Regulation (EC) No 1408/71, 470/2009, accompanied by documents proving that:
a. The method of preparation is described in a European Pharmacopoeia or in a pharmacopoeia officially used by a Member State;
b. no specific therapeutic indication is given both on the label and in the package leaflet of the veterinary medicinal product;
c. the degree of dilution is such that the harmlessness of the veterinary medicinal product is guaranteed; and
The veterinary medicinal product does not contain more than one part per 10 000 of the primal tincture.
2 Article 2.9, first paragraph, parts c, d and e shall not apply to the documents referred to in the first paragraph.
3 By way of derogation from Article 2.12, first paragraph, part c , an assessment report is not required in the provision of a permit for a homeopathic veterinary medicinal product.
4 If the application has been submitted for a series of homeopathic veterinary medicinal products derived from the same raw material or raw materials, the application shall be accompanied by documents complying with the rules laid down by ministerial arrangements to the quality and homogeneity of the parties to be able to establish homeopathic veterinary medicinal products.
5 Article 2.4, second paragraph -on homeopathic veterinary medicinal products as referred to in paragraph 1 shall apply only in respect of Articles 32 and 33, first to third paragraphs, of Directive 2001 /82/EC .
6 The Articles 2.23 and 2.24 shall not apply to an application for a homeopathic veterinary medicinal product referred to in the first paragraph.
1 If an application does not comply with Article 3.4, first paragraph, points (a) to (d) , it is deemed to be an application to Article 2.3 , unless the veterinary medicinal product is placed on the market for the purposes of pet food and exotic animal species, which are not intended for the production of foodstuffs and which comply with rules laid down by Ministerial Regulations. shall submit documents relating to the submission of documents concerning:
a. Harmfulness tests; and
b. Preclinical and clinical trials.
2 Our Secretary of State shall inform the European Commission of the rules referred to in paragraph 2.
3 Article 2.4, second paragraph , on veterinary medicinal products for use in pet animals and exotic species only, applies to Article 31 of this Regulation. Directive 2001 /82/EC .
4 The Articles 2.23 and 2.24 shall not apply to veterinary medicinal products for use in pet animals and exotic species.
1 An application for marketing authorisation as specified in: Article 2.1, first paragraph , a generic veterinary medicinal product may be submitted if:
a. At least a period of eight years has elapsed after an EEA Member State or the European Commission has authorised the placing on the market of a reference veterinary medicinal product in accordance with Directive 2001 /82/EC ; respectively in accordance with Regulation (EC) No 726/2004 has been provided, and
b. Relevant bioavailability studies shall be submitted.
2 An application as referred to in the first paragraph shall, by way of derogation from Article 2.3, first paragraph, part a, below 2 ° and 3 ° , not accompanied by the results of:
a. The non-harmfulness and residue trials; and
b. Clinical and pre-clinical trials.
3 When applying the first and second paragraphs, the oral pharmaceutical forms of the reference veterinary medicinal product and the generic veterinary medicinal product, which is placed on the market for direct application, and which relate to the oral medicinal product, shall be Pharmaceutical form has been modified, considered as a single pharmaceutical form.
4 By way of derogation from the second paragraph, the results of tests shall be submitted if Annex I, Title III (1), is to be added to: Directive 2001 /82/EC this determines or pursuant to Article 2.19, third paragraph, part f, of the Act Guidelines have been designated as regards the submission of additional data for the assessment of a generic veterinary medicinal product, which may contain an active substance with characteristics that are significant in terms of safety or efficacy from the substance of the substance. properties of the active substance in the reference veterinary medicinal product.
5 The first paragraph, part b, and fourth paragraph shall not apply if an applicant cannot be required to submit a study according to guidelines laid down by ministerial arrangement which are common to experts of the EEA Member States. established in connection with the implementation of Directive 2001 /82/EC or guidelines, as referred to in Article 2.19, third paragraph, part f, of the Act .
6 Where, for the reference veterinary medicinal product referred to in paragraph 1 (a), in another EEA Member State, in accordance with Directive 2001 /82/EC A licence has been issued or had been issued, and our Minister shall request that the EEA Member State to supply the following information within one month:
a. Confirmation of the granting of a marketing authorisation for the reference veterinary medicinal product;
b. the complete composition of the product; and
c. If necessary, other relevant documents.
7 By way of derogation from the first paragraph, subparagraph (a), the period referred to in that subparagraph shall be 10 years for applications submitted before or on 30 October 2005.
By way of derogation from Article 3.6, second paragraph , results of harmlessness tests, residue trials, clinical trials and pre-clinical trials shall be provided if an animal medicinal product as referred to in Article 3.6, first paragraph, as a hybrid veterinary medicinal product is not covered by the definition of generic veterinary medicinal product, if such veterinary medicinal product cannot be demonstrated by a bioavailability study, or that medicinal product has one or more active substances, a therapeutic indication, the concentration, pharmaceutical form, or method of administration have been modified Comparison of the reference veterinary medicinal product.
1 By way of derogation from Article 3.6, second paragraph, part b , in the case of an application for a generic veterinary medicinal product of a biological nature which does not comply with Article 3.6, first, third and fourth paragraphs, results of a pre-clinical trial or a clinical trial shall be submitted in accordance with the requirements set out in the Annex. in Article 2.19, third paragraph, of the Act , if:
a. A different raw material is used;
b. The biological veterinary medicinal product is not produced in the same way as the reference veterinary medicinal product; or
For other reasons, the veterinary medicinal product may not be Article 3.6, first, third and fourth members -That's right.
2 The results of the tests provided for in paragraph 1 shall be submitted in accordance with Annex I to: Directive 2001 /82/EC And the Article 2.19, third paragraph, part f, of the Act designated guidance.
3 The applicant is not required to produce results from other tests on the dossier of the reference veterinary medicinal product.
1 A generic veterinary medicinal product for which, according to the Articles 3.6 , 3.7 or 3.8 a licence has been issued, may only be placed on the market after:
a. A 10-year period or a period after the expiry of the second paragraph of this Article after the authorisation to place the reference veterinary medicinal product on the market has been granted by the European Commission or an EEA Member State; or
(b) a period of 13 years after the authorisation has been granted, where the authorisation is granted for the placing on the market of veterinary medicinal products for the purpose of bees or fish.
2 The period referred to in the first subparagraph of paragraph 1 shall be extended for one year per species, up to a maximum of 13 years for a marketing authorisation for four or more animal species intended for the production of food, if:
a. The reference veterinary medicinal product contains an active substance which, on 30 April 2004, has not been authorised by the European Commission or an EEA Member State in any veterinary medicinal product;
(b) within five years of the granting of an authorization to place the reference veterinary medicinal product on the market, an application for amendment of the product Article 2.18, first paragraph, part a , is granted for an extension of regulations as referred to in Article 2.19, third paragraph, part a, introductory sentence, of the Act , with one or more animal species intended for food;
(c) the veterinary medicinal product contains a pharmacologically active substance which has not already been included in a substance under Regulation (EC) EU legal act adopted on 470/2009; and
(d) the holder of the authorisation has submitted an application for the establishment of the maximum residue limits of the pharmacologically active substance in the species to which the extension relates, in accordance with Regulation (EC) No 470/2009.
