Commission Directive 2000/37/EC of 5 June 2000 amending Chapter VIa 'Pharmacovigilance' of Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products (Text with EEA relevance)

• Published date: 10 June 2000
• Subject Matter: Veterinary legislation,Free movement of goods,Approximation of laws,Technical barriers
• Official Gazette Publication: Official Journal of the European Communities, L 139, 10 June 2000

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Commission Directive 2000/37/EC of 5 June 2000 amending Chapter VIa 'Pharmacovigilance' of Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products (Text with EEA relevance)

Official Journal L 139 , 10/06/2000 P. 0025 - 0027

Commission Directive 2000/37/EC

of 5 June 2000

amending Chapter VIa "Pharmacovigilance" of Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 81/851/EEC of 28 September 1981 on the appriximation of the laws of the Member States relating to veterinary medicinal products(1), as last amended by Directive 93/40/EEC(2), and in particular Article 42i thereof;

Whereas:

(1) In order to ensure the continued safety of veterinary medicinal products in use, it is necessary to ensure that pharmacovigilance systems in the Community are continually adapted to take account of scientific and technical progress.

(2) For public health protection, relevant data on adverse effects in humans related to the use of veterinary medicines should be collected and evaluated.

(3) The pharmacovigilance systems should consider the available data on lack of efficacy.

(4) In addition, collection of information on adverse reactions due to off-label use, investigations of the validity of the withdrawal period and on potential environmental problems may contribute to improve regular monitoring of good usage of veterinary medicines.

(5) It is necessary to take account of changes arising as a result of international harmonisation of definitions, terminology and technological developments in the field of pharmacovigilance.

(6) The increasing use of the mutual recognition procedure established by Directive 81/851/EEC requires that current procedures for reporting and dissemination of suspected adverse reactions be amended to ensure better co-ordination between Member States.

(7) The increasing use of electronic means of communication of information on adverse reactions to veterinary medicinal products marketed in the Community is intended to allow a single reporting point for adverse reactions, at the same time ensuring that this information is shared with the competent authorities in all Member States.

(8) It is necessary to further define terms currently used within the veterinary pharmacovigilance systems.

(9) It is the interest of the Community to ensure that the veterinary pharmacovigilance systems for centrally authorised medicinal products and those authorised by other procedures are consistent.

(10) Holders of marketing authorisations should additionally be proactively responsible for ongoing pharmacovigilance of the veterinary medicinal products they place on the market.

(11) The measures provided for in this Directive are in conformity with the opinion of the Standing Committee on veterinary medicinal products,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Chapter VIa "Pharmacovigilance"...