CHAPTER 1 Marketing authorization
Article 5.(1) No veterinary medicinal product may be placed on the...
Article 6.(1) A veterinary medicinal product may not be the subject...
Article 7.Where the health situation so requires, a Member State may...
Article 8.In the event of serious epizootic diseases, Member States may...
Article 9.No veterinary medicinal product may be administered to animals unless...
Article 10.(1) Member States shall take the necessary measures to ensure...
Article 11.(1) Member States shall take the necessary measures to ensure...
Article 12.(1) For the purposes of obtaining a marketing authorisation in...
Article 13.(1) By way of derogation from point (j) of the...
Article 13a.(1) By way of derogation from point (j) of the...
Article 13b.In the case of veterinary medicinal products containing active substances...
Article 13c.After the marketing authorisation has been granted, the marketing authorisation...
Article 13d.By way of derogation from point (j) of the first...
Article 14.The summary of the product characteristics shall contain, in the...
Article 15.(1) Applicants shall ensure that the detailed and critical summaries...
CHAPTER 2 Particular provisions applicable to homeopathic veterinary medicinal products
Article 16.(1) Member States shall ensure that homeopathic veterinary medicinal products...
Article 17.(1) Without prejudice to the provisions of Regulation (EEC) No 2377/90...
Article 18.A special, simplified application for registration may cover a series...
Article 19.(1) Homeopathic veterinary medicinal products other than those referred to...
Article 20.This Chapter shall not apply to immunological homeopathic veterinary medicinal...
CHAPTER 3 Procedure for marketing authorization
Article 21.(1) Member States shall take all appropriate measures to ensure...
Article 22.Where a Member State is informed, in accordance with point...
Article 23.In order to examine the application submitted pursuant to Articles...
Article 24.Member States shall take all appropriate measures to ensure that:...
Article 25.(1) When granting a marketing authorisation, the competent authority shall...
Article 26.(1) The marketing authorisation may require the holder to indicate...
Article 27.(1) After a marketing authorization has been issued, the holder...
Article 27a.After a marketing authorisation has been granted, the holder of...
Article 27b.The Commission shall adopt appropriate arrangements for the examination of...
Article 28.(1) Without prejudice to paragraphs 4 and 5, a marketing...
Article 29.The granting of authorization shall not diminish the general legal...
Article 30.The marketing authorisation shall be refused if the file submitted...
CHAPTER 4 Mutual recognition procedure and decentralised procedure
Article 31.(1) A coordination group shall be set up for the...
Article 32.(1) With a view to the granting of a marketing...
Article 33.(1) If a Member State cannot, within the period allowed...
Article 34.(1) If two or more applications submitted in accordance with...
Article 35.(1) Member States or the Commission or the applicant or...
Article 36.(1) When reference is made to the procedure laid down...
Article 37.Within 15 days after receipt of the opinion, the Commission...
Article 38.(1) The Commission shall take a final decision in accordance...
Article 39.(1) Any application by the marketing authorization holder to vary...
Article 40.(1) Where a Member State considers that the variation of...
Article 41.Articles 39 and 40 shall apply by analogy to veterinary...
Article 42.(1) The Agency shall publish an annual report on the...
Article 43.Articles 33(4), (5) and (6) and 34 to 38 shall...
TITLE IV MANUFACTURE AND IMPORTS
Article 44.(1) Member States shall take all appropriate measures to ensure...
Article 45.In order to obtain the manufacturing authorization, the applicant shall...
Article 46.(1) The competent authority of the Member State shall not...
Article 47.The Member States shall take all appropriate measures to ensure...
Article 48.If the holder of the manufacturing authorization requests a change...
Article 49.The competent authority of the Member States may require from...
Article 50.The holder of a manufacturing authorization shall at least be...
Article 50a.(1) For the purposes of this Directive, manufacturing active substances...
Article 51.The principles and guidelines of good manufacturing practice for veterinary...
Article 52.(1) Member States shall take all appropriate measures to ensure...
Article 53.(1) Member States shall ensure that the qualified person referred...
Article 54.(1) A person engaging, in a Member State, in the...
Article 55.(1) Member States shall take all appropriate measures to ensure...
Article 56.Member States shall ensure that the obligations of qualified persons...
Article 57.The provisions of this Title shall apply to homeopathic veterinary...
TITLE V LABELLING AND PACKAGE INSERT
Article 58.(1) Except in the case of the medicinal products referred...
Article 59.(1) As regards ampoules, the particulars listed in the first...