1 By way of derogation from Article 2.3 an applicant shall not be required to produce documents or studies provided for in those articles if:
a. the active substance in the veterinary medicinal product has been used for at least 10 years without any problems in the European Union in veterinary medicine and provides an approved activity and an acceptable level of safety in accordance with the requirements of Annex I to Directive 2001 /82/EC , and
The applicant shall replace the results of such documents or studies by a relevant scientific bibliography, including, where appropriate, an assessment report by the Agency in respect of, in particular, the results of Non-harmfulness tests.
2 Where an applicant, as referred to in the first paragraph, submits documents containing results of new residue studies referred to in a Regulation adopted pursuant to Regulation (EC) No 1482/2 EU legal act adopted or new clinical trials as referred to in Annex I to this Regulation Directive 2001 /82/EC in the case of a species of animal intended for the production of foodstuffs, a third party may not rely on the said veterinary medicinal product for a period of three years from the date of issue of the authorisation with regard to the application of the veterinary medicinal product to that animal. documents.
By way of derogation from Article 2.3 require an applicant for a marketing authorisation for a veterinary medicinal product containing several active substances, to produce no documents or studies of each individual active substance in this veterinary medicinal product, provided that:
a. The separate pharmacotoxicological active substances are contained in veterinary medicinal products for which a marketing authorisation for an animal medicinal product has been previously granted; and
b. results of tests carried out as intended for the combined active substances Article 2.3, first paragraph, part a, below 2 ° , and, where necessary, results of new tests as referred to in Article 2.3, first paragraph, part a, below 3 °.
By way of derogation from the Articles 2.3 and 3.6, first paragraph, part b, and fourth member , if an applicant for marketing authorization for a veterinary medicinal product is not required to submit any documents or studies, if:
(a) a holder of a marketing authorisation previously granted for the placing on the market of an animal medicinal product, by means of a declaration of access, in order to make use of the application provided for in the introductory sentence, documents or studies submitted by the holder of the licence issued previously in the dossier of that authorisation;
(b) the veterinary medicinal product in respect of which an application is made has the same qualitative and quantitative composition; and
c. the veterinary medicinal product for which an application is made has the same pharmaceutical form.
In exceptional circumstances, an applicant for authorization to place an immunological veterinary medicinal product on the market should not produce results of certain field tests if the field tests are not justified on justified grounds. may be implemented, including for reasons of compliance with EU regulations, EU decisions or national regulations for the implementation of EU directives.
1 Our Minister decides on application for marketing authorisation as intended in the marketing year. Article 2.1, first paragraph , from a veterinary medicinal product for parallel imports which:
(a) be placed on the market in another EEA Member State under a licence;
b. is imported from another EEA Member State where the veterinary medicinal product has been placed on the market;
c. is identical to a veterinary medicinal product already authorised in the Netherlands for placing on the market; and
(d) originates from the undertaking which manufactures the veterinary medicinal product referred to in subparagraph (c), a related company, an undertaking which manufactures the veterinary medicinal product or an undertaking which has an attestation of its own access to the documents referred to in Article 2.3 .
2 By way of derogation from the first paragraph, parts c and d; and Article 2.3, first and second paragraphs , and without prejudice to Article 2.4 , where the application relates to an animal product complying with the first paragraph, parts a and b, and from documents submitted to that end, the Minister shall take up an application as referred to in the first paragraph, and documents submitted for that purpose indicate that in comparison with a veterinary medicinal product already placed on the market in the Netherlands, the composition, manner of application and packaging of the veterinary medicinal product does not differ substantially in quality and efficacy which may affect the public health, animal health, animal welfare or the environment.
3 The rules applicable to the placing on the market of the veterinary medicinal product referred to in paragraph 1 (c) shall also apply to the veterinary medicinal product for which, under the terms of paragraph 1, introductory wording, introductory wording, is to be applied. shall be provided.
4 The rules applicable to the placing on the market of the veterinary medicinal product already authorised in the Netherlands for placing on the market referred to in paragraph 1 (c) shall also apply to the placing on the market of the veterinary medicinal product. a veterinary medicinal product for which a marketing authorisation is granted under the second paragraph with the exception of provisions to be laid down by our Minister, by way of derogation from those rules, in respect of essential requirements for the marketing of differences as referred to in the second paragraph.
5 Our Minister shall suspend a licence for parallel imports as long as the licence provided for in paragraph 1 (c) is suspended.
6 Our Minister withdraws an authorization for parallel imports as soon as the authorization referred to in paragraph 1 (c) is withdrawn, other than at the request of the holder, or expiring no later than.
7 After revocation of the permit, referred to in paragraph 1 (c), at the request of the holder, the parallel import permit shall remain in force for a term of sale to be determined by Our Minister, unless the determination of a the term of sale shall be contrary to the interests of public health, animal health, animal welfare or the environment.
1 Our Minister decides on application to issue a derived marketing authorisation for an animal medicine which:
a. Is identical to an animal medicinal product for which a marketing authorisation has already been granted in the Netherlands;
(b) originates from the undertaking which manufactures the veterinary medicinal product referred to in subparagraph (a), a related company, an undertaking which manufactures the veterinary medicinal product or an undertaking which has a declaration of access to the documents referred to in Article 2.3 , and
c. satisfies part a, except brand name, name of the Marketing Authorisation Holder and outer design of the packaging.
2 The rules applicable to the placing on the market of the veterinary medicinal product referred to in paragraph 1 (a) shall also apply to the veterinary medicinal product for which a marketing authorisation has been granted under the first paragraph.
3 A derived licence has been suspended for as long as the licence referred to in paragraph 1 (a) (a) is suspended.
4. Our Minister shall withdraw a derived licence as soon as the authorization referred to in paragraph 1 (a) is withdrawn, other than at the request of the holder, or is terminated by law.
5 After revocation of the permit, referred to in paragraph 1 a, at the request of the holder thereof, the derived permit shall remain in force for a term of sale to be determined by Our Minister, unless it is determined by the the term of sale shall be contrary to the interests of public health, animal health, animal welfare or the environment.
Our Minister may, of its own motion, exempt from the prohibition provided for in Article 2.19, first paragraph, of the Act on the placing on the market of an animal medicinal product, if:
a. the active substance is not placed on the market for the purpose of application as a veterinary medicinal product;
(b) the manufacturer or importer does not claim that there is sufficient efficacy as referred to in Article 2.19, third paragraph, point (a) (1) of the Act , and
c. the veterinary medicinal product according to the opinion of Our Minister to the person concerned by or under Article 2.19, third paragraph, parts (a) to (c) of the Act is compliant.
