L_2009044EN.01001001.xml
| 14.2.2009 | EN | Official Journal of the European Union | L 44/10 |
COMMISSION DIRECTIVE 2009/9/EC
of 10 February 2009
amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to 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 (1), and in particular Article 88 thereof,
Whereas:
| (1) | In order to be placed on the European Community market, a veterinary medicinal product must be granted a marketing authorisation by a competent authority. For this purpose, an application dossier containing particulars and documents relating to the results of tests and trials carried out on the veterinary medicinal product must be submitted. |
| (2) | The purpose of Annex I to Directive 2001/82/EC is to lay down detailed scientific and technical requirements regarding the testing of veterinary medicinal products against which the quality, safety and efficacy of the veterinary medicinal product should be assessed. It also gives instructions concerning the presentation and content of the application dossier. |
| (3) | The detailed scientific and technical requirements of Annex I to Directive 2001/82/EC need to be adapted to take account of scientific and technical progress and in particular of a set of new requirements resulting from recent legislation. The presentation and content of the marketing authorisation application dossier should be improved in order to facilitate the assessment and the better use of certain parts of the dossier which are common to several veterinary medicinal products. |
| (4) | In order to simplify current procedures for the assessment of veterinary vaccines, both for the granting of a first marketing authorisation and for the subsequent changes to it due to modifications to the manufacturing process and testing of individual antigens involved in combined vaccines, a new system based on the concept of a master file (Vaccine Antigen Master File, VAMF) should be introduced for vaccines which involve several antigens. |
| (5) | To permit authorisation of vaccines against antigenically variable viruses in a way that ensures that the most effective measures can be taken swiftly by the Community against the incursion or spread of epizootic diseases, the concept of multi-strain dossier should be introduced. This will at the same time ensure that marketing authorisations are granted on the basis of objective scientific criteria of quality, safety and efficacy. |
| (6) | The measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Veterinary Medicinal Products, |
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annex I to Directive 2001/82/EC is replaced by the text set out in the Annex to this Directive.
Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 6 September 2009 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 10 February 2009.
For the Commission
Günter VERHEUGEN
Vice-President
(1) OJ L 311, 28.11.2001, p. 1.
ANNEX
‘ANNEX I
CHEMICAL, PHARMACEUTICAL AND ANALYTICAL STANDARDS, SAFETY AND RESIDUE TESTS, PRE-CLINICAL AND CLINICAL TRIALS IN RESPECT OF TESTING OF VETERINARY MEDICINAL PRODUCTS
TABLE OF CONTENTS
INTRODUCTION AND GENERAL PRINCIPLES
TITLE I
REQUIREMENTS FOR VETERINARY MEDICINAL PRODUCTS OTHER THAN IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS
| PART 1: | SUMMARY OF THE DOSSIER |
| A. | ADMINISTRATIVE INFORMATION |
| B. | SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET |
| C. | DETAILED AND CRITICAL SUMMARIES |
| PART 2: | PHARMACEUTICAL (PHYSICO-CHEMICAL, BIOLOGICAL OR MICROBIOLOGICAL INFORMATION (QUALITY)) |
Basic principles and requirements
| A. | QUALITATIVE AND QUANTITATIVE PARTICULARS OF THE CONSTITUENTS |
| 1. | Qualitative particulars |
| 3. | Quantitative particulars |
| 4. | Development pharmaceutics |
| B. | DESCRIPTION OF THE MANUFACTURING METHOD |
| C. | CONTROL OF STARTING MATERIALS |
| 1.1.1. | Active substances listed in pharmacopoeias |
| 1.1.2. | Active substances not in a pharmacopoeia |
| 1.1.3. | Physico-chemical characteristics liable to affect bioavailability |
| 1.3. | Container-closure systems |
| 1.4. | Substances of biological origin |
| D. | CONTROL TESTS CARRIED OUT AT INTERMEDIATE STAGES OF THE MANUFACTURING PROCESS |
| E. | TESTS ON THE FINISHED PRODUCT |
| 1. | General characteristics of the finished product |
| 2. | Identification and assay of active substance(s) |
| 3. | Identification and assay of excipient components |
| PART 3: | SAFETY AND RESIDUES TESTS |
| CHAPTER I: | PERFORMANCE OF TESTS |
| 1. | Precise identification of the product and of its active substance(s) |
| 3.1. | Single-dose toxicity |
| 3.2. | Repeat-dose toxicity |
| 3.3. | Tolerance in the target species |
| 3.4. | Reproductive toxicity including developmental toxicity |
| 3.4.1. | Study of the effects on reproduction |
| 3.4.2. | Study of developmental toxicity |
| 4.2. | Microbiological properties of residues |
| 4.2.1. | Potential effects on the human gut flora |
| 4.2.2. | Potential effects on the microorganisms used for industrial food processing |
| 4.3. | Observations in humans |
| 4.4. | Development of resistance |
| 6. | Environmental risk assessment |
| 6.1. | Environmental risk assessment of veterinary medicinal products not containing or consisting of genetically modified organisms |
| 6.2. | Environmental risk assessment for veterinary medicinal products containing or consisting of genetically modified organisms |
| CHAPTER II: | PRESENTATION OF PARTICULARS AND DOCUMENTS |
| CHAPTER I: | PERFORMANCE OF TESTS |
| 2. | Metabolism and residue kinetics |
| 2.1. | Pharmacokinetics (absorption, distribution, metabolism, excretion) |
| 2.2. | Depletion of residues |
| 3. | Residue analytical method |
| CHAPTER II: | PRESENTATION OF PARTICULARS AND DOCUMENTS |
| 1. | Identification of the product |
| PART 4: | PRE-CLINICAL AND CLINICAL TRIAL |
| CHAPTER I: | PRE-CLINICAL REQUIREMENTS |
| A.2. | Development of resistance |
| B. | Tolerance in the target animal species |
| CHAPTER II: | CLINICAL REQUIREMENTS |
| 2. | Conduct of clinical trials |
| CHAPTER III: | PARTICULARS AND DOCUMENTS |
| 1. | Results of pre-clinical trials |
| 2. | Results of clinical trials |
TITLE II
REQUIREMENTS FOR IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS
| PART 1: | SUMMARY OF THE DOSSIER |
| A. | ADMINISTRATIVE INFORMATION |
| B. | SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET |
| C. | DETAILED AND CRITICAL SUMMARIES |
| PART 2: | CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL/MICROBIOLOGICAL INFORMATION (QUALITY) |
| A. | QUALITATIVE AND QUANTITATIVE PARTICULARS OF THE CONSTITUENTS |
| 1. | Qualitative particulars |
| 3. | Quantitative particulars |
| B. | DESCRIPTION OF MANUFACTURING METHOD |
| C. | PRODUCTION AND CONTROL OF STARTING MATERIALS |
| 1. | Starting materials listed In Pharmacopoeias |
| 2. | Starting materials not listed in a pharmacopoeia |
| 2.1. | Starting materials of biological origin |
| 2.2. | Starting materials of non-biological origin |
| D. | CONTROL TESTS DURING THE MANUFACTURING PROCESS |
| E. | CONTROL TESTS ON THE FINISHED PRODUCT |
| 1. | General characteristics of the finished product |
| 2. | Identification of active substance(s) |
| 3. | Batch titre or potency |
| 4. | Identification and assay of adjuvants |
| 5. | Identification and assay of excipient components |
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