Article 60.Where there is no outer package, all the particulars which...
Article 61.(1) The inclusion of a package leaflet in the packaging...
Article 62.Where the provisions of this Title are not observed and...
Article 63.The requirements of Member States concerning conditions of supply to...
Article 64.(1) Without prejudice to paragraph 2, homeopathic veterinary medicinal products...
TITLE VI POSSESSION, DISTRIBUTION AND DISPENSING OF VETERINARY MEDICINAL PRODUCTS
Article 65.(1) Member States shall take all appropriate measures to ensure...
Article 66.(1) Member States shall take all appropriate measures to ensure...
Article 67.Without prejudice to stricter Community or national rules relating to...
Article 68.(1) Member States shall take all measures necessary to ensure...
Article 69.Member States shall ensure that the owners or keepers of...
Article 70.By way of derogation from Article 9 and without prejudice...
Article 71.(1) In the absence of specific Community legislation concerning the...
Article 72.(1) Member States shall take all appropriate measures to encourage...
Article 73.In order to ensure the adoption of appropriate and harmonised...
Article 73a.The management of funds intended for activities connected with pharmacovigilance,...
Article 74.The marketing authorization holder shall have permanently and continuously at...
Article 75.(1) The marketing authorisation holder shall maintain detailed records of...
Article 76.(1) The Agency, in collaboration with Member States and the...
Article 77.(1) In order to facilitate the exchange of information about...
Article 78.(1) Where, as a result of the evaluation of veterinary...
Article 79.Any amendments which may be necessary to update the provisions...
TITLE VIII SUPERVISION AND SANCTIONS
Article 80.(1) The competent authority of the Member State concerned shall...
Article 81.(1) Member States shall take all appropriate measures to ensure...
Article 82.(1) Where it considers it necessary for reasons of human...
Article 83.(1) Member States' competent authorities shall suspend, revoke, withdraw or...
Article 84.(1) Without prejudice to Article 83, Member States shall take...
Article 85.(1) The competent authority of a Member State shall suspend...
Article 86.The provisions of this Title shall apply to homeopathic veterinary...
Article 87.Member States shall take appropriate measures to encourage veterinarians and...
Article 90.Member States shall take all necessary measures to ensure that...
Article 91.(1) Each Member State shall take all appropriate measures to...
Article 92.Member States shall communicate to each other all the information...
Article 93.(1) At the request of the manufacturer or exporter of...
Article 94.Any decision referred to in this Directive, taken by the...
Article 95.Member States shall not permit foodstuffs for human consumption to...
Article 95a.Member States shall ensure that appropriate collection systems are in...
Article 95b.When a veterinary medicinal product is to be authorised in...
INTRODUCTION AND GENERAL PRINCIPLES
1. The particulars and documents accompanying an application for marketing authorisation...
2. In assembling the dossier for application for marketing authorisation, applicants...
3. For veterinary medicinal products other than immunological veterinary medicinal products,...
4. The manufacturing process shall comply with the requirements of Commission...
5. All information which is relevant to the evaluation of the...
6. Pharmacological, toxicological, residue and safety tests shall be carried out...
7. Member States shall ensure that all experiments on animals are...
8. In order to monitor the risk/benefit assessment, any new information...
9. The environmental risk assessment connected with the release of veterinary...
10. In cases of applications for marketing authorisations for veterinary medicinal...
PART 2: PHARMACEUTICAL (PHYSICO-CHEMICAL, BIOLOGICAL OR MICROBIOLOGICAL INFORMATION (QUALITY))
PART 4: PRE-CLINICAL AND CLINICAL TRIAL
TITLE II REQUIREMENTS FOR IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS
PART 2: CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL/MICROBIOLOGICAL INFORMATION (QUALITY)
CHAPTER I 1. General principles The purpose of the trials described in...
CHAPTER II A. General requirements 1. The choice of antigens or vaccine...
1. The choice of antigens or vaccine strains shall be justified...
2. Efficacy trials carried out in the laboratory shall be controlled...
3. The efficacy of an immunological veterinary medicinal product shall be...
4. The efficacy of each of the components of multivalent and...
5. Whenever a product forms part of a vaccination scheme recommended...
7. If there is a compatibility statement with other immunological products...
8. For diagnostic immunological veterinary medicinal products administered to animals, the...
9. For vaccines intended to allow a distinction between vaccinated and...
TITLE III REQUIREMENTS FOR SPECIFIC MARKETING AUTHORISATION APPLICATIONS