Our Minister may, in the interests of animal health and animal welfare, of the prohibition, Article 2.19, first paragraph, of the Act on the marketing of a veterinary medicinal product ex officio-exemption for placing on the market for the purpose of a veterinary medicinal product without authorization, where that veterinary medicinal product has been issued by another EEA Member State according to the procedures of Directive 2001 /82/EC a marketing authorisation has been issued.
1 In case of occurrence of severe epizootic diseases, our Minister of Prohibition, intended to Article 2.19, first paragraph, of the Act to exempt the marketing of a veterinary medicinal product from the marketing of an immunological veterinary medicinal product without authorisation if there is no suitable veterinary medicinal product in the Netherlands or in another EEA Member State Animal medicinal product is available.
2 An exemption referred to in paragraph 1 shall be granted only if the European Commission has been informed in advance by our Minister of the detailed rules applicable to the application.
1 Our Minister may be from the prohibition, intended in Article 2.19, first paragraph, of the Act on the marketing of a veterinary medicinal product ex officio relief for veterinary medicinal products which do not contain substances which, when applied, require veterinary control and which are intended solely for the purpose of:
a. aquarium fish;
b. kooibirds;
c. Post-pigeons;
d. terrarium animals;
e. small rodents;
f. ferrets not kept for animal products; or
g. rabbits not kept for animal products.
2 Under ministerial arrangements, rules are laid down to prevent the wrong-taking of veterinary medicinal products as referred to in the first paragraph from other species.
3 By way of derogation from the first paragraph, our Minister may grant an exemption upon application by corresponding application of the first paragraph.
1 Our Minister may be from the prohibition, intended in Article 2.19, first paragraph, of the Act on the marketing of a veterinary medicinal product, of its own initiative, for the marketing of an immunological veterinary medicinal product, provided that:
(a) an animal is imported from a third country or exported there;
b. specific mandatory health provisions of one of the countries concerned should be applied in connection with exports or imports; and
(c) the use of this veterinary medicinal product in the third country is authorised.
2 Our Minister proposes rules or restrictions as referred to in Article 7.5 of the Act with regard to the control of the import and use of the veterinary medicinal product referred to in paragraph 1 (a).
3 By way of derogation from the first paragraph, our Minister may grant an exemption upon application by corresponding application of the first and second paragraphs.
1 Our Minister may be prohibited from the prohibitions referred to in the Article 2.8 (b) (b) (b) , and 2.25, first paragraph, of the Act of its own motion, of its own motion, to grant an exemption for the use of a veterinary medicinal product on the basis of a radioactive isotope.
2 By way of derogation from the first paragraph, our Minister may grant an exemption upon application by corresponding application of the first paragraph.
1 Our Minister may be from the prohibition, intended in Article 2.19, first paragraph, of the Act on the marketing authorisation without a marketing authorisation of an animal medicinal product and Article 2.25, first paragraph, of the Act on the application of the veterinary medicinal products, feedingstuffs, substances or other substances or products to animals, or on the basis of their own-motion, or on the basis of their own initiative, to grant an exemption, inter alia, for the following tests:
a. tests the pharmaceutical (physicochemical, biological or microbiological);
b. the non-harmfulness and residue trials;
c. pre-clinical and clinical trials; or
d. tests for the evaluation of the risks to the environment.
2 Our Minister shall determine the exemption provided for in paragraph 1 that an animal or foodstuff from an animal to which an animal medicinal product has been tested has been:
a. is not placed on the market; or
b. is offered only for slaughter and marketed after a in accordance with Article 5.2, third paragraph, of the Decision Veterinary Medicinal products , or the Articles 2.10 and 2.11 of this decision by Our Minister fixed the waiting period.
3 By way of derogation from the first paragraph, our Minister may grant an exemption upon application by corresponding application of the first and second paragraphs.
4 By ministerial arrangement, research institutes for scientific research, quality control or monitoring of compliance with the rules to be established under that scheme may be designated as having a general derogation for the the application of veterinary medicinal products, feedingstuffs, substances or other substances or products to animals, or to animal or tissue cultures of animals with corresponding application of the second paragraph.
1 Our Minister may be prohibited from the prohibitions referred to in the Article 2.8 (b) (b) (b) , and 2.25, first paragraph, of the Act to grant an exemption for the application of veterinary medicinal products to material of animal origin.
2 By way of derogation from the first paragraph, our Minister may grant an exemption upon application by corresponding application of the first paragraph.
1 An application for authorisation for:
a. manufacture of a veterinary medicinal product as intended Article 2.19, first paragraph, of the Act , including a substance containing an active substance that can be applied to an animal as intended in Article 1.1, under the term "veterinary medicinal product", part 2 °, of the Act , or
b. possession of a veterinary medicinal product or substance as referred to in subparagraph (a), with anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties,
shall be submitted to our Minister.
2 In the case of a ministerial arrangement, cases where a distributor of a substance as referred to in paragraphs 1 and b of the first paragraph may be notified shall be sufficient to indicate the cases.
1 An application as referred to in Article 4.1 shall be accompanied by documents containing at least the following information:
a. a list of the veterinary medicinal products or substances referred to in Article 4.1 ;
b. A description of the pharmaceutical forms;
c. An indication of the place of manufacture or possession, including a description of the premises and method of preservation;
d. a description of the controls carried out by the holding;
e. an indication of the technical equipment; and
f. an indication of at least one person responsible for the quality assurance in the manufacture, as well as information about the training of this person.
2 Under ministerial arrangements, rules shall be laid down concerning:
(a) the provision of the documents referred to in paragraph 1 (a) to (f); and
(b) the designation referred to in paragraph 1 (f).
3 In the case of ministerial arrangements, the training of a person referred to in paragraph 1 shall be subject to the requirements of the first paragraph of this Article.
1 The time limit for a decision on an application as referred to in Article 4.1, first paragraph , shall be 90 days after an application by Our Minister has been deemed to be complete.
2 By ministerial arrangement, another period may be fixed for the adoption of a decision as referred to in the first paragraph.
1 Our Minister gives an applicant an opportunity to supplement the application in writing as intended Article 4:5, first to third paragraphs, of the General Law on administrative law , or to explain orally, and aort to that end the period referred to in Article 4.3, first paragraph , with application of Article 4.16, first paragraph, part a, of the General Administrative Law on if:
a. the documents referred to in Article 4.2, first paragraph , do not contain all the necessary particulars or documents for the consideration of the application, or
b. Further information has been requested on:
1. the information supplied in the application with regard to the requirements, specified in Article 4.9 ;
2 °. information provided on a person responsible for quality control.
2 A decision to suspend, as referred to in paragraph 1, shall leave the right to suspend, mentioned in the Article 4:15, first paragraph, part b, and the second member, of the General Law governing the administrative law , without prejudice.
1 On application of a licence as referred to in Article 4.1 is Section 4.1.3.3 of the General Administrative Law Act applicable mutatis mutandis.
2 By way of derogation from the first paragraph Section 4.1.3.3 of the General Law on administrative law Not applicable to an application for a first manufacturing authorisation.
Our Minister refuses to grant a licence as intended Article 4.1 to be provided where:
a. the documents referred to in Article 4.2, first paragraph does not correspond to the description of the method of manufacture in documents intended to be used in Article 2.3, first paragraph, parts a and b , established in an EEA Member State or by the European Commission, or corresponding documents adopted by a third country which agrees to the importation of the relevant veterinary medicinal product.
b. from an investigation by an appropriate Article 8.1, first paragraph , or Article 10.2 of the Act designated supervisor or otherwise, it appears that the information contained in the documents referred to in Article 4.2, first paragraph , not complete or not correct,
(c) the application relates to substances designated by EU legal act and is not fulfilled for the purpose of implementing that EU legal act under the terms of Chapter 2, Section 4 , the conditions laid down for the placing on the market and the application of the veterinary medicinal product concerned; or
d. The application does not comply with:
1 °. Article 4.9 rules set, or
2. other production rules necessary for the protection of public health, the consumer or the health of animals which our Minister may lay down under ministerial arrangements, in so far as they do not protect those interests. EU regulation or decision has been adopted.
The authorization for the manufacture of an animal medicinal product or the authorization of possession of a substance shall include:
(a) the application and the requirements of the authorisation;
b. the documents referred to in Article 4.2 .
The holder of the authorisation referred to in Article 4.7 , shall ensure that:
a. a veterinary medicinal product or substance as intended Article 4.1 be manufactured under the conditions laid down in Article 2.14, first paragraph, part b , requirements for placing on the market, and Article 2.13, part a rules on packaging and information on, in the case of packaging, or in the packaging;
b. the veterinary medicinal product or substance is manufactured and controlled according to generally accepted scientific methods, taking into account the progress of science and engineering and in accordance with the description of the scientific methods; manufacturing method in documents as referred to in Article 2.3, first paragraph, parts a and b , established in an EEA Member State or by the European Commission, or corresponding documents established by a third country which agrees to the importation of the relevant veterinary medicinal product or substance;
c. if any change to a document as intended by Article 4.2, first paragraph , it is necessary to make an application for modification of the authorisation in good time;
d. for the verification of compliance by any Article 8.1, first paragraph , or 10.2 of the Act The designated supervisor shall be required to make available sufficient quantities of veterinary medicinal products or other substances necessary to monitor the presence of residues of veterinary medicinal products or other substances and to be able to find and verify it and to appoint a ministerial order for the Minister to produce documents relating to these substances;
e. at the request of officials or other persons referred to in the Articles 8.1, 1st paragraph , and 10.2 of the Act , is to contribute to the implementation of analytical methods for the detection of residues of veterinary medicinal products for the purpose of implementing Directive 96 /23/EC in a reference laboratory to be designated for that purpose by ministerial arrangement;
f. without delay and on its own initiative, information shall be submitted to our Minister:
1 °. which may result in a change of documents as referred to in Article 4.2 , including suspected carry-over of infectious substances or any other non-conformity of the veterinary medicinal product;
2 °. in respect of a competent authority of a country in which the veterinary medicinal product or substance as referred to in Article 4.1 A prohibition or restriction imposed imposed on it;
(g) compliance with the rules laid down in ministerial arrangements for the implementation of an EU legal act on the production or import requirements of those substances, as specified in that scheme;
h. a veterinary medicinal product only:
1 °. is delivered to a holder of:
-an authorisation for manufacture in accordance with Article 4.1, first paragraph, part a ;
-a licence for possession as intended Article 4.1, first paragraph, part b ;
-a permit for import as referred to in Article 4.21, first paragraph ;
-a wholesale licence as referred to in Article 5.1, first paragraph ;
-a retail permit referred to in Article 5.1, second paragraph , or
2 ° in accordance with Section 7 is exported;
i. a substance as referred to in Article 4.1, first paragraph, second sentence, and second paragraph is only delivered to a manufacturing authorisation holder or in accordance with Section 7 This chapter will be implemented.
1 By Ministerial Regulations for the implementation of EU legal acts relating to the manufacture of veterinary medicinal products, rules shall be laid down concerning the manufacture of veterinary medicinal products or substances referred to in Article 3 (2). Article 4.1 , including rules relating to:
(a) substances and veterinary medicinal products to be imported;
b. quality management, including the involvement of those responsible and personnel;
c. personnel to be established, including the organisation, powers and training;
d. premises and equipment;
e. documentation;
f. production;
g. quality assurance, including time-limits for storage of samples and requirements for storage of small quantities;
h. outsourcing;
i. complaints and recalls, including the notification to our Minister of Defects;
j. self-inspection;
k. administration of transactions;
(l) supervision and supervision by supervisors and persons carrying out investigations, including a person referred to in Article 4.2, first paragraph, part f , and
m. the notification of modification of data in documents as referred to in Article 4.2, first paragraph, introductory wording .
2 The rules referred to in paragraph 1 may include a provision or a restriction as referred to in Article 3 (1) of the Treaty. Article 7.5 of the Act to the decision to issue the authorisation, as set out in Article 4.1 It's connected.
1 The authorisation, for the purpose of Article 4.7 , is valid for an indefinite period of time.
2 By way of derogation from the first paragraph, categories of veterinary medicinal products or substances referred to in the Agreement may be covered by a ministerial arrangement Article 4.1 shall be designated for which a first manufacturing authorisation for a given period of validity of at least five years is granted.
1 The Articles 4.1 to 4.5 shall apply mutatis mutandis in the examination of an application for renewal, modification or withdrawal of a licence as referred to in Article 4.7 .
2 By way of derogation from the first paragraph, the period referred to in paragraph 1 shall be: Article 4.3 , in relation to changes in one or more of the documents referred to in Article 4.2, first paragraph No more than thirty days.
3 In the case of a ministerial arrangement, exceptional cases for which the period referred to in paragraph 2 shall be extended for up to 90 days may be designated.
4 An application as referred to in paragraph 1 shall be considered only if the application is submitted by the holder of the authorisation.
1 An application for renewal or amendment of a licence as referred to in Article 4.11 shall be submitted at least 90 days prior to the duration of the entry for the period of validity of Article 4.10, second paragraph , has expired, or the manufacturing process is changed.
2 In the case of an application as referred to in paragraph 1, the applicant may, by way of derogation from Article 4.2, first paragraph It shall be sufficient to submit a list of relevant previously submitted documents and any changes made thereto, to the extent that the changes are of a limited nature.
3 Our Minister renews a permit as intended in Article 4.7 to an initial extension application, referred to in the first paragraph, for an indefinite period of time.
4 By way of derogation from the third paragraph, a licence as referred to in that paragraph may be extended for a period of up to five years if a decision has been taken as referred to in Article 2.17, fourth paragraph First sentence. In the case of a subsequent application, that authorisation shall be extended for an indefinite period.
1 Our Minister suspends a permit as intended in Article 4.7 , if he has a serious suspicion that:
a. the documents referred to in Article 4.2., first paragraph , to be incorrect or incomplete, that a different decision would have been taken on the application, if the correct information had been disclosed in the assessment, or
b. the veterinary medicinal product to be manufactured or the substance referred to in Article 4.1 no longer compliant Article 4.6 (a) .
2 Without prejudice to the first paragraph, our Minister may take a decision to suspend as referred to in paragraph 1, if there is a presumption that:
a. despite a prior written warning, regulations as referred to in Article 4.8 (a) , are not complied with, or
b. Requirements as set out in Article 4.8, parts b to g , or requirements as referred to in Article 4.9, first or second paragraph , they're not being complied with.
1 Our Minister withdraws a licence as intended Article 4.7 , without prejudice Article 4.11 , first member, of its own motion, if:
a. the documents referred to in Article 4.2, first paragraph , to be incorrect or incomplete, that a different decision would have been taken on the application, if the correct information had been disclosed in its assessment, or
b. the veterinary medicinal product to be manufactured or the substance referred to in Article 4.1 no longer compliant Article 4.6 (a) .
2 Without prejudice to paragraph 1, our Minister may withdraw a decision to revoke if:
a. after a written warning, regulations as referred to in Articles 4.8 (a) , are not complied with, or
b. Requirements as set out in Article 4.8, parts b to g , or requirements as referred to in Article 4.9, first or second paragraph , they're not being complied with.
1 The authorisation, for the purpose of Article 4.7 , no law shall be imposed in respect of an animal medicinal product included in a list as referred to in Article 1. Article 4.2, first paragraph, part a , if the licence is intended to Article 2.1, first paragraph , for that veterinary medicinal product has expired and, if the veterinary medicinal product is intended for export, no consent shall be given by the third country to the importation of the veterinary medicinal product as provided for in Article 4.6 (a) , has been granted.
2 Our Minister may, in exceptional circumstances or for reasons of human or animal health, postpone the expiry of the authorization referred to in paragraph 1 with a period of time to be determined.
1 A decision to grant, amend or revoke a permit as referred to in Article 4.7 shall be published in the Official Gazette and communicated to the applicant.
2 After publication of the notice referred to in paragraph 1, the Minister shall send to the Office a copy of the authorization or use any other manner designated by the European Commission to that effect.
3 Our Minister is responsible for a register as intended Article 7.2, first paragraph, of the Act the endorsement of any authorisation and decision to renew, change, suspend or revoke such authorisation.
1 Our Minister is responsible for a register as intended Article 7.2, first paragraph, of the Act Where a note is made of any manufacturer and distributor who is the subject of a substance Article 4.1, first paragraph, part b , with anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties, including veterinary medicinal products, may have.
2 The provision, amendment or revocation of a permit for the manufacture of a veterinary medicinal product or a permit for possession of a substance as referred to in Article 4.1, first paragraph, part b , or a notification as referred to in Article 4.1, second paragraph, shall be entered in the Register.
1 The prohibition, intended to Article 2.19, first paragraph, of the Act to prepare a veterinary medicinal product without authorization does not apply in cases where our Minister, under ministerial order, designes persons or bodies which are subject to the conditions laid down in that provision to manufacture veterinary medicinal products in small quantities, if that veterinary medicinal product:
a. Prepared, divided or altered for the purpose of packaging or presentation;
b. ex tempore is prepared; or
c. Is prepared using pathogenic organisms and antigens from one or more animals of a holding for the purpose of animals of the same holding.
2 At the ministerial level referred to in paragraph 1 of this Article Article 4.8, parts a, b, d, e, g and h , and Article 4.9, second paragraph The following shall be declared, in whole or in part, mutatis mutandis, pursuant to Article 4.9 (1) of the Rules of First Paragraph.
The prohibition, intended to Article 2.19, first paragraph, of the Act , in order to be a veterinary medicinal product or substance as intended Article 4.1 is not applicable from an EEA Member State without a licence in case the EEA Member State concerned is authorised to manufacture or import in accordance with Directive 2001 /82/EC has provided and:
a. A permit as specified in Article 2.1, first paragraph , has been provided, or
b. the veterinary medicinal product or substance with application of Article 4.22 (b) , is exported to a country outside the European Economic Area.
1 The person importing veterinary medicinal products for which a permit to manufacture or import as referred to in Article 4.19, first paragraph, introductory wording , has been granted and is not also the holder of a licence as referred to in Article 2.1, first paragraph , notify the intention to import a veterinary medicinal product or substance as referred to in Article 4.1, first paragraph , to the holder of the authorization referred to in Article 2.1, first paragraph, of that veterinary medicinal product.
2 The person importing veterinary medicinal products as referred to in paragraph 1 (1), who introduces an animal or substance for which no marketing authorization as provided for in Article 38 (1) of Regulation (EC) No 1482/18 is to be introduced. 726/2004 has been provided, report it to Our Minister.
3 Veterinary medicinal products referred to in paragraph 1 which are imported from another EEA Member State shall not be checked for quality if the person importing the veterinary medicinal products is accompanied by a person to that effect by a person of the type specified in the veterinary medicinal product. Article 4.2, first paragraph, part f , signed control reports.
4 In the case of Ministerial Regulations, detailed rules for supervision and control as referred to in Article 10.2 of the Act for control of imports from EEA Member States.
1 For the application of a licence for the importation of an animal medicinal product or of a substance as referred to in Article 4.1 from countries other than EEA Member States or an application for renewal, amendment or withdrawal of an import permit is Chapter 4, paragraphs 1 to 6 , mutatis mutandis.
2 In the case of Ministerial Regulations, detailed rules for supervision and control referred to in Article 10.2 of the Act on the quality of veterinary medicinal products introduced into the territory of the Netherlands from countries other than EEA Member States, including the provision of documents and the taking of veterinary medicinal products or substances of a copy of the authorisation for manufacture or corresponding documents from the country where manufacture has taken place.
3 Our Minister may renew, amend, suspend or revoke an import permit with corresponding application of the Articles 4.12 , 4.13 and 4.14 . Article 4.15 shall apply mutatis mutandis.
The person who is a veterinary medicinal product or a substance as intended Article 4.1 shall have the following:
a. A permit granted by Our Minister for the manufacture or possession of that veterinary medicinal product as intended Article 4.1, first paragraph , or for import as referred to in Article 4.21 , or
b. one by another EEA Member State in accordance with Article 44, first or third paragraph, of Directive 2001 /82/EC , authorisation for the manufacture or importation of that veterinary medicinal product.
Our Minister provides upon application by a manufacturer or exporter of any veterinary medicinal product or substance as intended Article 4.1, first paragraph , or at the request of the authorities of a non-EEA Member State according to rules adopted by our Minister for the implementation of Article 93 of the EC Treaty. Directive 2001 /82/EC by ministerial arrangement, a certificate proving the provision of an authorisation for manufacture as referred to in Article 4.1, first paragraph.
An exemption or exemption granted pursuant to Chapter 3, paragraph 6 may also provide for an exemption from or exemption from provisions in force under this Chapter.
1 An application for a marketing authorisation for veterinary medicinal products relating to the possession of, trade in and dispensing of veterinary medicinal products as referred to in Article 4 (2) of the EC Treaty. Article 2.19, first paragraph, of the Act shall be submitted to our Minister.
2 The first paragraph shall also apply to the application for a retail licence.
3 By way of derogation from the second paragraph, cases may be designated by ministerial order, which shall suffice to mention, under the conditions laid down by that ministerial arrangement, veterinary medicinal products which are to be applied in the event of a derogation from the provisions of the pet animals, including animal species, as intended Article 3.19 .
4 The Articles 4.3 , 4.4 , 4.5 and 4.10 shall apply mutatis mutandis to an application as referred to in the first and second paragraphs.
1 An application as referred to in Article 5.1 be accompanied by documents providing information on the manner in which the applicant will comply with rules laid down in ministerial arrangements in relation to, inter alia, the following:
a. training of personnel;
b. the suitability of the premises and installations;
(c) the preservation of veterinary medicinal products;
d. the treatment of veterinary medicinal products;
e. the emergency plan to be carried out by a wholesaler for the placing on the market of an animal product;
f. the measures to be taken by a retail trade to take a veterinary medicinal product from the market.
2 In the case of ministerial arrangements, rules may be laid down in the interests of animal health, animal welfare, public health or the environment which the holder of the authorization takes into account in the exercise of the authorization, including those relating to shall have on the subjects referred to in point (a) to (f) of the first paragraph.
3 A holder of a licence as referred to in Article 5.1 shall carry out an administration meeting requirements laid down in ministerial arrangements.
1 A pharmacist in charge of a pharmacy and is registered in the register of established pharmacists established by the State Supervision of Public Health, as set out in the Article 61, fifth paragraph, of the Pharmaceutical Act , by way of automatic marketing authorisation, is subject to a licence for retail sale. Article 5.1, second paragraph .
2 The rules of procedure may lay down detailed rules on the use of veterinary medicinal products by a pharmacist.
1 A veterinarian shall, by law, authorise the retail marketing of veterinary medicinal products to the holders of animals for which the veterinary surgeon has taken care of medical care in the exercise of his/her profession.
2 A veterinarian established in another EEA Member State shall be competent to apply to animals in the exercise of his profession in the Netherlands veterinary medicinal products which are not authorised to be authorised as such Article 2.12, first paragraph of this Decision is provided, subject to conditions laid down by ministerial arrangements.
3 By way of derogation from the first paragraph, a veterinarian is permitted to carry out a veterinary medicinal product by another person to the extent that it is in accordance with the duty of care specified in the veterinary medicinal product concerned. Article 4.2 of the Act and rules which may be laid down by a ministerial arrangement in respect of the surrender by another person.
4 By way of derogation from the first paragraph, persons referred to in the Article 4.1, first paragraph , in conjunction with Article 4.3, first paragraph, of the Act by law on a licence as referred to in paragraph 1, in cases which may be designated by ministerial arrangement, but only:
1 °. in case of a person, to whom it is Article 5.8 (c) (c) , an animal medicinal product may be applied, and
2 °. in accordance with the requirements of the Law rules laid down in respect of, inter alia, the competence of such persons.
1 Licences as referred to in Articles 5.1 , 5.3, 1st Member , and 5.4, 1st and 4th Member , may be amended or withdrawn by our Minister upon application or ex officio if not complied with or under the terms of the Article 5.2 , 5.3, or 5.4 regulations, or regulations or restrictions imposed by the authorisation.
2 The licence for retail trade may also be withdrawn if:
a. The veterinary medicinal product is not to be used in accordance with the information required by legal provisions or by Regulation (EC) No 148/ (EC). it has been placed on the packaging of an animal or feed medicinal product or is not accompanied by such packaging; or
b. Not in accordance with the Articles 5.1 and 5.2 of the Decision Veterinary Medicinal products shall be acting.
1 A decision to grant, amend or revoke a marketing authorization or a retail permit shall be published in the Official Gazette and communicated to the applicant.
2 Our Minister is responsible for a register as intended Article 7.2, first paragraph, of the Act the endorsement of any authorisation and decision to renew, change, suspend or revoke such authorisation.
3 The provision, amendment or revocation of a wholesale marketing authorisation for a veterinary medicinal product containing a substance with anabolic agents, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties shall be entered in the register provided for in Article 4.17 .
1 A holder of a marketing authorisation shall supply a veterinary medicinal product only:
a. A holder of an authorisation for manufacture;
b. A holder of an import licence;
c. A holder of a wholesale licence, or
d. A holder of a retail licence.
2 A holder of a retail permit may, without prejudice to: Article 5.8 , return a veterinary medicinal product to a holder of a licence as referred to in paragraph 1 (a) to (c) or deliver it in small quantities to another holder of a retail permit with the application of rules applicable to the marketing authorisation. Ministerial arrangements are to be made for the quantities and types of veterinary medicinal products to be delivered.
3 If Our Minister intends to submit a nomination, amendment, or repeal of a general measure of governance as referred to in Article 2.21, fourth or fifth paragraph, of the Act on a general binding declaration, if an immediate provision is required, he may, in accordance with the measures envisaged, lay down rules.
4 A system as referred to in paragraph 3 shall remain in force subject to prior revocation until the general measure referred to in that paragraph enters into force, but not later than 12 months after the entry into force of the scheme.
Ministerial arrangements shall be regulated:
a. in which cases an animal medicinal product is delivered only after being prescribed;
b. which information is a veterinarian or another person as intended in Article 4.1, first paragraph, of the Act indicates in a prescription and in what way the prescription can be provided;
c. in which cases the possession, control or application of an animal medicinal product is restricted to veterinarians or other persons referred to in Article 4.1, first paragraph, of the Act , and
d. which other provisions are necessary to ensure that the quantity prescribed, delivered or prepared is limited to what is necessary for the intended treatment or therapy.
The prohibition on the prices of veterinary medicinal products intended for Article 2.19, first paragraph, of the Act does not apply to veterinary medicinal products for which authorisation is authorised as intended Article 2.1, first paragraph , has been provided where:
a. veterinary medicinal products shall be established, which shall:
1 °. not only available on prescription under Article 5.8, first paragraph, part a , and
2. does not contain psychotropic or narcotic substances, such as those covered by the United Nations conventions of 1961 and 1971, or
b. The pricing, in view of the content and the manner in which it is expressed, is clearly not intended for the public.
An exemption or exemption granted under Chapter 3, paragraph 6 may also provide for an exemption from or exemption from the provisions in force under this Chapter, with the exception of: Article 5.9 .
1 Our Minister records information about:
a. Side effects including suspected side effects, unexpected side effects, and serious side effects coming from a licence holder as intended Article 6.1 or a veterinarian or other person as intended in Article 4.1, first paragraph, of the Act ;
b. A lower efficacy;
c. Derogation;
d. Examination of the correctness of the waiting period;
e. potential environmental problems; and
f. information referred to in Article 2.13, part f .
2 Our Minister shall send the information referred to in paragraph 1 to the competent authorities of the EEA Member States and of the Office.
1 A holder of the authorisation referred to in Article 2.1, first paragraph , reports a side effect, with due regard to the Article 2.13, parts b and j -The rules set.
2 Our Minister may arrange for a ministerial arrangement in which cases, within what period and to which bodies or persons a veterinarian or other person as referred to in the Article 4.1, first paragraph, of the Act Reports a side effect.
1 The holder of the authorisation referred to in Article 2.1, first paragraph provides information, intended to be provided Article 6.1, first paragraph , on worrying issues, including all side effects related to animal pharmacovigilance not to the public before our Minister has received this information.
2 Our Secretary of State shall ensure that the information referred to in paragraph 1 is accessible on a permanent basis and can be consulted by the public without delay.
3 A holder of the permit, intended to Article 2.12, first paragraph , information referred to in the first paragraph shall be presented in an objective manner and not misleading.
4 For the purposes of the third paragraph and Article 6.2, first paragraph , the holder of the licence shall apply, Article 2.12, first paragraph , terminology accepted at international level for veterinary medicinal products according to guidelines adopted by the European Commission.
This Chapter shall apply mutatis mutandis to an exemption or exemption granted under Chapter 3 (6) with the exception of an exemption or exemption provided for in the Articles 3.22 and 3.23 .
It shall be prohibited to perform an act which aims to prepare, edit, process, package, label, bring in or out of the Netherlands, offer or supply the medicated feed, to offer or deliver:
a. without a permit to manufacture or import pursuant to this Chapter;
b. In violation of a licence issued under this Chapter; and
c. In conflict with rules laid down in or pursuant to this Chapter.
1 The holder of an authorisation for manufacture as intended Article 7.1, part a , uses a premixture for a medicated feed for which:
a. A marketing authorisation for a veterinary medicinal product as intended for use in the veterinary medicinal product Article 2.1, third paragraph , or 2.12, first paragraph , has been granted, or an exemption or waiver provided for in Chapter 3, paragraph 6 has been granted, and
(b) a permit for the manufacture of a veterinary medicinal product as specified in Article 4.7 or a permit for import of an animal medicinal product as intended Article 4.21 has been provided or a notification as intended Article 4.20 has been done.
2 The first paragraph shall apply mutatis mutandis to importation by a holder of a licence for importation of a medicated feedingstuff.
1 The holder of an authorisation for manufacture as intended Article 7.1, part a , in the preparation of a medicated feedingstuff, uses feed, which complies with the application or Articles 2.17 and 2.18 or Article 6.4 in connection with Article 2.18, second paragraph, of the Act in relation to feed.
2 The first paragraph shall apply mutatis mutandis to importation by a holder of a licence for importation of a medicated feedingstuff.
1 The holder of an authorisation for manufacture as intended Article 7.1, part a , a medicated feedingstuff is prepared to produce no more than one premixture for a medicated feedingstuff.
2 The first paragraph shall apply mutatis mutandis to importation by a holder of a licence for importation of a medicated feedingstuff.
1 A holder of a licence as referred to in Article 7.1, part a , by way of automatic marketing authorisation, is subject to a licence for retail sale. Article 5.1, second paragraph .
2 In the case of and under the Articles 5.2, 2, 2 and 4 (4) , 5.5 to 5.10 certain provisions shall apply mutatis mutandis to premixtures for medicated feedingstuffs and medicated feedingstuffs.
1 The holder of an authorisation for manufacture as intended Article 7.1, part a , shall ensure that:
a. A medicated feedingstuff is prepared:
1 °. in service spaces and technical installations which comply with rules laid down by Ministerial Regulations and which are provided by a Article 10.2 of the Act Designated supervisor shall be checked in advance;
2 °. in a unit of sufficient suitable storage and control capability;
3 °. in a unit where there is sufficient staff with knowledge and qualification of mixing techniques;
(b) the feed used and the premixture are mixed into a homogeneous and stable product;
c. undesirable interactions between veterinary medicinal products and feedingstuffs are excluded;
(d) the medicated feedingstuff is tenable during the prescribed period;
e. for the preparation of medicated feedingstuffs, the person-in-person used does not contain the same antibiotics or the same coccidiostats as that used in the premixture as an active substance;
f. the under Article 2.19, third paragraph, part a, of the Act , prescribed daily dose of active substances is included in an amount of feed covering at least half of the daily ration of the treated animals and, in the case of ruminants, at least half of the daily need for non-mineral supplementary feed;
g. the rules laid down by Ministerial Regulations relating to the administration of operations of premixtures for medicated feedingstuffs and medicated feedingstuffs shall be complied with;
(h) compliance with the rules laid down by Ministerial Regulations on the storage and preservation of premixtures for medicated feedingstuffs and medicated feedingstuffs;
i. the rules laid down by ministerial rules on packaging, sealing, labelling or any other information, transport and delivery to be included in the packaging, in accordance with EU legal acts, shall be complied with.
2 The first paragraph shall apply mutatis mutandis to imports of a medicated feedingstuff.
1 An application for an authorisation for manufacture as intended Article 7.1, part a , is filed with our minister.
2 Under ministerial arrangements, rules shall be laid down concerning the documents to be submitted to the application.
3 The Articles 4.3 to 4.15 , 4.16, first and third paragraphs , and 4.17 shall be applicable mutatis mutandis subject to the following conditions:
a. in addition to Article 4.6 a licence is refused if the person concerned has not been complied with and under the conditions of Articles 7.2 to 7.6 ;
b. in addition to the Articles 4.13 and 4.14 Our minister may take a decision to suspend or revoke if not complied with and under the terms of the Articles 7.2 to 7.6 ;
c. where reference is made to one or more documents as referred to in Article 4.2 The documents referred to in paragraph 2 shall be read.
1 An application for an import authorisation as referred to in Article 7.1, part a , is filed with our minister.
2 The Articles 7.8, second and third members , 4.19 and 4.21 shall be applicable mutatis mutandis.
3 By way of derogation from Article 7.1 the person entering a medicated feedingstuff shall be sufficient to report to our Minister if the feed:
a. Prepared from a pre-mixture for medicated feed for which an EEA Member State is authorised to comply with Directive 2001 /82/EC has been provided;
b. contains the same active substances as a medicated pre-mixture for which a licence as referred to in Article 2.1, third paragraph , or Article 2.12, first paragraph , has been granted;
c. contains a qualitative and quantitative composition similar to that of premixture; and
(d) the consignment is accompanied by a complete declaration as referred to in Article 10, third paragraph, of the Directive 90 /167/EEC , which has been issued by the competent authority of the EEA Member State from which the medicated feed originates.
1 Article 4.22 shall apply mutatis mutandis.
2 Our Minister, on application by a manufacturer or exporter of a medicated feedingstuff according to rules which our Minister proposes to implement under Article 10 (3) of Directive 90 /167/EEC by ministerial order, statement as referred to in Article 10 (3), third paragraph, in conjunction with Annex B, to Directive 90 /167/EEC.
Our Minister may dispense for scientific purposes from the prohibition provided for in Article 2.19, first paragraph, of the Act and of the ban in Article 7.1 .
1 Before a licence as referred to in the Articles 4.1 , 4.21 , 5.1, first and second members , and 7.8 shall be provided, a preventive examination shall be carried out by persons referred to in Article 8.1 of the Act to verify that the compliance with the requirements of the Article 4.9, first paragraph , and 5.2, first paragraph , the rules laid down and the premises, plant and equipment meet the data submitted to the application.
2 In the case of a ministerial arrangement, cases may be designated, where a preventive examination is to be omitted.
1 The following Article 8.1, first paragraph, of the Act designated supervisory authority after a verification visit in the case of a licence holder as intended in the Article 2.1, third paragraph , 2.12, first paragraph , or 4.7 a report of the verification to the holder of the authorisation.
2 If the verification visit referred to in paragraph 1 leads to the conclusion that the holder of the authorization adheres to the principles and guidelines of good manufacturing practice, our Minister shall decide within 90 days of the date of the To provide a certificate of good manufacturing practice.
3 The period referred to in paragraph 2 shall not apply if a decision is taken after a verification visit at the request of an authority for the standardization of nomenclatures and quality standards within the meaning of the Convention on the composition of a European Pharmacopoeia (Trb. 1974, 42) with a view to the issue of a certificate of good manufacturing practice in which it is established whether the manufacturing practice is in conformity with the monographs of the European Pharmacopoeia.
4 If a verification visit leads to a decision of Our Minister that a good manufacturing certificate cannot be granted, this decision shall be taken within 90 days of the visit, referred to in paragraph 2, to the holder of the licence.
5 Our Minister shall report to the Office, as referred to in the second to fourth paragraphs.
Ministerial rules lay down rules for the control and investigation of the constituents, intermediate products and manufacture of an animal medicinal product and may be subject to rules for the control of immunological products. veterinary medicinal products, including administrative control, and where that is necessary for reasons of public or animal health, a control of the product in the form of an unpackaged form at an official laboratory for the control of medicinal products prior to the marketing of The veterinary medicinal product must be marketed.
Ministerial arrangements shall lay down rules for the implementation of EU legal acts relating to substances designated by such EU legal acts on:
investigations and monitoring of the presence of these substances in veterinary medicinal products;
(b) the examination and control of the presence of these substances in animals or animal products; and
(c) the holding and marketing of animals or animal products containing these substances.
1 By Ministerial Regulations, rules are laid down for the implementation of EU legal acts on research, control, monitoring of compliance and measures to be taken with regard to substances with anabolic agents, not authorised substances, residues of veterinary medicines and contaminants in:
a. veterinary medicinal products;
b. feed;
c. Drinking water; and
d. Live animals and products thereof, including excreta and biological liquids.
2 The rules referred to in paragraph 1 shall cover research, control, surveillance and action taken in response to such measures by:
a. The holder of the permit, intended in the Article 2.1, third paragraph , 2.12, first paragraph , 4.7 and 5.1 ;
b. The holders of animals, including farms placing farmed animals on the market;
(c) holdings with a first-processing establishment of primary products of animal origin; and
d. establishments, where research work takes place, officials and persons, including laboratories, official veterinarians and assistants, as well as other supervisors.
Without prejudice to the automatic application of the Articles 2.20, first paragraph , and 2.21, 1st Member , shall the Minister take the necessary measures to ensure that the delivery of an animal medicinal product is prohibited and that the veterinary medicinal product from the market is taken when:
a. indicates that the assessment, referred to in Article 2.9, first paragraph, part c, and third member , is not favourable;
b. there is no therapeutic effect as specified in Article 2.9 (d) (d) ;
c. the veterinary medicinal product does not have the qualitative and quantitative composition specified in the dossier, Article 2.3, first paragraph, part a , is indicated,
d. the waiting period, intended in Article 2.9, first paragraph, part e , is inadequate,
e. the manufacture differs from:
1 °. the method of manufacture specified in the information provided for in Article 4.2 , or
2 °. Rules set at or under the Articles 4.8 and 4.9 .
By way of derogation from Chapter 3, Section 2 , is Article 2.3 for the application for marketing authorisation of a homeopathic veterinary medicinal product which has been on the market in the Netherlands since 31 December 1993 and which does not comply with the requirements of Article 3.4, first paragraph, points (b) to (d) , not applicable, if that veterinary medicinal product complies with requirements laid down in ministerial arrangement with these veterinary medicinal products.
For a substance designated under Article 19 (f) of the Animal Medicinal Products Decision as at the time of the entry into force of this Decision, shall be subject to an exemption from the prohibition provided for in Article 4 (1) of the Treaty. Article 2.8, first paragraph, section c, of the Act to the time when Our Minister:
a. The exemption withdraws or amends, or
b. Grants an exemption on the basis of Article 3.16 .
1 Decisions, failure to comply with a general rule taken in respect of feed 2003 applicable to or pursuant to Regulation PDV, which applied immediately prior to the date of entry into force of this Article, are deemed to be taken on the basis of this Decision, subject to the same rules, restrictions and conditions.
2 Applications pending at the time of entry into force of this Article shall be treated in accordance with this Decision in accordance with the time limit which has elapsed since the date of the submission of the application.
Ministerial arrangements shall establish rules for the implementation of the following EU legal acts and EU legal acts adopted pursuant to those EU legal acts:
a. Directive 90 /167/EEC the Council of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs (PbEG 1990, L 092),
b. Directive 96 /22/EC of the Council of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists and of the withdrawal of the use of certain substances Directives 81 /602/EEC , 88 /146/EEC and 88 /299/EEC (PbEC 1996, L 125);
c. Directive 96 /23/EC ;
ed. Directive 2001 /82/EC ;
A ministerial arrangement to be adopted under this Decision shall be determined by our Minister in agreement with our Minister for Health, Welfare and Sport and after consultation with our Minister for Social Affairs and Employment.
This Decision shall enter into force on a date to be determined by Royal Decree.
This Decision is cited as: Decision on veterinary medicinal products.
Charges and orders that this Decision will be placed in the Official Journal by means of the note of explanatory note accompanying it.
' s-Gravenhage, 2 November 2012
Beatrix
The Secretary of State for Economic Affairs,
J. C. Verdaas
The Minister for Health, Welfare and Sport,
E. I. Schippers
Published the thirteenth of December 2012The Minister for Security and Justice,
I. W. Opstelten
